DDrare: Database of Drug Development for Rare Diseases

Searched query = "Systemic lupus erythematosus", "SLE"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Drug = 0.15mg KPG-818 dose; 0.6mg KPG-818 dose; 1 mg/kg CNTO 136; 10 mg/kg CNTO 136; 2-deoxy-2 [F-18] fluoro-2-d-glucose; 2mg KPG-818 dose; 4 mg/kg CNTO 136; 81mg aspirin; A-623; ABATACEPT; ABBV-105; ABETIMUS SODIUM; ABR-215757; ABT-199; ABT-494; AC0058TA; ACM; ACT-334441; AGS-009; AIDSVAX® B/E; AKBM-3031; ALDESLEUCHINA; ALDESLEUKIN; ALITRETINOIN; ALLOGENEIC MESENCHYMAL STROMAL CELLS DERIVED FROM THE UMBILICAL CORD; ALX-0061; ALX-0061 150 mg/mL; AMG 557; AMG 570; AMG 592; AMG 623; AMG 811; AMG592; AMG811; ANAKINRA; ANIFROLUMAB; ASF-1096 Cream 0.25%; ASF-1096 Cream 0.5%; ASF-1096 Cream 1.0%; ATACICEPT; Abatacept; Abetimus; Abetimus Sodium; Abetimus sodium; Abetimus sodium (LJP 394); Acetaminophen; Acetate; Acetylcysteine; Acido Micofenolico; Acido micofenolico; Acthar; Acthar Gel; Acthar high dose (80 U); Acthar low dose (40 U); Aldesleukin; Alfacalcidol; Alitretinoin; Allogeneic MSC (AlloMSC); Allogeneic Stem Cell Transplantation; Allogeneic bone marrow transplant; Alpha-tocopherol; Anakinra; Anifrolumab; Anifrolumab 1000 mg; Anifrolumab 300 mg; Anti BAFF (B cell activating factor); Anti LP40 antibody, subclass IgG4; Anti LP40 anticuerpo, subclase IgG4; Anti-CD19-CAR-T cells; Anti-CD20 B cell depletion with Truxima; Anti-CD28dAb; Anti-CD28dab; Anti-Macrophage Migration Inhibitory Factor (Anti-MIF) Antibody; Anti-blood dendritic cell antigen 2; Anti-pandemic H1N1 influenza vaccine; Anti-thymocyte globulin; Aspirin; Aspirin and meloxicam; Atacicept; Atacicept 150 mg; Atacicept 75 mg; Atacicept 75 milligram (mg); Atorvastatin; Autologous EBV specific CTL infusion; Aviptadil; Azathioprine; BARICITINIB; BELIMUMAB; BENLYSTA; BENLYSTA? (belimumab); BENLYSTA™ (belimumab); BI 705564; BIIB059; BMS-188667; BMS-931699; BMS-986165; BMS-986165 Capsule; BMS-986165 Tablet; BMS-986195; BMS986195; BORTEZOMIB; BOS161721; BR-DIM; BT063; Baricitinib; Behavioral: heart health educational program; Behavioral: questionnaires; Belimumab; Belimumab 1 mg/kg; Belimumab 10 mg/kg; Belimumab 10 mg/kg plus standard therapy; Belimumab 100 mg SC; Belimumab 10mg/kg; Belimumab 200 mg SC; Belimumab 200 mg/mL; Belimumab 4 mg/kg; Belimumab Injection; Belimumab Injection [Benlysta]; Belimumab for IV; Belimumab for SC; Belimumab or benlysta; Belimumab plus Early Vaccination; Belimumab plus Late Vaccination; Benazepril; Benazepril Pill; Benlysta; Benlysta (Belimumab); Benlysta (belimumab); Benlysta 400 mg powder for concentrate for solution for infusion; Benlysta 400 mg powder for concentrate for solution for infusions; Benlysta®; Blisibimod; Blood sample; Bortezomib; Branebrutinib; Brentuximab; Brentuximab vedotin; Busulfan; CC; CC-220; CDP3194; CDP7657; CEP-33457; CFZ533; CICLOSPORIN; CICLOSPORINA; CNTO1275; CSM allogéniques issues de cordons ombilicaux ( MTI-PP); CTLA4-IgG4m (RG2077); CTLA4Ig; Calcitriol; Calcium; Campath; CellCept; Cellcept; Cenerimod; Cenerimod 0.5 mg; Cenerimod 1 mg; Cenerimod 2 mg; Cenerimod 4 mg; Cervarix; Cervarix suspensie voor injectie; Chloroquine; Cholecalciferol; Cholecalciferol and C. Xanthorrhiza; Ciclosporin; Ciclosporina; Clofarabine; Clopidogrel; Combination Product: Belimumab; Conjugated equine estrogens; Conjugated equine estrogens 0.625 mg/d + MPA 5 mg/d/10d; Continuation of azathioprine; Corn starch; Corticosteroids; Corticosteroids (prednisone or prednisolone); Creatine; Crestor; Csa; Cumulative corticosteroid exposure; Curcumin; Curcumin supplement; Cyclophosphamide; Cyclophosphamide-prednisone-azathioprine; Cyclosporin; Cyclosporin A; Cyclosporine; Cyclosporine A; Cymbalta; Cytarabine; D-glucose; DELTACORTENE*20CPR 5MG; DHA; DHEA; DZP; Dapagliflozin; Dapirolizumab pegol; Dapirolizumab pegol (DZP); Dehydroepiandrosterone; Dehydroepiandrosterone (DHEA); Device: Belimumab autoinjector; Device: Doppler ultrasound; Device: Flash glucose monitoring system; Device: bone densitometry; Device: fan beam CT scan; Device: flow-mediated dilation of the brachial artery; Dihydroartemisinin; Dihydroartemisinin tablet; Dimethylfumarat; Diphenhydramine; Dipyridamole; Docosahexaenoic acid; Drug inducing arthritis, lupus, hepatitis, or capillary leak syndrom; ELSUBRUTINIB; EPA; EPA and DHA supplementation; EPRATUZUMAB; ERL080A; Edratide; Edratide Acetate; Eicosapentaenoic acid; Elsubrutinib; Enteric-Coated Mycophenolate Sodium; Epatuzumab; Epratuzumab; Epratuzumab 100 mg; Epratuzumab 1200 mg; Epratuzumab 400 mg; Epratuzumab 600 mg; Epratuzumab iv; Epratuzumab sc; Estradiol; Ethinyl estradiol; Ethylhydrogenfumarat, Calciumsalz; Ethylhydrogenfumarat, Magnesiumsalz; Ethylhydrogenfumarat, Zinksalz; Evobrutinib; Extended release dipyridamole 200mg/aspirin 25mg; Ezetimibe; Ezetimibe+Simvastatin Drug Combination; Faslodex; Filgrastim; Fish Oil; Fish oil; Fludarabine; Fludarabine phosphate; Fluzone; Focetria (Monovalent MF59-Adjuvanted vaccine); Folate; FolateScan (Technetium Tc 99mEC20); Folic acid; Forigerimod; Fostamatinib; Fostamatinib Disodium (R935788); Fumaderm®; Fumaderm® initial; G-CSF; GC+HCQ; GDC-0853; GDC-0853 RO7010939; GL701; GSK1550188; GSK1550188 1mg/kg or 10mg/kg; GSK1550188 IV; GSK1550188 SC; GSK2586184; GSK2586184 100 mg; GSK2586184 200 mg; GSK2586184 400 mg; GSK2586184 50 mg; GSK2586184 800mg single and repeat dose; GSK2586184 new formulation; GSK2586184 standard formulation; Gardasil; Genetic: Polymorphism Analysis; Glucose; Gold; Group A SLE prospective study; Growth colony stimulating factor (G-CSF); H.P. Acthar Gel; HCQ; HGS1006; HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA; HLL2; HLL2 (Epratuzumab); HLL2 (trivial name or chemical description); HLL2,IMMU-103; HPV prophylactic vaccine Gardasil; HYDROXYCHLOROQUINE; Hematopoietic stem cell transplantation; High Dietary Sodium; High Dose Mesenchymal Stem Cells (MSCs); Hiomega-3 supplement of Naturalis® company -; HrIL-2 active; Human papillomavirus vaccination (Gardasil); Human umbilical cord derived MSC transplantation for SLE; Hydroxychloroquine; Hydroxychloroquine (Z0188); Hydroxychloroquine high; Hydroxychloroquine or Chloroquine; Hydroxychloroquine reduced; ICI 182,780 (Faslodex); ICP-022; IFN-K; IFN-Kinoid; IFN-Kinoid Drug Substance; IFN-a 2b Kinoid Drug Substance; IFN-a2b Kinoid; IFNa-Kinoid; IL-2; IL-6R nanobody; ILT-101; IMMU-103; IMMUNOGLOBULIN G; INFLUENZA VACCINE (SURFACE ANTIGEN, INACTIVATED); INTERLEUKIN 2; INTERLEUKIN-2; IPP - 201101; IPP-201101; IPP-201101, P140; Ianalumab; Ibandronate; Ibandronate+alfacalcidol+calcium; Immune ablation and hematopoietic stem cell support.; Immunoglobulin G1, anti-(human type I interferon receptor) (human monoclonal MEDI-546 heavy chain), disulfide with human monoclonal MEDI-546-chain, dimer; Immunosuppressive regime (azathioprine, mycophenolate mofetil or methotrexate); Individualized dose of rituximab; Infliximab; Influenz virus surface antigens; Influvac; Interleukin 2; Interleukin-2; Intravenous immunoglobulin; Iscalimab; Itolizumab; Itolizumab [Bmab 600]; JBT-101; JNJ-55920839; JNJ-56022473; KINERET; KPG-818; KZR-616; Kineret; L04AA26; LA294; LJP 394; LJP394; LY2127399; LY3009104; LY3361237; LY3471851; Laquinimod; Leflunomide; Lenalidomide; Levothyroxine; Lisinopril; Lisinopril Pills; Loestrin 1.5/30 (1.5 mg norethindrone acetate/30 µg ethinyl estradiol); Low Dietary Sodium; Low Dose Mesenchymal Stem Cells (MSCs); Low-dose Aldesleukin (Proleukin®); Lulizumab Pegol; Lulizumab pegol; Lupuzor; LymphoStat-B; LymphoStat-B TM; LymphoStat-B®, monoclonal anti-BLyS, LSB, BENLYSTA®; M2951; M2951 (Other Name: Evobrutinib); M5049; MEDI 545; MEDI-545; MEDI-545 600; MEDI-546; MEDI-570 0.03 MG; MEDI-570 0.1 MG; MEDI-570 0.3 MG; MEDI-570 1 MG; MICOFENOLICO ACIDO; MMF; MONITOR; MPA; MRA 003 US; MSC treatment; MSC2364447C; MT-1303 High dose; MT-1303 Low dose; MTX; MYCOPHENOLIC ACID; MYFORTIC*50CPR RIV 360MG; MabThera; MabThera (Rituximab); Medi-546; Medroxyprogesterone; Melatonin; Meloxicam; Memantine; Mesenchymal Stromal Cells; Mesenchymal stem cells; Mesna; Metformin; Methotrexate; Methotrexate and folic acid; Methyl prednisolone; Methylprednisolone; Methylprednisolone sodium succinate; Micofenolico acido; Milatuzumab; Milnacipran; Mizoribine; Modafinil; Moxifloxacin; Multivitamin; Mycophenolate; Mycophenolate Mofetil; Mycophenolate mofetil; Mycophenolate mofetil (MMF); Mycophenolate motetil; Mycophenolic acid; Myfortic; N-(5-{4-[(3,3-dimethyl-1-azetidinyl)carbonyl]phenyl}[1,2,4]triazolo[1,5-a]pyridin-2-yl)cyclopropanecarboxamide; N-acetylcysteine; NNC 0151-0000-0000; NNC0114-0006; NOX-E36; Nelfinavir; Nicotinamide; Nivolumab; Norethindrone; Normal Saline; Null; ORENCIA; ORENCIA 125 mg solution for injection in pre-filled syringe; Ocrelizumab; Olive; Olive Oil; Olive oil; Olumiant; Omacor; Omega-3; Oral Prednisone 5mg; Oral prednisolone; Orencia; Ortho-Novum 777; Ortho-novum; Other: Blood drawing only Group C; Other: Coaching Sessions; Other: Concomitant Medication; Other: Drug free; Other: Fitbit Activity Monitor; Other: GSK2586184 single dose taken with food; Other: GSK2586184 single dose taken without food; Other: Group B SLE one blood donation; Other: ISA 51 VG; Other: Pharmacokinetic analysis; Other: SLE treatment; Other: Smartphone Application; Other: Standard of Care; Other: Standard therapy; Other: Standard treatment according to the Clinical protocols; Other: Ultrasonography assessment; Other: corn starch; Other: immunologic technique; Other: laboratory biomarker analysis; Oxygen; Ozone; P 140; PAH; PF-04236921; PF-06700841; PF-06700841 15 mg; PF-06700841 25mg; PF-06700841 30 mg; PF-06700841 45 mg; PF-06700841 5mg; PF-06700841-15; PF-06835375; PREDNISONA; PREDNISONE; Paquinimod; Paquinimod (ABR-215757); Phosphate; Phosphate-buffered saline; Pioglitazone; Pitavastatin; Placebo; Plaquenil; Pneumovax; Pooled mesenchymal stem cell; Prasterone; Prasterone (GL701); Pravastatin; Prednisolone; Prednisolone/prednisone; Prednisona; Prednisone; Prednisone acetate; Prednisone discontinuation; Premarin and Provera; Prevenar® and Pneumo23®; Procedure: Autologous CD34+HPC transplantation (HSCT); Procedure: Autologous Peripheral Blood Stem Cell Transplantation; Procedure: CD34+ Peripheral Blood Stem Cell Reinfusion; Procedure: Computed Tomography; Procedure: Leukapheresis; Procedure: MRI, Venipuncture; Procedure: Non-myeloablative high dose immunosuppressive therapy conditioning (HDIT); Procedure: Plasmapheresis; Procedure: Positron Emission Tomography; Procedure: Reduced Intensity Allogeneic Transplant; Procedure: autologous hematopoietic stem cell transplantation; Proleukin; Quinipril; R-salbutamol; R-salbutamol sulphate; R932333; RANKL/OPG ratio; RAYOS; RC18 160 mg plus standard therapy; RC18 240 mg plus standard therapy; RC18 80 mg plus standard therapy; RECOMBINANT FACTOR FC FUSION PROTEIN; RIQUENT; RITUXIMAB; RO 496-4913; RO7010939/F13; ROSUVASTATIN CALCIUM; RSLV-132; Rabbit; Rabbit anti-thymocyte globulin; Rabbit antithymocyte globulin; Radiation: Fluorine F 18 Clofarabine; Radiation: Total body irradiation; Ramipril; Rapamycin; Raptiva; Recombinant zoster vaccine; Remicade; RhuMAb 2H7; RhuMAb IFNalpha; Rigerimod; Riquent; Rituxan (rituximab); Rituximab; Rivaroxaban; Ro 106-1443; Rontalizumab; Rosuvastatin; Royal jelly; SAR113244; SBI-087; SC belimumab 200 mg; SM101; SM934; SOLU-MEDROL; SQ Fludarabine; STELARA®; Salbutamol; Sifalimumab; Sifalimumab 1,200 mg; Sifalimumab 200 mg; Sifalimumab 600 mg; Simvastatin; Sirolimus; Solu-Medrol; Solu-medrol; Soluble Fc receptor; Soluble Fc-gamma receptor IIb; Standard dose of rituximab; Standard of Care; Standard therapy; Standard therapy (Excluding Immunosuppressants); Standard therapy (Including Immunosuppressants); Stelara; Steroid Drug; Steroid Taper; Subcuvia; Sugar pill; Sulfamethoxazole; Sulfate; Switch to Myfortic; TAB08; TACI-Fc5; TAK-079; TRU-015; TV-4710; Tabalumab; Tabalumab Auto-Injector; Tabalumab Prefilled Syringe; Tacrolimus; Thalidomide; The generic name is warfarin and many producers will be involved; Tocopherol; Tocopherol acetate; Toctino; Toctino®; Tofacitinib; Tofacitinib citrate; Trade Name Xarelto; Trade name Xarelto; Trimethoprim; Trimethoprim-Sulfamethoxazole; Triptorelin; Triptorelin pamoate; Truxima; UPADACITINIB; USTEKINUMAB; Upadacitinib; Urine sample; Ustekinumab; Ustekinumab (approximately 6 mg/kg); Ustekinumab 90 mg; Ustekinumab 90 milligram (mg); Ustekinumab IV; Ustekinumab SC; VAY736; VIB7734; VIP; Vaccination; Vaccine; Velcade; Velcade®; Versus hydroxychloroquine; Vitamin D; Vitamin D 25(OH)D; Vitamin D3; Vitamin D3 400 IU; Vitamin D3 6000 IU; Vitamins: B6, B12, and folate; Vobarilizumab; Warfarin; Warfarin Sodium; Warfarin sodium; Xarelto; XmAb5871; Zishenqing; Zostavax; Zostavax vaccine

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	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
2	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]		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;Poland;Brazil;Romania;Australia;Germany;Japan;Korea, Republic of
3	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: 20.0;Level: LLT;Classification code 10042947;Term: Systemic lupus erythematosus synd;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		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;France;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Australia;Germany;Korea, Republic of
4	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;Israel;Russian Federation;Colombia;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Australia;Germany;Korea, Republic of
5	NCT03920267 (ClinicalTrials.gov)	March 26, 2019	27/3/2019	Long-Term Safety and Efficacy Study of BMS-986165 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	Recruiting	18 Years	75 Years	All	360	Phase 2	United States;Argentina;Australia;Brazil;Canada;Colombia;Germany;Hungary;Israel;Japan;Korea, Republic of;Mexico;Poland;Romania;Russian Federation;Spain;Taiwan
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
6	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
7	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	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	360	Phase 2	Taiwan;Russian Federation;Israel;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Australia;Germany;Japan;Spain;Colombia;Korea, Republic of;United States
8	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	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	400	Phase 2	United States;Taiwan;Ukraine;Russian Federation;Israel;Colombia;France;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Peru;Bulgaria;Germany;Japan;Korea, Republic of
9	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
10	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
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
11	NCT03252587 (ClinicalTrials.gov)	June 13, 2017	15/8/2017	An Investigational Study to Evaluate BMS-986165 in Patients 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	Recruiting	18 Years	75 Years	All	360	Phase 2	United States;Argentina;Australia;Brazil;Bulgaria;Canada;Colombia;France;Germany;Hungary;Israel;Japan;Korea, Republic of;Mexico;Peru;Poland;Romania;Russian Federation;Spain;Taiwan;Ukraine

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

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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

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]

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;Poland;Brazil;Romania;Australia;Germany;Japan;Korea, Republic of

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

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;France;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Australia;Germany;Korea, Republic of

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

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;Colombia;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Australia;Germany;Korea, Republic of

NCT03920267
(ClinicalTrials.gov)

March 26, 2019

27/3/2019

Long-Term Safety and Efficacy Study of BMS-986165 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

Recruiting

18 Years

75 Years

All

360

Phase 2

United States;Argentina;Australia;Brazil;Canada;Colombia;Germany;Hungary;Israel;Japan;Korea, Republic of;Mexico;Poland;Romania;Russian Federation;Spain;Taiwan

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

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

Phase 1

United States

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

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

Taiwan;Russian Federation;Israel;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Australia;Germany;Japan;Spain;Colombia;Korea, Republic of;United States

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

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

400

Phase 2

United States;Taiwan;Ukraine;Russian Federation;Israel;Colombia;France;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Peru;Bulgaria;Germany;Japan;Korea, Republic of

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

Phase 1

United States;Netherlands

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

Phase 1

United States

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

NCT03252587
(ClinicalTrials.gov)

June 13, 2017

15/8/2017

An Investigational Study to Evaluate BMS-986165 in Patients 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

Recruiting

18 Years

75 Years

All

360

Phase 2

United States;Argentina;Australia;Brazil;Bulgaria;Canada;Colombia;France;Germany;Hungary;Israel;Japan;Korea, Republic of;Mexico;Peru;Poland;Romania;Russian Federation;Spain;Taiwan;Ukraine