49. 全身性エリテマトーデス Systemic lupus erythematosus Clinical trials / Disease details
臨床試験数 : 993 / 薬物数 : 702 - (DrugBank : 184) / 標的遺伝子数 : 116 - 標的パスウェイ数 : 200
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05504187 (ClinicalTrials.gov) | October 2023 | 15/8/2022 | Study to Evaluate Safety, Tolerability and Pharmacodynamics of KP104 in Participants With Thrombotic Microangiopathy Secondary to Systemic Lupus Erythematosus | An Open-label, Phase 2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of KP104 in Subjects With Thrombotic Microangiopathy Secondary to Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: KP104 | Kira Pharmacenticals (US), LLC. | NULL | Not yet recruiting | 18 Years | 65 Years | All | 24 | Phase 2 | NULL |
| 2 | NCT05029336 (ClinicalTrials.gov) | September 2023 | 24/8/2021 | Autologous Stem Cell Transplant (ASCT) for Autoimmune Diseases | Autologous Hematopoietic Stem Cell Transplant for Children and Young Adults With Life Threatening Autoimmune Diseases | Systemic Lupus Erythematosus;Systemic Sclerosis | Biological: Depletion of CD3/CD19 in an autologous stem cell transplant | Stephan Grupp MD PhD | NULL | Recruiting | 8 Years | 25 Years | All | 20 | Phase 2 | United States |
| 3 | NCT04893161 (ClinicalTrials.gov) | June 1, 2023 | 16/5/2021 | A Model About the Response of Belimumab in SLE | A Model to Early Predict the Response of Belimumab Treatment in the Patients With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: Belimumab | First Affiliated Hospital Xi'an Jiaotong University | NULL | Not yet recruiting | 18 Years | N/A | All | 72 | Phase 4 | NULL |
| 4 | NCT05688696 (ClinicalTrials.gov) | March 31, 2023 | 10/1/2023 | Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Systemic Lupus Erythematosus | A Phase IIb, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus, SLE | Drug: Orelabrutinib (Low Dose);Drug: Orelabrutinib (High Dose);Drug: Orelabrutinib Placebo | Beijing InnoCare Pharma Tech Co., Ltd. | NULL | Not yet recruiting | 18 Years | 75 Years | All | 186 | Phase 2 | China |
| 5 | NCT05440422 (ClinicalTrials.gov) | March 22, 2023 | 29/6/2022 | The Role of Anifrolumab in Improving Markers of Vascular Risk in Patients With Systemic Lupus Erythematosus (SLE) | The Role of Anifrolumab in Improving Markers of Vascular Risk in Patients With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus;Cardiovascular Disease;Premature Atherosclerosis | Drug: anifrolumab;Other: Placebo | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NULL | Not yet recruiting | 18 Years | 80 Years | All | 45 | Phase 1 | United States |
| 6 | NCT05624749 (ClinicalTrials.gov) | March 7, 2023 | 7/11/2022 | Phase 3 Study to Evaluate Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 2) | A Randomized, Double-blind, Placebo-controlled Multicenter Phase 3 Study to Evaluate Efficacy, Safety and Tolerability of Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 2) | Systemic Lupus Erythematosus | Drug: ianalumab;Drug: placebo | Novartis Pharmaceuticals | NULL | Not yet recruiting | 12 Years | N/A | All | 280 | Phase 3 | NULL |
| 7 | NCT05639114 (ClinicalTrials.gov) | March 1, 2023 | 4/11/2022 | Phase 3 Study to Evaluate Two Regimens of Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 1) | A Randomized, Double-blind, Parallel Group, Placebo-controlled Multicenter Phase 3 Study to Evaluate Efficacy, Safety and Tolerability of Two Regimens of Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 1) | Systemic Lupus Erythematosus | Drug: Ianalumab;Drug: Placebo | Novartis Pharmaceuticals | NULL | Not yet recruiting | 12 Years | N/A | All | 406 | Phase 3 | NULL |
| 8 | NCT05638802 (ClinicalTrials.gov) | March 2023 | 28/11/2022 | A Study of DS-7011a in Patients With Systemic Lupus Erythematosus and Cutaneous Lupus Erythematosus | A Phase 1b/2, Double-Blind, Placebo-Controlled, Randomized, Parallel-Arm Study to Explore the Safety, Pharmacokinetics, and Proof of Biological Activity of DS-7011a in Patients With Systemic Lupus Erythematosus and Active Cutaneous Lupus Erythematosus | Systemic Lupus Erythematosus;Cutaneous Lupus Erythematosus | Drug: DS-7011a;Drug: Placebo | Daiichi Sankyo, Inc. | NULL | Not yet recruiting | 18 Years | N/A | All | 24 | Phase 1/Phase 2 | NULL |
| 9 | NCT05765006 (ClinicalTrials.gov) | February 24, 2023 | 6/2/2023 | CD19-CART(Relma-cel) for Moderate to Severe Active Systemic Lupus Erythematosus | A Phase I Dose-escalation Study Evaluate the Safety Tolerability Pharmacokinetics(PK) and Pharmacodynamics(PD) of Relma-cel in Subjects With Moderate to Severe Active Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Biological: Relma-cel | Shanghai Ming Ju Biotechnology Co., Ltd. | NULL | Recruiting | 18 Years | 70 Years | All | 24 | Phase 1 | China |
| 10 | NCT05559671 (ClinicalTrials.gov) | February 7, 2023 | 26/9/2022 | Safety of the Herpes Zoster Subunit Vaccine in Lupus | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Non-inferiority Crossover Study Evaluating the Safety and Immunogenicity of the Herpes Zoster Subunit Vaccine in Patients With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Biological: Herpes Zoster Subunit (HZ/su) Vaccine;Biological: Placebo | NYU Langone Health | NULL | Not yet recruiting | 18 Years | 90 Years | All | 224 | Phase 4 | United States |
| 11 | EUCTR2022-002691-36-SK (EUCTR) | 07/02/2023 | 24/10/2022 | Phase 3 study to evaluate two regimens of ianalumab on top of standard-of-care therapy in patients with systemic lupus erythematosus (SIRIUS-SLE 1) | A randomized, double-blind, parallel group, placebo-controlled multicenter phase 3 study to evaluate efficacy, safety and tolerability of two regimens of ianalumab on top of standard-of-care therapy in patients with systemic lupus erythematosus (SIRIUS-SLE 1) | Systemic Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ianalumab Product Code: VAY736 INN or Proposed INN: IANALUMAB Other descriptive name: VAY736 | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 406 | Phase 3 | Hungary;United States;Czechia;Japan;Thailand;Portugal;Spain;Canada;Czech Republic;Turkey;China;Brazil;Guatemala;Poland;South Africa;Slovakia;Israel;Bulgaria | ||
| 12 | EUCTR2022-002691-36-CZ (EUCTR) | 27/01/2023 | 23/11/2022 | Phase 3 study to evaluate two regimens of ianalumab on top of standard-of-care therapy in patients with systemic lupus erythematosus (SIRIUS-SLE 1) | A randomized, double-blind, parallel group, placebo-controlled multicenter phase 3 study to evaluate efficacy, safety and tolerability of two regimens of ianalumab on top of standard-of-care therapy in patients with systemic lupus erythematosus (SIRIUS-SLE 1) | Systemic Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ianalumab Product Code: VAY736 INN or Proposed INN: IANALUMAB Other descriptive name: VAY736 | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 406 | Phase 3 | Portugal;United States;Czechia;Slovakia;Thailand;Spain;Guatemala;Turkey;Israel;Hungary;Czech Republic;Canada;Brazil;Poland;South Africa;Bulgaria;China;Japan | ||
| 13 | NCT05672576 (ClinicalTrials.gov) | January 16, 2023 | 3/1/2023 | A Research Study to Evaluate the Efficacy and Safety of Cenerimod in Subjects Suffering From Systemic Lupus Erythematosus | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of Cenerimod in Adult Subjects With Moderate-to-severe Systemic Lupus Erythematosus (SLE) on Top of Background Therapy | Lupus Erythematosus, Systemic | Drug: Cenerimod;Drug: Placebo | Idorsia Pharmaceuticals Ltd. | NULL | Recruiting | 18 Years | 75 Years | All | 420 | Phase 3 | United States |
| 14 | NCT05620407 (ClinicalTrials.gov) | January 12, 2023 | 10/11/2022 | A Study to Evaluate Effectiveness and Safety of Deucravacitinib (BMS-986165) Compared With Placebo in Participants With Active Systemic Lupus Erythematosus | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants With Active Systemic Lupus Erythematosus (SLE) (POETYK SLE-2) | Systemic Lupus Erythematosus | Drug: Deucravacitinib;Other: Placebo | Bristol-Myers Squibb | NULL | Recruiting | 18 Years | 75 Years | All | 490 | Phase 3 | United States;Argentina;Australia;Brazil;Chile;Czechia;Greece;Hungary;Japan;Mexico;Peru;Poland;Portugal;Singapore;Spain;Taiwan;United Kingdom |
| 15 | NCT05617677 (ClinicalTrials.gov) | January 12, 2023 | 8/11/2022 | A Study to Assess Effectiveness and Safety of Deucravacitinib Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE) | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants With Active Systemic Lupus Erythematosus (SLE) (POETYK SLE-1) | Systemic Lupus Erythematosus | Drug: Deucravacitinib;Other: Placebo | Bristol-Myers Squibb | NULL | Recruiting | 18 Years | 75 Years | All | 490 | Phase 3 | United States;Argentina;Brazil;Bulgaria;Canada;China;Colombia;France;Germany;Hong Kong;Ireland;Italy;Korea, Republic of;Lithuania;Mexico;Peru;Poland;Portugal;Romania |
| 16 | EUCTR2021-006378-22-NL (EUCTR) | 11/01/2023 | 05/10/2022 | A Study to Evaluate the Continuous Safety and Efficacy of BIIB059 in Adults with Active Systemic Lupus Erythematosus | A Multicenter, Randomized, Dose-Blind, Phase 3 Long-Term Extension Study to Evaluate Continuous Safety and Efficacy of BIIB059 in Adult Participants with Active Systemic Lupus Erythematosus - EMERALD | Systemic Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Not applicable Product Code: BIIB059 INN or Proposed INN: BIIB059 | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 864 | Phase 3 | Israel;Chile;Colombia;Italy;France;Puerto Rico;Peru;Australia;Netherlands;China;Korea, Republic of;Czechia;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Romania;Bulgaria;Germany;Japan;Sweden;Serbia;United States;Philippines;Taiwan;Greece;Spain;Russian Federation | ||
| 17 | NCT05666336 (ClinicalTrials.gov) | December 31, 2022 | 8/12/2022 | Multi-omics Studies on the Efficacy of Telitacicept in Chinese SLE Patients | Proteomics Combined With Metabolomics Studies on the Efficacy of Telitacicept in Chinese Patients of Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Biological: Telitacicept;Drug: Hydroxychloroquine;Drug: Prednisone;Drug: Methylprednisolone;Drug: Cyclophosphamide;Drug: Mycophenolate Mofetil;Drug: Tacrolimus | Fen Li | NULL | Not yet recruiting | 18 Years | 75 Years | All | 30 | Phase 4 | NULL |
| 18 | EUCTR2022-002691-36-ES (EUCTR) | 22/12/2022 | 01/11/2022 | Phase 3 study to evaluate two regimens of ianalumab on top of standard-of-care therapy in patients with systemic lupus erythematosus (SIRIUS-SLE 1) | A randomized, double-blind, parallel group, placebo-controlled multicenter phase 3 study to evaluate efficacy, safety and tolerability of two regimens of ianalumab on top of standard-of-care therapy in patients with systemic lupus erythematosus (SIRIUS-SLE 1) | Systemic Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ianalumab Product Code: VAY736 INN or Proposed INN: IANALUMAB Other descriptive name: VAY736 | Novartis Farmacéutica, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 406 | Phase 3 | Portugal;United States;Czechia;Slovakia;Spain;Thailand;Guatemala;Turkey;Israel;Hungary;Canada;Brazil;Poland;South Africa;Bulgaria;China;Japan | ||
| 19 | NCT05648500 (ClinicalTrials.gov) | December 13, 2022 | 5/12/2022 | A Research Study to Evaluate the Effects of a New Oral Medicine Called Cenerimod in Adults With Systemic Lupus Erythematosus | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of Cenerimod in Adult Subjects With Moderate-to-Severe Systemic Lupus Erythematosus (SLE) on Top of Background Therapy | Lupus Erythematosus, Systemic | Drug: Cenerimod;Drug: Placebo | Idorsia Pharmaceuticals Ltd. | NULL | Recruiting | 18 Years | 75 Years | All | 420 | Phase 3 | United States |
| 20 | NCT05458622 (ClinicalTrials.gov) | November 29, 2022 | 13/6/2022 | 3TR (Taxonomy, Treatment, Targets and Remission) Systemic Lupus Erithematosus Study Protocol | 3TR (Taxonomy, Treatment, Targets and Remission) Systemic Lupus Erithematosus Study Protocol | Systemic Lupus Erythematosus (SLE) | Biological: Blood sample;Biological: Urine sample;Biological: Saliva sample;Biological: Stood sample;Procedure: Tissue sample | University Hospital, Brest | NULL | Recruiting | 18 Years | N/A | All | 25 | Phase 3 | France |
| 21 | NCT05306873 (ClinicalTrials.gov) | October 28, 2022 | 11/3/2022 | Examining Distinct Immunophenotypes to Validate and Enhance Rational Treatment in Systemic Lupus | A Phase 2, Double-Blind, Placebo-Controlled Trial of Mycophenolate Mofetil Alone or With Voclosporin for Systemic Lupus: Examining Distinct Immunophenotypes to Validate and Enhance Rational Treatment (DIVERT) (ALE10) | Systemic Lupus Erythematosus | Drug: Mycophenolate Mofetil;Drug: Placebo for Mycophenolate Mofetil;Drug: Voclosporin;Drug: Placebo for Voclosporin | National Institute of Allergy and Infectious Diseases (NIAID) | NULL | Recruiting | 18 Years | 60 Years | All | 120 | Phase 2 | United States |
| 22 | NCT05048238 (ClinicalTrials.gov) | September 30, 2022 | 31/8/2021 | Evaluation of Tofacitinib in Prevention of Photosensitivity in Lupus | Evaluation of Tofacitinib in Prevention of Photosensitivity in Lupus (ALE11) | Systemic Lupus Erythematosus;Cutaneous Lupus | Drug: Tofacitinib | National Institute of Allergy and Infectious Diseases (NIAID) | NULL | Recruiting | 18 Years | 65 Years | All | 10 | Phase 1 | United States |
| 23 | NCT05540327 (ClinicalTrials.gov) | September 16, 2022 | 12/9/2022 | The Willow LTE Study With M5049 in Participants With SCLE, DLE and/or SLE (WILLOW LTE) | A Phase II, Double-blind, Dose-Ranging, Parallel, Long-term Extension Study to Evaluate the Safety and Efficacy of Enpatoran in Participants With Subacute Cutaneous Lupus Erythematosus, Discoid Lupus Erythematosus and/or Systemic Lupus Erythematosus Having Completed the WILLOW (MS200569_0003) Study Treatment (WILLOW LTE) | Systemic Lupus Erythematosus | Drug: M5049 low dose;Drug: M5049 medium dose;Drug: M5049 high dose;Drug: Placebo | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | NULL | Recruiting | 18 Years | 76 Years | All | 440 | Phase 2 | United States;Bulgaria;Japan;Moldova, Republic of;Poland;Argentina;Australia;Brazil;Chile;China;Colombia;Greece;Israel;Korea, Republic of;Mauritius;Mexico;Philippines;Serbia;South Africa;Spain;Taiwan |
| 24 | EUCTR2019-003409-83-GR (EUCTR) | 12/09/2022 | 04/07/2022 | A Study to evaluate the safety and tolerability of dapirolizumab pegol in study participants with systemic lupus erythematosus | A Multicenter, Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of Dapirolizumab Pegol Treatment in Study Participants With Systemic Lupus Erythematosus | Systemic lupus erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 760 | Phase 3 | Serbia;Portugal;United States;Philippines;Taiwan;Hong Kong;Greece;Spain;Chile;Colombia;Italy;France;Peru;Australia;Denmark;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Germany;Japan | ||
| 25 | NCT05689580 (ClinicalTrials.gov) | September 1, 2022 | 10/1/2023 | The Influence of Ketogenic Diet on Lupus Nephritis Patients' Immunity | The Influence of Ketogenic Diet on Lupus Nephritis Patients' Immunity | Systemic Lupus Erythematosus;Ketogenic Dieting | Dietary Supplement: Ketogenic diet;Dietary Supplement: Balanced diet | Chang Gung Memorial Hospital | NULL | Recruiting | 20 Years | N/A | All | 30 | N/A | Taiwan |
| 26 | EUCTR2019-003407-35-DE (EUCTR) | 22/08/2022 | 17/02/2022 | A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus - PHOENYCS FLY | Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol Product Code: CDP7657 INN or Proposed INN: dapirolizumab pegol Other descriptive name: DZP | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | Serbia;Portugal;United States;Czechia;Hong Kong;Taiwan;Greece;Spain;Austria;United Kingdom;Italy;France;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;China;Japan | ||
| 27 | JPRN-jRCT2031220187 | 01/08/2022 | 07/07/2022 | Evaluate Efficacy, Safety and Tolerability, PK and PD of Emapalumab in Children and Adults With MAS in Still's or SLE | A Two-cohort, Open-label, Single-arm, Multicenter Study to Evaluate Efficacy, Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of Emapalumab in Children and Adults with Macrophage Activation Syndrome (MAS) in Still's Disease (Including Systemic Juvenile Idiopathic Arthritis and Adult Onset Still's Disease) or with MAS in Systemic Lupus Erythematosus - EMERALD | Macrophage Activation Syndrome, Secondary Hemophagocytic Lymphohistiocytosis, Still Disease, SLE | Emapalumab iv infusion initial dose: 6 mg/kg Subsequent doses: 3 mg/kg | Nakaoku Takahiro | NULL | Recruiting | >= 6month old | <= 80age old | Both | 2 | Phase 2-3 | Belgium;Canada;China;Czechia;France;Germany;Italy;Netherlands;Poland;Spain;Sweden;United Kingdom;United States;Japan |
| 28 | EUCTR2019-003407-35-DK (EUCTR) | 13/07/2022 | 17/06/2022 | A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus - PHOENYCS FLY | Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol Product Code: CDP7657 INN or Proposed INN: dapirolizumab pegol Other descriptive name: DZP | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | Serbia;Portugal;United States;Czechia;Hong Kong;Taiwan;Greece;Spain;Austria;United Kingdom;Italy;France;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;China;Japan | ||
| 29 | NCT05411016 (ClinicalTrials.gov) | July 11, 2022 | 6/6/2022 | A Study of KK4277 in Healthy Volunteers and Patients With Systemic Lupus Erythematosus and Cutaneous Lupus Erythematosus | A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose or Multiple Ascending Dose Study of KK4277 in Healthy Volunteers, Patient With Systemic Lupus Erythematosus, and Patient With Cutaneous Lupus Erythematosus | Healthy Volunteers;Systemic Lupus Erythematosus (SLE);Cutaneous Lupus Erythematosus (CLE) | Drug: Placebo;Drug: KK4277 | Kyowa Kirin Co., Ltd. | NULL | Not yet recruiting | 18 Years | 75 Years | All | 116 | Phase 1 | Japan |
| 30 | NCT05339217 (ClinicalTrials.gov) | July 1, 2022 | 2/4/2022 | Efficacy and Immunological Evaluation of Telitacicept and Low Dose IL2 in the Treatment of Systemic Lupus Erythematosus | Efficacy and Immunological Evaluation of Telitacicept and Low Dose IL2 in the Treatment of Systemic Lupus Erythematosus: a Randomise Prospective Study | Systemic Lupus Erythematosus | Drug: Telitacicept;Drug: Interleukin-2 | Peking University People's Hospital | NULL | Recruiting | 18 Years | 65 Years | All | 60 | Phase 3 | China |
| 31 | NCT05306574 (ClinicalTrials.gov) | June 20, 2022 | 23/3/2022 | A Study of Telitacicept for the Treatment of Moderately to Severely Active Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, 2-Stage Trial to Evaluate Efficacy and Safety of Telitacicept Compared to Placebo in Patients With Moderately to Severely Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: Telitacicept;Drug: Placebo | RemeGen Co., Ltd. | NULL | Recruiting | 12 Years | 70 Years | All | 341 | Phase 3 | United States;Bulgaria;Colombia;Poland;Puerto Rico |
| 32 | NCT05352919 (ClinicalTrials.gov) | June 10, 2022 | 25/4/2022 | A Study to Evaluate the Continuous Safety and Efficacy of BIIB059 (Litifilimab) in Adults With Active Systemic Lupus Erythematosus | A Multicenter, Randomized, Dose-Blind, Phase 3 Long-Term Extension Study to Evaluate Continuous Safety and Efficacy of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) | Drug: BIIB059 (litifilimab);Drug: Placebo | Biogen | NULL | Recruiting | 18 Years | N/A | All | 864 | Phase 3 | United States;Argentina;Australia;Belgium;Brazil;Bulgaria;Canada;Chile;China;Colombia;Czechia;France;Germany;Greece;Hungary;Israel;Italy;Japan;Korea, Republic of;Mexico;Netherlands;Peru;Philippines;Poland;Puerto Rico;Romania;Russian Federation;Serbia;Spain;Sweden;Taiwan;United Kingdom |
| 33 | NCT05433857 (ClinicalTrials.gov) | June 10, 2022 | 17/6/2022 | Probiotics in Systemic Lupus Erythematosus | Evaluation of the Clinical Outcome of Probiotics in Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: Lacteol forte capsules | Ain Shams University | NULL | Recruiting | 18 Years | 65 Years | All | 40 | Phase 2 | Egypt |
| 34 | NCT05430854 (ClinicalTrials.gov) | June 1, 2022 | 20/6/2022 | Study of Daxdilimab (HZN-7734) for the Treatment of Systemic Lupus Erythematosus in an Open-label Extension Study | An Open-Label Extension Study To Evaluate The Long- Term Safety And Tolerability Of Daxdilimab (Hzn-7734) In Subjects With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Biological: Daxdilimab | Horizon Therapeutics Ireland DAC | NULL | Enrolling by invitation | 18 Years | 72 Years | All | 156 | Phase 2 | United States;Argentina;Greece;India;Mexico;Poland;Serbia;Spain;Taiwan |
| 35 | NCT05392790 (ClinicalTrials.gov) | May 23, 2022 | 23/5/2022 | Progressive Resisted Exercise Plus Aerobic Exercise on Osteoporotic Systemic Lupus Erythmatosus | Progressive Resisted Exercise Program Combined With Aerobic Exercise on Osteoporotic Systemic Lupus Erythmatosus Patients, Randomized Controlled Trial | Systemic Lupus Erythematosus | Other: Progressive resisted exercise training;Drug: Calcium and Vit D;Other: Aerobic exercises | Cairo University | NULL | Recruiting | 30 Years | 50 Years | Female | 80 | N/A | Egypt |
| 36 | NCT05247203 (ClinicalTrials.gov) | May 17, 2022 | 26/1/2022 | Telitacicept Study in Chinese Subjects With Systemic Lupus Erythematosus | A Phase I, Multiple-Dose Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Telitacicept in Chinese Subjects With Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Biological: Telitacicept;Drug: standard therapy | RemeGen Co., Ltd. | NULL | Recruiting | 18 Years | 65 Years | All | 75 | Phase 1 | China |
| 37 | EUCTR2020-004529-22-DE (EUCTR) | 21/04/2022 | 23/09/2021 | Subcutaneous Anifrolumab in Adult Patients with Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Subcutaneous Anifrolumab in Adult Patients with Systemic Lupus Erythematosus - Tulip SC | Moderate-to-severe Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Anifrolumab Product Code: MEDI-546 INN or Proposed INN: ANIFROLUMAB Other descriptive name: ANIFROLUMAB | AstraZeneca | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 360 | Phase 3 | United States;Spain;Ukraine;Chile;Russian Federation;Colombia;United Kingdom;Hungary;Mexico;Argentina;Poland;Peru;Bulgaria;Germany;Japan | ||
| 38 | EUCTR2020-005776-35-DE (EUCTR) | 20/04/2022 | 01/10/2021 | A Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care | systemic lupus erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Not applicable Product Code: BIIB059 INN or Proposed INN: Not applicable Other descriptive name: Humanised IgG1 monoclonal antibody against blood dendritic cell antigen 2 | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 540 | Phase 3 | Serbia;United States;Czechia;Israel;Colombia;United Kingdom;Italy;Hungary;Canada;Argentina;Belgium;Romania;Germany;Netherlands;China;Japan | ||
| 39 | NCT05278663 (ClinicalTrials.gov) | April 14, 2022 | 4/3/2022 | A Study to Assess the Safety, Tolerability, and Pharmacokinetics of E6742 in Systemic Lupus Erythematosus Participants | A Randomized, Double-Blind, Placebo-Controlled, Multi-center, Multiple Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of E6742 in Systemic Lupus Erythematosus Patients | Lupus Erythematosus, Systemic | Drug: E6742;Other: Placebo | Eisai Co., Ltd. | NULL | Recruiting | 18 Years | 75 Years | All | 24 | Phase 1/Phase 2 | Japan |
| 40 | NCT05262686 (ClinicalTrials.gov) | April 1, 2022 | 22/2/2022 | Efficacy and Immunological Evaluation of Belimumab Plus Low Dose IL-2 in the Treatment of Systemic Lupus Erythematosus | Efficacy and Immunological Evaluation of Belimumab Plus Low Dose IL-2 in the Treatment of Systemic Lupus Erythematosus: a Randomised Prospective Study | Systemic Lupus Erythematosus | Drug: Belimumab;Drug: Interleukin-2 | Peking University People's Hospital | NULL | Recruiting | 18 Years | 70 Years | All | 10 | Phase 3 | China |
| 41 | EUCTR2020-005775-12-FR (EUCTR) | 01/04/2022 | 26/08/2021 | A Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care | systemic lupus erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Not applicable Product Code: BIIB059 INN or Proposed INN: Not applicable Other descriptive name: Humanised IgG1 monoclonal antibody against blood dendritic cell antigen 2 | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 540 | Phase 3 | United States;Philippines;Taiwan;Greece;Spain;Chile;Russian Federation;France;Mexico;Brazil;Poland;Australia;Peru;Bulgaria;Sweden;Korea, Republic of | ||
| 42 | NCT05162586 (ClinicalTrials.gov) | March 31, 2022 | 8/12/2021 | The WILLOW Study With M5049 in SLE and CLE (SCLE and/or DLE) (WILLOW) | A Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging, Parallel and Adaptive Study to Evaluate the Efficacy and Safety of Enpatoran in SLE and in CLE (SCLE and/or DLE) Participants Receiving Standard of Care (WILLOW) | Systemic Lupus Erythematosus | Drug: Enpatoran low dose;Drug: Enpatoran medium dose;Drug: Enpatoran high dose;Drug: Placebo | EMD Serono Research & Development Institute, Inc. | Merck KGaA, Darmstadt, Germany | Recruiting | 18 Years | 75 Years | All | 440 | Phase 2 | United States;Argentina;Australia;Bulgaria;Chile;China;Colombia;Greece;Japan;Korea, Republic of;Mauritius;Mexico;Moldova, Republic of;Philippines;Poland;South Africa;Spain;Taiwan;Germany |
| 43 | NCT00775476 (ClinicalTrials.gov) | March 31, 2022 | 17/10/2008 | Treatment of Systemic Lupus Erythematosus (SLE) With N-acetylcysteine | Treatment of Systemic Lupus Erythematosus (SLE) With N-acetylcysteine (NAC) (SNAC) | Systemic Lupus Erythematosus | Drug: N-acetylcysteine;Drug: Placebo | State University of New York - Upstate Medical University | NULL | Recruiting | 18 Years | N/A | All | 290 | Phase 2 | United States |
| 44 | EUCTR2021-004648-27-ES (EUCTR) | 21/03/2022 | 19/11/2021 | A Study of Enpatoran in Patients With Systemic Lupus Erythematosus andCutaneous Lupus Erythematosus | A Phase II, Randomized, Double-Blind, Placebo Controlled Dose-Ranging, Parallel and Adaptive Study to Evaluate the Efficacy and Safety of Enpatoran in Systemic Lupus Erythematosus and in Cutaneous Lupus Erythematosus (Subacute Cutaneous Lupus Erythematosus and/or Discoid Lupus Erythematosus) Participants Receiving Standard of Care - WILLOW | Systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE) MedDRA version: 21.1;Level: PT;Classification code 10056509;Term: Cutaneous lupus erythematosus;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 21.1;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.1;Classification code 10057903;Term: Subacute cutaneous lupus erythematosus;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Enpatoran 25mg Product Code: M5049 INN or Proposed INN: Enpatoran | Merck Healthcare KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 440 | Phase 2 | United States;Serbia;Philippines;Greece;Spain;Ukraine;Chile;Russian Federation;Colombia;Hungary;Mexico;Mauritius;Argentina;Poland;Brazil;Australia;Bulgaria;South Africa;China;Japan;Moldova, Republic of | ||
| 45 | NCT05203419 (ClinicalTrials.gov) | March 15, 2022 | 10/1/2022 | Multiple Ascending Dose Study of MHS552 in Adults Participants With Systemic Lupus Erythematosus (SLE) | A Two-part, Randomized, Investigator- and Participant- Blinded, Placebo-controlled, Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MHS552 in Adult Participants With Systemic Lupus Erythematosus (SLE) | Lupus Erythematosus, Systemic | Drug: MHS552;Drug: Placebo | Novartis Pharmaceuticals | NULL | Recruiting | 18 Years | 65 Years | All | 28 | Phase 1 | Germany |
| 46 | EUCTR2019-003407-35-ES (EUCTR) | 09/03/2022 | 17/01/2022 | A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus - PHOENYCS FLY | Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol Product Code: CDP7657 INN or Proposed INN: dapirolizumab pegol Other descriptive name: DZP | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Serbia;Portugal;Czechia;Taiwan;Hong Kong;Greece;Spain;Austria;United Kingdom;Italy;France;Canada;Poland;Belgium;Denmark;Bulgaria;Germany;Japan;China | ||
| 47 | NCT05236491 (ClinicalTrials.gov) | March 9, 2022 | 10/2/2022 | COvid-19 Vaccine Booster in Immunocompromised Rheumatic Diseases | COvid-19 Vaccine Booster in Immunocompromised Rheumatic Diseases | Rheumatoid Arthritis;Autoimmune Rheumatologic Disease;Systemic Lupus Erythematosus;Systemic Vasculitis;Systemic Sclerosis;Scleroderma;Undifferentiated Connective Tissue Diseases;Overlap Connective Tissue Disease;Immunosuppression | Biological: COVID-19 vaccine | Paul R Fortin | Canadian Institutes of Health Research (CIHR) | Recruiting | 18 Years | N/A | All | 287 | Phase 2/Phase 3 | Canada |
| 48 | EUCTR2019-003406-27-DK (EUCTR) | 09/03/2022 | 04/03/2021 | A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus - PHOENYCS GO | Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Serbia;Portugal;Philippines;Taiwan;Greece;Spain;Chile;Colombia;Italy;France;Peru;Australia;Denmark;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany | ||
| 49 | NCT05123586 (ClinicalTrials.gov) | March 7, 2022 | 16/11/2021 | A IMMA Master Protocol: A Study of LY3361237 in Participants With at Least Moderately Active Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Two-Arm, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of LY3361237 as a Treatment for Adults With At Least Moderately Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: LY3361237;Drug: Placebo | Eli Lilly and Company | NULL | Recruiting | 18 Years | 65 Years | All | 90 | Phase 2 | United States;Argentina;Czechia;France;Mexico;Poland;Puerto Rico;Taiwan;Russian Federation;Ukraine |
| 50 | JPRN-jRCT2071210076 | 03/03/2022 | 15/10/2021 | A Multicenter, Randomized, Double-Blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus | The purpose of this study is evaluating the efficacy and safety of SC antifrolumab in adult patients with moderate -to-severe SLE despite receiving standard therapy - Tulip SC | Systemic Lupus Erythematosus | Approximately 360 patients are planned to be randomly assigned in a 1:1 ratio (180 patients per treatment group) to receive either a fixed SC dose of anifrolumab or placebo once weekly (QW). | Hibi Kazushige | NULL | Recruiting | >= 18age old | <= 70age old | Both | 36 | Phase 3 | United States;Argentina;Bulgaria;Chile;Colombia;Hungary;Mexico;Peru;Poland;Russia;Ukraine;United Kingdom;Germany;Spain;Japan |
| 51 | EUCTR2020-004047-86-HU (EUCTR) | 28/02/2022 | 23/12/2021 | A Study of ALPN-101 in Active Lupus | A Randomised, Double-Blind, Placebo-controlled study of ALPN-101 in Systemic Lupus Erythematosus | Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042946;Term: Systemic lupus erythematosus rash;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 21.1;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.1;Level: LLT;Classification code 10042948;Term: Systemic lupus erythematosus syndrome aggravated;Classification code 10042947;Term: Systemic lupus erythematosus synd;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10029142;Term: Nephritis systemic lupus erythematosus;System Organ Class: 100000004857 MedDRA version: 20.1;Classification code 10067657;Term: Systemic lupus erythematosus disease activity index increased;System Organ Class: 10022891 - Investigations MedDRA version: 20.0;Classification code 10067658;Term: Systemic lupus erythematosus disease activity index decreased;System Organ Class: 10022891 - Investigations MedDRA version: 20.1;Classification code 10067659;Term: Systemic lupus erythematosus disease activity index abnormal;System Organ Class: 10022891 - Investigations MedDRA version: 21.0;Classification code 10080670;Term: Systemic lupus erythematosus reactivation;Classification code 10073694;Term: Lupus pleurisy;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 21.1;Classification code 10040968;Term: SLE arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: ALPN-101 INN or Proposed INN: Acazicolcept Other descriptive name: ALPN-101 | Alpine Immune Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 130 | Phase 2 | France;United States;Taiwan;Hungary;Spain;Poland;Russian Federation;Germany;Korea, Republic of | ||
| 52 | EUCTR2021-004648-27-BG (EUCTR) | 24/02/2022 | 12/01/2022 | A Study of Enpatoran in Patients With Systemic Lupus Erythematosus and Cutaneous Lupus Erythematosus | A Phase II, Randomized, Double-Blind, Placebo Controlled Dose-Ranging, Parallel and Adaptive Study to evaluate the Efficacy and Safety of Enpatoran in Systemic Lupus Erythematosus and in Cutaneous Lupus Erythematosus (Subacute Cutaneous Lupus Erythematosus and/or Discoid Lupus Erythematosus) Participants Receiving Standard of Care - WILLOW | Systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE) MedDRA version: 21.1;Level: PT;Classification code 10056509;Term: Cutaneous lupus erythematosus;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 21.1;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.1;Classification code 10057903;Term: Subacute cutaneous lupus erythematosus;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Enpatoran 25mg Product Code: M5049 INN or Proposed INN: Enpatoran | Merck Healthcare KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 440 | Phase 2 | United States;Serbia;Philippines;Greece;Spain;Ukraine;Chile;Russian Federation;Colombia;Hungary;Mexico;Mauritius;Argentina;Poland;Brazil;Australia;South Africa;Bulgaria;China;Japan;Moldova, Republic of | ||
| 53 | JPRN-jRCT2011210069 | 15/02/2022 | 05/02/2022 | A Study Evaluating the Efficacy and Safety of Afimetoran Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE) | A Phase 2, Multicenter, Randomized, Double-blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of Afimetoran in Participants With Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Arm A: Afimetoran 30mg QD Arm B: Afimetoran 10mg QD Arm C: Afimetoran 2.5mg QD Arm D: Placebo QD | Ranganathan Usha | NULL | Recruiting | >= 18age old | <= 70age old | Both | 20 | Phase 2 | Argentina;Australia;Brazil;Chile;Colombia;France;Germany;Ireland;Mexico;Poland;Romania;Spain;Taiwan;USA;United Kingdom;Japan |
| 54 | EUCTR2020-005776-35-RO (EUCTR) | 10/02/2022 | 29/04/2022 | A Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care | systemic lupus erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Not applicable Product Code: BIIB059 INN or Proposed INN: Not applicable Other descriptive name: Humanised IgG1 monoclonal antibody against blood dendritic cell antigen 2 | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 540 | Phase 3 | Serbia;United States;Czechia;Israel;Colombia;Italy;United Kingdom;Hungary;Canada;Argentina;Belgium;Romania;Germany;Netherlands;China;Japan | ||
| 55 | JPRN-jRCT2041210058 | 04/02/2022 | 20/08/2021 | A Study of Nipocalimab in Adult Participants with Active Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Nipocalimab in Adult Participants with Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Group 1_Placebo:Participants will receive placebo intravenously (IV) every two weeks (q2w) through Week 50 along with standard-of-care treatments (that is, immunomodulators, antimalarial drugs and Glucocorticoids [GCs]). Group 2_Nipocalimab Dose 1: Participants will receive nipocalimab dose 1 intravenously (IV) q2w through Week 50 along with standard-of-care treatments (that is, immunomodulators, antimalarial drugs and GCs). Group 3_Nipocalimab Dose 2: Participants will receive nipocalimab dose 2 intravenously (IV) q2w through Week 50 along with standard-of-care treatments (that is, immunomodulators, antimalarial drugs and GCs). | Numaguchi Hirotaka | NULL | Recruiting | >= 18age old | <= 65age old | Both | 225 | Phase 2 | Bulgaria;Colombia;Germany;Spain;Hungary;Poland;Taiwan, Province Of China;Ukraine;United States OfAmerica;South Africa;Japan |
| 56 | EUCTR2021-001406-30-PL (EUCTR) | 02/02/2022 | 12/01/2022 | A study investigating the treatment of Systemic Lupus Erythematosus with LY3361237 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Two Arm, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of LY3361237 to Treat Adults with At Least Moderately Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: LY3361237 INN or Proposed INN: LY3361237 Other descriptive name: LY3361237 | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 2 | United States;Czechia;Mexico;Puerto Rico;Argentina;Poland;Ukraine;Russian Federation | ||
| 57 | NCT05203692 (ClinicalTrials.gov) | February 2, 2022 | 20/1/2022 | A Study of a Single Ascending Dose Study of DS-7011a in Healthy Subjects | A Phase 1, Subjects- and Investigator-Blinded, Sponsor-Unblinded, Placebo-Controlled, Randomized, Sequential Cohort Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of Single Ascending Intravenous and Subcutaneous Doses of DS-7011a in Healthy Subjects | Systemic Lupus Erythematosus | Drug: DS-7011a;Drug: Placebo | Daiichi Sankyo, Inc. | NULL | Active, not recruiting | 18 Years | 45 Years | All | 80 | Phase 1 | United States |
| 58 | EUCTR2019-003409-83-DE (EUCTR) | 17/01/2022 | 26/07/2021 | A Study to evaluate the safety and tolerability of dapirolizumab pegol in study participants with systemic lupus erythematosus | A Multicenter, Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of Dapirolizumab Pegol Treatment in Study Participants With Systemic Lupus Erythematosus | Systemic lupus erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 760 | Phase 3 | Serbia;Portugal;United States;Philippines;Taiwan;Hong Kong;Greece;Spain;Chile;Colombia;Italy;France;Peru;Australia;Denmark;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Germany;Japan | ||
| 59 | NCT05155345 (ClinicalTrials.gov) | January 11, 2022 | 10/12/2021 | A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered Mosunetuzumab to Participants With Systemic Lupus Erythematosus | A Phase Ib, Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered Mosunetuzumab to Participants With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: Mosunetuzumab;Drug: Tocilizumab | Hoffmann-La Roche | NULL | Recruiting | 18 Years | 75 Years | All | 50 | Phase 1 | United States;Georgia;Moldova, Republic of;Poland;Ukraine |
| 60 | NCT05140824 (ClinicalTrials.gov) | December 30, 2021 | 4/11/2021 | A Study to Evaluate the Safety, Tolerability, and PK Profile of Single and Multiple Doses TJ202 in Patient With Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-blind, Placebo-Controlled, Phase 1 Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of Single and Multiple Doses of TJ202 in Patients With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) | Drug: Placebo;Biological: TJ202 injection | I-Mab Biopharma Co. Ltd. | NULL | Terminated | 18 Years | 65 Years | All | 1 | Phase 1 | China |
| 61 | EUCTR2020-005776-35-NL (EUCTR) | 24/12/2021 | 13/09/2021 | A Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care | systemic lupus erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Not applicable Product Code: BIIB059 INN or Proposed INN: Not applicable Other descriptive name: Humanised IgG1 monoclonal antibody against blood dendritic cell antigen 2 | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 540 | Phase 3 | Serbia;United States;Czechia;Israel;Colombia;United Kingdom;Italy;Hungary;Canada;Argentina;Belgium;Romania;Netherlands;Germany;China;Japan | ||
| 62 | EUCTR2019-004021-25-IE (EUCTR) | 17/12/2021 | 08/10/2021 | A Study Evaluating the Efficacy and Safety of Afimetoran Compared With Placebo in Participants With ActiveSystemic Lupus Erythematosus (SLE) | A Phase 2, Multicenter, Randomized, Double-blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of Afimetoran in Participants with Active Systemic Lupus Erythematosus. | Active Systemic Lupus Erythematosus. MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Afimetoran (2.5mg) Product Code: BMS-986256 INN or Proposed INN: Afimetoran Other descriptive name: BMS-986256-06, TLR7/8 Antagonist Product Name: Afimetoran (10mg) Product Code: BMS-986256 INN or Proposed INN: Afimetoran Other descriptive name: BMS-986256-06, TLR7/8 Antagonist | Bristol-Myers Squibb International Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 2 | United States;Taiwan;Spain;Ireland;Chile;Colombia;United Kingdom;France;Mexico;Argentina;Brazil;Poland;Romania;Australia;Germany;Japan | ||
| 63 | NCT05001737 (ClinicalTrials.gov) | December 15, 2021 | 16/6/2021 | Evaluate Efficacy, Safety and Tolerability, PK and PD of Emapalumab in Children and Adults With MAS in Still's or SLE | A Two-cohort, Open-label, Single Arm, Multicenter Study to Evaluate Efficacy, Safety and Tolerability, PK and PD, of Emapalumab in Children and Adults With MAS in Still's Disease or With MAS in Systemic Lupus Erythematous | Macrophage Activation Syndrome;Secondary Hemophagocytic Lymphohistiocytosis;Still Disease;Systemic Lupus Erythematosus;SJIA;AOSD;MAS | Drug: Emapalumab | Swedish Orphan Biovitrum | NULL | Recruiting | 6 Months | 80 Years | All | 41 | Phase 3 | United States;Belgium;Canada;China;Czechia;France;Germany;Italy;Japan;Netherlands;Poland;Spain;Sweden;United Kingdom |
| 64 | EUCTR2019-004021-25-ES (EUCTR) | 14/12/2021 | 25/08/2021 | A Phase 2, Multicenter, Randomized, Double-blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of BMS-986256 in Participants with Active Systemic Lupus Erythematosus. | A Phase 2, Multicenter, Randomized, Double-blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of BMS-986256 in Participants with Active Systemic Lupus Erythematosus. | Active Systemic Lupus Erythematosus. MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: TLR7/8 Antagonist (2.5mg) Product Code: BMS-986256 INN or Proposed INN: Not available Other descriptive name: BMS-986256-06, TLR7/8 Antagonist Product Name: TLR7/8 Antagonist (10mg) Product Code: BMS-986256 INN or Proposed INN: Not available Other descriptive name: BMS-986256-06, TLR7/8 Antagonist | Bristol-Myers Squibb International Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 2 | United States;Taiwan;Spain;Ireland;Chile;Colombia;United Kingdom;France;Mexico;Argentina;Brazil;Poland;Romania;Australia;Germany;Japan | ||
| 65 | NCT04702256 (ClinicalTrials.gov) | December 9, 2021 | 30/11/2020 | Induction Therapy for Lupus Nephritis With no Added Oral Steroids: A Trial Comparing Oral Corticosteroids Plus Mycophenolate Mofetil (MMF) Versus Obinutuzumab and MMF | Induction Therapy for Lupus Nephritis With no Added Oral Steroids: An Open Label Randomised Multicentre Controlled Trial Comparing Oral Corticosteroids Plus Mycophenolate Mofetil (MMF) Versus Obinutuzumab and MMF | Lupus Nephritis;Systemic Lupus Erythematosus (SLE) | Drug: Obinutuzumab administration;Drug: Administration of Methylprednisolone + Prednisone + Mycophenolate mofetil;Drug: Administration of methylprednisolone, paracetamol and dexchlorpheniramine | Assistance Publique - Hôpitaux de Paris | Roche Pharma AG | Recruiting | 14 Years | N/A | All | 196 | Phase 3 | France |
| 66 | ChiCTR2100052342 | 2021-12-01 | 2021-10-24 | A clinical study on drug reduction and withdrawal initiated by investigators in the treatment of SLE patients with belyumumab for injection | A clinical study on drug reduction and withdrawal initiated by investigators in the treatment of SLE patients with belyumumab for injection | systemic lupus erythematosus | standard treatment group:standard treatment ;Belimumab + standard therapy group 1:Belimumab(5mg/kg.m)+ standard therapy;Belimumab + standard therapy group 2:Belimumab(10mg/kg.m)+standard therapy;Belimumab + standard of care group 3:Belimumab(10mg/kg.2m)+standard of care group; | Affiliated Hospital of Guilin Medical College | NULL | Recruiting | 16 | 65 | Both | standard treatment group:25;Belimumab + standard therapy group 1:25;Belimumab + standard therapy group 2:25;Belimumab + standard of care group 3:25; | Phase 4 | China |
| 67 | EUCTR2020-005569-14-BG (EUCTR) | 12/11/2021 | 29/09/2021 | A Clinical Study of Nipocalimab in Adult Participants with Active Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Nipocalimab in Adult Participants with Active Systemic Lupus Erythematosus | Active Systemic Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nipocalimab Product Code: JNJ-80202135 INN or Proposed INN: Nipocalimab Other descriptive name: M281 | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 225 | Phase 2 | United States;Hong Kong;Taiwan;Spain;Ukraine;Russian Federation;Colombia;Hungary;Argentina;Poland;Bulgaria;South Africa;Germany;Japan | ||
| 68 | EUCTR2020-005776-35-HU (EUCTR) | 10/11/2021 | 08/10/2021 | A Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care | systemic lupus erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Not applicable Product Code: BIIB059 INN or Proposed INN: Not applicable Other descriptive name: Humanised IgG1 monoclonal antibody against blood dendritic cell antigen 2 | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 540 | Phase 3 | Serbia;United States;Czechia;Israel;Colombia;United Kingdom;Italy;Hungary;Canada;Argentina;Belgium;Romania;Germany;Netherlands;China;Japan | ||
| 69 | NCT05039840 (ClinicalTrials.gov) | November 10, 2021 | 1/9/2021 | Efficacy and Safety of SAR441344 in the Treatment of Systemic Lupus Erythematosus | Efficacy and Safety of SAR441344 in the Treatment of Systemic Lupus Erythematosus: A Randomized, Double Blind, Placebo-controlled, Phase 2, Proof of Concept Study | Systemic Lupus Erythematosus | Drug: SAR441344 IV;Drug: SAR441344 SC;Drug: Placebo IV;Drug: Placebo SC | Sanofi | NULL | Recruiting | 18 Years | 70 Years | All | 116 | Phase 2 | United States;Argentina;Brazil;Chile;Greece;Italy;Mauritius;Mexico;Russian Federation;Spain;Turkey;Ukraine |
| 70 | NCT05328557 (ClinicalTrials.gov) | November 7, 2021 | 30/3/2022 | A Phase Ia Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered CUG252 in Normal Healthy Volunteers | Phase Ia, Randomized Double-Blinded, Placebo-Controlled Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered CUG252 Following a Single Dose Administration in Normal Health Volunteers. | Systemic Lupus Erythematosus | Drug: CUG252;Drug: Placebo | Cugene Inc. | NULL | Active, not recruiting | 18 Years | 65 Years | All | 32 | Phase 1 | United States |
| 71 | JPRN-jRCT2011210019 | 06/11/2021 | 30/06/2021 | Phase 2 double blind study of cenerimod | A randomized, double-blind, parallel-group, multicenter, phase 2 study to investigate the safety and PD of cenerimod in Japanese subjects with moderate to severe systemic lupus erythematosus (SLE) | Systemic lupus erythematosus | Administration of two doses of cenerimod (2 and 4 mg) given orally once daily for 3 months in adult subjects with moderate to severe SLE concurrently receiving SLE background treatment | Yokoyama Yoshinari | NULL | Not Recruiting | >= 18age old | <= 75age old | Both | 16 | Phase 2 | Japan |
| 72 | NCT05261529 (ClinicalTrials.gov) | November 3, 2021 | 8/2/2022 | Effects of an Intervention With EVOO and Physical Activity in Patients With Systemic Lupus Erythematosus | Effects of a Nutricional Intervention With EVOO Oil and Physical Activity in Patients With Systemic Lupus Erythematosus: Effect on Clinical Course, Epigenetic and Microbiome | Lupus Erythematosus, Systemic | Dietary Supplement: Extra Virgin Olive Oil (EVOO);Behavioral: Physical Exercise Program | Universidad de Granada | Consejería de Economía, Innovación y Ciencia. Proyectos de I+D+I en el marco operativo Feder Andalucía 2014-2020 | Recruiting | 18 Years | 70 Years | Female | 90 | N/A | Spain |
| 73 | EUCTR2020-005776-35-IT (EUCTR) | 02/11/2021 | 27/01/2022 | A Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care - . | systemic lupus erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Not applicable Product Code: [BIIB059] INN or Proposed INN: HA 1A ANTICORPO MONOCLONALE UMANO CLASSE IGM | BIOGEN IDEC RESEARCH LIMITED | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 540 | Phase 3 | United States;Czechia;Israel;Colombia;United Kingdom;Italy;Hungary;Canada;Argentina;Belgium;Romania;Germany;Netherlands;China;Japan | ||
| 74 | EUCTR2020-005775-12-GR (EUCTR) | 02/11/2021 | 13/09/2021 | A Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care | systemic lupus erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Not applicable Product Code: BIIB059 INN or Proposed INN: Not applicable Other descriptive name: Humanised IgG1 monoclonal antibody against blood dendritic cell antigen 2 | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 540 | Phase 3 | United States;Philippines;Taiwan;Greece;Spain;Chile;Russian Federation;France;Mexico;Poland;Brazil;Australia;Peru;Bulgaria;Sweden;Korea, Republic of | ||
| 75 | NCT05019950 (ClinicalTrials.gov) | October 28, 2021 | 16/8/2021 | Safety Tolerability and Pharmacokinetics of Oral LABP-104 in Healthy Adult Male and Female Volunteers | A Randomized, Placebo-Controlled, Double-Blind, Single-Center Study to Evaluate Safety Tolerability and Pharmacokinetics of Oral LABP-104 in Healthy Adult Male and Female Volunteers | Systemic Lupus Erythematosus | Drug: LABP-104 250mg;Drug: Placebo | Landos Biopharma Inc. | NULL | Completed | 18 Years | 64 Years | All | 56 | Phase 1 | Australia |
| 76 | EUCTR2021-001802-30-DE (EUCTR) | 28/10/2021 | 02/09/2021 | Efficacy of the drug Benlysta (active ingredient: belimumab) to improve cardiac abnormalities in patients with systemic lupus erythematosus (BeCarma) | Efficacy of belimumab to improve subclinical cardiovascular abnormalitiesusing imaging endpoints with cardiac magnetic resonance in patients withsystemic lupus erythematosus (BeCarma) - BeCarma | Efficacy of belimumab to improve subclinical cardiovascular abnormalities using imaging endpoints with cardiac magnetic resonance in patients with systemic lupus erythematosus;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Benlysta® | Fraunhofer Institut für Translationale Medizin und Pharmakologie (ITMP) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 56 | Phase 4 | Germany | ||
| 77 | EUCTR2019-004021-25-PL (EUCTR) | 27/10/2021 | 24/09/2021 | A Study Evaluating the Efficacy and Safety of Afimetoran Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE) | A Phase 2, Multicenter, Randomized, Double-blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of Afimetoran in Participants with Active Systemic Lupus Erythematosus. | Active Systemic Lupus Erythematosus. MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Afimetoran (2.5mg) Product Code: BMS-986256 INN or Proposed INN: Afimetoran Other descriptive name: BMS-986256-06, TLR7/8 Antagonist Product Name: Afimetoran (10mg) Product Code: BMS-986256 INN or Proposed INN: Afimetoran Other descriptive name: BMS-986256-06, TLR7/8 Antagonist | Bristol-Myers Squibb International Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 2 | United States;Taiwan;Spain;Ireland;Chile;Colombia;United Kingdom;France;Mexico;Argentina;Poland;Brazil;Romania;Australia;Germany;Japan | ||
| 78 | NCT04963296 (ClinicalTrials.gov) | October 26, 2021 | 7/7/2021 | A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With Systemic Lupus Erythematosus | A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate The Efficacy And Safety of Obinutuzumab in Patients With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: Obinutuzumab;Drug: Placebo;Drug: Acetaminophen/Paracetamol;Drug: Diphenhydramine hydrochloride;Drug: Methylprednisolone | Hoffmann-La Roche | NULL | Recruiting | 18 Years | 75 Years | All | 200 | Phase 3 | United States;Argentina;Brazil;France;Italy;Mexico;New Zealand;Peru;Poland;Russian Federation;South Africa;Spain;United Kingdom |
| 79 | EUCTR2020-005760-57-PL (EUCTR) | 25/10/2021 | 21/09/2021 | A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Patients with Systemic Lupus Erythematosus | A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OBINUTUZUMAB IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Gazyvaro INN or Proposed INN: OBINUTUZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 3 | United States;Spain;Russian Federation;Italy;United Kingdom;France;Mexico;Argentina;Poland;Brazil;Australia;Peru;South Africa;New Zealand | ||
| 80 | EUCTR2021-001567-25-IT (EUCTR) | 22/10/2021 | 12/10/2021 | Efficacy and safety of SAR441344 in the treatment of Systemic Lupus Erythematosus | Efficacy and safety of SAR441344 in the treatment of Systemic Lupus Erythematosus: A randomized, double blind, placebo-controlled, Phase 2, proof of concept study - APATURA | Systemic lupus erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: SAR441344 Product Code: [SAR441344] INN or Proposed INN: NON APPLICABILE Other descriptive name: SAR441344 | SANOFI-AVENTIS RECHERCHE E DEVELOPPEMENT | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 166 | Phase 2 | United States;Mexico;Greece;Argentina;Spain;Ukraine;Turkey;Russian Federation;Chile;Germany;Italy | ||
| 81 | EUCTR2020-003509-72-FR (EUCTR) | 21/10/2021 | 10/03/2021 | Efficacy and Safety of Efavaleukin Alfa in Subjects with Active Systemic LupusErythematosus | A Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Efavaleukin Alfa in Subjects with Active Systemic Lupus Erythematosus With Inadequate Response to Standard of Care Therapy | Active Systemic Lupus Erythematosus MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Efavaleukin Alfa Product Code: AMG 592 INN or Proposed INN: EFAVALEUKIN ALFA Other descriptive name: RECOMBINANT FACTOR FC FUSION PROTEIN | Amgen Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 2 | United States;Hong Kong;Taiwan;Greece;Spain;Turkey;Austria;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Mexico;Canada;Poland;Bulgaria;Japan | ||
| 82 | NCT04908865 (ClinicalTrials.gov) | October 21, 2021 | 26/5/2021 | Open-label Study of Belimumab Plus Standard Therapy in Chinese Pediatric Participants With Active Systemic Lupus Erythematosus (SLE) | A Multi-Center, Open-Label Study to Evaluate Safety, Efficacy and Pharmacokinetics of Belimumab Plus Standard Therapy in Chinese Paediatric Patients With Active Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Drug: Belimumab;Drug: Standard therapy | GlaxoSmithKline | NULL | Recruiting | 5 Years | 17 Years | All | 65 | Phase 4 | China |
| 83 | EUCTR2019-003409-83-HU (EUCTR) | 15/10/2021 | 01/09/2021 | A Study to evaluate the safety and tolerability of dapirolizumab pegol in study participants with systemic lupus erythematosus | A Multicenter, Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of Dapirolizumab Pegol Treatment in Study Participants With Systemic Lupus Erythematosus | Systemic lupus erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 760 | Phase 3 | Portugal;Serbia;United States;Philippines;Hong Kong;Taiwan;Greece;Spain;Chile;Colombia;Italy;France;Peru;Australia;Denmark;Korea, Republic of;Czechia;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Japan | ||
| 84 | JPRN-jRCTs021210042 | 14/10/2021 | 14/10/2021 | Randomized , double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of belimumab for early systemic lupus erythematosus | Randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of belimumab for early systemic lupus erythematosus - BEFORE-S | Systemic Lupus Erythematosus : SLE Systemic Lupus Erythematosus, SLE;D008180 | Group A to which the test drug is administered and Group B to which the placebo is administered will be set. Group A: In addition to the usual treatment, belimumab (GlaxoSmithKline Co., Ltd., trade name Benlysta) will be administered subcutaneously once a week at 200 mg. Administration will be continued for 24 weeks. Group B: Placebo will be administered and standard of care will be performed. Both groups will receive a combination of hydroxychloroquine unless there is a reason not to use hydroxychloroquine as usual treatment. If the attending physician determines that it is not appropriate to administer the study drug, the attending physician will not administer the study drug during the week and will record the reason | Ishii Tomonori | NULL | Recruiting | >= 20age old | < 80age old | Both | 30 | N/A | Japan |
| 85 | EUCTR2019-004021-25-FR (EUCTR) | 13/10/2021 | 13/08/2021 | A Study Evaluating the Efficacy and Safety of BMS-986256 Compared With Placebo in Participants With ActiveSystemic Lupus Erythematosus (SLE) | A Phase 2, Multicenter, Randomized, Double-blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of BMS-986256 in Participants with Active Systemic Lupus Erythematosus. | Active Systemic Lupus Erythematosus. MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: TLR7/8 Antagonist (2.5mg) Product Code: BMS-986256 INN or Proposed INN: Not available Other descriptive name: BMS-986256-06, TLR7/8 Antagonist Product Name: TLR7/8 Antagonist (10mg) Product Code: BMS-986256 INN or Proposed INN: Not available Other descriptive name: BMS-986256-06, TLR7/8 Antagonist | Bristol-Myers Squibb International Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 2 | United States;Taiwan;Spain;Ireland;Chile;Colombia;United Kingdom;France;Mexico;Argentina;Brazil;Poland;Romania;Australia;Germany;Japan | ||
| 86 | NCT04895696 (ClinicalTrials.gov) | October 11, 2021 | 19/5/2021 | A Study Evaluating the Efficacy and Safety of Afimetoran Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE) | A Phase 2, Multicenter, Randomized, Double-blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of Afimetoran in Participants With Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: Afimetoran;Other: Placebo | Bristol-Myers Squibb | NULL | Recruiting | 18 Years | 70 Years | All | 344 | Phase 2 | United States;Argentina;Australia;Brazil;Chile;China;Colombia;France;Germany;Ireland;Japan;Mexico;Poland;Puerto Rico;Romania;Spain;Taiwan;United Kingdom |
| 87 | EUCTR2021-001567-25-DE (EUCTR) | 11/10/2021 | 29/07/2021 | Efficacy and safety of SAR441344 in the treatment of Systemic Lupus Erythematosus | Efficacy and safety of SAR441344 in the treatment of Systemic Lupus Erythematosus: A randomized, double blind, placebo-controlled, Phase 2, proof of concept study - APATURA | Systemic lupus erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: SAR441344 Product Code: SAR441344 INN or Proposed INN: Not Applicable Other descriptive name: SAR441344 | Sanofi-Aventis Recherche et Développement | NULL | Not Recruiting | Female: yes Male: yes | 166 | Phase 2 | United States;Mexico;Greece;Argentina;Spain;Ukraine;Turkey;Russian Federation;Chile;Germany;Italy | ||
| 88 | EUCTR2020-005775-12-ES (EUCTR) | 05/10/2021 | 08/07/2021 | A Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care | systemic lupus erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Not applicable Product Code: BIIB059 INN or Proposed INN: Not applicable Other descriptive name: Humanised IgG1 monoclonal antibody against blood dendritic cell antigen 2 | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 540 | Phase 3 | United States;Philippines;Taiwan;Greece;Spain;Chile;Russian Federation;France;Mexico;Poland;Brazil;Australia;Peru;Bulgaria;Sweden;Korea, Republic of | ||
| 89 | NCT05326841 (ClinicalTrials.gov) | October 3, 2021 | 23/3/2022 | Effect of Cholecalciferol Supplementation on Disease Activity and Quality of Life of Systemic Lupus Erythematosus Patients . | Effect of Cholecalciferol Supplementation on Disease Activity and Quality of Life of Systemic Lupus Erythematosus Patients | Lupus Erythematosus, Systemic;Cholecalciferol Supplementation;Disease Activity;Quality of Life | Drug: Vitamin D3 | Dr Cipto Mangunkusumo General Hospital | NULL | Completed | 18 Years | 60 Years | Female | 60 | Phase 3 | Indonesia |
| 90 | NCT04486118 (ClinicalTrials.gov) | October 1, 2021 | 28/10/2019 | Centrally Acting ACE Inhibition in SLE | A Novel Phase 2 Double-blind, Randomized, Controlled Clinical Trial to Evaluate the Efficacy of Centrally Acting, Non-toxic ACE Inhibition in Cognitive Impairment Associated With SLE | Systemic Lupus Erythematosus | Drug: Lisinopril Pills;Drug: Benazepril Pill | Northwell Health | Lupus Research Alliance | Recruiting | 18 Years | 55 Years | All | 36 | Phase 2 | United States |
| 91 | EUCTR2021-001567-25-ES (EUCTR) | 22/09/2021 | 27/07/2021 | Efficacy and safety of SAR441344 in the treatment of Systemic Lupus Erythematosus | Efficacy and safety of SAR441344 in the treatment of Systemic Lupus Erythematosus: A randomized, double blind, placebo-controlled, Phase 2, proof of concept study - APATURA | Systemic lupus erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: SAR441344 Product Code: SAR441344 INN or Proposed INN: Not Applicable Other descriptive name: SAR441344 | Sanofi-Aventis Recherche et Développement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 166 | Phase 2 | United States;Mexico;Greece;Argentina;Spain;Ukraine;Turkey;Russian Federation;Chile;Germany;Italy | ||
| 92 | EUCTR2019-003409-83-BG (EUCTR) | 21/09/2021 | 29/06/2021 | A Study to evaluate the safety and tolerability of dapirolizumab pegol in study participants with systemic lupus erythematosus | A Multicenter, Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of Dapirolizumab Pegol Treatment in Study Participants With Systemic Lupus Erythematosus | Systemic lupus erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 760 | Phase 3 | Serbia;United States;Portugal;Philippines;Taiwan;Hong Kong;Greece;Spain;Chile;Colombia;Italy;France;Peru;Australia;Denmark;Korea, Republic of;Czechia;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Japan | ||
| 93 | NCT05057481 (ClinicalTrials.gov) | September 15, 2021 | 16/9/2021 | Reappraisal of the Therapies of Refractory Autoimmune Hemolytic Anemia in Systemic Lupus Erythematosus | Reappraisal of Second-line Therapies of Refractory Autoimmune Hemolytic Anemia in Systemic Lupus Erythematosus | Autoimmune Hemolytic Anemia;Systemic Lupus Erythematosus | Drug: Mycophenolate Mofetil 500mg;Drug: Rituximab | Assiut University | NULL | Active, not recruiting | 18 Years | N/A | All | 30 | Phase 3 | Egypt |
| 94 | NCT04931563 (ClinicalTrials.gov) | September 13, 2021 | 29/4/2021 | Anifrolumab Asian PhIII Efficacy Study for Systemic Lupus Erythematosus (SLE) | A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase III Study Evaluating the Efficacy and Safety of Anifrolumab in Asian Participants With Active Systemic Lupus Erythematosus | Active Systemic Lupus Erythematosus | Biological: Anifrolumab;Drug: placebo | AstraZeneca | NULL | Recruiting | 18 Years | 70 Years | All | 328 | Phase 3 | China;Hong Kong;Korea, Republic of;Philippines;Taiwan;Thailand |
| 95 | NCT05030779 (ClinicalTrials.gov) | September 10, 2021 | 18/8/2021 | A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Systemic Lupus Erythematosus | Clinical Trial for the Safety and Efficacy of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Systemic Lupus Erythematosus | Systemic Lupus Erythematosus;Autoimmune Diseases | Biological: Assigned Interventions CD19/BCMA CAR T-cells | Zhejiang University | Yake Biotechnology Ltd. | Recruiting | N/A | N/A | All | 9 | Early Phase 1 | China |
| 96 | EUCTR2020-004529-22-BG (EUCTR) | 10/09/2021 | 23/07/2021 | Subcutaneous Anifrolumab in Adult Patients with Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Subcutaneous Anifrolumab in Adult Patients with Systemic Lupus Erythematosus - Tulip SC | Moderate-to-severe Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Anifrolumab Product Code: MEDI-546 INN or Proposed INN: ANIFROLUMAB Other descriptive name: ANIFROLUMAB | AstraZeneca | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 360 | Phase 3 | United States;Spain;Ukraine;Chile;Russian Federation;Colombia;United Kingdom;Hungary;Mexico;Argentina;Poland;Peru;Bulgaria;Germany;Japan | ||
| 97 | EUCTR2020-005760-57-IT (EUCTR) | 09/09/2021 | 12/10/2021 | A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Patients with Systemic Lupus Erythematosus | A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OBINUTUZUMAB IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS - ALLEGORY | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Gazyvaro Product Name: Gazyvaro Product Code: [na] INN or Proposed INN: OBINUTUZUMAB | F. HOFFMANN - LA ROCHE LTD. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 3 | United States;Spain;Russian Federation;Italy;United Kingdom;France;Mexico;Argentina;Brazil;Poland;Australia;Peru;South Africa;New Zealand | ||
| 98 | NCT04736953 (ClinicalTrials.gov) | September 1, 2021 | 4/12/2020 | Sirolimus Treatment Of Patients With SLE | Sirolimus Treatment of Patients With Systemic Lupus Erythematosus | Lupus Erythematosus, Systemic | Drug: Sirolimus;Other: Placebo | State University of New York - Upstate Medical University | NULL | Not yet recruiting | 18 Years | N/A | All | 220 | Phase 2 | NULL |
| 99 | ChiCTR2100050041 | 2021-09-01 | 2021-08-16 | A national multicentre retrospective study of beliuzumab in the treatment of Chinese children with systemic lupus erythematosus | A national multicentre retrospective study of beliuzumab in the treatment of Chinese children with systemic lupus erythematosus | systemic Lupus Erythematosus in children | belimumab group :treated with belimumab;Dmards group:treated with Dmards ; | Guangzhou Women's and Children's Medical Center | NULL | Recruiting | 5 | 18 | Both | belimumab group :137;Dmards group:50; | China | |
| 100 | EUCTR2020-003509-72-BG (EUCTR) | 31/08/2021 | 01/06/2021 | Efficacy and Safety of Efavaleukin Alfa in Subjects with Active Systemic LupusErythematosus | A Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Efavaleukin Alfa in Subjects with Active Systemic Lupus Erythematosus With Inadequate Response to Standard of Care Therapy | Active Systemic Lupus Erythematosus;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Efavaleukin Alfa Product Code: AMG 592 INN or Proposed INN: EFAVALEUKIN ALFA Other descriptive name: RECOMBINANT FACTOR FC FUSION PROTEIN | Amgen Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 2 | United States;Hong Kong;Taiwan;Greece;Spain;Turkey;Austria;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Mexico;Canada;Poland;Bulgaria;Japan | ||
| 101 | EUCTR2020-004529-22-HU (EUCTR) | 24/08/2021 | 18/06/2021 | Subcutaneous Anifrolumab in Adult Patients with Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Subcutaneous Anifrolumab in Adult Patients with Systemic Lupus Erythematosus - Tulip SC | Moderate-to-severe Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Anifrolumab Product Code: MEDI-546 INN or Proposed INN: ANIFROLUMAB Other descriptive name: ANIFROLUMAB | AstraZeneca | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 360 | Phase 3 | United States;Spain;Ukraine;Chile;Russian Federation;Colombia;United Kingdom;Hungary;Mexico;Argentina;Poland;Peru;Bulgaria;Germany;Japan | ||
| 102 | EUCTR2020-005569-14-HU (EUCTR) | 24/08/2021 | 09/07/2021 | A Clinical Study of Nipocalimab in Adult Participants with Active Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Nipocalimab in Adult Participants with Active Systemic Lupus Erythematosus | Active Systemic Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nipocalimab Product Code: JNJ-80202135 INN or Proposed INN: Nipocalimab Other descriptive name: M281 | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 225 | Phase 2 | United States;Hong Kong;Taiwan;Spain;Ukraine;Russian Federation;Colombia;Hungary;Argentina;Poland;South Africa;Bulgaria;Germany;Japan | ||
| 103 | NCT04882878 (ClinicalTrials.gov) | August 20, 2021 | 7/5/2021 | A Study of Nipocalimab in Adult Participants With Active Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Nipocalimab in Adult Participants With Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Other: Placebo;Drug: Nipocalimab;Drug: Standard-of-care treatment | Janssen Research & Development, LLC | NULL | Recruiting | 18 Years | 65 Years | All | 225 | Phase 2 | United States;Argentina;Bulgaria;Colombia;Germany;Hungary;Japan;Poland;South Africa;Spain;Taiwan;Ukraine;Hong Kong;Russian Federation |
| 104 | EUCTR2020-005528-12-ES (EUCTR) | 17/08/2021 | 18/08/2021 | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of VIB7734 for the Treatment of Moderate to Severely Active Systemic Lupus Erythematosus | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of VIB7734 for the Treatment of Moderate to Severely Active Systemic Lupus Erythematosus - RECAST SLE | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: VIB7734 Product Code: VIB7734 INN or Proposed INN: VIB7734 Other descriptive name: VIB7734, MEDI7734 | Viela Bio, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 195 | Phase 2 | United States;Serbia;Taiwan;Mexico;Greece;Argentina;Poland;Spain;Ukraine;Russian Federation;India | ||
| 105 | EUCTR2020-005569-14-ES (EUCTR) | 13/08/2021 | 13/08/2021 | A Clinical Study of Nipocalimab in Adult Participants with Active Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Nipocalimab in Adult Participants with Active Systemic Lupus Erythematosus | Active Systemic Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nipocalimab Product Code: JNJ-80202135 INN or Proposed INN: Nipocalimab Other descriptive name: M281 | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 225 | Phase 2 | United States;Hong Kong;Taiwan;Spain;Ukraine;Russian Federation;Colombia;Hungary;Argentina;Poland;South Africa;Bulgaria;Germany;Japan | ||
| 106 | NCT05000216 (ClinicalTrials.gov) | August 13, 2021 | 6/8/2021 | COVID-19 Booster Vaccine in Autoimmune Disease Non-Responders | Booster Effects With Autoimmune Treatments in Patients With Poor Response to Initial COVID-19 Vaccine (ACV01) | Rheumatoid Arthritis (RA);Systemic Lupus Erythematosus (SLE);Pemphigus Vulgaris;Multiple Sclerosis (MS);Systemic Sclerosis (SSc);Pediatric SLE;Juvenile Idiopathic Arthritis (JIA);Juvenile Dermatomyositis (JDM);Pediatric-Onset Multiple Sclerosis (POMS) | Biological: Moderna mRNA-1273;Biological: BNT162b2;Biological: Ad26.COV2.S;Drug: Continue IS (MMF or MPA);Drug: Continue IS (MTX);Biological: Continue IS (B cell depletion therapy);Biological: Monovalent [B.1.351] CoV2 preS dTM-AS03;Drug: Withhold IS (MMF or MPA);Drug: Withhold IS (MTX);Drug: Withhold IS (B cell depletion therapy);Biological: Moderna mRNA-1273, Bivalent;Biological: BNT162b2, Bivalent | National Institute of Allergy and Infectious Diseases (NIAID) | Autoimmunity Centers of Excellence;Rho Federal Systems Division, Inc. | Recruiting | 2 Years | N/A | All | 2340 | Phase 2 | United States |
| 107 | EUCTR2018-004175-12-IT (EUCTR) | 13/08/2021 | 17/08/2021 | A Phase 2b multicenter dose ranging study to evaluate efficacy and safety of PF-06700841 in systemic lupus erythematosus. | A PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06700841 IN PARTICIPANTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) - - | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: PF-06700841 Product Code: [PF-06700841 5 mg] INN or Proposed INN: brepocitinib Product Name: PF-06700841 Product Code: [PF-06700841 25mg] INN or Proposed INN: brepocitinib Other descriptive name: PF-06700841-15 | PFIZER INC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 448 | Phase 2 | United States;Serbia;Portugal;Taiwan;Greece;Spain;Ukraine;Colombia;Italy;France;Australia;China;Korea, Republic of;Czechia;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Japan | ||
| 108 | EUCTR2020-003509-72-AT (EUCTR) | 12/08/2021 | 11/05/2021 | Efficacy and Safety of Efavaleukin Alfa in Subjects with Active Systemic LupusErythematosus | A Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Efavaleukin Alfa in Subjects with Active Systemic Lupus Erythematosus With Inadequate Response to Standard of Care Therapy | Active Systemic Lupus Erythematosus MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Efavaleukin Alfa Product Code: AMG 592 INN or Proposed INN: EFAVALEUKIN ALFA Other descriptive name: RECOMBINANT FACTOR FC FUSION PROTEIN | Amgen Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 2 | United States;Hong Kong;Taiwan;Greece;Spain;Turkey;Austria;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Mexico;Canada;Poland;Bulgaria;Japan;Korea, Republic of | ||
| 109 | EUCTR2020-004047-86-ES (EUCTR) | 11/08/2021 | 23/06/2021 | A Study of ALPN-101 in Active Lupus | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF ALPN-101 IN SYSTEMIC LUPUS ERYTHEMATOSUS | Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042946;Term: Systemic lupus erythematosus rash;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 21.1;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.1;Level: LLT;Classification code 10042948;Term: Systemic lupus erythematosus syndrome aggravated;Classification code 10042947;Term: Systemic lupus erythematosus synd;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10029142;Term: Nephritis systemic lupus erythematosus;System Organ Class: 100000004857 MedDRA version: 20.1;Classification code 10067657;Term: Systemic lupus erythematosus disease activity index increased;System Organ Class: 10022891 - Investigations MedDRA version: 20.0;Classification code 10067658;Term: Systemic lupus erythematosus disease activity index decreased;System Organ Class: 10022891 - Investigations MedDRA version: 20.1;Classification code 10067659;Term: Systemic lupus erythematosus disease activity index abnormal;System Organ Class: 10022891 - Investigations MedDRA version: 21.0;Classification code 10080670;Term: Systemic lupus erythematosus reactivation;Classification code 10073694;Term: Lupus pleurisy;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 21.1;Classification code 10040968;Term: SLE arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: ALPN-101 INN or Proposed INN: Acazicolcept Other descriptive name: ALPN-101 | Alpine Immune Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 130 | Phase 2 | France;United States;Poland;Spain;Russian Federation;Germany;Korea, Republic of | ||
| 110 | EUCTR2020-005760-57-ES (EUCTR) | 30/07/2021 | 23/06/2021 | A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Patients with Systemic Lupus Erythematosus | A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OBINUTUZUMAB IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Gazyvaro INN or Proposed INN: OBINUTUZUMAB | Roche Farma S. A. U. que realiza el ensayo en España y que actúa como representante F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 3 | United States;Spain;Russian Federation;Italy;United Kingdom;France;Mexico;Argentina;Brazil;Poland;Australia;Peru;South Africa;New Zealand | ||
| 111 | NCT04976322 (ClinicalTrials.gov) | July 27, 2021 | 14/7/2021 | A Study to Evaluate the Safety and Tolerability of Dapirolizumab Pegol in Study Participants With Systemic Lupus Erythematosus | A Multicenter, Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of Dapirolizumab Pegol Treatment in Study Participants With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: Dapirolizumab pegol | UCB Biopharma SRL | NULL | Enrolling by invitation | 16 Years | N/A | All | 760 | Phase 3 | Germany;Greece;Hungary;Mexico;Poland;Romania;Serbia;Spain;Taiwan;United States;Argentina;Belgium;Bulgaria;Canada;Chile;Colombia;Czechia |
| 112 | EUCTR2020-003509-72-IT (EUCTR) | 27/07/2021 | 17/08/2021 | Efficacy and Safety of Efavaleukin Alfa in Subjects with Active Systemic Lupus Erythematosus | A Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Efavaleukin Alfa in Subjects with Active Systemic Lupus Erythematosus With Inadequate Response to Standard of Care Therapy - NA | Active Systemic Lupus Erythematosus MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Efavaleukin Alfa Product Code: [AMG 592] INN or Proposed INN: EFAVALEUKIN ALFA Other descriptive name: RECOMBINANT FACTOR FC FUSION PROTEIN | AMGEN INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 2 | United States;Hong Kong;Taiwan;Greece;Spain;Turkey;Austria;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Mexico;Canada;Poland;Bulgaria;Japan | ||
| 113 | ChiCTR2100048635 | 2021-07-19 | 2021-07-12 | The Impact of low-dose prednisone withdrawal on disease flare and organ damage in SLE patients: a randomized clinical trial | The Impact of low-dose prednisone withdrawal on disease flare and organ damage in SLE patients: a randomized clinical trial | Systemic Lupus Erythematosus | Withdrawal group:withdraw low dose prednisone;maintanence group:maintain low dose prednisone; | Peking University First Hospital | NULL | Pending | Both | Withdrawal group:92;maintanence group:92; | China | |||
| 114 | NCT04961567 (ClinicalTrials.gov) | July 16, 2021 | 5/7/2021 | A Study to Evaluate the Efficacy and Safety of BIIB059 (Litifilimab) in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care | Lupus Erythematosus, Systemic | Drug: BIIB059 (litifilimab);Drug: Placebo | Biogen | NULL | Recruiting | 18 Years | N/A | All | 540 | Phase 3 | United States;Argentina;Belgium;Canada;China;Colombia;Czechia;Germany;Hungary;Israel;Italy;Japan;Netherlands;Puerto Rico;Romania;Serbia;United Kingdom;Bulgaria |
| 115 | ITMCTR2100005063 | 2021-07-15 | 2021-07-16 | A prospective non-randomized controlled study of integrated traditional Chinese and western medicine for moderately active systemic lupus erythematosus | A prospective cohort study of integrated traditional Chinese and western medicine for moderately active systemic lupus erythematosus | Systemic lupus erythematosus | Experimental group:Western medicine + Jiedu Quyu Zishen Fang's modified treatment based on syndrome differentiation;Control Group:Western Medicine (glucocorticoid, hydroxychloroquine, methotrexate, azathioprine or cyclophosphamide); | Zhejiang Chinese Medical University | NULL | Pending | 18 | 65 | Female | Experimental group:264;Control Group:264; | N/A | China |
| 116 | EUCTR2019-003409-83-ES (EUCTR) | 15/07/2021 | 14/06/2021 | A Study to evaluate the safety and tolerability of dapirolizumab pegol in study participants with systemic lupus erythematosus | A Multicenter, Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of Dapirolizumab Pegol Treatment in Study Participants With Systemic Lupus Erythematosus | Systemic lupus erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 760 | Phase 3 | Serbia;United States;Portugal;Philippines;Taiwan;Hong Kong;Greece;Spain;Chile;Colombia;Italy;France;Peru;Australia;Denmark;Korea, Republic of;Czechia;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Japan | ||
| 117 | ChiCTR2100048796 | 2021-07-15 | 2021-07-16 | A prospective non-randomized controlled study of integrated traditional Chinese and western medicine for moderately active systemic lupus erythematosus | A prospective cohort study of integrated traditional Chinese and western medicine for moderately active systemic lupus erythematosus | Systemic lupus erythematosus | Experimental group:Western medicine + Jiedu Quyu Zishen Fang's modified treatment based on syndrome differentiation;Control Group:Western Medicine (glucocorticoid, hydroxychloroquine, methotrexate, azathioprine or cyclophosphamide); | Zhejiang Chinese Medical University | NULL | Pending | 18 | 65 | Female | Experimental group:264;Control Group:264; | N/A | China |
| 118 | EUCTR2020-004047-86-PL (EUCTR) | 14/07/2021 | 09/06/2021 | A Study of ALPN-101 in Active Lupus | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF ALPN-101 IN SYSTEMIC LUPUS ERYTHEMATOSUS | Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042946;Term: Systemic lupus erythematosus rash;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 21.1;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.1;Level: LLT;Classification code 10042948;Term: Systemic lupus erythematosus syndrome aggravated;Classification code 10042947;Term: Systemic lupus erythematosus synd;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10029142;Term: Nephritis systemic lupus erythematosus;System Organ Class: 100000004857 MedDRA version: 20.1;Classification code 10067657;Term: Systemic lupus erythematosus disease activity index increased;System Organ Class: 10022891 - Investigations MedDRA version: 20.0;Classification code 10067658;Term: Systemic lupus erythematosus disease activity index decreased;System Organ Class: 10022891 - Investigations MedDRA version: 20.1;Classification code 10067659;Term: Systemic lupus erythematosus disease activity index abnormal;System Organ Class: 10022891 - Investigations MedDRA version: 21.0;Classification code 10080670;Term: Systemic lupus erythematosus reactivation;Classification code 10073694;Term: Lupus pleurisy;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 21.1;Classification code 10040968;Term: SLE arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: ALPN-101 INN or Proposed INN: Acazicolcept Other descriptive name: ALPN-101 | Alpine Immune Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 130 | Phase 2 | United States;France;Taiwan;Hungary;Spain;Poland;Russian Federation;Germany;Korea, Republic of | ||
| 119 | NCT03684564 (ClinicalTrials.gov) | July 9, 2021 | 13/8/2018 | RIvaroxaban for Stroke Patients With AntiPhospholipid Syndrome | Rivaroxaban Versus Warfarin for Stroke Patients With Antiphospholipid Syndrome, With or Without SLE (RISAPS): a Randomised, Controlled, Open Label, Phase II/III, Non-inferiority Trial | Antiphospholipid Syndrome;Systemic Lupus Erythematosus;Stroke;Ischemic Stroke;Brain Ischemia | Drug: Rivaroxaban;Drug: Warfarin | University College, London | University College London Hospitals;Barking, Havering and Redbridge University Hospitals NHS Trust;Hammersmith Hospitals NHS Trust;Epsom and St Helier University Hospitals NHS Trust;Barts & The London NHS Trust;King's College Hospital NHS Trust;Versus Arthritis (Funder) | Recruiting | 18 Years | N/A | All | 140 | Phase 2/Phase 3 | United Kingdom |
| 120 | EUCTR2021-000962-14-DE (EUCTR) | 02/07/2021 | 19/04/2021 | A drug trial to evaluate the safety and efficacy of daratumumab, an agent already approved for other diseases, in combination with standard background anti-rheumatic therapy in patients with moderate-to-severe systemic lupus erythematosus | A Monocenter, Open Label Study to Evaluate the Safety and Efficacy of Daratumumab in Combination with Standard Background Therapy in Participants with Moderate to Severe Systemic Lupus Erythematosus - DARALUP | Systemic Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Darzalex Product Name: Daratumumab Product Code: JNJ-54767414 | Charité - Universitätsmedizin Berlin | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 10 | Phase 2 | Germany | ||
| 121 | ChiCTR2100048082 | 2021-07-01 | 2021-06-30 | Identification of Serum and Exosome Markers in Lupus Nephritis | Development and Application of an Early Diagnosis Scheme for Lupus Nephritis Based on Serum Noncoding Small RNA | Systemic Lupus Erythematosus | Gold Standard:The SLE classification standard revised by the American Academy of Rheumatology in 1997 and the SLE classification standard revised by the American Academy of Rheumatology in 2009;Index test:serum and exosome markers; | The Affiliated Drum Tower Hospital of Nanjing University Medical School | NULL | Recruiting | Both | Target condition:100;Difficult condition:100 | China | |||
| 122 | NCT04750057 (ClinicalTrials.gov) | July 1, 2021 | 9/2/2021 | Anifrolumab Early Access Program | An Early Access Program for Anifrolumab Treatment in Adult Patients With Active Systemic Lupus Erythematosus - AMANA | Systemic Lupus Erythematosus | Drug: Anifrolumab | AstraZeneca | Clinigen, Inc. | No longer available | 18 Years | N/A | All | NULL | ||
| 123 | NCT04810754 (ClinicalTrials.gov) | June 30, 2021 | 11/3/2021 | An Open Label Study to Evaluate Daratumumab in Participants With Moderate to Severe Systemic Lupus Erythematosus | A Monocenter, Open Label Study to Evaluate the Safety and Efficacy of Daratumumab in Combination With Standard Background Therapy in Participants With Moderate to Severe Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: Daratumumab Injection | Charite University, Berlin, Germany | Janssen-Cilag G.m.b.H;Labor Berlin-Charité Vivantes G.m.b.H;Deutsches Rheuma-Forschungszentrum Berlin (DRFZ);Charité Clinical Trial Office (CTO) | Not yet recruiting | 18 Years | 60 Years | All | 10 | Phase 2 | NULL |
| 124 | NCT04925934 (ClinicalTrials.gov) | June 24, 2021 | 4/5/2021 | Study of VIB7734 for the Treatment of Moderate to Severely Active SLE | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of VIB7734 for the Treatment of Moderate to Severely Active Systemic Lupus Erythematosus | Lupus Erythematosus, Systemic | Drug: VIB7734;Other: Placebo | Viela Bio (acquired by Horizon Therapeutics) | NULL | Active, not recruiting | 18 Years | 70 Years | All | 214 | Phase 2 | United States;Argentina;Greece;India;Mexico;Poland;Russian Federation;Serbia;Spain;Taiwan;Ukraine |
| 125 | NCT04835441 (ClinicalTrials.gov) | June 22, 2021 | 5/4/2021 | ALPN-101 (Acazicolcept) in Systemic Lupus Erythematosus | A Randomized, Double-blind, Placebo-controlled Study of ALPN-101 in Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: ALPN-101;Drug: Placebo | Alpine Immune Sciences, Inc. | NULL | Recruiting | 18 Years | 70 Years | All | 130 | Phase 2 | United States;France;Hungary;Korea, Republic of;Poland;Spain;Taiwan |
| 126 | EUCTR2020-003509-72-GR (EUCTR) | 17/06/2021 | 22/04/2021 | A Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Efavaleukin Alfa in Subjects with Active Systemic Lupus Erythematosus With Inadequate Response to Standard of Care Therapy | A Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Efavaleukin Alfa in Subjects with Active Systemic Lupus Erythematosus With Inadequate Response to Standard of Care Therapy | Active Systemic Lupus Erythematosus MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Efavaleukin Alfa Product Code: AMG 592 INN or Proposed INN: EFAVALEUKIN ALFA Other descriptive name: RECOMBINANT FACTOR FC FUSION PROTEIN | Amgen Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 2 | United States;Taiwan;Hong Kong;Greece;Spain;Turkey;Austria;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Mexico;Canada;Poland;Bulgaria;Japan | ||
| 127 | EUCTR2020-003509-72-ES (EUCTR) | 17/06/2021 | 11/06/2021 | Efficacy and Safety of Efavaleukin Alfa in Subjects with Active Systemic Lupus Erythematosus | A Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Efavaleukin Alfa in Subjects with Active Systemic Lupus Erythematosus With Inadequate Response to Standard of Care Therapy | Active Systemic Lupus Erythematosus MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Efavaleukin Alfa Product Code: AMG 592 INN or Proposed INN: EFAVALEUKIN ALFA Other descriptive name: RECOMBINANT FACTOR FC FUSION PROTEIN | Amgen Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 2 | United States;Hong Kong;Taiwan;Greece;Spain;Turkey;Austria;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Mexico;Canada;Poland;Bulgaria;Japan | ||
| 128 | NCT05260255 (ClinicalTrials.gov) | June 15, 2021 | 12/5/2021 | Effect of Vitamin D Supplement on Disease Activity in SLE | The Effect of Vitamin D Supplementation on Disease Activity of Systemic Lupus Erythematosus Patients: A Randomized Clinical Trial in Rajavithi Hospital | Vitamin D Deficiency;Hypocalcemia;Hyperparathyroidism;Systemic Lupus Erythematosus (Disorder) | Drug: vitamin D2 ( calciferol );Drug: Placebo | Rajavithi Hospital | NULL | Recruiting | 18 Years | N/A | All | 100 | N/A | Thailand |
| 129 | EUCTR2019-002205-22-NL (EUCTR) | 15/06/2021 | 11/02/2020 | Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment. | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis. | SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 23.1;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Branebrutinib Product Code: BMS-986195 INN or Proposed INN: Branebrutinib Other descriptive name: BMS986195 Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: ORENCIA | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 185 | Phase 2 | France;United States;Mexico;Argentina;Spain;Poland;Belgium;Germany;Netherlands;United Kingdom | ||
| 130 | EUCTR2019-000328-16-GR (EUCTR) | 10/06/2021 | 12/05/2021 | Safety and Efficacy of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) | A Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Rozibafusp Alfa (AMG 570) in Subjects With Active Systemic Lupus Erythematosus (SLE) With Inadequate Response to Standard of Care (SOC) Therapy - Safety and Efficacy of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) | Active Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: AMG 570 INN or Proposed INN: AMG 570 Other descriptive name: AMG 570 Product Code: AMG 570 INN or Proposed INN: AMG 570 Other descriptive name: AMG 570 Product Code: AMG 570 INN or Proposed INN: AMG 570 Other descriptive name: AMG 570 | Amgen Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 2 | Portugal;United States;Czechia;Hong Kong;Greece;Spain;Russian Federation;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Australia;Bulgaria;Germany;Japan;Korea, Republic of | ||
| 131 | NCT04877691 (ClinicalTrials.gov) | June 8, 2021 | 4/5/2021 | Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-Blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: Medi-546;Drug: Placebo | AstraZeneca | Iqvia Pty Ltd | Recruiting | 18 Years | 70 Years | All | 360 | Phase 3 | United States;Argentina;Bulgaria;Chile;Colombia;Germany;Hungary;Japan;Mexico;Peru;Poland;Russian Federation;Spain;Ukraine;United Kingdom |
| 132 | NCT04643067 (ClinicalTrials.gov) | June 3, 2021 | 12/11/2020 | Phase 1b/2a Study to Evaluate Safety and Efficacy of KPG-818 in SLE | A Phase 1b/2a Multicenter Study to Assess the Safety and Tolerability, Pharmacokinetics, and Preliminary Efficacy of KPG-818 in Patients With Systemic Lupus Erythematosus | SLE; Drug | Drug: 0.15mg KPG-818 dose;Drug: 0.6mg KPG-818 dose;Drug: 2mg KPG-818 dose;Drug: Placebo | Kangpu Biopharmaceuticals, Ltd. | NULL | Recruiting | 18 Years | N/A | All | 60 | Phase 1/Phase 2 | United States |
| 133 | NCT04902807 (ClinicalTrials.gov) | June 2021 | 21/5/2021 | Conception of a Diagnosis, Prognosis and Therapeutic Decision Tool for Patients With Autoimmunity and Inflammation | Conception of a Diagnosis, Prognosis and Therapeutic Decision Tool for Patients With Autoimmunity and Inflammation | Autoimmune Lymphoproliferative Syndrome;Autoimmune Cytopenia;Autoimmune Diseases;Autoimmune Anemia;Autoimmune Thrombocytopenia;Autoimmune Hepatitis;Autoimmune Diabetes;Autoimmune Rheumatologic Disease;Systemic Lupus Erythematosus;Juvenile Idiopathic Arthritis;Hemophagocytic Lymphohistiocytoses;EBV Lymphoproliferation;RAS-Associated Autoimmune Leucoproliferative Disease;Primary Immunodeficiency;APECED;IPEX;BENTA;Enteropathy, Autoimmune;Combined Immunodeficiency;IBD | Biological: Collection of samples | Institut National de la Santé Et de la Recherche Médicale, France | NULL | Not yet recruiting | 1 Year | 18 Years | All | 500 | NULL | |
| 134 | NCT04895241 (ClinicalTrials.gov) | May 25, 2021 | 17/5/2021 | A Study to Evaluate the Efficacy and Safety of BIIB059 (Litifilimab) in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care | Lupus Erythematosus, Systemic | Drug: BIIB059 (litifilimab);Drug: Placebo | Biogen | NULL | Recruiting | 18 Years | N/A | All | 540 | Phase 3 | Australia;Bulgaria;Chile;United States;France;Greece;Korea, Republic of;Mexico;Poland;Spain;Sweden;Taiwan;China |
| 135 | EUCTR2020-003509-72-PL (EUCTR) | 21/05/2021 | 11/05/2021 | Efficacy and Safety of Efavaleukin Alfa in Subjects with Active Systemic LupusErythematosus | A Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Efavaleukin Alfa in Subjects with Active Systemic Lupus Erythematosus With Inadequate Response to Standard of Care Therapy | Active Systemic Lupus Erythematosus MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Efavaleukin Alfa Product Code: AMG 592 INN or Proposed INN: EFAVALEUKIN ALFA Other descriptive name: RECOMBINANT FACTOR FC FUSION PROTEIN | Amgen Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 2 | Russian Federation;Chile;Colombia;Italy;Switzerland;France;Mexico;Canada;Poland;Bulgaria;Japan;Korea, Republic of;Spain;Turkey;Austria;United States;Hong Kong;Taiwan;Greece | ||
| 136 | NCT04680637 (ClinicalTrials.gov) | May 6, 2021 | 18/12/2020 | Efficacy and Safety of Efavaleukin Alfa in Subjects With Active Systemic Lupus Erythematosus | A Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Efavaleukin Alfa in Subjects With Active Systemic Lupus Erythematosus With Inadequate Response to Standard of Care Therapy | Active Systemic Lupus Erythematosus | Drug: Efavaleukin Alfa;Drug: Placebo;Other: Standard of Care | Amgen | NULL | Recruiting | 18 Years | 75 Years | All | 320 | Phase 2 | United States;Austria;Bulgaria;Canada;Chile;Colombia;France;Greece;Hong Kong;Italy;Japan;Korea, Republic of;Mexico;Poland;Russian Federation;Spain;Switzerland;Taiwan;Turkey |
| 137 | JPRN-jRCT2041210076 | 06/05/2021 | 01/10/2021 | Efficacy and Safety of Efavaleukin Alfa in Subjects With Active Systemic Lupus Erythematosus | A Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Efavaleukin Alfa in Subjects With Active Systemic Lupus Erythematosus With Inadequate Response to Standard of Care Therapy | Active Systemic Lupus Erythematosus | Placebo Comparator: Placebo + Standard of Care Interventions: Drug: Placebo Other: Standard of Care Experimental: Efavaleukin Alfa Dose Level One + Standard of Care Interventions: Drug: Efavaleukin Alfa Other: Standard of Care Experimental: Efavaleukin Alfa Dose Level Two + Standard of Care Interventions: Drug: Efavaleukin Alfa Other: Standard of Care Experimental: Efavaleukin Alfa Dose Level Three + Standard of Care Interventions: Drug: Efavaleukin Alfa Other: Standard of Care | Hama Yoriko | NULL | Recruiting | >= 18age old | <= 75age old | Both | 320 | Phase 2 | United States;Korea, Republic of;Poland;Turkey;Greece,;Spain;Japan |
| 138 | EUCTR2020-001690-72-BG (EUCTR) | 23/04/2021 | 11/03/2021 | A Study to Investigate the Long-Term Safety and Efficacy of ABBV-599 (ABBV-105 and ABT-494 Given Alone or in Combination) in Participants with Moderately to Severely Active Systemic Lupus Erythematosus who have completed Study M19-130. | A Phase 2, Long-Term Extension (LTE) Study with Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus Who Have Completed the M19-130 Phase 2 Randomized Controlled Trial (RCT) - A Phase 2, Long-Term Extension (LTE) Study in Subjects with Moderately to Severely Active SLE | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Elsubrutinib Product Code: ABBV-105 INN or Proposed INN: Elsubrutinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: UPADACITINIB Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: UPADACITINIB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 260 | Phase 2 | United States;Taiwan;Spain;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Australia;Bulgaria;Netherlands;Germany;China;Japan;Korea, Republic of | ||
| 139 | NCT04516408 (ClinicalTrials.gov) | April 20, 2021 | 13/8/2020 | Recombinant Zoster Vaccine in Stable SLE Patients | Efficacy and Safety of Recombinant Zoster Vaccine in Stable SLE Patients(Vtrial) | Herpes Zoster;Recombinant Zoster Vaccine;Systemic Lupus Erythematosus | Biological: Recombinant zoster vaccine;Biological: Placebo | RenJi Hospital | NULL | Recruiting | 50 Years | N/A | All | 464 | N/A | China |
| 140 | ChiCTR2100043138 | 2021-04-01 | 2021-02-05 | Efficacy of belimumab combined with standard of care in patients with untreated systemic lupus erythematosus | Efficacy of belimumab combined with standard of care in patients with untreated systemic lupus erythematosus | Systemic lupus erythematosus | Belimumab+SoC group:Belimumab+SoC;SoC group:SoC; | Affiliated Hospital of Guilin Medical College | NULL | Recruiting | 16 | 65 | Both | Belimumab+SoC group:40;SoC group:40; | Phase 4 | China |
| 141 | EUCTR2019-003406-27-CZ (EUCTR) | 23/03/2021 | 23/12/2020 | A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus - PHOENYCS GO | Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Serbia;Portugal;Philippines;Taiwan;Greece;Spain;Chile;Colombia;Italy;France;Peru;Australia;Denmark;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany | ||
| 142 | NCT04515719 (ClinicalTrials.gov) | March 19, 2021 | 13/8/2020 | Efficacy and Safety of Belimumab in SLE Patients | Efficacy and Safety of Belimumab for Prevention of Disease Flares in SLE Patients With Low Disease Activity | Systemic Lupus Erythematosus | Biological: Belimumab;Biological: Placebo | RenJi Hospital | NULL | Recruiting | 18 Years | 70 Years | All | 334 | Phase 4 | China |
| 143 | EUCTR2020-001690-72-DE (EUCTR) | 02/03/2021 | 15/01/2021 | A Study to Investigate the Long-Term Safety and Efficacy of ABBV-599 (ABBV-105 and ABT-494 Given Alone or in Combination) in Participants with Moderately to Severely Active Systemic Lupus Erythematosus who have completed Study M19-130. | A Phase 2, Long-Term Extension (LTE) Study with Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus Who Have Completed the M19-130 Phase 2 Randomized Controlled Trial (RCT) - A Phase 2, Long-Term Extension (LTE) Study in Subjects with Moderately to Severely Active SLE | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Elsubrutinib Product Code: ABBV-105 INN or Proposed INN: Elsubrutinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: UPADACITINIB Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: UPADACITINIB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 260 | Phase 2 | United States;Taiwan;Spain;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Australia;Bulgaria;Netherlands;Germany;China;Japan;Korea, Republic of | ||
| 144 | EUCTR2020-001177-78-FR (EUCTR) | 25/02/2021 | 09/04/2020 | Certolizumab to Prevent Pregnancy Complications in High-Risk Patients with Antiphospholipid syndrome (APS) or systemic lupus erythematosus (SLE) | Certolizumab to Prevent Pregnancy Complications in High-Risk Patients with APS or SLE - IMPACT | Pregnant women with Antiphospholipid Syndrom (APS) and Lupus Antocoagulant (LAC) MedDRA version: 20.0;Level: PT;Classification code 10002817;Term: Antiphospholipid syndrome;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 20.1;Level: LLT;Classification code 10058347;Term: Lupus anticoagulant positive;System Organ Class: 100000004848 MedDRA version: 20.0;Classification code 10058355;Term: Lupus anticoagulant;System Organ Class: 100000004848;Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13] | Trade Name: CIMZIA Product Name: Certolizumab INN or Proposed INN: CERTOLIZUMAB PEGOL | University of Utah | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: no | 50 | Phase 2 | United States;France | ||
| 145 | NCT04839315 (ClinicalTrials.gov) | February 15, 2021 | 5/4/2021 | COVID-19 Vaccination in Rheumatic Disease Patients | Immunological Consequences of COVID-19 Vaccination in Patients With Rheumatic Diseases | Systemic Lupus Erythematosus;Sjogren's Syndrome;Inflammatory Myositis;Psoriatic Arthritis;Gout;Ankylosing Spondylitis;Arthritis of Multiple Sites Associated With Inflammatory Bowel Disease (Diagnosis);Osteoarthritis | Biological: mRNA COVD19 vaccine | Mayo Clinic | NULL | Terminated | 18 Years | N/A | All | 58 | Early Phase 1 | United States |
| 146 | EUCTR2019-003323-38-DE (EUCTR) | 21/01/2021 | 03/07/2020 | A study to determinate the safety and efficacy of LY3471851 in Adult Patients with Systemic Lupus Erythematosus | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of LY3471851 (NKTR-358) in Adults with Systemic Lupus Erythematosus - ISLAND-SLE | Systemic Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: LY3471851 Product Code: LY3471851 INN or Proposed INN: Not Applicable Other descriptive name: LY3471851 | Eli Lilly & Company | NULL | Not Recruiting | Female: yes Male: yes | 280 | Phase 2 | Argentina;Russian Federation;Romania;Hungary;United States;Japan;Ukraine;United Kingdom;India;Spain;Canada;Czech Republic;Taiwan;Korea, Republic of;Poland;Mexico;Israel;Australia;Germany | ||
| 147 | NCT04726553 (ClinicalTrials.gov) | January 20, 2021 | 22/1/2021 | Nature of Anifrolumab Impact on Vaccine-Emergent Immunity in SLE | Nature of Anifrolumab Impact on Vaccine-Emergent Immunity in Patients With Moderately to Severely Active Systemic Lupus Erythematosus: A Multi-Centre Open Label Parallel Group Trial: | Systemic Lupus Erythematosus (SLE) | Drug: Anifrolumab;Drug: Standard of Care | Oklahoma Medical Research Foundation | NYU Langone Health;Yale University;Piedmont Heart Institute, Inc., Atlanta, GA;Columbia University | Recruiting | 18 Years | 70 Years | All | 20 | Early Phase 1 | United States |
| 148 | ChiCTR2200055471 | 2021-01-01 | 2022-01-10 | Efficacy and safety of low-dose CTX combined with belimumab based on B/T cell balance in the treatment of moderate to severe systemic lupus erythematosus: a medical record-based study | Efficacy and safety of low-dose CTX combined with belimumab based on B/T cell balance in the treatment of moderate to severe systemic lupus erythematosus | Systemic Lupus Erythematosus (SLE) | belimumab group:Low-dose cyclophosphamide combined with belimumab;cyclophosphamide group:Standard dose cyclophosphamide; | The Second Hospital of Shanxi Medical University | NULL | Recruiting | 18 | 80 | Both | belimumab group:40;cyclophosphamide group:42; | China | |
| 149 | NCT04570306 (ClinicalTrials.gov) | December 31, 2020 | 19/6/2020 | Transcriptional and Immine Parameters of Response to Belinumab | Whole Blood Transcriptional and Mass Cytometry Immune Profiling in Systemic Lupus Erythematosus (SLE) Patients to Discern the Salutary Effects of Belimumab on Halting Disease Progression and Flares Without Compromising Host Fitness | Systemic Lupus Erythematosus | Drug: Belimumab | Biomedical Research Foundation, Academy of Athens | NULL | Not yet recruiting | 18 Years | 65 Years | All | 80 | NULL | |
| 150 | NCT04700267 (ClinicalTrials.gov) | December 28, 2020 | 6/1/2021 | A Study Evaluating the Effects of GLPG3970 Given as Oral Treatment for 12 Weeks in Adults With Systemic Lupus Erythematosus | A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of Orally Administered GLPG3970 for 12 Weeks in Adult Subjects With Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: GLPG3970 film-coated tablet;Drug: Placebo film-coated tablet | Galapagos NV | NULL | Terminated | 18 Years | 65 Years | All | 11 | Phase 1 | Bulgaria;Moldova, Republic of;Poland;Spain;Ukraine |
| 151 | EUCTR2020-001690-72-IT (EUCTR) | 22/12/2020 | 24/05/2021 | A Study to Investigate the Long-Term Safety and Efficacy of ABBV-599 (ABBV-105 and ABT-494 Given Alone or in Combination) in Participants with Moderately to Severely Active Systemic Lupus Erythematosus who have completed Study M19-130. | A Phase 2, Long-Term Extension (LTE) Study with Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus Who Have Completed the M19-130 Phase 2 Randomized Controlled Trial (RCT) - A Phase 2, Long-Term Extension (LTE) Study in Subjects with Moderately to Severely Active SLE | Systemic Lupus Erythematosus (SLE)E.1.1.1.IT - Condizione clinica in un linguaggio facilmente comprensibile Il lupus eritematoso sistemico (LES) è una patologia cronica in cui il sistema immunitario dell’organismo può attaccare la pelle, le articolazioni, i reni, il cervello e/o altri organi dell’organismo stesso. Spesso colpisce con maggiore frequenza le donne e le persone di origine africana. MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Elsubrutinib Product Code: [ABBV-105] INN or Proposed INN: Elsubrutinib Product Name: Upadacitinib Product Code: [ABT-494] INN or Proposed INN: UPADACITINIB Product Name: Upadacitinib Product Code: [ABT-494] INN or Proposed INN: UPADACITINIB | ABBVIE DEUTSCHLAND GMBH & CO. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 260 | Phase 2 | United States;Taiwan;Spain;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Australia;Bulgaria;Netherlands;Germany;China;Japan;Korea, Republic of | ||
| 152 | EUCTR2020-001690-72-NL (EUCTR) | 21/12/2020 | 10/09/2020 | A Study to Investigate the Long-Term Safety and Efficacy of ABBV-599 (ABBV-105 and ABT-494 Given Alone or in Combination) in Participants with Moderately to Severely Active Systemic Lupus Erythematosus who have completed Study M19-130. | A Phase 2, Long-Term Extension (LTE) Study with Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus Who Have Completed the M19-130 Phase 2 Randomized Controlled Trial (RCT) - A Phase 2, Long-Term Extension (LTE) Study in Subjects with Moderately to Severely Active SLE | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Elsubrutinib Product Code: ABBV-105 INN or Proposed INN: Elsubrutinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: UPADACITINIB Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: UPADACITINIB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 260 | Phase 2 | United States;Taiwan;Spain;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Australia;Bulgaria;Netherlands;Germany;China;Japan;Korea, Republic of | ||
| 153 | NCT04647708 (ClinicalTrials.gov) | December 16, 2020 | 23/11/2020 | Study of M5049 in CLE and SLE Participants | A Phase Ib, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Safety and Pharmacokinetics of Multiple Ascending Doses of M5049 Administered Orally in SLE and CLE Participants Treated With Standard of Care | Systemic Lupus Erythematosus;Cutaneous Lupus Erythematosus | Drug: M5049;Drug: Placebo | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | NULL | Recruiting | 18 Years | 65 Years | All | 44 | Phase 1 | Bulgaria;Germany;Moldova, Republic of;North Macedonia;Spain;Ukraine |
| 154 | EUCTR2019-003406-27-PT (EUCTR) | 14/12/2020 | 29/06/2020 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus - PHOENYCS GO | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus - PHOENYCS GO | Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Serbia;Portugal;Philippines;Taiwan;Greece;Spain;Chile;Colombia;Italy;France;Peru;Australia;Denmark;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany | ||
| 155 | EUCTR2019-000638-20-BG (EUCTR) | 09/11/2020 | 14/08/2020 | A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus | A Phase 2 Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Elsubrutinib Product Code: ABBV-105 INN or Proposed INN: ELSUBRUTINIB Other descriptive name: ABBV-105 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: UPADACITINIB Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: UPADACITINIB Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 325 | Phase 2 | United States;Taiwan;Spain;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Puerto Rico;Canada;Argentina;Poland;Australia;Bulgaria;Netherlands;Germany;New Zealand;China;Japan;Korea, Republic of | ||
| 156 | EUCTR2019-003323-38-GB (EUCTR) | 06/11/2020 | 13/10/2020 | A study to determinate the safety and efficacy of LY3471851 in Adult Patients with Systemic Lupus Erythematosus | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of LY3471851 (NKTR-358) in Adults with Systemic Lupus Erythematosus - ISLAND-SLE | Systemic Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: LY3471851 Product Code: LY3471851 INN or Proposed INN: Not applicable Other descriptive name: LY3471851 | Eli Lilly & Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 280 | Phase 2 | United States;Taiwan;Spain;Ukraine;Russian Federation;Israel;United Kingdom;India;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Australia;Germany;Japan;Korea, Republic of | ||
| 157 | EUCTR2019-003323-38-HU (EUCTR) | 04/11/2020 | 10/09/2020 | A study to determinate the safety and efficacy of LY3471851 in Adult Patients with Systemic Lupus Erythematosus | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of LY3471851 (NKTR-358) in Adults with Systemic Lupus Erythematosus - ISLAND-SLE | Systemic Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: LY3471851 Product Code: LY3471851 INN or Proposed INN: Not applicable Other descriptive name: LY3471851 | Eli Lilly & Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 280 | Phase 2 | United States;Taiwan;Spain;Ukraine;Russian Federation;Israel;United Kingdom;India;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Romania;Australia;Germany;Japan;Korea, Republic of | ||
| 158 | NCT04582136 (ClinicalTrials.gov) | November 2020 | 3/10/2020 | Efficacy and Safety of Sirolimus in Active Systemic Lupus Erythematosus | Efficacy and Safety of Sirolimus in Patients With Active Systemic Lupus Erythematosus Despite Standard of Care: a Multi-center, Double Blinded, Randomized, Placebo-controlled, Phase 2 Trial | Systemic Lupus Erythematosus | Drug: Sirolimus;Drug: Placebo | Chinese SLE Treatment And Research Group | Beijing Municipal Science & Technology Commission;North China Pharmaceutical Group Corporation | Not yet recruiting | 18 Years | 65 Years | All | 146 | Phase 2 | NULL |
| 159 | NCT04440566 (ClinicalTrials.gov) | October 13, 2020 | 17/6/2020 | O-GlcNAcylation Role in the Pathophysiology of Systemic Lupus Erythematosus | O-GlcNAcylation Role in the Pathophysiology of Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Biological: blood sample | University Hospital, Bordeaux | NULL | Recruiting | 18 Years | N/A | All | 100 | N/A | France |
| 160 | EUCTR2019-003323-38-PL (EUCTR) | 09/10/2020 | 07/10/2020 | A study to determinate the safety and efficacy of LY3471851 in Adult Patients with Systemic Lupus Erythematosus | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of LY3471851 (NKTR-358) in Adults with Systemic Lupus Erythematosus - ISLAND-SLE | Systemic Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: LY3471851 Product Code: LY3471851 INN or Proposed INN: Not applicable Other descriptive name: LY3471851 | Eli Lilly & Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 280 | Phase 2 | United States;Czechia;Taiwan;Spain;Ukraine;Israel;Russian Federation;United Kingdom;India;Hungary;Mexico;Canada;Argentina;Poland;Romania;Australia;Germany;Japan;Korea, Republic of | ||
| 161 | EUCTR2019-003406-27-IT (EUCTR) | 07/10/2020 | 21/01/2021 | A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus - - | Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol Product Code: [CDP7657] INN or Proposed INN: Dapirolizumab pegol | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | Portugal;Serbia;United States;Philippines;Taiwan;Estonia;Slovakia;Greece;Spain;Chile;Colombia;Switzerland;Italy;France;Denmark;Peru;Australia;Netherlands;Korea, Republic of;Czechia;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Sweden | ||
| 162 | EUCTR2019-002205-22-FR (EUCTR) | 01/10/2020 | 13/01/2020 | Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment. | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis. | SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Branebrutinib Product Code: BMS-986195 INN or Proposed INN: Branebrutinib Other descriptive name: BMS986195 Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: ORENCIA | Bristol-Myers Squibb International Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 185 | Phase 2 | United States;France;Mexico;Argentina;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom | ||
| 163 | ChiCTR2000038519 | 2020-10-01 | 2020-09-23 | A study of T lymphocyte subsets in children with systemic lupus erythematosus | A study of T lymphocyte subsets in children with systemic lupus erythematosus | systemic lupus erythematosus in children | Gold Standard:anti-nuclear antibodies;Index test:WBC, CD4+T cells, CD4+CCR7+CD95+T cells, CD4+CD45RA-CCR7+T cells, CD4+CD45RA-CCR7-Tcells; | Tianjin Children's Hospital | NULL | Pending | 8 | 17 | Both | Target condition:100;Difficult condition:50 | N/A | China |
| 164 | EUCTR2020-001690-72-HU (EUCTR) | 28/09/2020 | 10/09/2020 | A Study to Investigate the Long-Term Safety and Efficacy of ABBV-599 (ABBV-105 and ABT-494 Given Alone or in Combination) in Participants with Moderately to Severely Active Systemic Lupus Erythematosus who have completed Study M19-130. | A Phase 2, Long-Term Extension (LTE) Study with Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus Who Have Completed the M19-130 Phase 2 Randomized Controlled Trial (RCT) - A Phase 2, Long-Term Extension (LTE) Study in Subjects with Moderately to Severely Active SLE | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Elsubrutinib Product Code: ABBV-105 INN or Proposed INN: Elsubrutinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: UPADACITINIB Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: UPADACITINIB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 260 | Phase 2 | United States;Taiwan;Spain;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Australia;Bulgaria;Netherlands;Germany;China;Japan;Korea, Republic of | ||
| 165 | EUCTR2017-005028-11-NL (EUCTR) | 23/09/2020 | 02/07/2020 | A study of Baricitinib in patients with Lupus | A Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | United States;Serbia;Philippines;Taiwan;Greece;Spain;Chile;Israel;Russian Federation;Colombia;Switzerland;Italy;India;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan | ||
| 166 | EUCTR2019-003406-27-DE (EUCTR) | 17/09/2020 | 15/04/2020 | A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus - PHOENYCS GO | Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | Portugal;Serbia;United States;Philippines;Taiwan;Estonia;Slovakia;Greece;Spain;Chile;Colombia;Switzerland;Italy;France;Peru;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Sweden | ||
| 167 | EUCTR2019-003323-38-RO (EUCTR) | 16/09/2020 | 20/05/2022 | A study to determinate the safety and efficacy of LY3471851 in Adult Patients with Systemic Lupus Erythematosus | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of LY3471851 (NKTR-358) in Adults with Systemic Lupus Erythematosus - ISLAND-SLE | Systemic Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: LY3471851 Product Code: LY3471851 INN or Proposed INN: Not applicable Other descriptive name: LY3471851 | Eli Lilly & Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 280 | Phase 2 | United States;Czechia;Taiwan;Spain;Ukraine;Russian Federation;Israel;United Kingdom;India;Hungary;Mexico;Canada;Argentina;Poland;Romania;Australia;Germany;Japan;Korea, Republic of | ||
| 168 | EUCTR2019-003406-27-AT (EUCTR) | 11/09/2020 | 29/05/2020 | A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus - PHOENYCS GO | Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | Portugal;Serbia;United States;Philippines;Taiwan;Estonia;Slovakia;Greece;Spain;Chile;Colombia;Switzerland;Italy;France;Peru;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Bulgaria;Germany;Norway;Sweden | ||
| 169 | EUCTR2019-003406-27-GB (EUCTR) | 09/09/2020 | 15/07/2020 | A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus | Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Serbia;Portugal;Philippines;Taiwan;Estonia;Slovakia;Greece;Spain;Chile;Colombia;Switzerland;Italy;France;Australia;Peru;Netherlands;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Norway;Sweden | ||
| 170 | NCT04447053 (ClinicalTrials.gov) | September 2020 | 23/6/2020 | Sequential Belimumab and T-cell Based Therapy in SLE | Sequential Belimumab Followed by T-cell Based Therapy in the Treatment of Systemic Lupus Erythematosus (SUBTLE) - a Preliminary Proof-of-concept Mechanistic Study | Systemic Lupus Erythematosus | Drug: Belimumab Injection [Benlysta] | National University Hospital, Singapore | GlaxoSmithKline | Not yet recruiting | 21 Years | 70 Years | All | 80 | Phase 4 | Singapore |
| 171 | NCT04127747 (ClinicalTrials.gov) | August 18, 2020 | 14/10/2019 | Efficacy of Individualized Rituximab in Maintaining Remission of Moderate and Severe Systemic Lupus Erythematosus | A Multicenter, Randomized Controlled Clinical Study About Efficacy and Safety of Standard Dose and Individualized Dose of Rituximab in Maintaining Remission in Patients With Moderate to Severe Systemic Lupus Erythematosus | Autoimmune Diseases | Drug: Standard dose of rituximab;Drug: Individualized dose of rituximab | Second Affiliated Hospital, School of Medicine, Zhejiang University | NULL | Recruiting | 18 Years | 65 Years | All | 110 | Phase 4 | China |
| 172 | NCT04294667 (ClinicalTrials.gov) | August 12, 2020 | 27/2/2020 | A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: DZP;Other: Placebo | UCB Biopharma SRL | NULL | Recruiting | 16 Years | N/A | All | 450 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Bulgaria;Canada;Chile;Colombia;Czechia;Denmark;France;Germany;Greece;Hong Kong;Hungary;Italy;Korea, Republic of;Mexico;Peru;Philippines;Poland;Portugal;Romania;Serbia;Spain;Taiwan;United Kingdom |
| 173 | EUCTR2019-002205-22-DE (EUCTR) | 12/08/2020 | 07/07/2020 | Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment. | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis. | SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 23.1;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Branebrutinib Product Code: BMS-986195 INN or Proposed INN: Branebrutinib Other descriptive name: BMS986195 Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: ORENCIA | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 185 | Phase 2 | United States;France;Mexico;Argentina;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom | ||
| 174 | EUCTR2019-003406-27-GR (EUCTR) | 30/07/2020 | 02/06/2020 | A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus - PHOENYCS GO | Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Serbia;Portugal;Philippines;Taiwan;Greece;Spain;Chile;Colombia;Italy;France;Peru;Australia;Denmark;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany | ||
| 175 | EUCTR2018-001808-11-GR (EUCTR) | 29/07/2020 | 16/07/2020 | A research study to evaluate the effects of a new oral drug called cenerimod in adults with Systemic Lupus Erythematosus disease | A Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of cenerimod in subjects with moderate to severe systemic lupus erythematosus (SLE) - CARE: Cenerimod Assessing S1P1 Receptor modulation in Systemic Lupus Erythematosus | Moderate to severe systemic lupus erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod Other descriptive name: ACT-334441 Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod Other descriptive name: ACT-334441 Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod Other descriptive name: ACT-334441 Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod Other descriptive name: ACT-334441 | Idorsia Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 325 | Phase 2 | United States;Czechia;Philippines;Taiwan;Greece;Spain;Thailand;Ukraine;Turkey;Chile;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Mexico;Poland;Romania;Bulgaria;Georgia;Germany;China | ||
| 176 | EUCTR2019-003406-27-HU (EUCTR) | 28/07/2020 | 20/05/2020 | A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus | Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 | UCB Biopharma SRL | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | Portugal;United States;Serbia;Philippines;Taiwan;Estonia;Slovakia;Greece;Spain;Chile;Colombia;Switzerland;Italy;France;Denmark;Peru;Australia;Netherlands;Korea, Republic of;Czechia;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Norway;Sweden | ||
| 177 | NCT04451772 (ClinicalTrials.gov) | July 27, 2020 | 29/6/2020 | A Study of the Safety of Oral Elsubrutinib Capsules and Oral Upadacitinib Tablets Given Alone or in Combination (ABBV-599) for Adult Participants With Moderately to Severely Active Systemic Lupus Erythematosus to Assess Change in Disease State | A Phase 2, Long-Term Extension (LTE) Study With Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599) in Subjects With Moderately to Severely Active Systemic Lupus Erythematosus Who Have Completed the M19-130 Phase 2 Randomized Controlled Trial (RCT) | Systemic Lupus Erythematosus (SLE) | Drug: Elsubrutinib;Drug: Placebo for Elsubrutinib;Drug: Upadacitinib;Drug: Placebo for Upadacitinib | AbbVie | NULL | Active, not recruiting | 18 Years | 65 Years | All | 260 | Phase 2 | United States;Argentina;Australia;Bulgaria;China;Colombia;Germany;Hungary;Italy;Japan;Korea, Republic of;Mexico;New Zealand;Poland;Puerto Rico;Spain;Taiwan;United Kingdom;Canada;Netherlands |
| 178 | NCT05659407 (ClinicalTrials.gov) | July 24, 2020 | 13/12/2022 | BAFF-var as a Biomarker of Response to B-depletive Treatment in Systemic Lupus Erythematosus and Rheumatoid Arthritis | The BAFF-var Polymorphism as a Biomarker of Response to B-depletive Treatment in Patients Affected by Systemic Lupus Erythematosus and Rheumatoid Arthritis: a Prospective Study | Systemic Lupus Erythematosus;Rheumatoid Arthritis;BLyS Polymorphism | Drug: Belimumab in SLE patients / Rituximab in RA patients | University of Cagliari | Azienda Ospedaliero Universitaria di Cagliari | Recruiting | 18 Years | N/A | All | 60 | Italy | |
| 179 | JPRN-jRCT2031210119 | 17/07/2020 | 28/05/2021 | [M20-186] A Phase 2, Long-Term Extension (LTE) Study With Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599) in Subjects With Moderately to Severely Active Systemic Lupus Erythematosus Who Have Completed the M19-130 Phase 2 Randomized Controlled Trial (RCT) | [M20-186] A Phase 2, Long-Term Extension (LTE) Study With Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599) in Subjects With Moderately to Severely Active Systemic Lupus Erythematosus Who Have Completed the M19-130 Phase 2 Randomized Controlled Trial (RCT) | Systemic Lupus Erythematosus | Drug: Elsubrutinib Oral; Capsule Other Name: ABBV-105 Drug: Placebo for Elsubrutinib Oral; Capsule Drug: Upadacitinib Oral; Tablet Other Names:ABT-494, RINVOQ Drug: Placebo for Upadacitinib Oral; Tablet | Yamazaki Hayato | NULL | Recruiting | >= 18age old | <= 65age old | Both | 260 | Phase 2 | Argentina;Bulgaria;China;Germany;Hungary;Mexico;Netherlands;Poland;Puerto Rico;Spain;Taiwan;United States;Japan |
| 180 | NCT04060888 (ClinicalTrials.gov) | July 14, 2020 | 16/8/2019 | A Study of Ustekinumab in Chinese Participants With Active Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Chinese Subjects With Active Systemic Lupus Erythematosus | Lupus Erythematosus, Systemic | Drug: Ustekinumab (approximately 6 mg/kg);Drug: Ustekinumab 90 milligram (mg);Drug: Placebo | Janssen Research & Development, LLC | NULL | Withdrawn | 18 Years | 75 Years | All | 0 | Phase 3 | China |
| 181 | NCT04305197 (ClinicalTrials.gov) | July 9, 2020 | 10/3/2020 | A Study of ICP-022 in Patients With Systemic Lupus Erythematosus (SLE) | A Phase Ib/IIa Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety, Tolerance, Pharmacokinetics/ Pharmacodynamics(PK/PD) of ICP-022 in Patients With Mild and Moderate Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: ICP-022;Drug: Placebos | Beijing InnoCare Pharma Tech Co., Ltd. | NULL | Completed | 18 Years | 75 Years | All | 60 | Phase 1/Phase 2 | China |
| 182 | EUCTR2019-003406-27-BG (EUCTR) | 09/06/2020 | 21/04/2020 | A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus - PHOENYCS GO | Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | Portugal;Serbia;United States;Philippines;Taiwan;Estonia;Slovakia;Greece;Spain;Chile;Colombia;Switzerland;Italy;France;Peru;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Sweden | ||
| 183 | EUCTR2017-005028-11-HR (EUCTR) | 05/06/2020 | 23/11/2020 | A study of Baricitinib in patients with Lupus | A Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | United States;Serbia;Philippines;Taiwan;Greece;Spain;Chile;Israel;Russian Federation;Colombia;Switzerland;Italy;India;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan | ||
| 184 | EUCTR2019-003406-27-ES (EUCTR) | 02/06/2020 | 28/05/2020 | A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus | Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Serbia;Portugal;Philippines;Taiwan;Estonia;Slovakia;Greece;Spain;Chile;Colombia;Switzerland;Italy;France;Australia;Peru;Netherlands;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Norway;Sweden | ||
| 185 | EUCTR2017-005028-11-GR (EUCTR) | 20/05/2020 | 26/11/2019 | A study of Baricitinib in patients with Lupus | A Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | United States;Serbia;Philippines;Taiwan;Greece;Spain;Chile;Israel;Russian Federation;Colombia;Switzerland;Italy;India;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan | ||
| 186 | EUCTR2018-003471-35-ES (EUCTR) | 06/05/2020 | 10/05/2020 | Long-Term Safety and Efficacy of BMS-986165 in Subjects with Systemic Lupus Erythematosus | A Multi-Center Study to Characterize the Long-Term Safety and Efficacy of BMS-986165 in Subjects with Systemic Lupus Erythematosus | Systemic Lupus Erythematosus MedDRA version: 21.1;Level: LLT;Classification code 10042947;Term: Systemic lupus erythematosus synd;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BMS-986165 Product Code: BMS-986165 INN or Proposed INN: BMS-986165 Product Name: BMS-986165 Product Code: BMS-986165 INN or Proposed INN: BMS-986165 Product Name: BMS-986165 Product Code: BMS-986165 INN or Proposed INN: BMS-986165 | Bristol-Myers Squibb International Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 360 | Phase 2 | United States;Taiwan;Spain;Russian Federation;Israel;Colombia;France;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Romania;Australia;Germany;Korea, Republic of | ||
| 187 | EUCTR2019-002205-22-BE (EUCTR) | 05/05/2020 | 21/01/2020 | Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment. | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis. | SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 23.1;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Branebrutinib Product Code: BMS-986195 INN or Proposed INN: Branebrutinib Other descriptive name: BMS986195 Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: ORENCIA | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 185 | Phase 2 | France;United States;Mexico;Argentina;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom | ||
| 188 | EUCTR2019-002205-22-GB (EUCTR) | 01/05/2020 | 07/01/2020 | Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment. | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis. | SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Branebrutinib Product Code: BMS-986195 INN or Proposed INN: Branebrutinib Other descriptive name: BMS986195 Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: ORENCIA | Bristol-Myers Squibb International Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 185 | Phase 2 | United States;France;Mexico;Argentina;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom | ||
| 189 | EUCTR2019-002205-22-ES (EUCTR) | 06/04/2020 | 23/01/2020 | Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment. | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis. | SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Branebrutinib Product Code: BMS-986195 INN or Proposed INN: Branebrutinib Other descriptive name: BMS986195 Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: ORENCIA | Bristol-Myers Squibb International Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 185 | Phase 2 | United States;France;Mexico;Argentina;Poland;Belgium;Spain;Netherlands;Germany;United Kingdom | ||
| 190 | ChiCTR2000030342 | 2020-04-01 | 2020-02-29 | Treatment of connective tissue diseases (including systemic lupus erythematosus, primary Sjogren's syndrome, etc.) by intensive immunosuppressive therapy combined with targeted drugs(PAH targeted therapy)——A double center clinical observation study of pulmonary hypertension | Treatment of connective tissue diseases (including systemic lupus erythematosus, primary Sjogren's syndrome, etc.) by intensive immunosuppressive therapy combined with targeted drugs(PAH targeted therapy)——A double center clinical observation study of pulmonary hypertension | Connective tissue disease | Case series:immunosuppressive and PAH target therapy; | Guangdong Provincial People's Hospital | NULL | Pending | 18 | 75 | Both | Case series:20; | N/A | China |
| 191 | EUCTR2019-002205-22-PL (EUCTR) | 29/03/2020 | 07/02/2020 | Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment. | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis. | SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 23.1;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Branebrutinib Product Code: BMS-986195 INN or Proposed INN: Branebrutinib Other descriptive name: BMS986195 Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: ORENCIA | Bristol-Myers Squibb International Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 185 | Phase 2 | France;United States;Mexico;Argentina;Belgium;Spain;Poland;Germany;Netherlands;United Kingdom | ||
| 192 | JPRN-jRCTs011190011 | 13/03/2020 | 13/03/2020 | Steroid-Independent protocol using BELImumab for disease flare in patients with systemic lupUS erythematosus | Steroid-Independent protocol using BELImumab for disease flare in patients with systemic lupUS erythematosus - Sibelius Study | Systemic lupus erythematosus Systemic lupus erhythematosus;D008180 | Subjects who have met the entry criteria will be randomly to one of the two treatment groups based on a computer-generated randomization schedule as follows: 1) BEL group and 2) CS increased group using standard CS therapy (CS group) . 1. Subjects in BEL group will receive BEL 200 mg weekly SC on Day 0, and then every 7 days through week 24 or BEL 10mg/kg IV on Day 0, 14, 28 and every 1 month. 2. Subjects in CS group will receive prednisolone (All subjects will start treatment with MMF oral 1g/day In both groups, if subjects are not on treatment with HCQ, their drug will be started at a dose individually adjusted on basis of the patient's height (from 200 to 400mg/day). In the BEL group, the baseline dose of CS | Atsumi Tatsuya | NULL | Recruiting | >= 18age old | Not applicable | Both | 48 | Phase 4 | Japan |
| 193 | NCT04233164 (ClinicalTrials.gov) | March 4, 2020 | 16/1/2020 | Genomic Effects of Glucocorticoids in Patients With Systemic Lupus Erythematosus | Genomic Effects of Glucocorticoids in Patients With Systemic Lupus Erythematosus | Systemic Lupus Erythematous (SLE) | Drug: SOLU-MEDROL | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NULL | Active, not recruiting | 18 Years | 80 Years | All | 47 | Early Phase 1 | United States |
| 194 | EUCTR2019-000328-16-PT (EUCTR) | 02/03/2020 | 09/08/2019 | A Study to Evaluate the Efficacy and Safety of Rozibafusp Alfa (AMG 570) in Subjects With Active Systemic Lupus Erythematosus (SLE) With Inadequate Response to Standard of Care (SOC) Therapy | A Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Rozibafusp Alfa (AMG 570) in Subjects With Active Systemic Lupus Erythematosus (SLE) With Inadequate Response to Standard of Care (SOC) Therapy - Safety and Efficacy of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) | Active Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: AMG 570 INN or Proposed INN: AMG 570 Other descriptive name: AMG 570 Product Code: AMG 570 INN or Proposed INN: AMG 570 Other descriptive name: AMG 570 Product Code: AMG 570 INN or Proposed INN: AMG 570 Other descriptive name: AMG 570 | Amgen Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 2 | Portugal;United States;Czechia;Greece;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Canada;Poland;Australia;Bulgaria;Germany;Japan;Korea, Republic of | ||
| 195 | ITMCTR2000003055 | 2020-03-01 | 2020-02-26 | Clinical study of guanxining tablet in the treatment of rheumatoid arthritis with cardiovascular damage | Clinical study of guanxining tablet in the treatment of rheumatoid arthritis with cardiovascular damage | Systemic lupus erythematosus | experimental group:Integrative MTX with Guanxinning;control group:MTX; | Zhejinag University of f Chinese Medicine | NULL | Recruiting | Both | experimental group:30;control group:30; | China | |||
| 196 | ChiCTR2000030247 | 2020-03-01 | 2020-02-26 | Clinical study of guanxining tablet in the treatment of rheumatoid arthritis with cardiovascular damage | Clinical study of guanxining tablet in the treatment of rheumatoid arthritis with cardiovascular damage | Systemic lupus erythematosus | experimental group:Integrative MTX with Guanxinning;control group:MTX; | Zhejinag University of f Chinese Medicine | NULL | Recruiting | Both | experimental group:30;control group:30; | China | |||
| 197 | NCT04058028 (ClinicalTrials.gov) | February 19, 2020 | 30/7/2019 | Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) | A Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Rozibafusp Alfa (AMG 570) in Subjects With Active Systemic Lupus Erythematosus (SLE) With Inadequate Response to Standard of Care (SOC) Therapy | Systemic Lupus Erythematosus (SLE) | Drug: Rozibafusp Alfa;Drug: Placebo for Rozibafusp Alfa | Amgen | NULL | Active, not recruiting | 18 Years | 75 Years | All | 320 | Phase 2 | United States;Argentina;Australia;Bulgaria;Canada;Czechia;France;Germany;Greece;Hong Kong;Hungary;Italy;Japan;Korea, Republic of;Mexico;Poland;Portugal;Russian Federation;Spain |
| 198 | EUCTR2019-000638-20-NL (EUCTR) | 07/02/2020 | 09/12/2019 | A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of ABBV-105 and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus | A Phase 2 Study to Investigate the Safety and Efficacy of ABBV-105 and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Code: ABBV-105 INN or Proposed INN: N/A Other descriptive name: ABBV-105 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: UPADACITINIB Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: UPADACITINIB Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 325 | Phase 2 | United States;Czechia;Taiwan;Spain;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Puerto Rico;Canada;Argentina;Poland;Romania;Australia;Bulgaria;Netherlands;Germany;New Zealand;China;Japan;Korea, Republic of | ||
| 199 | EUCTR2018-004645-16-NL (EUCTR) | 29/01/2020 | 29/10/2019 | A study of belimumab in children with lupus | A Multi-Center, Open-Label Trial to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Subcutaneously Administered Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Participants with Systemic Lupus Erythematosus (SLE) - Ph 2,Benlysta, PLUTO-SC, PK-PD study in pediatric patients with SLE | Lupus - SLE MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Trade Name: Benlysta Product Name: Belimumab Product Code: GSK1550188 INN or Proposed INN: BELIMUMAB Other descriptive name: LymphoStat-B®, monoclonal anti-BLyS, LSB, BENLYSTA® | GlaxoSmithKline Research & Development Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 24 | Phase 2 | United States;Mexico;Argentina;Spain;Germany;Netherlands;Japan | ||
| 200 | EUCTR2019-000638-20-DE (EUCTR) | 22/01/2020 | 09/09/2019 | A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus | A Phase 2 Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Elsubrutinib Product Code: ABBV-105 INN or Proposed INN: Elsubrutinib Other descriptive name: ABBV-105 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: UPADACITINIB Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: UPADACITINIB Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 325 | Phase 2 | United States;Taiwan;Spain;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Canada;Puerto Rico;Argentina;Poland;Australia;Bulgaria;Netherlands;Germany;China;Japan;New Zealand;Korea, Republic of | ||
| 201 | NCT04186871 (ClinicalTrials.gov) | January 7, 2020 | 28/11/2019 | Study to Assess Safety and Effectiveness of Branebrutinib Treatment in Participants With Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Study Participants With Active Rheumatoid Arthritis | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects With Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects With Active Rheumatoid Arthritis | Autoimmune Disorder;Rheumatoid Arthritis;Systemic Lupus Erythematosus;Primary Sjögren's Syndrome | Drug: branebrutinib;Drug: abatacept;Drug: branebrutinib placebo | Bristol-Myers Squibb | NULL | Completed | 18 Years | 75 Years | All | 112 | Phase 2 | United States;Argentina;Belgium;France;Germany;Mexico;Netherlands;Poland;Spain;United Kingdom;Australia |
| 202 | EUCTR2018-003471-35-RO (EUCTR) | 31/12/2019 | 07/03/2022 | Long-Term Safety and Efficacy of BMS-986165 in Subjects with Systemic Lupus Erythematosus | A Multi-Center Study to Characterize the Long-Term Safety and Efficacy of BMS-986165 in Subjects with Systemic Lupus Erythematosus | Systemic Lupus Erythematosus MedDRA version: 21.1;Level: LLT;Classification code 10042947;Term: Systemic lupus erythematosus synd;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BMS-986165 Product Code: BMS-986165 INN or Proposed INN: BMS-986165 Product Name: BMS-986165 Product Code: BMS-986165 INN or Proposed INN: BMS-986165 Product Name: BMS-986165 Product Code: BMS-986165 INN or Proposed INN: BMS-986165 | Bristol-Myers Squibb International Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 360 | Phase 2 | United States;Taiwan;Spain;Israel;Russian Federation;France;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Australia;Germany;Korea, Republic of | ||
| 203 | EUCTR2018-004175-12-GB (EUCTR) | 30/12/2019 | 23/07/2019 | A Phase 2b multicenter dose ranging study to evaluate efficacy and safety of PF-06700841 in systemic lupus erythematosus | A PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, DOSE RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06700841 IN PARTICIPANTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: PF-06700841 Product Code: PF-06700841 5mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 Product Name: PF-06700841 Product Code: PF-06700841 25mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 | Pfizer Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 448 | Phase 2 | Hong Kong;Greece;Spain;Ukraine;Colombia;United Kingdom;France;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Germany;Japan;China;Korea, Republic of;United States;Serbia;Portugal;Taiwan | ||
| 204 | EUCTR2018-004645-16-DE (EUCTR) | 27/12/2019 | 18/09/2019 | A study of belimumab in children with lupus | A Multi-Center, Open-Label Trial to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Subcutaneously Administered Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Participants with Systemic Lupus Erythematosus (SLE) - Ph 2,Benlysta, PLUTO-SC, PK-PD study in pediatric patients with SLE | Lupus - SLE MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Trade Name: Benlysta Product Name: Belimumab Product Code: GSK1550188 INN or Proposed INN: BELIMUMAB Other descriptive name: LymphoStat-B®, monoclonal anti-BLyS, LSB, BENLYSTA® | GlaxoSmithKline Research & Development Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 24 | Phase 2 | United States;Mexico;Argentina;Spain;Netherlands;Germany;Japan | ||
| 205 | EUCTR2019-000328-16-FR (EUCTR) | 20/12/2019 | 16/07/2019 | A Study to Evaluate the Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) With Inadequate Response to Standard of Care (SOC) Therapy | A Phase 2 Dose Ranging Study to Evaluate the Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) With Inadequate Response to Standard of Care (SOC) Therapy - Safety and Efficacy of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) | Active Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: AMG 570 INN or Proposed INN: AMG 570 Other descriptive name: AMG 570 Product Code: AMG 570 INN or Proposed INN: AMG 570 Other descriptive name: AMG 570 Product Code: AMG 570 INN or Proposed INN: AMG 570 Other descriptive name: AMG 570 | Amgen Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Portugal;United States;Austria;Russian Federation;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Canada;Poland;Australia;Bulgaria;Germany;Japan;Korea, Republic of | ||
| 206 | EUCTR2017-005028-11-IT (EUCTR) | 19/12/2019 | 22/01/2021 | A study of Baricitinib in patients with Lupus | A Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE) - NA | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Olumiant Product Name: Baricitinib Product Code: [LY3009104] INN or Proposed INN: Baricitinib Other descriptive name: Baricitinib Trade Name: Olumiant Product Name: Baricitinib Product Code: [LY3009104] INN or Proposed INN: Baricitinib Other descriptive name: Baricitinib | ELI LILLY & COMPANY, LILLY CORPORATE CENTER | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | Serbia;United States;Philippines;Taiwan;Greece;Spain;Ukraine;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Australia;Netherlands;China;Korea, Republic of;Czechia;Korea, Democratic People's Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan | ||
| 207 | EUCTR2018-004645-16-ES (EUCTR) | 16/12/2019 | 11/11/2019 | A study of belimumab in children with lupus | A Multi-Center, Open-Label Trial to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Subcutaneously Administered Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Participants with Systemic Lupus Erythematosus (SLE) - Ph 2,Benlysta, PLUTO-SC, PK-PD study in pediatric patients with SLE | Lupus - SLE MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Trade Name: Benlysta Product Name: Belimumab Product Code: GSK1550188 INN or Proposed INN: BELIMUMAB Other descriptive name: LymphoStat-B®, monoclonal anti-BLyS, LSB, BENLYSTA® | GlaxoSmithKline, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 24 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Mexico;Argentina;Spain;Netherlands;Germany;Japan | ||
| 208 | NCT04179032 (ClinicalTrials.gov) | November 28, 2019 | 25/11/2019 | Study of Subcutaneous (SC) Belimumab in Pediatric Participants With Systemic Lupus Erythematosus (SLE) | A Multi-Center, Open-Label Trial to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Subcutaneously Administered Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Participants With Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Combination Product: Belimumab | GlaxoSmithKline | NULL | Active, not recruiting | 5 Years | 17 Years | All | 30 | Phase 2 | United States;Argentina;Germany;Japan;Mexico;Netherlands;Spain |
| 209 | EUCTR2018-004175-12-PT (EUCTR) | 25/11/2019 | 30/07/2019 | A Phase 2b multicenter dose ranging study to evaluate efficacy and safety of PF-06700841 in systemic lupus erythematosus | A PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, DOSE RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06700841 IN PARTICIPANTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: PF-06700841 Product Code: PF-06700841 5mg INN or Proposed INN: brepocitinib Other descriptive name: PF-06700841-15 Product Name: PF-06700841 Product Code: PF-06700841 25mg INN or Proposed INN: brepocitinib Other descriptive name: PF-06700841-15 | Pfizer Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 448 | Phase 2 | United States;Serbia;Portugal;Hong Kong;Taiwan;Greece;Spain;Ukraine;Colombia;Italy;France;Australia;Netherlands;China;Korea, Republic of;Czechia;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Japan | ||
| 210 | EUCTR2018-004175-12-ES (EUCTR) | 12/11/2019 | 11/11/2019 | A Phase 2b multicenter dose ranging study to evaluate efficacy and safety of PF-06700841 in systemic lupus erythematosus | A PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, DOSE RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06700841 IN PARTICIPANTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: PF-06700841 Product Code: PF-06700841 5mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 Product Name: PF-06700841 Product Code: PF-06700841 25mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 | Pfizer Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 448 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Portugal;Serbia;Taiwan;Hong Kong;Greece;Spain;Ukraine;Colombia;France;Australia;Netherlands;China;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan | ||
| 211 | NCT04136145 (ClinicalTrials.gov) | October 28, 2019 | 21/10/2019 | Single Dose Study to Investigate the Pharmacokinetics (PK) and Safety of Belimumab 200 Milligrams (mg) Intravenous and 200 mg Subcutaneous Via Auto-injector in Chinese Healthy Subjects | An Open-label, Randomized, Parallel Group, Single Dose Study to Investigate the PK and Safety of Belimumab 200 mg Intravenous and 200 mg Subcutaneous Via Auto-injector in Chinese Healthy Participants | Systemic Lupus Erythematosus | Drug: Belimumab for IV;Drug: Belimumab for SC | GlaxoSmithKline | NULL | Completed | 18 Years | 45 Years | All | 36 | Phase 1 | China |
| 212 | EUCTR2017-005026-37-HR (EUCTR) | 24/10/2019 | 20/01/2020 | A study of Baricitinib in patients with Lupus | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 825 | Phase 3 | United States;Taiwan;Greece;Ukraine;Austria;Russian Federation;United Kingdom;Switzerland;Czech Republic;Hungary;Mexico;Belgium;Brazil;Croatia;Australia;Netherlands;Germany;China | ||
| 213 | EUCTR2017-005028-11-GB (EUCTR) | 24/10/2019 | 18/03/2019 | A study of Baricitinib in patients with Lupus | A Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1100 | Phase 3 | United States;Serbia;Philippines;Taiwan;Spain;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Australia;South Africa;China;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Brazil;Belgium;Poland;Romania;Germany;Japan | ||
| 214 | NCT04275193 (ClinicalTrials.gov) | October 22, 2019 | 12/2/2020 | The Safety and Efficacy of Zishenqing in Subjects With Active Systemic Lupus Erythematosus | The Safety and Efficacy of the Traditional Chinese Medicine Zishenqing in Subjects With Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: Zishenqing;Drug: Placebo | Shanghai University of Traditional Chinese Medicine | RenJi Hospital | Recruiting | 18 Years | 65 Years | All | 118 | Phase 2/Phase 3 | China |
| 215 | EUCTR2019-000638-20-IT (EUCTR) | 22/10/2019 | 17/06/2021 | A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus | A Phase 2 Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus - na | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Elsubrutinib Product Code: [ABBV-105] INN or Proposed INN: Elsubrutinib Product Name: Upadacitinib Product Code: [ABT-494] INN or Proposed INN: UPADACITINIB Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: [ABT-494] INN or Proposed INN: UPADACITINIB | ABBVIE DEUTSCHLAND GMBH & CO. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 325 | Phase 2 | United States;Czechia;Taiwan;Spain;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Canada;Puerto Rico;Argentina;Poland;Romania;Australia;Bulgaria;Netherlands;Germany;China;Japan;New Zealand;Korea, Republic of | ||
| 216 | EUCTR2018-004175-12-RO (EUCTR) | 17/10/2019 | 26/07/2019 | A Phase 2b multicenter dose ranging study to evaluate efficacy and safety of PF-06700841 in systemic lupus erythematosus | A PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, DOSE RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06700841 IN PARTICIPANTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: PF-06700841 Product Code: PF-06700841 5mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 Product Name: PF-06700841 Product Code: PF-06700841 25mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 | Pfizer Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 448 | Phase 2 | United States;Serbia;Portugal;Taiwan;Hong Kong;Greece;Spain;Ukraine;Colombia;Italy;France;Australia;Netherlands;China;Korea, Republic of;Czechia;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan | ||
| 217 | NCT04082416 (ClinicalTrials.gov) | October 16, 2019 | 1/9/2019 | Study of Recombinant Human B Lymphocyte(RC18) Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus(SLE) | A Phase III, Placebo-Controlled ,Multi-Center, Randomized, Double-Blind, Dose-exploring Trial of RC18,a Recombinant Human B Lymphocyte Stimulating Factor Receptor-Antibody Fusion Protein in Subjects With Systemic Lupus Erythematosus (SLE). | Systemic Lupus Erythematosus | Biological: Placebo plus standard therapy;Biological: RC18 160 mg plus standard therapy | RemeGen Co., Ltd. | NULL | Active, not recruiting | 18 Years | 65 Years | All | 335 | Phase 3 | China |
| 218 | EUCTR2018-004175-12-BG (EUCTR) | 11/10/2019 | 30/07/2019 | A Phase 2b multicenter dose ranging study to evaluate efficacy and safety of PF-06700841 in systemic lupus erythematosus | A PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, DOSE RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06700841 IN PARTICIPANTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: PF-06700841 Product Code: PF-06700841 5mg INN or Proposed INN: brepocitinib Other descriptive name: PF-06700841-15 Product Name: PF-06700841 Product Code: PF-06700841 25mg INN or Proposed INN: brepocitinib Other descriptive name: PF-06700841-15 | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 2 | United States;Portugal;Taiwan;Hong Kong;Greece;Spain;Ukraine;Colombia;Italy;France;Australia;China;Korea, Republic of;Czechia;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Germany;Japan;Serbia | ||
| 219 | EUCTR2018-004175-12-DE (EUCTR) | 08/10/2019 | 02/08/2019 | A Phase 2b multicenter dose ranging study to evaluate efficacy and safety of PF-06700841 in systemic lupus erythematosus | A PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, DOSE RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06700841 IN PARTICIPANTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: PF-06700841 Product Code: PF-06700841 5mg INN or Proposed INN: brepocitinib Other descriptive name: PF-06700841-15 Product Name: PF-06700841 Product Code: PF-06700841 25mg INN or Proposed INN: brepocitinib Other descriptive name: PF-06700841-15 | Pfizer Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 448 | Phase 2 | Serbia;United States;Portugal;Taiwan;Hong Kong;Greece;Spain;Ukraine;Colombia;Italy;France;Australia;Netherlands;China;Korea, Republic of;Czechia;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Japan | ||
| 220 | EUCTR2018-001808-11-DE (EUCTR) | 04/10/2019 | 18/10/2018 | A research study to evaluate the effects of a new oral drug called cenerimod in adults with Systemic Lupus Erythematosus disease | A Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of cenerimod in subjects with moderate to severe systemic lupus erythematosus (SLE) - CARE: Cenerimod Assessing S1P1 Receptor modulation in Systemic Lupus Erythematosus | Moderate to severe systemic lupus erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod | Idorsia Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 500 | Phase 2 | United States;Taiwan;Thailand;Spain;Ukraine;Turkey;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Poland;Romania;Bulgaria;Georgia;Germany;China | ||
| 221 | EUCTR2019-000328-16-IT (EUCTR) | 01/10/2019 | 15/06/2021 | A Study to Evaluate the Efficacy and Safety of Rozibafusp Alfa (AMG 570) in Subjects With Active Systemic Lupus Erythematosus (SLE) With Inadequate Response to Standard of Care (SOC) Therapy | Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Rozibafusp Alfa (AMG 570) in Subjects With Active Systemic Lupus Erythematosus (SLE) With Inadequate Response to Standard of Care (SOC) Therapy - Safety and Efficacy of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) | Active Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: AMG 570 Product Code: [AMG 570] Other descriptive name: AMG 570 Product Name: AMG 570 Product Code: [AMG 570] Other descriptive name: AMG 570 Product Name: AMG 570 Product Code: [AMG 570] Other descriptive name: AMG 570 | AMGEN INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 2 | Portugal;United States;Czechia;Greece;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Canada;Poland;Australia;Bulgaria;Germany;Japan;Korea, Republic of | ||
| 222 | NCT04128579 (ClinicalTrials.gov) | October 1, 2019 | 30/9/2019 | Study of EQ001 (Itolizumab) in Systemic Lupus Erythematosus With or Without Active Proliferative Nephritis | A Phase 1b Multiple Ascending-dose Study of EQ001 in Subjects With Systemic Lupus Erythematosus With or Without Active Proliferative Lupus Nephritis | Lupus Erythematosus;Lupus Nephritis | Drug: Itolizumab [Bmab 600] | Equillium | Biocon Limited | Recruiting | 18 Years | 75 Years | All | 55 | Phase 1 | United States;India;Poland |
| 223 | EUCTR2018-000305-23-RO (EUCTR) | 30/09/2019 | 09/06/2022 | No | A Randomized Double-Blind Phase 1b/2 Combined Staggered Multiple Dose Escalation Study of BOS161721 in Systemic Lupus Erythematosus (SLE) Patients on a Background of Limited Standard of Care | Systemic lupus erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: BOS161721 Product Code: BOS161721 INN or Proposed INN: Not known Other descriptive name: IMMUNOGLOBULIN G | Boston Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 156 | Phase 2 | United States;Philippines;Hungary;Mexico;Argentina;Poland;Ukraine;Romania;Peru;Georgia;Bulgaria;Colombia | ||
| 224 | NCT04835883 (ClinicalTrials.gov) | September 26, 2019 | 6/4/2021 | Exploring the Efficacy and Safety of CS20AT04 (Allogenic Bone Marrow-Derived Stem Cell) in Systemic Lupus Erythematosus Patients | Open-label, Single-arm, 24-week Investigator Study to Evaluate the Efficacy and Safety of CS20AT04 (HLA-haplo Matched Allogenic Bone Marrow-Derived Stem Cells) Administered in Patients With Lupus Nephritis or Lupus Cytopenia | Systemic Lupus Erythematosus | Biological: CS20AT04 (allogenic bone marrow derived mesenchymal stem cell) | Hanyang University Seoul Hospital | Corestem, Inc.;Ministry of Health & Welfare, Korea | Recruiting | 18 Years | 70 Years | All | 10 | Phase 2 | Korea, Republic of |
| 225 | EUCTR2018-004175-12-HU (EUCTR) | 23/09/2019 | 23/07/2019 | A Phase 2b multicenter dose ranging study to evaluate efficacy and safety of PF-06700841 in systemic lupus erythematosus | A PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, DOSE RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06700841 IN PARTICIPANTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: PF-06700841 Product Code: PF-06700841 5mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 Product Name: PF-06700841 Product Code: PF-06700841 25mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 | Pfizer Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 448 | Phase 2 | United States;Portugal;Serbia;Taiwan;Hong Kong;Greece;Spain;Ukraine;Colombia;France;Australia;Netherlands;China;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan | ||
| 226 | EUCTR2019-000328-16-HU (EUCTR) | 23/09/2019 | 16/07/2019 | A Study to Evaluate the Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) With Inadequate Response to Standard of Care (SOC) Therapy | A Phase 2 Dose Ranging Study to Evaluate the Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) With Inadequate Response to Standard of Care (SOC) Therapy - Safety and Efficacy of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) | Active Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: AMG 570 INN or Proposed INN: AMG 570 Other descriptive name: AMG 570 Product Code: AMG 570 INN or Proposed INN: AMG 570 Other descriptive name: AMG 570 Product Code: AMG 570 INN or Proposed INN: AMG 570 Other descriptive name: AMG 570 | Amgen Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Portugal;United States;Austria;Russian Federation;Switzerland;United Kingdom;Italy;France;Hungary;Czech Republic;Mexico;Canada;Poland;Australia;Bulgaria;Germany;Japan;Korea, Republic of | ||
| 227 | EUCTR2019-000638-20-HU (EUCTR) | 18/09/2019 | 02/10/2019 | A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus | A Phase 2 Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Elsubrutinib Product Code: ABBV-105 INN or Proposed INN: ELSUBRUTINIB Other descriptive name: ABBV-105 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: UPADACITINIB Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: UPADACITINIB Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 325 | Phase 2 | United States;Taiwan;Spain;Colombia;United Kingdom;Italy;France;Hungary;Czech Republic;Mexico;Puerto Rico;Canada;Argentina;Poland;Romania;Australia;Bulgaria;Netherlands;Germany;New Zealand;China;Japan;Korea, Republic of | ||
| 228 | EUCTR2019-000328-16-DE (EUCTR) | 17/09/2019 | 11/07/2019 | A Study to Evaluate the Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) With Inadequate Response to Standard of Care (SOC) Therapy | A Phase 2 Dose Ranging Study to Evaluate the Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) With Inadequate Response to Standard of Care (SOC) Therapy - Safety and Efficacy of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) | Active Systemic Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: AMG 570 INN or Proposed INN: AMG 570 Other descriptive name: AMG 570 Product Code: AMG 570 INN or Proposed INN: AMG 570 Other descriptive name: AMG 570 Product Code: AMG 570 INN or Proposed INN: AMG 570 Other descriptive name: AMG 570 | Amgen Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Portugal;United States;Austria;Russian Federation;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Canada;Poland;Australia;Bulgaria;Germany;Japan;Korea, Republic of | ||
| 229 | NCT03562065 (ClinicalTrials.gov) | September 11, 2019 | 22/5/2018 | Treatment of Refractory Systemic Lupus Erythematosus by Allogeneic Mesenchymal Stem Cells Derived From the Umbilical Cord | Treatment of Refractory Systemic Lupus Erythematosus by Injection of Allogeneic Mesenchymal Stem Cells Derived From the Umbilical Cord | Lupus Erythematosus;Stem Cell Transplant | Biological: mesenchymal stem cells | Assistance Publique - Hôpitaux de Paris | NULL | Recruiting | 18 Years | 70 Years | All | 10 | Phase 1/Phase 2 | France |
| 230 | NCT04077684 (ClinicalTrials.gov) | September 10, 2019 | 1/9/2019 | Efficacy and Safety of Low-dose IL-2 in Patients With SLE: a Multicenter, Randomised, Placebo-controlled Trial | Efficacy and Safety of Low-dose Interleukin-2 in Patients With Systemic Lupus Erythematosus: a Multicenter, Randomised, Placebo-controlled Trial | Systemic Lupus Erythematosus | Drug: Interleukin-2 | Peking University People's Hospital | NULL | Recruiting | 18 Years | 75 Years | All | 500 | Phase 2 | China |
| 231 | NCT03843125 (ClinicalTrials.gov) | September 9, 2019 | 14/2/2019 | A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (SLE) | A Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients With Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Drug: Baricitinib | Eli Lilly and Company | Incyte Corporation | Terminated | 18 Years | N/A | All | 1156 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Chile;China;Colombia;Croatia;Czechia;France;Germany;Greece;Hungary;India;Israel;Italy;Japan;Korea, Republic of;Mexico;Netherlands;Philippines;Poland;Romania;Russian Federation;Serbia;South Africa;Spain;Switzerland;Taiwan;United Kingdom |
| 232 | EUCTR2019-000638-20-ES (EUCTR) | 09/09/2019 | 27/09/2019 | A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of ABBV-105 and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus | A Phase 2 Study to Investigate the Safety and Efficacy of ABBV-105 and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Code: ABBV-105 INN or Proposed INN: ABBV-105 Other descriptive name: ABBV-105 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: UPADACITINIB Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: UPADACITINIB Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 325 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Taiwan;Spain;Colombia;Italy;United Kingdom;France;Czech Republic;Hungary;Mexico;Puerto Rico;Canada;Argentina;Poland;Romania;Australia;Germany;New Zealand;Japan;China;Korea, Republic of | ||
| 233 | EUCTR2018-004175-12-PL (EUCTR) | 03/09/2019 | 06/08/2019 | A Phase 2b multicenter dose ranging study to evaluate efficacy and safety of PF-06700841 in systemic lupus erythematosus | A PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06700841 IN PARTICIPANTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: PF-06700841 Product Code: PF-06700841 5mg INN or Proposed INN: brepocitinib Other descriptive name: PF-06700841-15 Product Name: PF-06700841 Product Code: PF-06700841 25mg INN or Proposed INN: brepocitinib Other descriptive name: PF-06700841-15 | Pfizer Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 448 | Phase 2 | United States;Serbia;Portugal;Taiwan;Hong Kong;Greece;Spain;Ukraine;Colombia;Italy;France;Australia;Netherlands;China;Korea, Republic of;Czechia;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Germany;Japan | ||
| 234 | ChiCTR1900025376 | 2019-09-01 | 2019-08-25 | Lenalidomide in Treatment-Refractory Lupus-Associated Skin Lesions in Systemic Lupus Erythematosus: A Single-Center, Randomized, Double-Blinded, Placebo-Controlled Clinical Trial | Lenalidomide in Treatment-Refractory Lupus-Associated Skin Lesions in Systemic Lupus Erythematosus: A Single-Center, Randomized, Double-Blinded, Placebo-Controlled Clinical Trial | systemic lupus erythematosus | intervention group:lenalidomide 10mg qd;control group:placebo 10mg qd; | Chinese Academy of Medical Sciences Peking Union Medical College Hospital | NULL | Recruiting | 18 | 70 | Both | intervention group:15;control group:15; | Phase 4 | China |
| 235 | EUCTR2018-004175-12-CZ (EUCTR) | 21/08/2019 | 25/07/2019 | A Phase 2b multicenter dose ranging study to evaluate efficacy and safety of PF-06700841 in systemic lupus erythematosus | A PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, DOSE RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06700841 IN PARTICIPANTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: PF-06700841 Product Code: PF-06700841 5mg INN or Proposed INN: brepocitinib Other descriptive name: PF-06700841-15 Product Name: PF-06700841 Product Code: PF-06700841 25mg INN or Proposed INN: brepocitinib Other descriptive name: PF-06700841-15 | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 2 | Serbia;United States;Portugal;Taiwan;Hong Kong;Greece;Spain;Ukraine;Colombia;Italy;France;Australia;Netherlands;China;Korea, Republic of;Czechia;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Germany;Japan | ||
| 236 | EUCTR2017-005026-37-NL (EUCTR) | 06/08/2019 | 13/05/2019 | A study of Baricitinib in patients with Lupus | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 825 | Phase 3 | United States;Czechia;Taiwan;Greece;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Switzerland;Czech Republic;Hungary;Mexico;Brazil;Belgium;Croatia;Australia;Germany;Netherlands;China | ||
| 237 | EUCTR2017-005026-37-GR (EUCTR) | 26/07/2019 | 03/05/2019 | A study of Baricitinib in patients with Lupus | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 825 | Phase 3 | United States;Taiwan;Greece;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Switzerland;Czech Republic;Hungary;Mexico;Belgium;Brazil;Croatia;Australia;Germany;Netherlands;China | ||
| 238 | NCT03978520 (ClinicalTrials.gov) | July 25, 2019 | 3/6/2019 | A Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination in Participants With Moderately to Severely Active Systemic Lupus Erythematosus (SLE) | A Phase 2 Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects With Moderately to Severely Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) | Drug: Elsubrutinib;Drug: Placebo for Elsubrutinib;Drug: Upadacitinib;Drug: Placebo for upadacitinib | AbbVie | NULL | Completed | 18 Years | 65 Years | All | 341 | Phase 2 | United States;Argentina;Australia;Bulgaria;Canada;China;Colombia;France;Germany;Hungary;Italy;Japan;Korea, Republic of;Mexico;Netherlands;New Zealand;Poland;Puerto Rico;Spain;Taiwan;United Kingdom |
| 239 | NCT03951259 (ClinicalTrials.gov) | July 24, 2019 | 14/5/2019 | Safety and Efficacy of SM934 Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus | A Randomised, Double-blind, Placebo-controlled, Phase 2 Study Evaluating the Safety and Efficacy of SM934 in Adult Subjects With Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: SM934;Drug: Placebos | RenJi Hospital | Jiangsu ZuoYou Medicine Co., Ltd. | Recruiting | 18 Years | 70 Years | All | 48 | Phase 2 | China |
| 240 | EUCTR2017-005028-11-RO (EUCTR) | 22/07/2019 | 15/03/2022 | A study of Baricitinib in patients with Lupus | A Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | Serbia;United States;Philippines;Taiwan;Greece;Spain;Russian Federation;Chile;Colombia;Switzerland;Italy;India;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan | ||
| 241 | EUCTR2017-005028-11-PL (EUCTR) | 05/07/2019 | 23/04/2019 | A study of Baricitinib in patients with Lupus | A Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-TermSafety and Efficacy of Baricitinib in Patients with Systemic LupusErythematosus (SLE) | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | United States;Serbia;Philippines;Taiwan;Greece;Spain;Chile;Russian Federation;Colombia;Italy;Switzerland;India;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan | ||
| 242 | EUCTR2018-001735-49-GB (EUCTR) | 01/07/2019 | 22/01/2019 | RIvaroxaban for Stroke patients with AntiPhospholipid Syndrome | Rivaroxaban versus warfarin for stroke patients with antiphospholipid syndrome, with or without SLE (RISAPS): a randomised, controlled, open-label, phase II/III, non-inferiority trial - RIvaroxaban for Stroke patients with AntiPhospholipid Syndrome | Patients with stroke or other ischaemic brain injury who have antiphospholipid syndrome (APS), with or without systemic lupus erythematosus (SLE) MedDRA version: 20.0;Level: PT;Classification code 10002817;Term: Antiphospholipid syndrome;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Rivaroxaban Product Name: Rivaroxaban INN or Proposed INN: Rivaroxaban Other descriptive name: Trade Name Xarelto Trade Name: Warfarin Sodium Product Name: Warfarin Sodium INN or Proposed INN: Warfarin sodium | University College London | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 2;Phase 3 | United Kingdom | ||
| 243 | NCT04184258 (ClinicalTrials.gov) | July 1, 2019 | 1/12/2019 | Treatment of Systemic Lupus Erythematosus With Pooled Allogenic Mesenchymal Stem Cells | Treatment of Systemic Lupus Erythematosus With Pooled Allogenic Olfactory Mucosa Derived Mesenchymal Stem Cells | Systemic Lupus Erythematosus | Biological: Pooled mesenchymal stem cell;Other: Standard treatment according to the Clinical protocols | Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus | Belarusian State Medical University | Completed | 18 Years | 75 Years | All | 7 | Phase 1/Phase 2 | Belarus |
| 244 | NCT03984227 (ClinicalTrials.gov) | July 2019 | 28/5/2019 | New Signaling Pathway Targeting Systemic Lupus Erythematosus | Studying of New Signaling Pathway Targeting Systemic Lupus Erythematosus | SLE | Genetic: Taking peripheral blood samples | Assiut University | NULL | Not yet recruiting | 18 Years | 60 Years | All | 60 | NULL | |
| 245 | NCT03656627 (ClinicalTrials.gov) | June 27, 2019 | 31/8/2018 | Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer and Pre-existing Autoimmune Disease | Safety, Activity, and Pharmacology of Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer and Pre-existing Autoimmune Disease | Autoimmune Diseases;Non-small Cell Lung Cancer;Rheumatoid Arthritis;Psoriasis;Giant Cell Arteritis;Polymyalgia Rheumatica;Systemic Lupus Erythematosus;Crohn Disease;Multiple Sclerosis;Ulcerative Colitis | Drug: Nivolumab | Alliance Foundation Trials, LLC. | Bristol-Myers Squibb | Terminated | 18 Years | N/A | All | 7 | Phase 1 | United States |
| 246 | ChiCTR1900022934 | 2019-06-20 | 2019-05-04 | Study for the metabolic mechanism of Langchuangjing granule in the treatment of systemic lupus erythematosusin | Study for the metabolic mechanism of Langchuangjing granule in the treatment of systemic lupus erythematosusin | Systemic Lupus Erythematosus | Experimental group:Langchuangjing granule + Prednisone acetate tablets, Hydroxychloroquine;control group:Prednisone acetate tablets?Hydroxychloroquine;healthy control group:nothing; | Nanjing University of Chinese Medicine Affiliated Hospital | NULL | Pending | Both | Experimental group:20;control group:20;healthy control group:20; | Phase 1 | China | ||
| 247 | ITMCTR1900002316 | 2019-06-20 | 2019-05-04 | Study for the metabolic mechanism of Langchuangjing granule in the treatment of systemic lupus erythematosusin | Study for the metabolic mechanism of Langchuangjing granule in the treatment of systemic lupus erythematosusin | Systemic Lupus Erythematosus | healthy control group:nothing;control group:Prednisone acetate tablets\Hydroxychloroquine;Experimental group:Langchuangjing granule + Prednisone acetate tablets, Hydroxychloroquine; | Nanjing University of Chinese Medicine Affiliated Hospital | NULL | Pending | Both | healthy control group:20;control group:20;Experimental group:20; | Phase 1 | China | ||
| 248 | EUCTR2017-001203-79-ES (EUCTR) | 11/06/2019 | 30/04/2019 | A clinical study to test the efficacy and safety of BMS-986165 in Subjects with Systemic Lupus Erythematosus. | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of BMS-986165 in Subjects with Systemic Lupus Erythematosus | Systemic Lupus Erythematosus MedDRA version: 20.0;Level: LLT;Classification code 10042947;Term: Systemic lupus erythematosus synd;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BMS-986165 Product Code: BMS-986165 INN or Proposed INN: BMS-986165 | Bristol-Myers Squibb International Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 360 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Taiwan;Spain;Russian Federation;Israel;Colombia;France;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Australia;Germany;Japan;Korea, Republic of | ||
| 249 | EUCTR2017-005028-11-AT (EUCTR) | 02/06/2019 | 28/03/2019 | A study of Baricitinib in patients with Lupus | A Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | Serbia;United States;Philippines;Taiwan;Greece;Spain;Russian Federation;Chile;Colombia;Switzerland;Italy;India;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan | ||
| 250 | NCT03804723 (ClinicalTrials.gov) | June 2019 | 11/1/2019 | Glucocorticoids Withdrawal in Early Systemic Lupus Erythematosus | Glucocorticoids Withdrawal in Early Systemic Lupus Erythematosus: a Randomized Placebo-controlled Equivalence Trial | Systemic Lupus Erythematosus;Glucocorticoids;Therapy Withdrawal | Drug: oral Prednisone 5mg | University of Pisa | NULL | Not yet recruiting | 18 Years | 85 Years | All | 321 | N/A | NULL |
| 251 | EUCTR2017-005028-11-ES (EUCTR) | 30/05/2019 | 31/05/2019 | A study of Baricitinib in patients with Lupus | A Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus (SLE) MedDRA version: 20.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | United States;Serbia;Philippines;Taiwan;Greece;Spain;Ukraine;Chile;Russian Federation;Colombia;Italy;Switzerland;India;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan | ||
| 252 | EUCTR2018-003471-35-HU (EUCTR) | 29/05/2019 | 02/04/2019 | Long-Term Safety and Efficacy of BMS-986165 in Subjects with Systemic Lupus Erythematosus | A Multi-Center Study to Characterize the Long-Term Safety and Efficacy of BMS-986165 in Subjects with Systemic Lupus Erythematosus | Systemic Lupus Erythematosus MedDRA version: 21.1;Level: LLT;Classification code 10042947;Term: Systemic lupus erythematosus synd;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BMS-986165 Product Code: BMS-986165 INN or Proposed INN: BMS-986165 Product Name: BMS-986165 Product Code: BMS-986165 INN or Proposed INN: BMS-986165 Product Name: BMS-986165 Product Code: BMS-986165 INN or Proposed INN: BMS-986165 | Bristol-Myers Squibb International Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 360 | Phase 2 | United States;Taiwan;Spain;Russian Federation;Colombia;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Romania;Japan;Korea, Republic of | ||
| 253 | NCT03933943 (ClinicalTrials.gov) | May 21, 2019 | 30/4/2019 | A Study of LY3361237 in Participants With Systemic Lupus Erythematosus | A Phase 1, Randomized, Placebo-Controlled, Multiple- Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous LY3361237 in Patients With Systemic Lupus Erythematosus | Lupus Erythematosus, Systemic | Drug: LY3361237;Drug: Placebo | Eli Lilly and Company | NULL | Completed | 18 Years | 70 Years | All | 28 | Phase 1 | United States |
| 254 | EUCTR2017-005028-11-HU (EUCTR) | 20/05/2019 | 02/04/2019 | A study of Baricitinib in patients with Lupus | A Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus (SLE) MedDRA version: 20.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | United States;Serbia;Philippines;Taiwan;Greece;Spain;Chile;Russian Federation;Colombia;Italy;Switzerland;India;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan | ||
| 255 | EUCTR2018-001808-11-PL (EUCTR) | 17/05/2019 | 15/05/2019 | A research study to evaluate the effects of a new oral drug called cenerimod in adults with Systemic Lupus Erythematosus disease | A Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of cenerimod in subjects with moderate to severe systemic lupus erythematosus (SLE) - CARE: Cenerimod Assessing S1P1 Receptor modulation in Systemic Lupus Erythematosus | Moderate to severe systemic lupus erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod | Idorsia Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 325 | Phase 2 | Georgia;Germany;Romania;Bulgaria;United States;Philippines;Czechia;Taiwan;Greece;Spain;Thailand;Ukraine;Turkey;Chile;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Mexico;Poland | ||
| 256 | EUCTR2017-005028-11-DE (EUCTR) | 10/05/2019 | 28/03/2019 | A study of Baricitinib in patients with Lupus | A Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | China;United States;Serbia;Philippines;Taiwan;Greece;Spain;Chile;Russian Federation;Colombia;Italy;Switzerland;India;France;Australia;South Africa;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan | ||
| 257 | EUCTR2018-003471-35-PL (EUCTR) | 04/05/2019 | 03/04/2019 | Long-Term Safety and Efficacy of BMS-986165 in Subjects with Systemic Lupus Erythematosus | A Multi-Center Study to Characterize the Long-Term Safety and Efficacy of BMS-986165 in Subjects with Systemic Lupus Erythematosus | Systemic Lupus Erythematosus MedDRA version: 21.1;Level: LLT;Classification code 10042947;Term: Systemic lupus erythematosus synd;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BMS-986165 Product Code: BMS-986165 INN or Proposed INN: BMS-986165 Product Name: BMS-986165 Product Code: BMS-986165 INN or Proposed INN: BMS-986165 Product Name: BMS-986165 Product Code: BMS-986165 INN or Proposed INN: BMS-986165 | Bristol-Myers Squibb International Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 360 | Phase 2 | United States;Taiwan;Spain;Russian Federation;Israel;Colombia;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Japan;Korea, Republic of | ||
| 258 | NCT03949426 (ClinicalTrials.gov) | May 1, 2019 | 8/5/2019 | Safety, Tolerability and Pharmacokinetics of KPG-818 in Healthy Subjects | A First-in-Human, Randomized, Double-blind, Placebo-controlled, Sequential Parallel Group, Single Ascending Dose Study in Healthy Participants to Evaluate the Safety, Tolerability and Pharmacokinetics of KPG-818 | Systemic Lupus Erythematosus | Drug: KPG-818 | Kangpu Biopharmaceuticals, Ltd. | NULL | Completed | 18 Years | 55 Years | All | 40 | Phase 1 | United States |
| 259 | NCT03845517 (ClinicalTrials.gov) | April 18, 2019 | 15/2/2019 | A DOSE-RANGING STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-06700841 IN SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) | A PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06700841 IN PARTICIPANTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) | Systemic Lupus Erythematosus | Drug: Placebo;Drug: PF-06700841 15 mg;Drug: PF-06700841 30 mg;Drug: PF-06700841 45 mg | Pfizer | NULL | Active, not recruiting | 18 Years | 75 Years | All | 346 | Phase 2 | United States;Argentina;Australia;Belgium;Bulgaria;Canada;China;Colombia;Czechia;France;Germany;Greece;Hong Kong;Hungary;Italy;Japan;Korea, Republic of;Mexico;Poland;Portugal;Romania;Serbia;Spain;Taiwan;Ukraine;United Kingdom |
| 260 | EUCTR2017-005028-11-CZ (EUCTR) | 08/04/2019 | 28/03/2019 | A study of Baricitinib in patients with Lupus | A Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | United States;Serbia;Philippines;Taiwan;Greece;Spain;Chile;Russian Federation;Colombia;Italy;Switzerland;India;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan | ||
| 261 | NCT03816345 (ClinicalTrials.gov) | April 4, 2019 | 24/1/2019 | Nivolumab in Treating Patients With Autoimmune Disorders and Advanced, Metastatic, or Unresectable Cancer | A Phase Ib Study of Nivolumab in Patients With Autoimmune Disorders and Advanced Malignancies (AIM-NIVO) | Advanced Malignant Solid Neoplasm;Autoimmune Disease;Crohn Disease;Dermatomyositis;Hematopoietic and Lymphoid Cell Neoplasm;Inflammatory Bowel Disease;Metastatic Malignant Solid Neoplasm;Multiple Sclerosis;Psoriasis;Psoriatic Arthritis;Rheumatoid Arthritis;Sjogren Syndrome;Systemic Lupus Erythematosus;Systemic Scleroderma;Ulcerative Colitis;Unresectable Malignant Solid Neoplasm | Procedure: Biospecimen Collection;Biological: Nivolumab | National Cancer Institute (NCI) | NULL | Recruiting | 18 Years | N/A | All | 300 | Phase 1 | United States;Canada |
| 262 | NCT03917797 (ClinicalTrials.gov) | April 2, 2019 | 2/4/2019 | Mesenchymal Stromal Cells (MSC´s) in Renal Lupus | Dose-response and Efficacy of Umbilical Cord-derived Mesenchymal Stromal Cells in Renal Systemic Lupus Erythematosus | Lupus Erythematosus, Systemic;Lupus Glomerulonephritis | Biological: MSC treatment;Drug: Standard of Care;Drug: Placebo | Universidad de los Andes, Chile | NULL | Recruiting | 18 Years | 75 Years | All | 39 | Phase 2 | Chile |
| 263 | EUCTR2017-005026-37-GB (EUCTR) | 27/03/2019 | 19/09/2018 | A study of Baricitinib in patients with Lupus | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 825 | Phase 3 | United States;Taiwan;Greece;Ukraine;Austria;Russian Federation;United Kingdom;Switzerland;Czech Republic;Hungary;Mexico;Belgium;Brazil;Croatia;Australia;Netherlands;Germany;China | ||
| 264 | NCT03920267 (ClinicalTrials.gov) | March 26, 2019 | 27/3/2019 | Long-Term Safety and Efficacy Study of Deucravacitinib in Participants With Systemic Lupus Erythematosus | A Multi-Center Study to Characterize the Long-Term Safety and Efficacy of BMS-986165 in Subjects With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: BMS-986165 | Bristol-Myers Squibb | NULL | Active, not recruiting | 18 Years | 75 Years | All | 261 | Phase 2 | United States;Argentina;Brazil;Canada;Colombia;Hungary;Japan;Korea, Republic of;Mexico;Poland;Romania;Russian Federation;Spain;Taiwan;Australia;Germany;Israel |
| 265 | EUCTR2018-001808-11-BG (EUCTR) | 20/03/2019 | 06/12/2018 | A research study to evaluate the effects of a new oral drug called cenerimod in adults with Systemic Lupus Erythematosus disease | A Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of cenerimod in subjects with moderate to severe systemic lupus erythematosus (SLE) - CARE: Cenerimod Assessing S1P1 Receptor modulation in Systemic Lupus Erythematosus | Moderate to severe systemic lupus erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod | Idorsia Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 325 | Phase 2 | United States;Philippines;Czechia;Taiwan;Greece;Spain;Thailand;Ukraine;Turkey;Chile;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Mexico;Poland;Romania;Bulgaria;Georgia;Germany | ||
| 266 | EUCTR2018-000305-23-BG (EUCTR) | 20/03/2019 | 12/11/2018 | A Phase 1b/2 Study of BOS161721 in Systemic Lupus Erythematosus (SLE) Patients | A Randomized Double-Blind Phase 1b/2 Combined Staggered Multiple Dose Escalation Study of BOS161721 in Systemic Lupus Erythematosus (SLE) Patients on a Background of Limited Standard of Care | Systemic lupus erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: BOS161721 Product Code: BOS161721 INN or Proposed INN: Not known Other descriptive name: IMMUNOGLOBULIN G | Boston Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 156 | Phase 2 | United States;Philippines;Hungary;Mexico;Argentina;Poland;Ukraine;Romania;Peru;Georgia;Bulgaria;Colombia | ||
| 267 | NCT03771885 (ClinicalTrials.gov) | March 16, 2019 | 10/12/2018 | BI 705564 in Patients With Systemic Lupus Erythematosus (SLE) | A Phase Ib, Multicentre, Randomised, Double-blind, Placebo Controlled, 8 Week Crossover Study to Assess the Safety, Tolerability and Pharmacokinetics of Orally Administered BI 705564 in Patients With Systemic Lupus Erythematosus. | Lupus Erythematosus, Systemic | Drug: BI 705564;Drug: Placebo | Boehringer Ingelheim | NULL | Withdrawn | 18 Years | N/A | All | 0 | Phase 1 | NULL |
| 268 | ChiCTR1900020803 | 2019-03-01 | 2019-01-19 | Efficacy of Melatonin in patients with stable systemic lupus erythematosus complicated with insomnia: a single-center, randomized, double-blind, placebo-controlled clinical trial | Efficacy of Melatonin in patients with stable systemic lupus erythematosus complicated with insomnia: a single-center, randomized, double-blind, placebo-controlled clinical trial | systemic lupus erythematosus | intervention group:melatonin 6mg qn;control group:placebo qn; | Chinese Academy of Medical Sciences Peking Union Medical College Hospital | NULL | Pending | 18 | 65 | Both | intervention group:88;control group:88; | Phase 4 | China |
| 269 | EUCTR2018-001808-11-HU (EUCTR) | 08/02/2019 | 22/11/2018 | A research study to evaluate the effects of a new oral drug called cenerimod in adults with Systemic Lupus Erythematosus disease | A Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of cenerimod in subjects with moderate to severe systemic lupus erythematosus (SLE) | Moderate to severe systemic lupus erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod | Idorsia Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 2 | United States;Taiwan;Thailand;Spain;Ukraine;Turkey;Lithuania;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Mexico;Poland;Romania;Bulgaria;Georgia;Germany;China | ||
| 270 | EUCTR2018-001808-11-IT (EUCTR) | 07/02/2019 | 28/01/2021 | A research study to evaluate the effects of a new oral drug called cenerimod in adults with Systemic Lupus Erythematosus disease | A Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of cenerimod in subjects with moderate to severe systemic lupus erythematosus (SLE) - CARE:Cenerimod Assessing S1P1 Receptor modulation in Systemic Lupus Erythematosus | Moderate to severe systemic lupus erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Cenerimod Product Code: [ACT-334441] INN or Proposed INN: Cenerimod Product Name: Cenerimod Product Code: [ACT-334441] INN or Proposed INN: Cenerimod Product Name: Cenerimod Product Code: [ACT-334441] INN or Proposed INN: Cenerimod Product Name: Cenerimod Product Code: [ACT-334441] INN or Proposed INN: Cenerimod | IDORSIA PHARMACEUTICALS LTD | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 500 | Phase 2 | United States;Czechia;Philippines;Taiwan;Greece;Spain;Thailand;Ukraine;Turkey;Chile;Israel;Russian Federation;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Poland;Romania;Bulgaria;Georgia;Germany;China | ||
| 271 | EUCTR2018-000305-23-HU (EUCTR) | 07/02/2019 | 28/11/2018 | No | A Randomized Double-Blind Phase 1b/2 Combined Staggered Multiple Dose Escalation Study of BOS161721 in Systemic Lupus Erythematosus (SLE) Patients on a Background of Limited Standard of Care | Systemic lupus erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: BOS161721 Product Code: BOS161721 INN or Proposed INN: Not known Other descriptive name: IMMUNOGLOBULIN G | Boston Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 156 | Phase 2 | United States;Philippines;Hungary;Mexico;Argentina;Poland;Ukraine;Romania;Peru;Georgia;Bulgaria;Colombia | ||
| 272 | EUCTR2018-001508-12-FR (EUCTR) | 05/02/2019 | 13/11/2018 | Study the efficacy and safety of VAY736 and CFZ533 in patients with systemic lupus erythematosus (SLE) | A placebo-controlled, patient and investigator blinded, randomized parallel cohort study to assess pharmacodynamics, pharmacokinetics, safety, tolerability and preliminary clinical efficacy of VAY736 and CFZ533 in patients with systemic lupus erythematosus (SLE) | Systemic lupus erythematosus (SLE) MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: VAY736 INN or Proposed INN: ianalumab Other descriptive name: VAY736 Product Code: CFZ533 INN or Proposed INN: iscalimab Other descriptive name: CFZ533 | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Taiwan;Spain;Thailand;Russian Federation;Israel;France;Czech Republic;Hungary;Argentina;Poland;Australia;Germany;China;Japan;Korea, Republic of | ||
| 273 | EUCTR2017-001489-53-PT (EUCTR) | 04/02/2019 | 08/11/2018 | Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus - LOTUS | Systemic Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Stelara INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB Trade Name: Stelara INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | United States;Serbia;Portugal;Taiwan;Ecuador;Thailand;Spain;Ukraine;Lithuania;Russian Federation;Colombia;Hungary;Canada;Argentina;Poland;South Africa;Bulgaria;Germany;China;Japan;Korea, Republic of | ||
| 274 | ChiCTR1800020286 | 2019-02-01 | 2018-12-22 | Clinical evaluation of the application of Langchuangjing granule in the treatment of systemic lupus erythematosus | Efficacy and safety of Langchuangjing granule in the treatment of systemic lupus erythematosus: a clinical evaluation | Systemic Lupus Erythematosus | Group 2:Langchuangjing granule + Prednisone acetate tablets, hydroxychloroquine and other Western medicines for 12 weeks.;Group 1:Prednisone acetate tablets, hydroxychloroquine and other Western medicines for 12 weeks.; | Nanjing University of Chinese Medicine Affiliated Hospital | NULL | Pending | Both | Group 2:40;Group 1:20; | I (Phase 1 study) | China | ||
| 275 | EUCTR2018-001808-11-ES (EUCTR) | 24/01/2019 | 16/11/2018 | A research study to evaluate the effects of a new oral drug called cenerimod in adults with Systemic Lupus Erythematosus disease | A Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of cenerimod in subjects with moderate to severe systemic lupus erythematosus (SLE) | Moderate to severe systemic lupus erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod | Idorsia Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 500 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Hong Kong;Taiwan;Spain;Thailand;Ukraine;Lithuania;Turkey;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Mexico;Poland;Romania;Bulgaria;Georgia;Germany;China | ||
| 276 | EUCTR2018-001808-11-FR (EUCTR) | 14/01/2019 | 31/08/2018 | A research study to evaluate the effects of a new oral drug called cenerimod in adults with Systemic Lupus Erythematosus disease | A Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of cenerimod in subjects with moderate to severe systemic lupus erythematosus (SLE) | Moderate to severe systemic lupus erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod | Idorsia Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 500 | Phase 2 | United States;Taiwan;Thailand;Spain;Ukraine;Turkey;Lithuania;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Poland;Romania;Bulgaria;Georgia;Germany;China | ||
| 277 | NCT03742037 (ClinicalTrials.gov) | December 21, 2018 | 12/11/2018 | Efficacy and Safety of Four Doses of Cenerimod Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus | A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Cenerimod in Subjects With Moderate to Severe Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Drug: Cenerimod 0.5 mg;Drug: Cenerimod 1 mg;Drug: Cenerimod 2 mg;Drug: Cenerimod 4 mg;Drug: Placebo | Idorsia Pharmaceuticals Ltd. | NULL | Completed | 18 Years | 75 Years | All | 427 | Phase 2 | United States;Bulgaria;Chile;Czechia;France;Georgia;Greece;Hungary;Israel;Italy;Mexico;Philippines;Poland;Romania;Russian Federation;Spain;Taiwan;Thailand;Turkey;Ukraine;United Kingdom;Germany;Lithuania |
| 278 | EUCTR2017-005027-25-IT (EUCTR) | 20/12/2018 | 22/01/2021 | A study of Baricitinib in patients with Lupus | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus - - | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Olumiant - EU/1/16/1170/009-016 Product Name: Baricitinib Product Code: [LY3009104] INN or Proposed INN: Baricitinib Trade Name: Olumiant - EU/1/16/1170/001-008 Product Name: Baricitinib Product Code: [LY3009104] INN or Proposed INN: Baricinitib | ELI LILLY & COMPANY, LILLY CORPORATE CENTER | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 825 | Phase 3 | Serbia;United States;Philippines;Spain;Chile;Colombia;Italy;India;France;Argentina;Poland;Romania;South Africa;Japan;Korea, Republic of | ||
| 279 | NCT03618056 (ClinicalTrials.gov) | December 19, 2018 | 1/8/2018 | Evaluating HIV-1 Neutralization Antibody Breadth in Response to HIV gp120 Protein Vaccine in HIV-uninfected Adults With Quiescent Systemic Lupus Erythematosus | A Phase 1b Open Label Clinical Trial to Evaluate HIV-1 Neutralization Antibody Breadth in Response to HIV gp120 Protein Vaccine in HIV-uninfected Adults With Quiescent Systemic Lupus Erythematosus | HIV Infections;Systemic Lupus Erythematosus | Biological: AIDSVAX® B/E | National Institute of Allergy and Infectious Diseases (NIAID) | NULL | Completed | 18 Years | 50 Years | All | 1 | Phase 1 | United States |
| 280 | NCT03656562 (ClinicalTrials.gov) | December 19, 2018 | 19/7/2018 | Study the Efficacy and Safety of VAY736 and CFZ533 in SLE Patients | A Placebo-controlled, Patient and Investigator Blinded, Randomized Parallel Cohort Study to Assess Pharmacodynamics, Pharmacokinetics, Safety, Tolerability and Preliminary Clinical Efficacy of VAY736 and CFZ533 in Patients With Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus (SLE) | Drug: VAY736;Drug: VAY736 Placebo;Drug: CFZ533;Drug: CFZ533 Placebo | Novartis Pharmaceuticals | NULL | Active, not recruiting | 18 Years | 75 Years | All | 107 | Phase 2 | Spain;Taiwan;Thailand;Argentina;Australia;China;Czechia;France;Germany;Hungary;Israel;Japan;Korea, Republic of;Poland;Russian Federation;United States |
| 281 | EUCTR2017-005026-37-AT (EUCTR) | 18/12/2018 | 25/09/2018 | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 825 | Phase 3 | United States;Czechia;Taiwan;Greece;Ukraine;Austria;Russian Federation;United Kingdom;Switzerland;Czech Republic;Hungary;Mexico;Brazil;Belgium;Croatia;Australia;Netherlands;Germany;China | ||
| 282 | EUCTR2017-005026-37-BE (EUCTR) | 17/12/2018 | 25/09/2018 | A study of Baricitinib in patients with Lupus | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United States;Taiwan;Greece;Ukraine;Austria;Russian Federation;United Kingdom;Switzerland;Czech Republic;Hungary;Mexico;Belgium;Brazil;Croatia;Australia;Netherlands;Germany;China | ||
| 283 | EUCTR2018-001808-11-GB (EUCTR) | 17/12/2018 | 17/09/2018 | A research study to evaluate the effects of a new oral drug called cenerimod in adults with Systemic Lupus Erythematosus disease | A Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of cenerimod in subjects with moderate to severe systemic lupus erythematosus (SLE) - CARE: Cenerimod Assessing S1P1 Receptor modulation in Systemic Lupus Erythematosus | Moderate to severe systemic lupus erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod Other descriptive name: ACT-334441 Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod Other descriptive name: ACT-334441 Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod Other descriptive name: ACT-334441 Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod Other descriptive name: ACT-334441 | Idorsia Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 325 | Phase 2 | United States;Czechia;Philippines;Taiwan;Greece;Spain;Thailand;Ukraine;Turkey;Chile;Israel;Russian Federation;Italy;United Kingdom;France;Hungary;Mexico;Poland;Romania;Georgia;Bulgaria;Germany | ||
| 284 | NCT03817424 (ClinicalTrials.gov) | December 13, 2018 | 22/1/2019 | A Study to Evaluate VIB7734 in Participants With Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE), Sjogren's Syndrome, Systemic Sclerosis, Polymyositis, and Dermatomyositis | A Phase 1 Randomized, Placebo-Controlled, Blinded, Multiple Ascending Dose Study to Evaluate VIB7734 in Systemic Lupus Erythematosus, Cutaneous Lupus Erythematosus, Sjogren's Syndrome, Systemic Sclerosis, Polymyositis, and Dermatomyositis | Systemic Lupus Erythematosus;Cutaneous Lupus Erythematosus;Sjogren's Syndrome;Systemic Sclerosis;Polymyositis;Dermatomyositis | Drug: VIB7734;Drug: Placebo | Viela Bio | NULL | Completed | 18 Years | 75 Years | All | 31 | Phase 1 | United States;Poland;Spain |
| 285 | EUCTR2018-001508-12-ES (EUCTR) | 12/12/2018 | 09/10/2018 | Study the efficacy and safety of VAY736 and CFZ533 in patients with systemic lupus erythematosus (SLE) | A placebo-controlled, patient and investigator blinded, randomized parallel cohort study to assess pharmacodynamics, pharmacokinetics, safety, tolerability and preliminary clinical efficacy of VAY736 and CFZ533 in patients with systemic lupus erythematosus (SLE) | Systemic lupus erythematosus (SLE) MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: VAY736 INN or Proposed INN: ianalumab Other descriptive name: VAY736 Product Code: CFZ533 INN or Proposed INN: iscalimab Other descriptive name: CFZ533 | Novartis Farmacéutica, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Taiwan;Spain;Thailand;Russian Federation;Israel;France;Czech Republic;Hungary;Argentina;Poland;Australia;Germany;China;Japan;Korea, Republic of | ||
| 286 | EUCTR2017-001203-79-DE (EUCTR) | 12/12/2018 | 27/02/2018 | A clinical study to test the efficacy and safety of BMS-986165 in Subjects with Systemic Lupus Erythematosus. | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of BMS-986165 in Subjects with Systemic Lupus Erythematosus | Systemic Lupus Erythematosus MedDRA version: 21.1;Level: LLT;Classification code 10042947;Term: Systemic lupus erythematosus synd;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BMS-986165 Product Code: BMS-986165 INN or Proposed INN: BMS-986165 | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 2 | United States;Taiwan;Spain;Israel;Russian Federation;Colombia;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Australia;Germany;Japan;Korea, Republic of | ||
| 287 | EUCTR2018-001508-12-DE (EUCTR) | 05/12/2018 | 28/08/2018 | Study the efficacy and safety of VAY736 and CFZ533 in patients with systemic lupus erythematosus (SLE) | A placebo-controlled, patient and investigator blinded, randomized parallelcohort study to assess pharmacodynamics, pharmacokinetics, safety,tolerability and preliminary clinical efficacy of VAY736 and CFZ533 inpatients with systemic lupus erythematosus (SLE) | Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: VAY736 INN or Proposed INN: ianalumab Other descriptive name: VAY736 Product Code: CFZ533 INN or Proposed INN: iscalimab Other descriptive name: CFZ533 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 135 | Phase 2 | United States;Czechia;Taiwan;Spain;Thailand;Israel;Russian Federation;France;Czech Republic;Hungary;Argentina;Poland;Australia;Germany;China;Japan;Korea, Republic of | ||
| 288 | NCT02525835 (ClinicalTrials.gov) | December 1, 2018 | 13/8/2015 | Tissue Sodium in Autoimmune Disease | Tissue Sodium in Autoimmune Disease | Systemic Lupus Erythematosus | Dietary Supplement: Low Dietary Sodium;Dietary Supplement: High Dietary Sodium | Vanderbilt University | NULL | Withdrawn | 18 Years | N/A | All | 0 | N/A | United States |
| 289 | NCT03878303 (ClinicalTrials.gov) | November 28, 2018 | 5/3/2019 | Study of AC0058TA in Patients With Systemic Lupus Erythematosus (SLE) | A Phase 1b Double-Blind, Randomized, Placebo-Controlled Study of the Safety, Pharmacokinetics and Pharmacodynamics of AC0058TA in Patients With Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Drug: AC0058TA;Drug: Placebo AC0058TA | ACEA Therapeutics, Inc. | Hangzhou ACEA Pharmaceutical Research Co., Ltd. | Recruiting | 18 Years | 75 Years | All | 32 | Phase 1 | United States |
| 290 | NCT03724916 (ClinicalTrials.gov) | November 26, 2018 | 18/10/2018 | A Study to Evaluate the Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of TAK-079 in Combination With Standard Background Therapy in Participants With Moderate to Severe Systemic Lupus Erythematosus (SLE) | A Phase 1b Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of TAK-079 in Combination With Standard Background Therapy in Patients With Moderate to Severe Systemic Lupus Erythematosus | Systemic Lupus Erythematosus;Lupus Erythematosus, Systemic | Drug: TAK-079;Drug: TAK-079 Placebo | Millennium Pharmaceuticals, Inc. | NULL | Completed | 18 Years | 75 Years | All | 58 | Phase 1 | United States |
| 291 | EUCTR2017-005026-37-HU (EUCTR) | 19/11/2018 | 25/09/2018 | A study of Baricitinib in patients with Lupus | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 825 | Phase 3 | United States;Taiwan;Greece;Ukraine;Austria;Russian Federation;United Kingdom;Switzerland;Hungary;Czech Republic;Mexico;Belgium;Brazil;Croatia;Australia;Netherlands;Germany;China | ||
| 292 | ChiCTR1800019308 | 2018-11-12 | 2018-11-04 | Efficacy and tolerability of multitarget therapy with NHMX for systemic lupus erythematosus | Efficacy and tolerability of multitarget therapy with NHMX for systemic lupus erythematosus | systemic lupus erythematosus | NHMX:One kind of non-steroid anti-inflammatory drugs combines with hydroxychloroquine sulfate(=200mg/bid) and methotrexate(7.5-20mg/w), with addition of glucocorticoid (=0.5mg/kg·d) or cyclosporine (maintaining the drug concentration between 30-90ug/l);control:hydroxychloroquine sulfate(=200mg/bid) and methotrexate(7.5-20mg/w), with addition of glucocorticoid (=0.5mg/kg·d) or cyclosporine(maintaining the drug concentration between 30-90ug/l); | The Third Affiliated Hospital, Southern Medical University | NULL | Recruiting | 18 | 65 | Both | NHMX:75;control:75; | China | |
| 293 | EUCTR2017-005026-37-CZ (EUCTR) | 12/11/2018 | 26/10/2018 | A study of Baricitinib in patients with Lupus | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 825 | Phase 3 | United States;Taiwan;Greece;Ukraine;Austria;Russian Federation;United Kingdom;Switzerland;Czech Republic;Hungary;Mexico;Belgium;Brazil;Croatia;Australia;Netherlands;Germany;China | ||
| 294 | EUCTR2018-001508-12-CZ (EUCTR) | 02/11/2018 | 28/08/2018 | Study the efficacy and safety of VAY736 and CFZ533 in patients with systemic lupus erythematosus (SLE) | A placebo-controlled, patient and investigator blinded, randomized parallelcohort study to assess pharmacodynamics, pharmacokinetics, safety,tolerability and preliminary clinical efficacy of VAY736 and CFZ533 inpatients with systemic lupus erythematosus (SLE) | Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: VAY736 INN or Proposed INN: ianalumab Other descriptive name: VAY736 Product Code: CFZ533 INN or Proposed INN: iscalimab Other descriptive name: CFZ533 | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 135 | Phase 2 | Argentina;Russian Federation;Hungary;Japan;Thailand;Spain;Czech Republic;China;Taiwan;Korea, Republic of;Poland;Israel;Australia;France;Germany | ||
| 295 | NCT02633163 (ClinicalTrials.gov) | October 26, 2018 | 15/12/2015 | Phase 2 Trial of Mesenchymal Stem Cells in Systemic Lupus Erythematosus (MiSLE) | A Phase II Controlled Trial of Allogeneic Mesenchymal Stem Cells for the Treatment of Refractory Lupus | Systemic Lupus Erythematosus | Drug: Low Dose Mesenchymal Stem Cells (MSCs);Drug: High Dose Mesenchymal Stem Cells (MSCs);Drug: Placebo Infusion | Medical University of South Carolina | NULL | Recruiting | 18 Years | 65 Years | All | 81 | Phase 2 | United States |
| 296 | NCT03626311 (ClinicalTrials.gov) | October 23, 2018 | 6/6/2018 | Omega-3 Replacement With Krill Oil in Disease Management of SLE | A Double-Blind, Placebo-Controlled Randomized, Multicenter Study to Assess Changes in Omega-3 Index in Erythrocytes and Health Benefit After 24 Weeks of Daily Consumption of AKBM-3031 (Omega-3 Phospholipids From Krill), Followed by a 24 Week Open-Label Extension, in Patients With Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus (SLE) | Dietary Supplement: AKBM-3031;Other: Placebo | Aker Biomarine Antarctic AS | Ampel BioSolutions, LLC | Completed | 18 Years | N/A | All | 76 | N/A | United States;Canada |
| 297 | NCT03747159 (ClinicalTrials.gov) | October 1, 2018 | 12/10/2018 | Synergetic B-cell Immunomodulation in SLE - 2nd Study. | A Randomized Trial to Investigate the Reset of Humoral Autoimmunity by Combining Belimumab With Rituximab in Severe Systemic Lupus Erythematosus | Lupus Erythematosus, Systemic | Drug: Belimumab Injection | Leiden University Medical Center | Dutch Kidney Foundation;GlaxoSmithKline | Recruiting | 18 Years | N/A | All | 70 | Phase 2 | Netherlands |
| 298 | EUCTR2018-001392-21-NL (EUCTR) | 25/09/2018 | 25/09/2018 | Synergetic B-cell immunomodulation in SLE – 2nd study | A randomized trial to investigate the reset of humoral autoimmunity by combining belimumab with rituximab in severe systemic lupus erythematosus | systemic lupus erythematosus MedDRA version: 21.1;Level: LLT;Classification code 10042947;Term: Systemic lupus erythematosus synd;System Organ Class: 100000004859 MedDRA version: 20.0;Classification code 10029142;Term: Nephritis systemic lupus erythematosus;System Organ Class: 100000004857 MedDRA version: 21.1;Classification code 10042948;Term: Systemic lupus erythematosus syndrome aggravated;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: belimumab or benlysta Trade Name: anti-CD20 B cell depletion with Truxima Product Name: truxima | Leiden University Medical Center | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 2;Phase 3 | Netherlands | ||
| 299 | EUCTR2017-001489-53-PL (EUCTR) | 24/09/2018 | 23/07/2018 | Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus - LOTUS | Systemic Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Stelara INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB Trade Name: Stelara INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | United States;Serbia;Portugal;Taiwan;Thailand;Spain;Ukraine;Lithuania;Russian Federation;Colombia;Hungary;Canada;Argentina;Poland;South Africa;Bulgaria;Germany;China;Japan;Korea, Republic of | ||
| 300 | EUCTR2017-005027-25-ES (EUCTR) | 21/09/2018 | 24/09/2018 | A study of Baricitinib in patients with Lupus | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3Study of Baricitinib in Patients with Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) MedDRA version: 20.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 750 | Phase 3 | Serbia;United States;Philippines;Spain;Chile;Colombia;Argentina;Poland;Romania;South Africa;Japan;Korea, Republic of;Italy;India;France | ||
| 301 | NCT03575156 (ClinicalTrials.gov) | September 20, 2018 | 7/6/2018 | Microparticles's Role in the Pathophysiology of Systemic Lupus Erythematosus and Systemic Sclerosis | Microparticles's Role in the Pathophysiology of Systemic Lupus Erythematosus and Systemic Sclerosis | Systemic Lupus Erythematosus;Systemic Scleroderma | Biological: blood sample;Biological: urine sample | University Hospital, Bordeaux | NULL | Completed | 18 Years | N/A | All | 208 | N/A | France |
| 302 | ChiCTR1800017540 | 2018-09-01 | 2018-08-03 | A randomized controlled trial for the long-term outcomes of MMF on new onset SLE patients with high titers of anti-dsDNA antibody for reducing main organ involvement | A randomized controlled trial for the long-term outcomes of MMF on new onset SLE patients with high titers of anti-dsDNA antibody for reducing main organ involvement | systemic lupus erythematosus | 1:Hydroxychloroquine (5mg/kg/day) plus prednisone (0.5mg/kg/day);2:Hydroxychloroquine (5mg/kg/day) plus prednisone (0.5mg/kg/day) plus Mycophenolate Mofetil 500mg bid; | Ruijin Hospital | NULL | Completed | 18 | 65 | Both | 1:65;2:65; | Phase 4 | China |
| 303 | NCT03527472 (ClinicalTrials.gov) | August 23, 2018 | 3/5/2018 | Memantine for the Treatment of Cognitive Impairment in Systemic Lupus Erythematosus | A Randomized Placebo-controlled, Double Blind Phase 2 Clinical Trial of Memantine for the Treatment of Cognitive Impairment in Systemic Lupus Erythematosus | Lupus Erythematosus, Systemic | Drug: Memantine;Drug: Placebo | Vanderbilt University Medical Center | Kleberg Foundation | Recruiting | 18 Years | 70 Years | All | 80 | Phase 2 | United States |
| 304 | JPRN-JapicCTI-183973 | 16/8/2018 | 29/05/2018 | A Study of Ustekinumab in Participants with Active Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus | Lupus Erythematosus, Systemic | Intervention name : Ustekinumab INN of the intervention : Ustekinumab Dosage And administration of the intervention : Participants will receive ustekinumab approximately 6 milligram per kilogram (mg/kg) intravenously (IV) based on body weight-range at Week 0 followed by 90 mg ustekinumab subcutaneously (SC) at Week 8 and every 8 weeks (q8w) thereafter through Week 48 during double-blind period. Eligible participants who will enter the extension period will continue to receive 90 mg ustekinumab SC q8w through Week 160 Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Participants will receive matching placebo to ustekinumab IV at Week 0, followed by matching placebo to ustekinumab SC at Week 8 and q8w thereafter through Week 48 during double-blind period. Eligible participants who will enter the extension period will cross-over to receive 90 mg ustekinumab SC q8w through Week 160. | Janssen Pharmaceutical K.K. | NULL | complete | 16 | 75 | BOTH | 500 | Phase 3 | Japan, Asia except Japan, North America, South America, Europe, Africa |
| 305 | NCT03312335 (ClinicalTrials.gov) | August 8, 2018 | 29/9/2017 | Low-dose Interleukin-2 for Treatment of Systemic Lupus Erythematosus | Open-label, Monocentric, Phase II, Investigator-initiated Clinical Trial on Unbiased Characterization of Immunological Parameters in Interleukin-2-treated Systemic Lupus Erythematosus | Lupus Erythematosus, Systemic | Drug: Low-dose Aldesleukin (Proleukin®) | Onur Boyman, MD | NULL | Completed | 18 Years | N/A | All | 16 | Phase 2 | Switzerland |
| 306 | NCT03616964 (ClinicalTrials.gov) | August 2, 2018 | 1/8/2018 | A Study of Baricitinib in Participants With Systemic Lupus Erythematosus | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: Baricitinib;Drug: Placebo | Eli Lilly and Company | Incyte Corporation | Completed | 18 Years | N/A | All | 777 | Phase 3 | United States;Argentina;Chile;Colombia;France;India;Italy;Japan;Korea, Republic of;Philippines;Poland;Romania;Serbia;South Africa;Spain |
| 307 | NCT03616912 (ClinicalTrials.gov) | August 2, 2018 | 1/8/2018 | A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: Baricitinib;Drug: Placebo | Eli Lilly and Company | Incyte Corporation | Terminated | 18 Years | N/A | All | 830 | Phase 3 | United States;Australia;Austria;Belgium;Brazil;China;Croatia;Czechia;Germany;Greece;Hungary;Israel;Mexico;Netherlands;Russian Federation;Switzerland;Taiwan;United Kingdom;Ukraine |
| 308 | EUCTR2017-001489-53-BG (EUCTR) | 27/06/2018 | 28/03/2018 | Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus - LOTUS | Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Stelara INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB Trade Name: Stelara INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | United States;Serbia;Portugal;Taiwan;Thailand;Spain;Ukraine;Lithuania;Russian Federation;Colombia;Hungary;Canada;Argentina;Poland;South Africa;Bulgaria;Germany;China;Japan;Korea, Republic of | ||
| 309 | EUCTR2017-001489-53-HU (EUCTR) | 14/06/2018 | 03/04/2018 | Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus - LOTUS | Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Stelara INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB Trade Name: Stelara INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Portugal;United States;Serbia;Philippines;Taiwan;Ecuador;Spain;Ukraine;Lithuania;Russian Federation;Colombia;Hungary;Argentina;Poland;Romania;Australia;Peru;South Africa;Bulgaria;Germany;China;Japan;Korea, Republic of | ||
| 310 | EUCTR2017-001489-53-ES (EUCTR) | 12/06/2018 | 14/03/2018 | Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus - LOTUS | Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Stelara INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB Trade Name: Stelara INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Portugal;United States;Serbia;Philippines;Taiwan;Ecuador;Spain;Ukraine;Lithuania;Russian Federation;Colombia;Hungary;Argentina;Poland;Romania;Australia;Peru;South Africa;Bulgaria;Germany;China;Japan;Korea, Republic of | ||
| 311 | NCT03541564 (ClinicalTrials.gov) | May 30, 2018 | 17/5/2018 | An Investigational Study of Experimental Medication BMS-986165 in Healthy Participants to Study Electrocardiogram Effects | A Randomized, Double-Blind, Positive-Controlled, Placebo-Controlled, 4-Period Crossover Study to Investigate the Electrocardiographic Effects of BMS-986165 in Healthy Subjects | Systemic Lupus Erythematosus;Healthy Participants | Drug: BMS-986165;Drug: Moxifloxacin;Other: Placebo | Bristol-Myers Squibb | NULL | Completed | 18 Years | 50 Years | All | 84 | Phase 1 | United States |
| 312 | EUCTR2016-000488-17-FR (EUCTR) | 16/05/2018 | 19/03/2019 | A study to evaluate the effectiveness and safety of the study drug, when patients are given dosage of ILT-101 with active moderate to severe systemic lupus erythematosus(SLE) | A Phase II, multi-centre, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety and pharmacokinetics of ILT-101 in patients with active moderate to severe systemic lupus erythematosus (SLE) | Systematic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: ILT-101 Product Code: ILT-101 INN or Proposed INN: Aldesleukin Other descriptive name: INTERLEUKIN-2 | ILTOO PHARMA | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | Portugal;France;Mexico;Spain;Austria;Bulgaria;Italy | ||
| 313 | EUCTR2017-001764-37-PT (EUCTR) | 14/05/2018 | 12/10/2017 | An Extension Study of Patients Previously Enrolled in Study GA30044 to Evaluate the Long-Term Safety and Efficacy of GDC-0853 in Patients with Moderate to Severe Active Systemic Lupus Erythematosus | A PHASE II, OPEN-LABEL EXTENSION STUDY OF PATIENTS PREVIOUSLY ENROLLED IN STUDY GA30044 TO EVALUATE THE LONG-TERMSAFETY AND EFFICACY OF GDC-0853 IN PATIENTS WITH MODERATE TO SEVERE ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS | Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: GDC-0853 Product Code: RO7010939/F13 INN or Proposed INN: not available yet Other descriptive name: GDC-0853 RO7010939 | Genentech, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | Portugal;United States;Taiwan;Spain;Chile;Colombia;United Kingdom;Mexico;Argentina;Brazil;Bulgaria;Germany;Korea, Republic of | ||
| 314 | EUCTR2017-001489-53-DE (EUCTR) | 08/05/2018 | 23/03/2018 | Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus - LOTUS | Systemic Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Stelara INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB Trade Name: Stelara INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 500 | Phase 3 | United States;Serbia;Portugal;Taiwan;Thailand;Spain;Ukraine;Lithuania;Russian Federation;Colombia;Hungary;Canada;Argentina;Poland;South Africa;Bulgaria;Germany;China;Japan;Korea, Republic of | ||
| 315 | EUCTR2017-001489-53-LT (EUCTR) | 07/05/2018 | 19/03/2018 | Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus - LOTUS | Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Stelara INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB Trade Name: Stelara INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | United States;Serbia;Portugal;Taiwan;Thailand;Spain;Ukraine;Lithuania;Russian Federation;Colombia;Hungary;Canada;Argentina;Poland;South Africa;Bulgaria;Germany;China;Japan;Korea, Republic of | ||
| 316 | NCT03556007 (ClinicalTrials.gov) | April 18, 2018 | 7/5/2018 | A Study of NKTR-358 (LY3471851) in Participants With Systemic Lupus Erythematosus (SLE) | A Phase 1, Double-blind, Randomized, Placebo-controlled, Ascending Multiple-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous NKTR-358 in Patients With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: LY3471851;Drug: Placebo | Eli Lilly and Company | Nektar Therapeutics | Completed | 18 Years | 70 Years | All | 48 | Phase 1 | United States |
| 317 | NCT03517722 (ClinicalTrials.gov) | April 16, 2018 | 13/4/2018 | A Study of Ustekinumab in Participants With Active Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects With Active Systemic Lupus Erythematosus | Lupus Erythematosus, Systemic | Drug: Placebo;Drug: Ustekinumab (approximately 6 mg/kg);Drug: Ustekinumab 90 mg | Janssen Research & Development, LLC | NULL | Terminated | 16 Years | 75 Years | All | 516 | Phase 3 | United States;Argentina;Bulgaria;Canada;China;Colombia;Germany;Hungary;Japan;Korea, Republic of;Lithuania;Poland;Portugal;Russian Federation;Serbia;South Africa;Spain;Taiwan;Thailand;Ukraine;Australia;Ecuador;France;Peru;Philippines;Romania |
| 318 | NCT03492255 (ClinicalTrials.gov) | April 12, 2018 | 16/3/2018 | CYCLONES - CYClophosphamide LOw Dose and No Extra Steroid | CYCLONES - CYClophosphamide LOw Dose and No Extra Steroid | Systemic Lupus Erythematosus (SLE) | Drug: Cyclophosphamide;Drug: Methylprednisolone;Drug: Prednisone;Drug: Mycophenolate Mofetil | University of Sao Paulo General Hospital | Fundação de Amparo à Pesquisa do Estado de São Paulo | Terminated | 18 Years | N/A | All | 49 | N/A | Brazil |
| 319 | EUCTR2017-002564-40-DE (EUCTR) | 10/04/2018 | 04/12/2017 | Safety and Efficacy of AMG 592 in Subjects With Active Systemic Lupus Erythematosus | A Phase 1b/2a Study to Evaluate the Safety and Efficacy of AMG 592 in Subjects With Active Systemic Lupus Erythematosus With Inadequate Response to Standard of Care Therapy. | Systemic Lupus Erythematosus MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: AMG592 Other descriptive name: RECOMBINANT FACTOR FC FUSION PROTEIN | Amgen Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 1;Phase 2 | United States;France;Poland;Germany | ||
| 320 | NCT03451422 (ClinicalTrials.gov) | April 10, 2018 | 1/2/2018 | Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Efavaleukin Alfa in Participants With Systemic Lupus Erythematosus | A Randomized, Double-blind, Placebo-controlled Phase 1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Multiple Ascending Subcutaneous Doses of Efavaleukin Alfa in Subjects With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: Efavaleukin Alfa;Drug: Placebo | Amgen | NULL | Completed | 18 Years | 70 Years | All | 35 | Phase 1 | United States;France;Germany;Poland |
| 321 | EUCTR2017-001400-29-FR (EUCTR) | 16/03/2018 | 31/07/2018 | Treatment of systemic lupus erythematosus by injection iv of mesenchymal stem cells (MSC-LES) | Treatment of severe refractory systemic lupus erythematosus by injection of allogeneic mesenchymal stem cells derived from the umbilical cord - MSC SLE - MSC-LES | Treatment of Systemic Lupus Erythematosus refractory to standard treatments. MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ALLOGENEIC MESENCHYMAL STROMAL CELLS DERIVED FROM THE UMBILICAL CORD Product Code: 0 INN or Proposed INN: 0 Other descriptive name: CSM allogéniques issues de cordons ombilicaux ( MTI-PP) | ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 10 | Phase 1;Phase 2 | France | ||
| 322 | EUCTR2017-004060-35-HU (EUCTR) | 12/03/2018 | 10/01/2018 | An open-label study to evaluate the safety and tolerability of 200-mcg Dose of IPP-201101 in Patients With SLE | An open-label study of the safety and tolerability of repeated administration of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: IPP-201101 Product Code: IPP-201101 INN or Proposed INN: IPP-201101 | ImmuPharma | NULL | Not Recruiting | Female: yes Male: yes | 75 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Hungary;Mauritius | ||
| 323 | NCT03393013 (ClinicalTrials.gov) | March 7, 2018 | 21/12/2017 | A Study of KZR-616 in Patients With SLE With and Without Lupus Nephritis | A Phase 1b/2 Study of KZR-616 in Patients With Systemic Lupus Erythematosus With and Without Nephritis | Lupus Nephritis;Systemic Lupus Erythematosus | Drug: KZR-616 | Kezar Life Sciences, Inc. | NULL | Completed | 18 Years | 75 Years | All | 69 | Phase 1/Phase 2 | United States;Australia;Colombia;Mexico;Peru;Poland;Russian Federation;Ukraine |
| 324 | NCT03312907 (ClinicalTrials.gov) | March 1, 2018 | 13/10/2017 | A Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination With Rituximab to Adult Subjects With Systemic Lupus Erythematosus (SLE) - BLISS-BELIEVE | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 104-Week Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination With Rituximab to Adult Subjects With Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Drug: Belimumab;Drug: Rituximab;Drug: Rituximab-placebo;Drug: Standard therapy (Including Immunosuppressants);Drug: Standard therapy (Excluding Immunosuppressants);Drug: Steroid Taper | GlaxoSmithKline | NULL | Completed | 18 Years | N/A | All | 292 | Phase 3 | United States;Argentina;Brazil;Canada;France;Germany;Korea, Republic of;Mexico;Netherlands;Russian Federation;Spain |
| 325 | NCT03480529 (ClinicalTrials.gov) | March 1, 2018 | 21/3/2018 | Monitoring the IMmUological TOXicity of Drugs | Monitoring the IMmUological TOXicity of Drugs | Arthritis;Systemic Lupus Erythematosus;Rheumatoid Arthritis;Capillary Leak Syndrome;Hepatitis | Drug: drug inducing arthritis, lupus, hepatitis, or capillary leak syndrom | Groupe Hospitalier Pitie-Salpetriere | Institut National de la Santé Et de la Recherche Médicale, France | Completed | 18 Years | N/A | All | 662 | France | |
| 326 | ChiCTR1800015030 | 2018-03-01 | 2018-03-01 | A Clinical Trial on Safety and effect of Dapagliflozin to Control Blood Glucose Levels in Systemic Lupus Erythematosus | The Safety of SGLT2-i Dapagliflozin on Treating Blood Glucose Levels in SLE | Systemic Lupus Erythematosus | Case series:add-on or replace dapagliflozin; | Dept. Rheumatology, Renji Hospital South Campus | NULL | Pending | 18 | 70 | Both | Case series:35; | 4 (Phase 4 study) | China |
| 327 | NCT03396393 (ClinicalTrials.gov) | March 2018 | 4/1/2018 | Exploratory Study of DHA in Systemic Lupus Erythematosus Patients | A Phase II, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Safety, Pharmacokinetics and Efficacy of Dihydroartemisinin Tablets in Patients With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: Dihydroartemisinin tablet;Drug: Placebo tablet | Kunming Pharmaceuticals, Inc. | NULL | Not yet recruiting | 18 Years | 65 Years | All | 120 | Phase 2 | NULL |
| 328 | NCT03427151 (ClinicalTrials.gov) | February 27, 2018 | 8/12/2017 | Study of Repeated Administration of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus | An Open-label Study of the Safety and Tolerability of Repeated Administration of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus | Lupus Erythematosus, Systemic | Drug: IPP-201101 | ImmuPharma | NULL | Completed | 18 Years | N/A | All | 62 | Phase 3 | United States;Czechia;France;Germany;Hungary;Mauritius;Puerto Rico;Poland |
| 329 | EUCTR2016-003050-32-NL (EUCTR) | 16/02/2018 | 24/10/2017 | A Phase 3 Study to Evaluate the Efficacy and Safety of BelimumabAdministered in Combination with Rituximab to Adult Subjects with Systemic LupusErythematosus (SLE) – BLISS-BELIEVE | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 104-Week Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination with Rituximab to Adult Subjects with Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus (SLE) or Lupus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: MabThera (Rituximab) Product Name: MabThera (Rituximab) INN or Proposed INN: RITUXIMAB Trade Name: Benlysta (Belimumab) Product Name: Benlysta (Belimumab) INN or Proposed INN: BELIMUMAB Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 280 | Phase 3 | United States;Mexico;Canada;Argentina;Spain;Brazil;Russian Federation;Germany;Netherlands;Korea, Republic of | ||
| 330 | NCT03371251 (ClinicalTrials.gov) | February 7, 2018 | 8/12/2017 | Study of BOS161721 in Systemic Lupus Erythematosus (SLE) Patients on a Background of Limited Standard of Care | A Randomized Double-Blind Phase 1b/2 Combined Staggered Multiple Dose Escalation Study of BOS161721 in Systemic Lupus Erythematosus (SLE) Patients on a Background of Limited Standard of Care | Systemic Lupus Erythematosus | Drug: BOS161721;Drug: Placebo | Boston Pharmaceuticals | NULL | Completed | 18 Years | 70 Years | All | 143 | Phase 1/Phase 2 | United States;Argentina;Bulgaria;Colombia;Georgia;Hungary;Mexico;Peru;Philippines;Poland;Romania;Ukraine |
| 331 | NCT03370263 (ClinicalTrials.gov) | January 15, 2018 | 6/12/2017 | BENLYSTA® Special Drug Use Investigation | BENLYSTA for Intravenous Injection / Subcutaneous Injection Special Drug Use Investigation | Systemic Lupus Erythematosus | Drug: Benlysta | GlaxoSmithKline | NULL | Recruiting | N/A | N/A | All | 600 | Japan | |
| 332 | EUCTR2016-003050-32-DE (EUCTR) | 09/01/2018 | 21/06/2017 | A Phase 3 Study to Evaluate the Efficacy and Safety of BelimumabAdministered in Combination with Rituximab to Adult Subjects with Systemic LupusErythematosus (SLE) – BLISS-BELIEVE | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 104-Week Study to Evaluate the Efficacy and Safety of BelimumabAdministered in Combination with Rituximab to Adult Subjects with Systemic LupusErythematosus (SLE) | Systemic Lupus Erythematosus (SLE) or Lupus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: MabThera (Rituximab) Product Name: MabThera (Rituximab) INN or Proposed INN: RITUXIMAB Trade Name: Benlysta (Belimumab) Product Name: Benlysta (Belimumab) INN or Proposed INN: BELIMUMAB Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 280 | Phase 3 | United States;Mexico;Canada;Argentina;Spain;Brazil;Russian Federation;Netherlands;Germany;Korea, Republic of | ||
| 333 | NCT03407482 (ClinicalTrials.gov) | January 9, 2018 | 15/1/2018 | An Extension Study of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus | A Phase II, Open-Label Extension Study of Patients Previously Enrolled in Study GA30044 to Evaluate the Long-Term Safety and Efficacy of GDC-0853 in Patients With Moderate to Severe Active Systemic Lupus Erythematosus | Lupus Erythematosus, Systemic | Drug: GDC-0853 | Genentech, Inc. | NULL | Completed | 18 Years | 76 Years | All | 160 | Phase 2 | United States;Argentina;Brazil;Bulgaria;Chile;Colombia;Korea, Republic of;Mexico;Spain;Taiwan;United Kingdom;Germany;Portugal |
| 334 | EUCTR2017-001203-79-PL (EUCTR) | 05/01/2018 | 03/11/2017 | A clinical study to test the efficacy and safety of BMS-986165 in Subjects with Systemic Lupus Erythematosus. | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of BMS-986165 in Subjects with Systemic Lupus Erythematosus | Systemic Lupus Erythematosus MedDRA version: 21.1;Level: LLT;Classification code 10042947;Term: Systemic lupus erythematosus synd;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BMS-986165 Product Code: BMS-986165 INN or Proposed INN: BMS-986165 | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 2 | United States;Taiwan;Spain;Israel;Russian Federation;Colombia;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Australia;Germany;Japan;Korea, Republic of | ||
| 335 | NCT03030118 (ClinicalTrials.gov) | December 28, 2017 | 15/1/2017 | Study of Anti-Malarials in Incomplete Lupus Erythematosus | Study of Anti-Malarials in Incomplete Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: Hydroxychloroquine;Drug: Placebo Oral Capsule | Milton S. Hershey Medical Center | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Active, not recruiting | 15 Years | 49 Years | All | 187 | Phase 2 | United States |
| 336 | NCT03093402 (ClinicalTrials.gov) | December 21, 2017 | 21/2/2017 | JBT-101 in Systemic Lupus Erythematosus (SLE) | A Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Efficacy, Safety, and Tolerability of JBT-101 in Systemic Lupus Erythematosus | Systemic Lupus Erythematosus;SLE;Lupus | Drug: JBT-101;Drug: Placebo | National Institute of Allergy and Infectious Diseases (NIAID) | Corbus Pharmaceuticals Inc.;Autoimmunity Centers of Excellence;Rho Federal Systems Division, Inc. | Completed | 18 Years | 70 Years | All | 109 | Phase 2 | United States |
| 337 | EUCTR2017-001764-37-BG (EUCTR) | 15/12/2017 | 16/10/2017 | An Extension Study of Patients Previously Enrolled in Study GA30044 to Evaluate the Long-Term Safety and Efficacy of GDC-0853 in Patients with Moderate to Severe Active Systemic Lupus Erythematosus | A PHASE II, OPEN-LABEL EXTENSION STUDY OF PATIENTS PREVIOUSLY ENROLLED IN STUDY GA30044 TO EVALUATE THE LONG-TERMSAFETY AND EFFICACY OF GDC-0853 IN PATIENTS WITH MODERATE TO SEVERE ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS | Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: GDC-0853 Product Code: RO7010939/F13 INN or Proposed INN: not available yet Other descriptive name: GDC-0853 RO7010939 | Genentech, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | Portugal;United States;Taiwan;Spain;Chile;Colombia;United Kingdom;Mexico;Argentina;Brazil;Bulgaria;Germany;Korea, Republic of | ||
| 338 | EUCTR2016-003050-32-ES (EUCTR) | 05/12/2017 | 01/12/2017 | A Phase 3 Study to Evaluate the Efficacy and Safety of BelimumabAdministered in Combination with Rituximab to Adult Subjects with Systemic Lupus Erythematosus (SLE) – BLISS-BELIEVE | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 104-Week Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination with Rituximab to Adult Subjects with Systemic Lupus Erythematosus (SLE). | Systemic Lupus Erythematosus (SLE) or Lupus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: MabThera (Rituximab) Product Name: MabThera (Rituximab) INN or Proposed INN: RITUXIMAB Trade Name: Benlysta (Belimumab) Product Name: Benlysta (Belimumab) INN or Proposed INN: BELIMUMAB Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA | GlaxoSmithKline, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | United States;Mexico;Canada;Argentina;Brazil;Spain;South Africa;Russian Federation;Netherlands;Germany;Korea, Republic of | ||
| 339 | EUCTR2017-001203-79-HU (EUCTR) | 04/12/2017 | 04/10/2017 | A clinical study to test the efficacy and safety of BMS-986165 in Subjects with Systemic Lupus Erythematosus. | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of BMS-986165 in Subjects with Systemic Lupus Erythematosus | Systemic Lupus Erythematosus MedDRA version: 20.0;Level: LLT;Classification code 10042947;Term: Systemic lupus erythematosus synd;System Organ Class: 100000017968;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: BMS-986165 Product Code: BMS-986165 INN or Proposed INN: BMS-986165 | Bristol-Myers Squibb international Corporation | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | United States;Taiwan;Spain;Ukraine;Russian Federation;Israel;Colombia;France;Hungary;Mexico;Argentina;Brazil;Poland;Romania;Peru;Bulgaria;Germany;Japan;Korea, Republic of | ||
| 340 | EUCTR2016-004574-17-FR (EUCTR) | 30/11/2017 | 28/11/2018 | A study to measure how safe CC-220 is and how well CC-220 works in people with lupus. | A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLEBLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-220 IN SUBJECTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS | SYSTEMIC LUPUS ERYTHEMATOSUS MedDRA version: 20.0;Level: LLT;Classification code 10025134;Term: Lupus erythematosus;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: CC-220 INN or Proposed INN: CC-220 Other descriptive name: CC-220 Product Code: CC-220 INN or Proposed INN: CC-220 Other descriptive name: CC-220 Product Code: CC-220 INN or Proposed INN: CC-220 Other descriptive name: CC-220 | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 280 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;United States;Spain;Russian Federation;Colombia;Italy;France;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Germany | ||
| 341 | NCT03334851 (ClinicalTrials.gov) | November 17, 2017 | 3/11/2017 | Safety and Tolerability Study Of PF-06835375 In Subjects With Seropositive Systemic Lupus Erythematosus Or Rheumatoid Arthritis | A PHASE 1, RANDOMIZED, MULTI-CENTER, DOUBLE-BLIND, SPONSOR OPEN, PLACEBO-CONTROLLED, SINGLE AND MULTIPLE DOSE-ESCALATION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF PF-06835375 IN SUBJECTS WITH SEROPOSITIVE SYSTEMIC LUPUS ERYTHEMATOSUS OR RHEUMATOID ARTHRITIS | Systemic Lupus Erythematosus;Rheumatoid Arthritis | Drug: PF-06835375;Drug: Placebo | Pfizer | NULL | Completed | 18 Years | 70 Years | All | 74 | Phase 1 | United States;Puerto Rico |
| 342 | EUCTR2016-004574-17-BE (EUCTR) | 14/11/2017 | 07/06/2017 | A study to measure how safe CC-220 is and how well CC-220 works in people with lupus. | A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLEBLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-220 IN SUBJECTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS | SYSTEMIC LUPUS ERYTHEMATOSUS MedDRA version: 20.0;Level: LLT;Classification code 10025134;Term: Lupus erythematosus;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: CC-220 INN or Proposed INN: CC-220 Other descriptive name: CC-220 Product Code: CC-220 INN or Proposed INN: CC-220 Other descriptive name: CC-220 Product Code: CC-220 INN or Proposed INN: CC-220 Other descriptive name: CC-220 | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 280 | Phase 2 | United States;Serbia;Spain;Russian Federation;Colombia;Italy;France;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Germany | ||
| 343 | EUCTR2017-001764-37-GB (EUCTR) | 14/11/2017 | 15/08/2017 | An Extension Study of Patients Previously Enrolled in Study GA30044 to Evaluate the Long-Term Safety and Efficacy of GDC-0853 in Patients with Moderate to Severe Active Systemic Lupus Erythematosus | A PHASE II, OPEN-LABEL EXTENSION STUDY OF PATIENTS PREVIOUSLY ENROLLED IN STUDY GA30044 TO EVALUATE THE LONG-TERMSAFETY AND EFFICACY OF GDC-0853 IN PATIENTS WITH MODERATE TO SEVERE ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS | Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: GDC-0853 Product Code: RO7010939/F13 INN or Proposed INN: not available yet Other descriptive name: GDC-0853 RO7010939 | Genentech, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 2 | United States;Portugal;Taiwan;Spain;Chile;Colombia;United Kingdom;Mexico;Argentina;Brazil;Bulgaria;Germany;Korea, Republic of | ||
| 344 | EUCTR2017-001764-37-ES (EUCTR) | 07/11/2017 | 18/09/2017 | An Extension Study of Patients Previously Enrolled in Study GA30044 to Evaluate the Long-Term Safety and Efficacy of GDC-0853 in Patients with Moderate to Severe Active Systemic Lupus Erythematosus | A PHASE II, OPEN-LABEL EXTENSION STUDY OF PATIENTS PREVIOUSLY ENROLLED IN STUDY GA30044 TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF GDC-0853 IN PATIENTS WITH MODERATE TO SEVERE ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS | Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: GDC-0853 Product Code: RO7010939/F13 INN or Proposed INN: not available yet Other descriptive name: GDC-0853 RO7010939 | Roche Farma, S.A por delegación de Genentech, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Portugal;Taiwan;Spain;Chile;Colombia;United Kingdom;Mexico;Argentina;Brazil;Bulgaria;Germany;Korea, Republic of | ||
| 345 | EUCTR2016-004574-17-DE (EUCTR) | 27/09/2017 | 21/04/2017 | A study to measure how safe CC-220 is and how well CC-220 works in people with lupus. | A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLEBLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-220 IN SUBJECTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS | SYSTEMIC LUPUS ERYTHEMATOSUS MedDRA version: 20.0;Level: LLT;Classification code 10025134;Term: Lupus erythematosus;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: CC-220 INN or Proposed INN: CC-220 Other descriptive name: CC-220 Product Code: CC-220 INN or Proposed INN: CC-220 Other descriptive name: CC-220 Product Code: CC-220 INN or Proposed INN: CC-220 Other descriptive name: CC-220 | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 280 | Phase 2 | United States;Serbia;Spain;Russian Federation;Colombia;Italy;France;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Germany | ||
| 346 | ChiCTR-IOR-17012802 | 2017-09-26 | 2017-09-26 | Synergy effects and health regulation effect of oxygen-ozone therapy on systemic lupus erythematosus (SLE) | Synergy effects and health regulation effect of oxygen-ozone therapy on systemic lupus erythematosus (SLE) | systemic lupus erythematosus (SLE) | the Controled Group:basic oral therapy;the Treated Group:basic oral therapy + Autologous blood transfusion with oxygen-ozone + acupoint injection with oxygen-ozone on ST 36; | Guangdong Provincial Hospital of Chinese Medicine | NULL | Recruiting | 18 | 65 | Both | the Controled Group:30;the Treated Group:30; | China | |
| 347 | NCT03252587 (ClinicalTrials.gov) | September 21, 2017 | 15/8/2017 | An Investigational Study to Evaluate BMS-986165 in Participants With Systemic Lupus Erythematosus | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of BMS-986165 in Subjects With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: BMS-986165;Other: Placebo | Bristol-Myers Squibb | NULL | Active, not recruiting | 18 Years | 75 Years | All | 363 | Phase 2 | United States;Argentina;Australia;Brazil;Canada;Colombia;Germany;Hungary;Israel;Japan;Korea, Republic of;Mexico;Poland;Romania;Russian Federation;Spain;Taiwan;Bulgaria;France;Peru;Ukraine |
| 348 | NCT03054259 (ClinicalTrials.gov) | September 21, 2017 | 17/1/2017 | Rituximab Objective Outcome Measures Trial in SLE | A Feasibility Randomised Placebo-controlled Trial With Objective Outcome Measures to Evaluate the Efficacy of Biosimilar Rituximab in Musculoskeletal and Mucocutaneous Systemic Lupus Erythematosus | Systemic Lupus Erythematosus Arthritis | Drug: Rituximab;Drug: Methylprednisolone;Drug: Normal Saline | University of Leeds | NULL | Recruiting | 18 Years | 99 Years | All | 30 | Phase 2 | United Kingdom |
| 349 | NCT03254784 (ClinicalTrials.gov) | September 13, 2017 | 17/8/2017 | A Study to Evaluate BMS-986165 Tablet Formulation Relative to BMS-986165 Capsule Formulation and the Effect of a High-Fat/ High-Calorie Meal and Increased Gastric pH on the BMS-986165 Tablet Formulation | A Phase 1, Randomized, Open-Label, Single-Dose, Crossover Study To Evaluate the Bioavailability of BMS-986165 Tablet Formulation Relative To BMS-986165 Capsule Formulation and the Effect of a High-Fat/ High-Calorie Meal And Increased Gastric pH on the Bioavailability of BMS-986165 Tablet Formulation in Healthy Subjects | Systemic Lupus Erythematosus;Arthritic Psoriasis;Psoriasis;Inflammatory Bowel Diseases | Drug: BMS-986165 Capsule;Drug: BMS-986165 Tablet | Bristol-Myers Squibb | NULL | Completed | 18 Years | 50 Years | All | 49 | Phase 1 | United States;Netherlands |
| 350 | NCT03098823 (ClinicalTrials.gov) | September 12, 2017 | 21/3/2017 | A Crossover Study to Compare RAYOS to IR Prednisone to Improve Fatigue and Morning Symptoms for SLE | A Randomized, Double-Blind, Active Comparator-Controlled, Crossover Study to Assess the Capacity of RAYOS® Compared to Immediate-Release Prednisone to Improve Fatigue and Control Morning Symptoms in Subjects With Systemic Lupus Erythematosus | Lupus Erythematosus, Systemic;Lupus Erythematosus;Fatigue | Drug: RAYOS;Drug: Prednisone | Ampel BioSolutions, LLC | NULL | Completed | 18 Years | 99 Years | All | 62 | Phase 4 | United States |
| 351 | NCT03262727 (ClinicalTrials.gov) | September 1, 2017 | 24/8/2017 | The Effect of BMS-986165 Combined With an Oral Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female Patients | The Effect of BMS-986165 on the Pharmacokinetics of a Combined Oral Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female Subjects | Systemic Lupus Erythematosus;Arthritic Psoriasis;Psoriasis;Inflammatory Bowel Diseases | Drug: BMS-986165;Drug: Loestrin 1.5/30 (1.5 mg norethindrone acetate/30 µg ethinyl estradiol) | Bristol-Myers Squibb | NULL | Completed | 18 Years | 40 Years | Female | 49 | Phase 1 | United States |
| 352 | NCT03260166 (ClinicalTrials.gov) | August 31, 2017 | 10/8/2017 | Nicotinamide Treatment for Lupus-associated Skin Lesions in Lupus Erythematosus | An Open-label Study for Assessing the Efficacy and Safety of Nicotinamide Treatment for Lupus-associated Skin Lesions in Patients With Cutaneous Lupus Erythematosus or Systemic Lupus Erythematosus | Cutaneous Lupus Erythematosus;Systemic Lupus Erythematosus Rash | Drug: nicotinamide | Second Xiangya Hospital of Central South University | National Natural Science Foundation of China;Hunan Provincial Natural Science Foundation of China;National Key Clinical Specialty Construction Project of China | Active, not recruiting | 18 Years | 65 Years | All | 40 | Phase 2 | China |
| 353 | NCT03288324 (ClinicalTrials.gov) | August 23, 2017 | 29/8/2017 | Open-label Study of Tofacitinib for Moderate to Severe Skin Involvement in Young Adults With Lupus | A 3-part Open-label Study Assessing Safety, Tolerability, Pharmacokinetic and -Dynamic Profiles, and Efficacy of Tofacitinib in Young Adults From Age 18 to 45 With Moderate to Severe Skin Involvement Due to Lupus | Cutaneous Lupus;Systemic Lupus Erythematosus | Drug: Tofacitinib | Children's Hospital Medical Center, Cincinnati | Pfizer | Completed | 18 Years | 45 Years | All | 13 | Phase 1/Phase 2 | United States |
| 354 | NCT03219801 (ClinicalTrials.gov) | August 1, 2017 | 10/7/2017 | Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Systemic Lupus Erythematosus | Evaluation of Safety and Efficacy in Patients With Systemic Lupus Erythematosus by Transplantation of Umbilical Cord Derived Mesenchymal Stem Cells | Systemic Lupus Erythematosus | Biological: mesenchymal stem cells | Hebei Medical University | NULL | Not yet recruiting | 14 Years | 60 Years | All | 10 | Early Phase 1 | China |
| 355 | NCT03161483 (ClinicalTrials.gov) | July 6, 2017 | 18/5/2017 | A Study to Evaluate the Efficacy and Safety of CC-220 in Subjects With Active Systemic Lupus Erythematosus | A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-220 IN SUBJECTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS | Lupus Erythematosus, Systemic | Drug: CC-220;Other: Placebo | Celgene | NULL | Active, not recruiting | 18 Years | N/A | All | 289 | Phase 2 | United States;Argentina;Belgium;Brazil;Canada;Colombia;France;Germany;Hungary;Italy;Mexico;Poland;Russian Federation;Serbia;Spain |
| 356 | NCT03189017 (ClinicalTrials.gov) | July 3, 2017 | 12/6/2017 | A Phase I Study of ICP-022 in Healthy Subjects | A Phase I Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Trial in Healthy Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ICP-022 Following Single and Multiple Escalating Dose | Systemic Lupus Erythematosus;Rheumatoid Arthritis | Drug: ICP-022;Drug: Placebos | Innocare Pharma Australia Pty Ltd | NULL | Completed | 18 Years | 55 Years | Male | 64 | Phase 1 | Australia |
| 357 | NCT02920424 (ClinicalTrials.gov) | June 30, 2017 | 29/9/2016 | A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-56022473 in Subjects With Systemic Lupus Erythematosus | A Phase 1b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-56022473 in Subjects With Systemic Lupus Erythematosus | Lupus Erythematosus, Systemic | Drug: JNJ-56022473;Drug: Placebo | Janssen Research & Development, LLC | NULL | Withdrawn | 18 Years | 65 Years | All | 0 | Phase 1 | Germany |
| 358 | EUCTR2016-002950-19-DE (EUCTR) | 19/06/2017 | 12/04/2017 | A Phase II Study of M2951 in SLE | A Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study To Evaluate the Safety and Efficacy of M2951 in Subjects with Systemic Lupus Erythematosus (SLE) - N/A | Systemic Lupus Erythematosus (SLE) MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Evobrutinib Product Code: M2951 INN or Proposed INN: Evobrutinib Other descriptive name: M2951 | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 468 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Philippines;Taiwan;Russian Federation;Chile;Colombia;Italy;Mexico;Mauritius;Argentina;Poland;Brazil;Malaysia;Romania;Peru;South Africa;Bulgaria;Germany;Japan;Korea, Republic of | ||
| 359 | EUCTR2016-004574-17-HU (EUCTR) | 19/06/2017 | 13/04/2017 | A study to measure how safe CC-220 is and how well CC-220 works in people with lupus. | A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLEBLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-220 IN SUBJECTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS | SYSTEMIC LUPUS ERYTHEMATOSUS MedDRA version: 21.1;Level: LLT;Classification code 10025134;Term: Lupus erythematosus;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: CC-220 INN or Proposed INN: CC-220 Other descriptive name: CC-220 Product Code: CC-220 INN or Proposed INN: CC-220 Other descriptive name: CC-220 Product Code: CC-220 INN or Proposed INN: CC-220 Other descriptive name: CC-220 | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 280 | Phase 2 | Serbia;United States;Spain;Russian Federation;Colombia;Italy;France;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany | ||
| 360 | EUCTR2015-004359-32-PL (EUCTR) | 10/06/2017 | 24/04/2017 | Study to Evaluate BIIB059 in CLE with or without SLE | A 2-Part Phase 2 Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of BIIB059 in Subjects with Systemic Lupus Erythematosus and Active Skin Manifestations and in Subjects with Active Cutaneous Lupus Erythematosus with or without Systemic Manifestations. | Systemic Lupus Erythematosus (SLE) with Active Skin Manifestations and Active Cutaneous Lupus Erythematosus (CLE) with or without Systemic Manifestations MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BIIB059 Product Code: BIIB059 INN or Proposed INN: Not Available Other descriptive name: anti-blood dendritic cell antigen 2 | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 320 | Phase 2 | United States;Serbia;Philippines;Taiwan;Mexico;Argentina;Thailand;Poland;Israel;Bulgaria;Colombia;Korea, Republic of | ||
| 361 | EUCTR2016-004574-17-ES (EUCTR) | 08/06/2017 | 07/04/2017 | A study to measure how safe CC-220 is and how well CC-220 works in people with lupus. | A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLEBLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-220 IN SUBJECTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS | SYSTEMIC LUPUS ERYTHEMATOSUS MedDRA version: 19.1;Level: LLT;Classification code 10025134;Term: Lupus erythematosus;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: CC-220 INN or Proposed INN: CC-220 Other descriptive name: CC-220 Product Code: CC-220 INN or Proposed INN: CC-220 Other descriptive name: CC-220 Product Code: CC-220 INN or Proposed INN: CC-220 Other descriptive name: CC-220 | Celgene Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 280 | Phase 2 | Serbia;United States;Spain;Russian Federation;Colombia;Italy;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Germany | ||
| 362 | NCT03122431 (ClinicalTrials.gov) | June 5, 2017 | 17/4/2017 | Relevance of Monitoring Blood and Salivar Levels of Drugs Used in Rheumatic Autoimmune Diseases | Relevance of Monitoring Blood Levels Compared to Salivar Levels of Drugs Used in Rheumatic Autoimmune Diseases: Adherence and Understanding the Possible Underlying Mechanisms Involved in Effectiveness and in Adverse Effects | Systemic Lupus Erythematosus (SLE);Juvenile SLE;Cutaneous Lupus | Drug: Thalidomide;Drug: Hydroxychloroquine reduced;Drug: standard dose of HCQ | University of Sao Paulo General Hospital | Fundação de Amparo à Pesquisa do Estado de São Paulo | Completed | 5 Years | 64 Years | All | 93 | Phase 4 | Brazil |
| 363 | ChiCTR-INR-17011495 | 2017-05-25 | 2017-05-26 | Canceled by the investigator The efficacy and safety of metformin hydrochloride combined with atorvastatin in the treatment of primary mild to moderate systemic sy | The efficacy and safety of metformin hydrochloride combined with atorvastatin in the treatment of primary mild to moderate systemic systemic lupus erythematosus | Primary mild to moderate systemic systemic lupus erythematosus | Immunomodulatory treatment group:The level of SELSNA-SLEDAI was evaluated at week 4, week 12 and week 24, the BILAG table, the SLE lesion index, and the SLE damage index were measured at 4 weeks, 12 weeks and 24 weeks. The levels of Th17, Treg and Th17 / Treg were measured.;Leflunomide treatment group:Leflunomide tablets 10m, 1 times / day, orally. The SELSNA-SLEDAI score table, BILAG worksheet, SLE damage index score were assessed at week 4, week 12 and week 24, and serum Th17, Treg and Th17 / Treg ratios were measured.;Immunomodulatory treatment group and Leflunomide treatment group :0 weeks to give prednisone acetate tablets 0.5-1mg / kg.d (or patients can choose to take the same dose of methylprednisolone tablets), 4 weeks after the beginning of the dose by 2 weeks to reduce the regular dose of 10% Reduction to prednisone acetate tablets 10mg / day to maintain.;Immunomodulatory treatment group and Leflunomide treatment group:All patients without contraindications plus hydroxychloroquine tablets 0.2,2 / day, orally; and according to the condition plus calcium (800-1200mg / day), vitamin D (200-800IU / day) and other treatment.; | The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology | NULL | Recruiting | Both | Immunomodulatory treatment group:15;Leflunomide treatment group:15;Immunomodulatory treatment group and Leflunomide treatment group :30;Immunomodulatory treatment group and Leflunomide treatment group:30; | China | |||
| 364 | ChiCTR-INC-17011497 | 2017-05-25 | 2017-05-26 | Canceled by the investigator The efficacy and safety of metformin hydrochloride combined with atorvastatin in the treatment of moderate to severe activity systemic lupus erythematosus | The efficacy and safety of metformin hydrochloride combined with atorvastatin in the treatment of moderate to severe activity systemic lupus erythematosus | moderate to severe active systemic lupus erythematosus | Immunomodulation combined with traditional DMARDS treatment group:Immunomodulation combined with traditional DMARDS group: On the basis of glucocorticoid and traditional DMARDS treatment, metformin hydrochloride tablets 250mg, 3 times / day, oral; atorvastatin tablets 10mg, 1 times / day; in the first 4 weeks , 12 weeks and 24 weeks to assess the SELSNA-SLEDAI score table,traditional DMARDS treatment group:Traditional DMARDS treatment group: the use of glucocorticoid and traditional DMARDS treatment. The SELSNA-SLEDAI score table, BILAG worksheet, SLE damage index score were assessed at week 4, week 12 and week 24, and serum Th17, Treg and Th17 / Treg ratios were measured.; | The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology | NULL | Pending | Both | Immunomodulation combined with traditional DMARDS treatment group:60;traditional DMARDS treatment group:60; | China | |||
| 365 | EUCTR2016-000625-39-BG (EUCTR) | 17/05/2017 | 08/03/2017 | A study to characterize the safety and tolerability of Anifrolumab in adult patients with Systemic Lupus Erythematosus | A Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus - Tulip SLE LTE | Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Anifrolumab Product Code: MEDI-546 INN or Proposed INN: Anifrolumab | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 575 | Phase 3 | United States;Taiwan;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;France;Australia;Peru;South Africa;Korea, Republic of;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Japan;New Zealand | ||
| 366 | EUCTR2016-002950-19-BG (EUCTR) | 27/04/2017 | 27/03/2017 | A Phase II Study of M2951 in SLE | A Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study To Evaluate the Safety and Efficacy of M2951 in Subjects with Systemic Lupus Erythematosus (SLE) - N/A | Systemic Lupus Erythematosus (SLE) MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Evobrutinib Product Code: M2951 INN or Proposed INN: Evobrutinib Other descriptive name: M2951 | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 468 | Phase 2 | United States;Philippines;Taiwan;Russian Federation;Chile;Colombia;Italy;Mexico;Mauritius;Argentina;Poland;Brazil;Malaysia;Romania;Peru;South Africa;Bulgaria;Germany;Japan;Korea, Republic of | ||
| 367 | NCT03171194 (ClinicalTrials.gov) | April 27, 2017 | 4/5/2017 | Pilot Trial of Mesenchymal Stem Cells for Systemic Lupus Erythematosus | A Phase I Safety Trial of Allogeneic Mesenchymal Stem Cells for Systemic Lupus Erythematosus | System; Lupus Erythematosus | Drug: Low Dose Mesenchymal Stem Cells (MSCs) | Medical University of South Carolina | NULL | Completed | 18 Years | 65 Years | All | 6 | Phase 1 | United States |
| 368 | JPRN-JapicCTI-173544 | 26/4/2017 | 23/03/2017 | TULIP SLE LTE | A Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus | Active Systemic Lupus Erythematosus | Intervention name : Anifrolumab INN of the intervention : anifrolumab Dosage And administration of the intervention : Anifrolumab IV administration every 4 weeks from Week 0 to Week 152 for a total of 39 doses Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Placebo IV administration every 4 weeks from Week 0 to Week 152 for a total of 39 doses | AstraZeneca | NULL | complete | 18 | BOTH | 50 | Phase 3 | Japan, Asia except Japan, North America, South America, Europe, Oceania | |
| 369 | EUCTR2016-002950-19-PL (EUCTR) | 25/04/2017 | 28/03/2017 | A Phase II Study of M2951 in SLE | A Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study To Evaluate the Safety and Efficacy of M2951 in Subjects with Systemic Lupus Erythematosus (SLE) - N/A | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Evobrutinib Product Code: M2951 INN or Proposed INN: Evobrutinib Other descriptive name: M2951 | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 468 | Phase 2 | United States;Philippines;Taiwan;Russian Federation;Chile;Colombia;Italy;Mexico;Mauritius;Argentina;Poland;Brazil;Malaysia;Romania;Peru;South Africa;Bulgaria;Germany;Japan;Korea, Republic of | ||
| 370 | EUCTR2015-001341-86-BG (EUCTR) | 10/04/2017 | 16/02/2017 | Phase IIb study of IFN-K in Systemic Lupus Erythematosus | A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Neutralization of the Interferon Gene Signature and the Clinical Efficacy of IFNa-Kinoid in Adult Subjects with Systemic Lupus Erythematosus - Phase IIb study of IFN-K in Systemic Lupus Erythematosus | Systemic Lupus Erythematosus MedDRA version: 19.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: IFN-Kinoid Product Code: IFN-K INN or Proposed INN: Not yet assigned Other descriptive name: IFN-Kinoid Drug Substance | Neovacs S.A. | NULL | Not Recruiting | Female: yes Male: yes | 178 | Phase 2 | United States;Serbia;Philippines;Taiwan;Thailand;Spain;Ukraine;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Peru;Tunisia;Moldova, Republic of;Korea, Republic of;Mexico;Argentina;Belgium;Poland;Croatia;Bulgaria;Georgia;Germany | ||
| 371 | NCT03355482 (ClinicalTrials.gov) | April 10, 2017 | 22/11/2017 | MRI Evaluation Assessing Synovitis to Address the Unmet Need for Reliable Endpoints in SLE | MRI Evaluation Assessing Synovitis to Address the Unmet Need for Reliable Endpoints in SLE | Systemic Lupus Erythematosus Arthritis | Drug: Methylprednisolone;Drug: Placebos | Oklahoma Medical Research Foundation | Bristol-Myers Squibb | Recruiting | 18 Years | 70 Years | All | 40 | Phase 2 | United States |
| 372 | NCT03125486 (ClinicalTrials.gov) | April 7, 2017 | 18/4/2017 | Compassionate Use for Subcutaneous (SC) Belimumab | Compassionate Use for Subcutaneous (SC) Belimumab | Systemic Lupus Erythematosus | Drug: SC belimumab 200 mg | GlaxoSmithKline | NULL | No longer available | 18 Years | N/A | All | United States | ||
| 373 | EUCTR2016-001039-11-DE (EUCTR) | 03/04/2017 | 22/12/2016 | A Study of the Safety and Efficacy of GDC 0853 in Patients With Moderate to Severe Active Systemic Lupus Erythematosus | A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF GDC-0853 IN PATIENTS WITH MODERATE TO SEVERE ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS | Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: GDC-0853 Product Code: RO7010939/F13 INN or Proposed INN: not available yet Other descriptive name: GDC-0853 RO7010939 | Genentech, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Portugal;Taiwan;Spain;Chile;Colombia;United Kingdom;Mexico;Argentina;Brazil;Bulgaria;Germany;Korea, Republic of | ||
| 374 | NCT03159936 (ClinicalTrials.gov) | April 3, 2017 | 2/5/2017 | Oral Tofacitinib in Adult Subjects With Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE) | Open Label Phase 2 Pilot Trial of Oral Tofacitinib in Adult Subjects With Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE) | Discoid Lupus Erythematosus;Systemic Lupus Erythematosus | Biological: Tofacitinib citrate | Tufts Medical Center | Pfizer | Recruiting | 18 Years | 65 Years | All | 12 | Early Phase 1 | United States |
| 375 | EUCTR2016-000488-17-BG (EUCTR) | 27/03/2017 | 13/02/2017 | A study to evaluate the effectiveness and safety of the study drug, when patients are given dosage of ILT-101 with active moderate to severe systemic lupus erythematosus(SLE) | A Phase II, multi-centre, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety and pharmacokinetics of ILT-101 in patients with active moderate to severe systemic lupus erythematosus (SLE) | Systematic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: ILT-101 Product Code: ILT-101 INN or Proposed INN: Aldesleukin Other descriptive name: INTERLEUKIN-2 | ILTOO PHARMA | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | Portugal;France;Mexico;Spain;Romania;Austria;Bulgaria;Germany;Italy | ||
| 376 | EUCTR2016-000488-17-IT (EUCTR) | 02/03/2017 | 10/05/2019 | A study to evaluate the effectiveness and safety of the study drug, when patients are given dosage of ILT-101 with active moderate to severe systemic lupus erythematosus(SLE) | A Phase II, multi-centre, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety and pharmacokinetics of ILT-101 in patients with active moderate to severe systemic lupus erythematosus (SLE) - A study to evaluate the effectiveness and safety of the study drug, when patients are given dosage o | Systematic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: ILT-101 Product Code: ILT-101 INN or Proposed INN: ALDESLEUCHINA Other descriptive name: ALDESLEUCHINA | ILTOO PHARMA | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | France;Portugal;Spain;Austria;Bulgaria;Italy | ||
| 377 | NCT03042260 (ClinicalTrials.gov) | March 1, 2017 | 10/1/2017 | Prophylactic Trimethoprim/Sulfamethoxazole to Prevent Severe Infections in Patients With Lupus Erythematous | Prophylactic Trimethoprim-Sulfamethoxazole for the Prevention of Serious Infections in Patients With Systemic Lupus Erythematosus: a Randomized Placebo Controlled Trial | Lupus Erythematosus, Systemic | Drug: Trimethoprim-Sulfamethoxazole;Drug: Placebo Oral Tablet | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran | National Council of Science and Technology, Mexico | Recruiting | 18 Years | N/A | All | 310 | Phase 4 | Mexico |
| 378 | EUCTR2015-001341-86-ES (EUCTR) | 01/03/2017 | 27/12/2016 | Phase IIb study of IFN-K in Systemic Lupus Erythematosus | A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Neutralization of the Interferon Gene Signature and the Clinical Efficacy of IFNa-Kinoid in Adult Subjects with Systemic Lupus Erythematosus - Phase IIb study of IFN-K in Systemic Lupus Erythematosus | Systemic Lupus Erythematosus MedDRA version: 19.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: IFN-Kinoid Product Code: IFN-K INN or Proposed INN: Not yet assigned Other descriptive name: IFN-Kinoid Drug Substance | Neovacs S.A. | NULL | Not Recruiting | Female: yes Male: yes | 178 | Phase 2 | United States;Serbia;Philippines;Taiwan;Thailand;Spain;Ukraine;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Peru;Tunisia;Moldova, Republic of;Korea, Republic of;Mexico;Argentina;Belgium;Poland;Croatia;Bulgaria;Georgia;Germany | ||
| 379 | NCT03030976 (ClinicalTrials.gov) | March 2017 | 22/1/2017 | A Study of CD19 Redirected Autologous T Cells for CD19 Positive Systemic Lupus Erythematosus (SLE) | An Open-labeled, Uncontrolled, Single-arm Pilot Study to Evaluate Cellular Immunotherapy Using CD19-targeted Chimeric Antigen Receptor Engineered T Cells in Patients With CD19+ B Cell Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus (SLE) | Drug: cyclophosphamide;Drug: anti-CD19-CAR-T cells | Shanghai GeneChem Co., Ltd. | RenJi Hospital | Recruiting | 18 Years | 69 Years | All | 5 | Phase 1 | China |
| 380 | EUCTR2016-001039-11-BG (EUCTR) | 20/02/2017 | 08/11/2016 | A Study of the Safety and Efficacy of GDC 0853 in Patients With Moderate to Severe Active Systemic Lupus Erythematosus | A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF GDC-0853 IN PATIENTS WITHMODERATE TO SEVERE ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS | Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: GDC-0853 Product Code: RO7010939/F13 INN or Proposed INN: not available yet Other descriptive name: GDC-0853 RO7010939 | Genentech, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Portugal;Taiwan;Spain;Chile;Colombia;United Kingdom;Mexico;Argentina;Brazil;Bulgaria;Germany;Korea, Republic of | ||
| 381 | NCT02962960 (ClinicalTrials.gov) | February 14, 2017 | 23/9/2016 | A Study to Characterize the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab in Adult Type I Interferon Test High Systemic Lupus Erythematosus Subject With Active Skin Manifestations | A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study Characterizing the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab Following Subcutaneous Administration in Adult Systemic Lupus Erythematosus Subjects With Type I Interferon Test High Result and Active Skin Manifestations. | Systemic Lupus Erythematosus | Drug: Anifrolumab;Drug: Placebo | AstraZeneca | NULL | Completed | 18 Years | 70 Years | All | 36 | Phase 2 | United States;Hungary;Korea, Republic of;Poland |
| 382 | EUCTR2016-001039-11-ES (EUCTR) | 07/02/2017 | 26/10/2016 | A Study of the Safety and Efficacy of GDC 0853 in Patients With Moderate to Severe Active Systemic Lupus Erythematosus | A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF GDC-0853 IN PATIENTS WITH MODERATE TO SEVERE ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS | Systemic Lupus Erythematosus MedDRA version: 19.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: GDC-0853 Product Code: RO7010939/F13 INN or Proposed INN: not available yet Other descriptive name: GDC-0853 RO7010939 | Genentech, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Portugal;United States;Taiwan;Spain;Chile;Colombia;United Kingdom;France;Mexico;Argentina;Brazil;Bulgaria;Germany;Korea, Republic of | ||
| 383 | EUCTR2015-004359-32-BG (EUCTR) | 01/02/2017 | 03/11/2016 | Study to Evaluate BIIB059 in CLE with or without SLE | A 2-Part Phase 2 Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of BIIB059 in Subjects with Systemic Lupus Erythematosus and Active Skin Manifestations and in Subjects with Active Cutaneous Lupus Erythematosus with or without Systemic Manifestations. | Systemic Lupus Erythematosus (SLE) with Active Skin Manifestations and Active Cutaneous Lupus Erythematosus (CLE) with or without Systemic Manifestations MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BIIB059 Product Code: BIIB059 INN or Proposed INN: Not Available Other descriptive name: anti-blood dendritic cell antigen 2 | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 320 | Phase 2 | United States;Serbia;Philippines;Taiwan;Mexico;Argentina;Thailand;Poland;Israel;Bulgaria;Colombia;Korea, Republic of | ||
| 384 | EUCTR2016-001039-11-PT (EUCTR) | 30/01/2017 | 23/09/2016 | A Study of the Safety and Efficacy of GDC 0853 in Patients With Moderate to Severe Active Systemic Lupus Erythematosus | A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF GDC-0853 IN PATIENTS WITH MODERATE TO SEVERE ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS | Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: GDC-0853 Product Code: RO7010939/F13 INN or Proposed INN: not available yet Other descriptive name: GDC-0853 RO7010939 | Genentech, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Portugal;United States;Taiwan;Spain;Chile;Colombia;United Kingdom;France;Mexico;Argentina;Brazil;Bulgaria;Germany;Korea, Republic of | ||
| 385 | EUCTR2016-003246-93-PL (EUCTR) | 26/01/2017 | 13/12/2016 | A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study Characterizing the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab following subcutaneous administration in Adult Systemic Lupus Erythematosus Subjects with Type I Interferon test high result and active skin manifestations | A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study Characterizing the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab following subcutaneous administration in Adult Systemic Lupus Erythematosus Subjects with Type I Interferon test high result and active skin manifestations | Systemic Lupus Erythematosus;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Anifrolumab Product Code: MEDI-546 INN or Proposed INN: ANIFROLUMAB Other descriptive name: Immunoglobulin G1, anti-(human type I interferon receptor) (human monoclonal MEDI-546 heavy chain), disulfide with human monoclonal MEDI-546-chain, dimer | Astrazeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 32 | Phase 2 | United States;Hungary;Poland;Korea, Republic of | ||
| 386 | NCT02880852 (ClinicalTrials.gov) | January 23, 2017 | 23/8/2016 | Belimumab Phase I Study in Chinese Subjects With Systemic Lupus Erythematosus | A Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSK1550188 in Chinese Subjects With Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Drug: Belimumab | GlaxoSmithKline | NULL | Completed | 18 Years | N/A | All | 20 | Phase 1 | China |
| 387 | JPRN-JapicCTI-183957 | 20/1/2017 | 14/05/2018 | A Phase II Study of M2951 in Systemic Lupus Erythematosus (SLE) | A Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study To Evaluate the Safety and Efficacy of M2951 in Subjects With Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Intervention name : M2951 (Other Name: Evobrutinib) INN of the intervention : - Dosage And administration of the intervention : M2951 low dose will be administered for 52 weeks in double-blind treatment period. Intervention name : M2951 (Other Name: Evobrutinib) INN of the intervention : - Dosage And administration of the intervention : M2951 mid dose will be administered for 52 weeks in double-blind treatment period. Intervention name : M2951 (Other Name: Evobrutinib) INN of the intervention : - Dosage And administration of the intervention : M2951 high dose will be administered for 52 weeks in double-blind treatment period. Intervention name : M2951 (Other Name: Evobrutinib) INN of the intervention : - Dosage And administration of the intervention : M2951 will be administered for 104 weeks in open-lable extension period at a dose of 50 milligrams twice a day. Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Placebo matched to M2951 will be administered for 52 weeks in double-blind treatment period. | Merck Biopharma Co., Ltd | Merck KGaA | complete | 18 | 75 | BOTH | 480 | Phase 2 | Japan, Asia except Japan, North America, South America, Europe, Africa |
| 388 | NCT02908100 (ClinicalTrials.gov) | January 19, 2017 | 14/9/2016 | A Study of the Safety and Efficacy of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus | A Phase II, Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of GDC-0853 in Patients With Moderate to Severe Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: GDC-0853;Drug: Placebo | Genentech, Inc. | NULL | Completed | 18 Years | 75 Years | All | 260 | Phase 2 | United States;Argentina;Brazil;Bulgaria;Chile;Colombia;Germany;Korea, Republic of;Mexico;Spain;Taiwan;United Kingdom;France;Portugal;Thailand |
| 389 | NCT02955615 (ClinicalTrials.gov) | January 18, 2017 | 17/10/2016 | ILT-101 in Patients With Active Moderate to Severe Systemic Lupus Erythematosus (SLE) | A Phase II, Multi-centre, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of ILT-101 in Patients With Active Moderate to Severe Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Drug: ILT-101;Drug: Placebo | Iltoo Pharma | NULL | Completed | 18 Years | N/A | All | 100 | Phase 2 | Austria;Bulgaria;France;Germany;Italy;Mauritius;Mexico;Portugal;Romania;Spain |
| 390 | NCT02975336 (ClinicalTrials.gov) | January 4, 2017 | 23/11/2016 | A Phase II Study of M2951 in Systemic Lupus Erythematosus (SLE) | A Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study To Evaluate the Safety and Efficacy of M2951 in Subjects With Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Drug: Placebo;Drug: M2951 | EMD Serono Research & Development Institute, Inc. | Merck KGaA, Darmstadt, Germany | Terminated | 18 Years | 75 Years | All | 480 | Phase 2 | United States;Argentina;Bulgaria;Chile;Colombia;Germany;Italy;Japan;Korea, Republic of;Malaysia;Mauritius;Mexico;Peru;Philippines;Poland;Romania;Russian Federation;South Africa;Taiwan |
| 391 | NCT02953821 (ClinicalTrials.gov) | December 16, 2016 | 1/11/2016 | Acthar Gel for Active Systemic Lupus Erythematosus (SLE) | A Multicenter, Randomized, Double Blind, Placebo Controlled Study to Assess the Efficacy and Safety of Acthar Gel in Subjects With Persistently Active Systemic Lupus Erythematosus Despite Moderate Dose Corticosteroids | Lupus Erythematosus, Systemic | Drug: Acthar Gel;Drug: Placebo Gel | Mallinckrodt | NULL | Completed | 18 Years | N/A | All | 172 | Phase 4 | United States;Argentina;Chile;Mexico;Peru;Colombia |
| 392 | EUCTR2016-000625-39-DE (EUCTR) | 13/12/2016 | 05/07/2016 | A study to characterize the safety and tolerability of Anifrolumab in adult patients with Systemic Lupus Erythematosus | A Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus - Tulip SLE LTE | Systemic Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Anifrolumab Product Code: MEDI-546 INN or Proposed INN: Anifrolumab | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 575 | Phase 3 | United States;Taiwan;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;France;Peru;Australia;South Africa;Korea, Republic of;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan | ||
| 393 | EUCTR2016-003246-93-HU (EUCTR) | 06/12/2016 | 19/10/2016 | The purpose of this study is to investigate how a new experimental medication called anifrolumab is distributed in the body when given as subcutaneous (under the skin) injections to subjects with the autoimmune disease called Systemic Lupus Erythematosus (SLE), also known as Lupus. The study will also explore if anifrolumab may improve Lupus skin symptoms. | A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study Characterizing the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab following subcutaneous administration in Adult Systemic Lupus Erythematosus Subjects with Type I Interferon test high result and active skin manifestations | Systemic Lupus Erythematosus;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Anifrolumab Product Code: MEDI-546 | Astrazeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 32 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Hungary;Poland;Korea, Republic of | ||
| 394 | EUCTR2016-000488-17-ES (EUCTR) | 21/11/2016 | 18/11/2016 | A study to evaluate the effectiveness and safety of the study drug, when patients are given dosage of ILT-101 with active moderate to severe systemic lupus erythematosus(SLE) | A Phase II, multi-centre, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety and pharmacokinetics of ILT-101 in patients with active moderate to severe systemic lupus erythematosus (SLE) | Systematic Lupus Erythematosus MedDRA version: 19.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: ILT-101 Product Code: ILT-101 INN or Proposed INN: Aldesleukin Other descriptive name: INTERLEUKIN-2 | ILTOO PHARMA | NULL | Not Recruiting | Female: yes Male: yes | 100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Portugal;Mexico;Spain;Austria;Bulgaria;Italy | ||
| 395 | EUCTR2016-001039-11-GB (EUCTR) | 16/11/2016 | 24/08/2016 | A Study of the Safety and Efficacy of GDC 0853 in Patients With Moderate to Severe Active Systemic Lupus Erythematosus | A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF GDC-0853 IN PATIENTS WITH MODERATE TO SEVERE ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS | Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: GDC-0853 Product Code: RO7010939/F13 INN or Proposed INN: not available yet Other descriptive name: GDC-0853 RO7010939 | Genentech, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Portugal;Taiwan;Spain;Chile;Colombia;United Kingdom;Mexico;Argentina;Brazil;Bulgaria;Germany;Korea, Republic of | ||
| 396 | EUCTR2015-004457-40-PL (EUCTR) | 04/11/2016 | 02/09/2016 | A clinical trial undertaken around the world in adult patients with lupus erythematosus currently havingsymptoms. These patients are randomly (like flipping a coin) given a drug (at 3 different doses) or aninactive drug in addition to their usual medication given for lupus. Neither the sponsor nor the doctornor the patient will know which additional treatment is given. | A MULTI-CENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE RANGING STUDY FOLLOWED BY AN OBSERVATIONAL PERIOD TO EVALUATE THE EFFICACY AND SAFETY OF DAPIROLIZUMAB PEGOL IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS | SUBJECTSWITH MODERATELY TO SEVERELY ACTIVE SYSTEMICLUPUS ERYTHEMATOSUS MedDRA version: 20.0;Level: LLT;Classification code 10040967;Term: SLE;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol (DZP) Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | United States;Spain;Ukraine;Chile;Russian Federation;Colombia;Hungary;Mexico;Poland;Romania;Peru;Bulgaria;Germany | ||
| 397 | EUCTR2016-000625-39-LT (EUCTR) | 03/11/2016 | 17/08/2016 | A study to characterize the safety and tolerability of Anifrolumab in adult patients with Systemic Lupus Erythematosus | A Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus - Tulip SLE LTE | Systemic Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Anifrolumab Product Code: MEDI-546 INN or Proposed INN: Anifrolumab | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 575 | Phase 3 | South Africa;Korea, Republic of;Lithuania;United States;Taiwan;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;France;Peru;Australia;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan | ||
| 398 | ChiCTR-IPR-16009451 | 2016-11-01 | 2016-10-16 | The Efficacy and Safety of Low Dose IL-2 Conbined Rapamycin Therapy in Chinese Over-treated Patients with Systemic Lupus Erythematosus | The Efficacy and Safety of Low Dose IL-2 Conbined Rapamycin Therapy in Chinese Over-treated Patients with Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | IL-2 group:IL-2;IL-2 + Rapamycin group :IL-2 and Rapamycin;non IL-2 or IL-6 antagonist group :Glucocorticoids and DMARDs; | the Second Hospital of Shanxi Medical University | NULL | Pending | 18 | 80 | Both | IL-2 group:20;IL-2 + Rapamycin group :20;non IL-2 or IL-6 antagonist group :20; | China | |
| 399 | EUCTR2016-000488-17-PT (EUCTR) | 24/10/2016 | 28/07/2016 | A study to evaluate the effectiveness and safety of the study drug, when patients are given dosage of ILT-101 with active moderate to severe systemic lupus erythematosus(SLE) | A Phase II, multi-centre, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety and pharmacokinetics of ILT-101 in patients with active moderate to severe systemic lupus erythematosus (SLE) | Systematic Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: ILT-101 Product Code: ILT-101 INN or Proposed INN: Aldesleukin Other descriptive name: INTERLEUKIN-2 | ILTOO PHARMA | NULL | Not Recruiting | Female: yes Male: yes | 100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Portugal;Mexico;Mauritius;Spain;Romania;Austria;Bulgaria;Germany;Italy | ||
| 400 | NCT02847598 (ClinicalTrials.gov) | October 20, 2016 | 6/6/2016 | Study to Evaluate BIIB059 in Cutaneous Lupus Erythematosus (CLE) With or Without Systemic Lupus Erythematosus (SLE) | A 2-Part Phase 2 Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of BIIB059 in Subjects With Systemic Lupus Erythematosus and Active Skin Manifestations and in Subjects With Active Cutaneous Lupus Erythematosus With or Without Systemic Manifestations | Systemic Lupus Erythematosus;Active Cutaneous Lupus Erythematosus | Drug: BIIB059;Drug: Placebo | Biogen | NULL | Completed | 18 Years | 75 Years | All | 264 | Phase 2 | United States;Argentina;Bulgaria;Colombia;Israel;Korea, Republic of;Mexico;Philippines;Poland;Serbia;Taiwan;Thailand |
| 401 | EUCTR2015-003341-25-GB (EUCTR) | 17/10/2016 | 22/09/2016 | A study to evaluate the effectiveness and safety of the study drug, when patients are given a 200-mcg dosage of IPP-201101 plus standard of care in patients with systemic lupus erythematosus. | A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus - A study to evaluate the effectiveness and safety of the study drug for patients with SLE. | Systemic Lupus Erythematosus MedDRA version: 19.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Code: IPP-201101 INN or Proposed INN: IPP-201101 | ImmuPharma SA | NULL | Not Recruiting | Female: yes Male: yes | 200 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Hungary;Germany;United Kingdom | ||
| 402 | EUCTR2015-004457-40-ES (EUCTR) | 10/10/2016 | 05/08/2016 | A clinical trial undertaken around the world in adult patients with lupus erythematosus currently havingsymptoms. These patients are randomly (like flipping a coin) given a drug (at 3 different doses) or aninactive drug in addition to their usual medication given for lupus. Neither the sponsor nor the doctornor the patient will know which additional treatment is given. | A MULTI-CENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE RANGING STUDY FOLLOWED BY AN OBSERVATIONAL PERIOD TO EVALUATE THE EFFICACY AND SAFETY OF DAPIROLIZUMAB PEGOL IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS. | SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS. MedDRA version: 19.0;Level: LLT;Classification code 10040967;Term: SLE;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol (DZP) Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 Product Name: Dapirolizumab pegol (DZP) Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 Product Name: Dapirolizumab pegol (DZP) Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | United States;Spain;Ukraine;Chile;Russian Federation;Colombia;Hungary;Mexico;Poland;Romania;Peru;Bulgaria;Germany | ||
| 403 | NCT02842814 (ClinicalTrials.gov) | October 2016 | 3/6/2016 | Prediction of Relapse Risk in Stable Systemic Lupus Erythematosus | Evaluation and Prediction of Relapse Risk After Glucocorticoid Withdrawal in Patients With Stable Systemic Lupus Erythematosus: An Open-labeled Multi-centric Randomized Controlled Study From China | Systemic Lupus Erythematosus | Other: Drug free;Drug: HCQ;Drug: GC+HCQ | Peking Union Medical College Hospital | Xiangya Hospital of Central South University;Shengjing Hospital;People's Hospital of Xinjiang Uygur Autonomous Region;Anhui Provincial Hospital;Beijing Hospital | Completed | 18 Years | 60 Years | All | 333 | N/A | China |
| 404 | NCT02779153 (ClinicalTrials.gov) | October 2016 | 18/5/2016 | Acthar SLE (Systemic Lupus Erythematosus) | Efficacy, Safety, and Steroid Sparing Effect of Acthar in Patients With Hematologic Manifestations of Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE);Repository Corticotropin Injection | Drug: Acthar low dose (40 U);Drug: Acthar high dose (80 U) | NYU Langone Health | Mallinckrodt | Withdrawn | 18 Years | N/A | All | 0 | Phase 4 | United States |
| 405 | EUCTR2015-004457-40-HU (EUCTR) | 20/09/2016 | 13/07/2016 | A clinical trial undertaken around the world in adult patients with lupus erythematosus currently having symptoms. These patients are randomly (like flipping a coin) given a drug (at 3 different doses) or an inactive drug in addition to their usual medication given for lupus. Neither the sponsor nor the doctor nor the patient will know which additional treatment is given. | A MULTI-CENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE RANGING STUDY FOLLOWED BY AN OBSERVATIONAL PERIOD TO EVALUATE THE EFFICACY AND SAFETY OF DAPIROLIZUMAB PEGOL IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS | SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS MedDRA version: 19.0;Level: LLT;Classification code 10040967;Term: SLE;System Organ Class: 100000004859 ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol (DZP) Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 Product Name: Dapirolizumab pegol (DZP) Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 Product Name: Dapirolizumab pegol (DZP) Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 160 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Spain;Ukraine;Chile;Russian Federation;Colombia;Hungary;Mexico;Poland;Romania;Peru;Bulgaria;Germany | ||
| 406 | EUCTR2015-004457-40-DE (EUCTR) | 19/09/2016 | 22/06/2016 | A clinical trial undertaken around the world in adult patients with lupus erythematosus currently having symptoms. These patients are randomly (like flipping a coin) given a drug (at 3 different doses) or an inactive drug in addition to their usual medication given for lupus. Neither the sponsor nor the doctor nor the patient will know which additional treatment is given. | A MULTI-CENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE RANGING STUDY FOLLOWED BY AN OBSERVATIONAL PERIOD TO EVALUATE THE EFFICACY AND SAFETY OF DAPIROLIZUMAB PEGOL IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS | SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS MedDRA version: 20.0;Level: LLT;Classification code 10040967;Term: SLE;System Organ Class: 100000004859 ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol (DZP) Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 160 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Spain;Ukraine;Chile;Russian Federation;Colombia;Hungary;Mexico;Poland;Romania;Peru;Bulgaria;Germany | ||
| 407 | NCT02080195 (ClinicalTrials.gov) | September 13, 2016 | 28/2/2014 | Nonmyeloablative Conditioning and Transplantation for Patients With Refractory Systemic Lupus Erythematosus (SLE) | A Phase I/II Study of Nonmyeloablative Conditioning and Transplantation of Human Leukocyte Antigen (HLA)-Matched, Partially HLA-mismatched, HLA-haploidentical or Matched Unrelated Bone Marrow for Patients With Refractory SLE | Lupus Erythematosus;Graft-versus-host Disease | Drug: Cyclophosphamide;Drug: Fludarabine;Drug: Tacrolimus;Drug: Mycophenolate Mofetil;Drug: Rabbit antithymocyte globulin;Radiation: Total body irradiation;Biological: Allogeneic bone marrow transplant | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Maryland Stem Cell Research Fund | Terminated | 18 Years | 75 Years | All | 1 | Phase 1/Phase 2 | United States |
| 408 | EUCTR2015-004457-40-BG (EUCTR) | 13/09/2016 | 03/08/2016 | A clinical trial undertaken around the world in adult patients with lupus erythematosus currently having symptoms. These patients are randomly (like flipping a coin) given a drug (at 3 different doses) or an inactive drug in addition to their usual medication given for lupus. Neither the sponsor nor the doctor nor the patient will know which additional treatment is given. | A MULTI-CENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE RANGING STUDY FOLLOWED BY AN OBSERVATIONAL PERIOD TO EVALUATE THE EFFICACY AND SAFETY OF DAPIROLIZUMAB PEGOL IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS | SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS MedDRA version: 19.1;Level: LLT;Classification code 10040967;Term: SLE;System Organ Class: 100000004859 ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol (DZP) Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 160 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Spain;Ukraine;Chile;Russian Federation;Colombia;Hungary;Mexico;Poland;Romania;Peru;Bulgaria;Germany | ||
| 409 | EUCTR2016-000625-39-ES (EUCTR) | 24/08/2016 | 15/07/2016 | A study to characterize the safety and tolerability of Anifrolumab in adult patients with Systemic Lupus Erythematosus | A Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus - Tulip SLE LTE | Systemic Lupus Erythematosus MedDRA version: 19.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Anifrolumab Product Code: MEDI-546 INN or Proposed INN: Anifrolumab | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 575 | Phase 3 | United States;Taiwan;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Peru;Australia;South Africa;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Bulgaria;Germany;Japan;New Zealand | ||
| 410 | EUCTR2016-000625-39-HU (EUCTR) | 18/08/2016 | 23/06/2016 | A study to characterize the safety and tolerability of Anifrolumab in adult patients with Systemic Lupus Erythematosus | A Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus - Tulip SLE LTE | Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Anifrolumab Product Code: MEDI-546 INN or Proposed INN: Anifrolumab | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 575 | Phase 3 | United States;Taiwan;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;France;Australia;Peru;South Africa;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Japan;New Zealand | ||
| 411 | EUCTR2016-000488-17-AT (EUCTR) | 08/08/2016 | 21/07/2016 | A study to evaluate the effectiveness and safety of the study drug, when patients are given dosage of ILT-101 with active moderate to severe systemic lupus erythematosus(SLE) | A Phase II, multi-centre, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety and pharmacokinetics of ILT-101 in patients with active moderate to severe systemic lupus erythematosus (SLE) | Systematic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: ILT-101 Product Code: ILT-101 INN or Proposed INN: Aldesleukin Other descriptive name: INTERLEUKIN-2 | ILTOO PHARMA | NULL | Not Recruiting | Female: yes Male: yes | 100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Portugal;France;Mexico;Mauritius;Spain;Romania;Austria;Bulgaria;Germany;Italy | ||
| 412 | EUCTR2015-003341-25-DE (EUCTR) | 29/07/2016 | 17/03/2016 | A study to evaluate the effectiveness and safety of the study drug, when patients are given a 200-mcg dosage of IPP-201101 plus standard of care in patients with systemic lupus erythematosus. | A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus - A study to evaluate the effectiveness and safety of the study drug for patients with SLE. | Systemic Lupus Erythematosus MedDRA version: 19.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Code: IPP-201101 INN or Proposed INN: IPP-201101 | ImmuPharma SA | NULL | Not Recruiting | Female: yes Male: yes | 200 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Hungary;Germany;United Kingdom | ||
| 413 | EUCTR2015-005543-14-GB (EUCTR) | 19/07/2016 | 19/11/2018 | Safety and efficacy of Belimumab After B cell depletion therapy in systemic LUPUS erythematosus – BEAT LUPUS | Safety and efficacy of Belimumab After B cell depletion therapy in systemic LUPUS erythematosus - BEAT LUPUS | Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Belimumab Product Name: Belimumab | University College London | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 50 | Phase 2 | United Kingdom | ||
| 414 | EUCTR2015-003341-25-IT (EUCTR) | 06/07/2016 | 19/01/2021 | Uno studio per valutare l'efficacia e la sicurezza del farmaco in studio, quando ai pazienti ¿ dato un dosaggio di 200 mcg di IPP-201101 pi¿ standard di cura, in pazienti con lupus eritematoso sistemico. | A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus - A study to evaluate the effectiveness and safety of the study drug for patients with SLE. | Systemic Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Code: IPP-201101 | IMMUPHARMA | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | France;Hungary;Germany;United Kingdom;Italy | ||
| 415 | NCT02794285 (ClinicalTrials.gov) | June 30, 2016 | 6/6/2016 | Long Term Safety of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus | A Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus. | Active Systemic Lupus Erythematosus | Biological: Anifrolumab;Drug: Placebo | AstraZeneca | PRA Health Sciences | Completed | 18 Years | 70 Years | All | 559 | Phase 3 | United States;Argentina;Australia;Bulgaria;Canada;Chile;Colombia;France;Germany;Hungary;Israel;Japan;Korea, Republic of;Lithuania;Mexico;Peru;Poland;Romania;Russian Federation;South Africa;Spain;Taiwan;Ukraine;United Kingdom;Belgium;Brazil;Czech Republic;Czechia;Italy;New Zealand;Singapore |
| 416 | NCT03155477 (ClinicalTrials.gov) | June 10, 2016 | 13/5/2017 | Effect Of Curcuma Xanthorrhiza and Vitamin D3 Supplementation in SLE Patients With Hypovitamin D | Effect Of Curcuma Xanthorrhiza Supplementation In Systemic Lupus Erythematosus Patients (SLE) With Hypovitamin D Which Were Given Vitamin D3 Towards Disease Activity (SLEDAI), Interleukin-6 (IL-6) And Tumor Growth Factor-ß1 (TGF-ß1) Serum | SLE | Dietary Supplement: Cholecalciferol and C. Xanthorrhiza;Dietary Supplement: Cholecalciferol and placebo | Saiful Anwar Hospital | NULL | Completed | 18 Years | 45 Years | Female | 39 | N/A | NULL |
| 417 | NCT02804763 (ClinicalTrials.gov) | June 2, 2016 | 14/6/2016 | A Phase 2 Efficacy and Safety Study of Dapirolizumab Pegol (DZP) in Systemic Lupus Erythematosus | A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study Followed by an Observational Period to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Subjects With Moderately to Severely Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) | Drug: Placebo;Drug: Dapirolizumab pegol (DZP) | UCB Biopharma S.P.R.L. | NULL | Completed | 18 Years | N/A | All | 182 | Phase 2 | United States;Bulgaria;Chile;Colombia;Germany;Hungary;Mexico;Peru;Poland;Romania;Russian Federation;Spain;Ukraine |
| 418 | NCT02514967 (ClinicalTrials.gov) | June 2016 | 31/7/2015 | CHABLIS7.5: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus With or Without Nephritis | A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With Systemic Lupus Erythematosus With or Without Nephritis | Systemic Lupus Erythematosus | Drug: Blisibimod;Drug: Placebo | Anthera Pharmaceuticals | NULL | Terminated | 18 Years | N/A | All | 3 | Phase 3 | Georgia |
| 419 | NCT02741960 (ClinicalTrials.gov) | May 24, 2016 | 7/4/2016 | The Effect of Metformin on Reducing Lupus Flares | A Multicenter, Randomised, Double-blind Placebo Controlled Trial on the Efficacy and Safety of add-on Metformin to Conventional Immunosuppressants in Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: metformin;Drug: placebo | RenJi Hospital | NULL | Completed | 18 Years | 70 Years | All | 180 | Phase 4 | China |
| 420 | NCT02932137 (ClinicalTrials.gov) | May 5, 2016 | 8/10/2016 | Anti-infection of Low-does IL-2 in SLE | Potential Effect of Anti-infection by Low-dose IL-2 in Treatment of SLE | Systemic Lupus Erythematosus | Drug: Interleukin-2 | Peking University People's Hospital | NULL | Completed | 18 Years | 60 Years | All | 30 | N/A | China |
| 421 | EUCTR2015-003341-25-HU (EUCTR) | 02/05/2016 | 07/03/2016 | A study to evaluate the effectiveness and safety of the study drug, when patients are given a 200-mcg dosage of IPP-201101 plus standard of care in patients with systemic lupus erythematosus. | A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus - A study to evaluate the effectiveness and safety of the study drug for patients with SLE. | Systemic Lupus Erythematosus MedDRA version: 18.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Code: IPP-201101 INN or Proposed INN: IPP-201101 | ImmuPharma SA | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | France;United States;Hungary;Germany | ||
| 422 | EUCTR2015-004404-35-ES (EUCTR) | 29/04/2016 | 04/04/2016 | A study in Lupus | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE) | Patients with Systemic Lupus Erythematosus (SLE) MedDRA version: 18.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB | Lilly S.A. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | France;United States;Taiwan;Mexico;Argentina;Poland;Spain;Romania;Austria;Japan;Korea, Republic of | ||
| 423 | JPRN-JapicCTI-153064 | 27/4/2016 | 11/11/2015 | TULIP | A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus | Active Systemic Lupus Erythematosus | Intervention name : anifrolumab INN of the intervention : anifrolumab Dosage And administration of the intervention : Intravenous infusion (IV) Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Intravenous infusion (IV) | AstraZeneca | NULL | complete | 18 | 70 | BOTH | 60 | Phase 3 | Japan, Asia except Japan, North America, South America, Europe, Africa |
| 424 | EUCTR2015-004404-35-RO (EUCTR) | 18/04/2016 | 22/06/2016 | A study in Lupus | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE) | Patients with Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | France;United States;Taiwan;Mexico;Argentina;Spain;Poland;Romania;Austria;Japan;Korea, Republic of | ||
| 425 | EUCTR2015-004404-35-FR (EUCTR) | 12/04/2016 | 04/05/2016 | A study in Lupus | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE) | Patients with Systemic Lupus Erythematosus (SLE) MedDRA version: 19.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | United States;France;Taiwan;Mexico;Argentina;Poland;Spain;Romania;Austria;Japan;United Kingdom;Korea, Republic of | ||
| 426 | EUCTR2015-004404-35-PL (EUCTR) | 12/04/2016 | 31/03/2016 | A study in Lupus | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE) | Patients with Systemic Lupus Erythematosus (SLE) MedDRA version: 19.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | France;United States;Taiwan;Mexico;Argentina;Spain;Poland;Romania;Austria;Japan;United Kingdom;Korea, Republic of | ||
| 427 | EUCTR2015-004404-35-AT (EUCTR) | 06/04/2016 | 24/03/2016 | A study in Lupus | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE) | Patients with Systemic Lupus Erythematosus (SLE) MedDRA version: 18.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | France;United States;Taiwan;Mexico;Argentina;Poland;Spain;Romania;Austria;Japan;Korea, Republic of | ||
| 428 | NCT02331810 (ClinicalTrials.gov) | April 2016 | 5/12/2014 | Pharmacodynamics Assessment Study After Single Subcutaneous Dose Of SAR113244 Versus Placebo In Lupus Male And Female Patients | A Randomized, Double-blind, Placebo-controlled Study Of Safety, Tolerability, And Pharmacokinetics Of Repeated Ascending Subcutaneous Doses Of SAR113244 And Pharmacodynamics Of Single Dose Of SAR113244 In Male And Female Lupus Patient | Systemic Lupus Erythematosus | Drug: SAR113244;Drug: placebo | Sanofi | NULL | Withdrawn | 18 Years | 75 Years | Both | 0 | Phase 1 | NULL |
| 429 | NCT02618967 (ClinicalTrials.gov) | March 28, 2016 | 13/10/2015 | Single Ascending Dose Study of AMG 570 in Healthy Subjects | A Randomized, Double Blind Placebo Controlled, First in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Subcutaneous Doses of AMG 570 in Healthy Subjects | Systemic Lupus Erythematosus | Biological: AMG 570;Biological: AMG 570 Matching Placebo | Amgen | NULL | Completed | 18 Years | 65 Years | All | 56 | Phase 1 | United States |
| 430 | NCT02708095 (ClinicalTrials.gov) | March 24, 2016 | 10/3/2016 | A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus (SLE) | A Randomized, Double-Blind, Placebo-Controlled, Parallel- Group, Phase 2 Study of Baricitinib in Patients With Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Drug: Baricitinib;Drug: Placebo | Eli Lilly and Company | NULL | Completed | 18 Years | N/A | All | 314 | Phase 2 | United States;Argentina;Austria;France;Japan;Korea, Republic of;Mexico;Poland;Puerto Rico;Romania;Spain;Taiwan |
| 431 | JPRN-JapicCTI-163359 | 01/3/2016 | A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus (SLE)-I4V-MC-JAHH | A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus (SLE)-I4V-MC-JAHH | Systemic Lupus Erythematosus (SLE) | Intervention name : Baricitinib INN of the intervention : Baricitinib Dosage And administration of the intervention : Baricitinib given orally once a day for 24 weeks Control intervention name : Placebo Dosage And administration of the control intervention : Placebo given orally once a day for 24 weeks | Eli Lilly Japan K.K. | NULL | 18 | BOTH | Phase 2 | NULL | ||||
| 432 | NCT02711813 (ClinicalTrials.gov) | March 2016 | 14/3/2016 | TAB08 in Patients With Systemic Lupus Erythematosus (SLE), Not Adequately Controlled With Current Treatment | Study to Assess Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of TAB08 in Patients With Systemic Lupus Erythematosus, Not Adequately Controlled With Current Concomitant Therapy | Lupus Erythematosus, Systemic | Drug: TAB08;Other: Placebo | Theramab LLC | NULL | Terminated | 18 Years | 60 Years | All | 60 | Phase 2 | Russian Federation |
| 433 | EUCTR2015-003341-25-FR (EUCTR) | 24/02/2016 | 20/04/2016 | A study to evaluate the effectiveness and safety of the study drug, when patients are given a 200-mcg dosage of IPP-201101 plus standard of care in patients with systemic lupus erythematosus. | A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus - A study to evaluate the effectiveness and safety of the study drug for patients with SLE. | Systemic Lupus Erythematosus MedDRA version: 19.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Code: IPP-201101 INN or Proposed INN: IPP-201101 | ImmuPharma SA | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | United States;France;Hungary;Germany | ||
| 434 | NCT02725515 (ClinicalTrials.gov) | February 16, 2016 | 8/1/2016 | A Study of the Effect of XmAb®5871 in Patients With Systemic Lupus Erythematosus | A Randomized, Double-Blinded, Placebo-Controlled Study of the Effect of XmAb®5871 on Systemic Lupus Erythematosus Disease Activity | Systemic Lupus Erythematosus | Biological: XmAb5871;Biological: Placebo to match XmAb5871 | Xencor, Inc. | PPD;ICON plc | Completed | 18 Years | 65 Years | All | 105 | Phase 2 | United States |
| 435 | NCT02660944 (ClinicalTrials.gov) | January 3, 2016 | 16/1/2016 | A Phase 2a of RSLV-132 in Subjects With Systemic Lupus Erythematosus (SLE) | A Phase 2a, Double-blind, Placebo-Controlled Study of RSLV-132 in Subjects With Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Drug: RSLV-132;Drug: Placebo | Resolve Therapeutics | NULL | Completed | 18 Years | 70 Years | All | 64 | Phase 2 | United States |
| 436 | NCT02677688 (ClinicalTrials.gov) | January 2016 | 28/1/2016 | Autologous EBV-specific Cytotoxic T Cells for the Treatment of Systemic Lupus Erythematosus (SLE) | Restauration of EBV Control in SLE Phase 1-2 Trial Evaluating Adoptive Transfer of Autologous EBV- Specific Cytotoxic T Lymphocytes in SLE Treatment | Serologically Active Adult Systemic Lupus Erythematosus | Biological: Autologous EBV specific CTL infusion | Nantes University Hospital | NULL | Terminated | 18 Years | N/A | All | 9 | Phase 1/Phase 2 | France |
| 437 | NCT02483624 (ClinicalTrials.gov) | January 2016 | 23/6/2015 | 3,3'-Diindolylmethane in Patients With Systemic Lupus Erythematosus | A Single-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of 3,3'-Diindolylmethane (BR-DIM) in Patients With Systemic Lupus Erythematosus (SLE) | SLE | Drug: BR-DIM;Drug: Placebo | North Shore Long Island Jewish Health System | NULL | Terminated | 18 Years | 50 Years | Female | 6 | Phase 1 | NULL |
| 438 | EUCTR2014-002184-14-NL (EUCTR) | 22/12/2015 | 03/09/2015 | Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythomatosus | A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of lulizumab pegol vs. Placebo on a Background of Limited Standard of care in the Treatment of Subjects with Active Systemic Lupus Erythematosus | Active Systemic Lupus Erythematosus MedDRA version: 18.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: lulizumab pegol Product Code: BMS-931699 INN or Proposed INN: lulizumab pegol Other descriptive name: Anti-CD28dAb | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 2 | United States;Taiwan;Spain;Chile;Colombia;Italy;France;Hungary;Mexico;Puerto Rico;Canada;Argentina;Poland;Brazil;Romania;South Africa;Netherlands;Germany;Korea, Republic of | ||
| 439 | EUCTR2014-004632-19-BG (EUCTR) | 11/12/2015 | 27/10/2015 | A study to evaluate the efficacy and safety of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus | A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Anifrolumab INN or Proposed INN: Anifrolumab | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | Argentina;Russian Federation;Singapore;United States;Spain;Canada;Czech Republic;Belgium;Brazil;Korea, Republic of;Mexico;South Africa;Bulgaria;France;Lithuania;Germany | ||
| 440 | ChiCTR-ONC-15007547 | 2015-12-05 | 2015-12-04 | Clinical theraputic effect of traditional Chinese medicine on systemic lupus erythematosus: a multicenter prospective cohort study | Study of the clinical theraputic effect of traditional Chinese medicine on systemic lupus erythematosus | systemic lupus erythematosus | The combination of Chinese and western group:Traditional Chinese medicine combined western medicine;Treating by Western Medicine group:Treating by Western medicine (sugar cortical hormone, hydroxychloroquine, and methotrexate, azathioprine, or cyclophosphamide); | Zhejiang Chinese Medical University | NULL | Recruiting | 18 | 60 | Both | The combination of Chinese and western group:264;Treating by Western Medicine group:264; | China | |
| 441 | JPRN-UMIN000025328 | 2015/12/05 | 25/12/2016 | A Randomized Open-label Study to Evaluate the Efficacy and Safety of Tacrolimus and Corticosteroids in Comparison With Mycophenolate Mofetil and Corticosteroids in Subjects With Class III/IV+/-V Lupus Nephritis | A Randomized Open-label Study to Evaluate the Efficacy and Safety of Tacrolimus and Corticosteroids in Comparison With Mycophenolate Mofetil and Corticosteroids in Subjects With Class III/IV+/-V Lupus Nephritis - Efficacy and Safety of Tacrolimus Versus Mycophenolate in Lupus Nephritis | systemic lupus erythematosus | Tacrolimus Mycophenolate Mofetil | The University of Hong Kong | NULL | Recruiting | 18years-old | 75years-old | Male and Female | 200 | Not selected | Japan,Asia(except Japan) |
| 442 | NCT02074020 (ClinicalTrials.gov) | December 2015 | 26/2/2014 | CHABLIS-SC2: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus With or Without Nephritis | A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With Systemic Lupus Erythematosus With or Without Nephritis | Systemic Lupus Erythematosus | Drug: Blisibimod;Drug: Placebo | Anthera Pharmaceuticals | NULL | Withdrawn | 18 Years | N/A | Both | 0 | Phase 3 | NULL |
| 443 | NCT02885610 (ClinicalTrials.gov) | December 2015 | 26/8/2016 | Study of RC18 Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus(SLE) | A Phase IIb , Placebo-Controlled ,Multi-Center, Randomized, Double-Blind, Dose-explorating Trial of RC18,a Recombinant Human B Lymphocyte Stimulating Factor Receptor-Antibody Fusion Protein in Subjects With Systemic Lupus Erythematosus (SLE). | Systemic Lupus Erythematosus | Biological: Placebo plus standard therapy;Biological: RC18 80 mg plus standard therapy;Biological: RC18 160 mg plus standard therapy;Biological: RC18 240 mg plus standard therapy | RemeGen | NULL | Completed | 18 Years | 65 Years | All | 249 | Phase 2 | China |
| 444 | NCT02609789 (ClinicalTrials.gov) | December 2015 | 18/11/2015 | A Single Ascending Dose Study in Healthy Participants and Multiple Dose Study of JNJ-55920839 in Participants With Mild to Moderate Systemic Lupus Erythematosus | A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study in Healthy Subjects and Multiple Dose Study of JNJ-55920839 in Subjects With Mild to Moderate Systemic Lupus Erythematosus | Systemic Lupus Erythematosus;Healthy | Drug: JNJ-55920839;Drug: Placebo | Janssen Research & Development, LLC | NULL | Completed | 18 Years | 55 Years | All | 72 | Phase 1 | United States;Belgium;Moldova, Republic of;Poland;Romania;Spain;Taiwan |
| 445 | NCT02537028 (ClinicalTrials.gov) | November 30, 2015 | 28/8/2015 | MSC2364447C Phase 1b in Systemic Lupus Erythematosus | A Phase Ib Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Biological Effect of MSC2364447C in Systemic Lupus Erythematosus | Lupus Erythematosus, Systemic | Drug: MSC2364447C;Drug: Placebo | EMD Serono Research & Development Institute, Inc. | Merck KGaA | Completed | 18 Years | 65 Years | All | 24 | Phase 1 | United States;Bulgaria |
| 446 | EUCTR2014-004633-96-RO (EUCTR) | 26/11/2015 | 08/10/2015 | A study to evaluate the efficacy and safety of two doses of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus | A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus MedDRA version: 18.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Anifrolumab INN or Proposed INN: Anifrolumab Product Name: Anifrolumab INN or Proposed INN: Anifrolumab | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 450 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Taiwan;Ukraine;Chile;Israel;Colombia;Italy;United Kingdom;Hungary;Argentina;Poland;Brazil;Romania;Peru;Australia;Germany;New Zealand;Korea, Republic of | ||
| 447 | EUCTR2015-001341-86-DE (EUCTR) | 19/11/2015 | 01/09/2015 | Phase IIb study of IFN-K in Systemic Lupus Erythematosus | A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Neutralization of the Interferon Gene Signature and the Clinical Efficacy of IFNa-Kinoid in Adult Subjects with Systemic Lupus Erythematosus - Phase IIb study of IFN-K in Systemic Lupus Erythematosus | Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: IFN-Kinoid Product Code: IFN-K INN or Proposed INN: Not yet assigned Other descriptive name: IFN-Kinoid Drug Substance | Neovacs S.A. | NULL | Not Recruiting | Female: yes Male: yes | 178 | Phase 2 | Russian Federation;United States;Thailand;Korea, Republic of;Poland;Bulgaria;Chile;France;Serbia;Tunisia;Croatia;Colombia;Argentina;Philippines;Ukraine;Switzerland;Spain;Belgium;Moldova, Republic of;Taiwan;Italy;Mexico;Georgia;Peru;Germany | ||
| 448 | EUCTR2014-004632-19-DE (EUCTR) | 12/11/2015 | 06/08/2015 | A study to evaluate the efficacy and safety of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus | A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Anifrolumab INN or Proposed INN: Anifrolumab | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | Argentina;Russian Federation;United States;Spain;Canada;Czech Republic;Belgium;Brazil;Korea, Republic of;Mexico;South Africa;Bulgaria;France;Lithuania;Germany | ||
| 449 | EUCTR2014-004633-96-DE (EUCTR) | 12/11/2015 | 28/05/2015 | A study to evaluate the efficacy and safety of two doses of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus | A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus MedDRA version: 19.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Anifrolumab INN or Proposed INN: Anifrolumab Product Name: Anifrolumab INN or Proposed INN: Anifrolumab | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | United States;Taiwan;Ukraine;Chile;Israel;Colombia;United Kingdom;Italy;Hungary;Argentina;Brazil;Poland;Romania;Australia;Peru;Germany;New Zealand;Korea, Republic of | ||
| 450 | NCT02477150 (ClinicalTrials.gov) | November 2015 | 17/6/2015 | Safety and Immunogenicity of a Zoster Vaccine in SLE | Immunogenicity and Safety of a Herpes Zoster Vaccine (Zostavax) in Patients With Systemic Lupus Erythematosus: a Randomized Controlled Trial | Systemic Lupus Erythematosus | Biological: Zostavax;Biological: placebo | Tuen Mun Hospital | NULL | Completed | 18 Years | N/A | All | 90 | Phase 4 | China |
| 451 | EUCTR2015-001341-86-HR (EUCTR) | 23/10/2015 | 10/11/2015 | Phase IIb study of IFN-K in Systemic Lupus Erythematosus | A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Neutralization of the Interferon Gene Signature and the Clinical Efficacy of IFNa-Kinoid in Adult Subjects with Systemic Lupus Erythematosus - Phase IIb study of IFN-K in Systemic Lupus Erythematosus | Systemic Lupus Erythematosus;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: IFN-Kinoid Product Code: IFN-K INN or Proposed INN: Not yet assigned Other descriptive name: IFN-Kinoid Drug Substance | Neovas S.A. | NULL | Not Recruiting | Female: yes Male: yes | 178 | Phase 2 | Italy;France;Mexico;Argentina;Poland;Belgium;Croatia;Peru;Bulgaria;Georgia;Netherlands;Germany;Moldova, Republic of;Korea, Republic of;United States;Philippines;Taiwan;Spain;Thailand;Russian Federation;Chile;Colombia;Switzerland | ||
| 452 | JPRN-JapicCTI-153077 | 21/10/2015 | 20/11/2015 | A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of lulizumab pegol of Subjects with Active Systemic Lupus Erythematosus | A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of lulizumab pegol vs. Placebo on a Background of Limited Standard of Care in the Treatment of Subjects with Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Intervention name : Lulizumab pegol INN of the intervention : - Dosage And administration of the intervention : Four treatments of lulizumab pegol will be administered along with placebo treatment:12.5 mg weekly, 12.5 mg every other week (EOW), 5 mg EOW and 1.25mg EOW, on a background of limited standard of care medications. The dose levels may be modified based on the interim analysis results. Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | Bristol-Myers Squibb K.K. | NULL | complete | 18 | 70 | BOTH | 350 | Phase 2 | Japan, Asia except Japan, North America, South America, Europe |
| 453 | NCT02349061 (ClinicalTrials.gov) | October 15, 2015 | 23/1/2015 | A Phase 2a, Efficacy and Safety Study of Ustekinumab in Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Study of Ustekinumab in Subjects With Active Systemic Lupus Erythematosus | Lupus Erythematosus, Systemic | Drug: Ustekinumab IV;Drug: Placebo Infusion;Drug: Placebo SC;Drug: Ustekinumab SC;Other: Concomitant Medication | Janssen Research & Development, LLC | NULL | Completed | 18 Years | 75 Years | All | 102 | Phase 2 | United States;Argentina;Australia;Germany;Hungary;Mexico;Poland;Spain;Taiwan;United Kingdom |
| 454 | EUCTR2014-004633-96-PL (EUCTR) | 14/10/2015 | 05/08/2015 | A study to evaluate the efficacy and safety of two doses of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus | A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Anifrolumab INN or Proposed INN: Anifrolumab | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | United States;Taiwan;Ukraine;Chile;Israel;Colombia;United Kingdom;Italy;Hungary;Argentina;Poland;Brazil;Romania;Australia;Peru;Germany;New Zealand;Korea, Republic of | ||
| 455 | EUCTR2015-000372-95-DE (EUCTR) | 08/10/2015 | 17/06/2015 | Study Evaluating ALX-0061 Administered Subcutaneously in Patients with Systemic Lupus Erythematosus | A Phase II Multicenter, Randomized, Double-blind, Placebo controlled, Dose-range Finding Study to Evaluate the Safety and Efficacy of ALX 0061 Administered Subcutaneously in Subjects with Moderate to Severe Active Systemic Lupus Erythematosus - STEADY | Moderate to Severe Active Systemic Lupus Erythematosus MedDRA version: 19.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ALX-0061 150 mg/mL INN or Proposed INN: vobarilizumab Other descriptive name: IL-6R nanobody | Ablynx N.V. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | Serbia;Portugal;United States;Philippines;Taiwan;Spain;Ukraine;Russian Federation;Chile;Czech Republic;Hungary;Mexico;Argentina;Poland;Peru;Germany;Korea, Republic of | ||
| 456 | NCT02429934 (ClinicalTrials.gov) | October 2015 | 24/4/2015 | Abatacept for SLE Arthritis (IM101-330) | Efficacy of Abatacept in Inflammatory Polyarthritis of Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus Arthritis | Biological: abatacept also known as Orencia also known as CTLA4-Ig;Drug: Placebo | University of California, Los Angeles | Bristol-Myers Squibb | Terminated | 18 Years | N/A | All | 28 | Phase 1/Phase 2 | United States |
| 457 | NCT02554019 (ClinicalTrials.gov) | September 28, 2015 | 16/9/2015 | Proof-of-Concept Study With BT063 in Subjects With Systemic Lupus Erythematosus | A Prospective, Double-blind, Randomized, Placebo-controlled, Repeated Dose, Multicentre Phase IIa Proof-of-Concept Study With BT063 in Subjects With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Biological: BT063;Biological: Placebo | Biotest | NULL | Completed | 18 Years | 75 Years | All | 36 | Phase 2 | Belarus;Georgia;Poland;Serbia |
| 458 | EUCTR2015-000372-95-HU (EUCTR) | 24/09/2015 | 30/06/2015 | Study Evaluating ALX-0061 Administered Subcutaneously in Patients with Systemic Lupus Erythematosus | A Phase II Multicenter, Randomized, Double-blind, Placebo controlled, Dose-range Finding Study to Evaluate the Safety and Efficacy of ALX 0061 Administered Subcutaneously in Subjects with Moderate to Severe Active Systemic Lupus Erythematosus - STEADY | Moderate to Severe Active Systemic Lupus Erythematosus MedDRA version: 19.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ALX-0061 150 mg/mL INN or Proposed INN: vobarilizumab Other descriptive name: IL-6R nanobody | Ablynx N.V. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | Serbia;Portugal;United States;Philippines;Taiwan;Spain;Ukraine;Russian Federation;Chile;Hungary;Czech Republic;Mexico;Argentina;Poland;Peru;Germany;Korea, Republic of | ||
| 459 | EUCTR2014-004632-19-CZ (EUCTR) | 23/09/2015 | 28/07/2015 | A study to evaluate the efficacy and safety of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus | A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus MedDRA version: 18.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Anifrolumab INN or Proposed INN: Anifrolumab | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | Argentina;Russian Federation;Singapore;United States;Spain;Canada;Czech Republic;Belgium;Brazil;Korea, Republic of;Mexico;South Africa;Bulgaria;France;Lithuania;Germany | ||
| 460 | NCT02665364 (ClinicalTrials.gov) | September 23, 2015 | 17/11/2015 | Phase IIb Study of IFN-K in Systemic Lupus Erythematosus | A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Neutralization of the Interferon Gene Signature and the Clinical Efficacy of IFNa-Kinoid in Adult Subjects With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Biological: IFNa-Kinoid;Other: Placebo;Other: ISA 51 VG | Neovacs | NULL | Terminated | 18 Years | 65 Years | All | 185 | Phase 2 | United States;Argentina;Belgium;Chile;Colombia;Croatia;France;Georgia;Germany;Italy;Korea, Republic of;Mexico;Moldova, Republic of;Peru;Philippines;Poland;Russian Federation;Switzerland;Taiwan;Thailand;Tunisia |
| 461 | EUCTR2014-005000-19-PL (EUCTR) | 22/09/2015 | 18/08/2015 | A Phase 2a, Efficacy and Safety Study of Ustekinumab in Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Study of Ustekinumab in Subjects With Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 102 | Phase 2 | United States;Hungary;Taiwan;Mexico;Argentina;Spain;Poland;Australia;Germany | ||
| 462 | EUCTR2014-004632-19-ES (EUCTR) | 21/09/2015 | 24/06/2015 | A study to evaluate the efficacy and safety of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus | A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus MedDRA version: 18.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Anifrolumab INN or Proposed INN: Anifrolumab | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 360 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Lithuania;Russian Federation;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;South Africa;Bulgaria;Germany;Korea, Republic of | ||
| 463 | EUCTR2015-001341-86-IT (EUCTR) | 19/09/2015 | 10/11/2020 | Phase IIb study of IFN-K in Systemic Lupus Erythematosus | A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study toEvaluate the Neutralization of the Interferon Gene Signature and theClinical Efficacy of IFNa-Kinoid in Adult Subjects with Systemic LupusErythematosus - IFN-K-002 | Systemic Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: IFN-Kinoid Product Code: IFN-K | NEOVACS | NULL | Not Recruiting | Female: yes Male: yes | 178 | Phase 2 | United States;Phi |