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 | 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 | ||
| 2 | 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 | ||
| 3 | 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 | ||
| 4 | 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 | ||
| 5 | 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 |
| 6 | 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;Philippines;Taiwan;Spain;Thailand;Korea, Democratic People's Republic of;Russian Federation;Chile;Colombia;Italy;France;Mexico;Argentina;Poland;Belgium;Croatia;Peru;Bulgaria;Georgia;Netherlands;Germany;Moldova, Republic of;Korea, Republic of | ||
| 7 | EUCTR2015-001341-86-BE (EUCTR) | 07/09/2015 | 03/09/2015 | 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 | ||
| 8 | EUCTR2009-012059-47-DE (EUCTR) | 12/08/2010 | 21/01/2010 | A phase I-II, randomized, double-blind, placebo-controlled, dose escalation study of Neovacs’ IFNa-Kinoid in adult subjects with Systemic Lupus Erythematosus. - IFN-Kinoid in Systemic Lupus Erythematosus | A phase I-II, randomized, double-blind, placebo-controlled, dose escalation study of Neovacs’ IFNa-Kinoid in adult subjects with Systemic Lupus Erythematosus. - IFN-Kinoid in Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) MedDRA version: 12.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: IFN-a2b Kinoid Product Code: IFN-K INN or Proposed INN: Not assigned yet Other descriptive name: IFN-a 2b Kinoid Drug Substance | Neovacs SA | NULL | Not Recruiting | Female: yes Male: yes | 28 | Phase 1;Phase 2 | France;Belgium;Bulgaria;Germany | ||
| 9 | EUCTR2009-012059-47-FR (EUCTR) | 07/05/2010 | 02/02/2010 | A phase I-II, randomized, observer-blind, placebo-controlled, dose escalation study to evaluate the safety and immune responses of various doses of Neovacs’ IFNa-Kinoid in adult patients with Systemic Lupus Erythematosus. - IFN-Kinoid in Systemic Lupus Erythematosus | A phase I-II, randomized, observer-blind, placebo-controlled, dose escalation study to evaluate the safety and immune responses of various doses of Neovacs’ IFNa-Kinoid in adult patients with Systemic Lupus Erythematosus. - IFN-Kinoid in Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) MedDRA version: 12.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: IFN-a2b Kinoid Product Code: IFN-K INN or Proposed INN: Not assigned yet Other descriptive name: IFN-a 2b Kinoid Drug Substance | Neovacs SA | NULL | Not Recruiting | Female: yes Male: yes | 28 | Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Belgium;Bulgaria;Germany | ||
| 10 | EUCTR2009-012059-47-BG (EUCTR) | 23/04/2010 | 15/04/2010 | A phase I-II, randomized, double-blind, placebo-controlled, dose escalation study of Neovacs’ IFNa-Kinoid in adult subjects with Systemic Lupus Erythematosus. | A phase I-II, randomized, double-blind, placebo-controlled, dose escalation study of Neovacs’ IFNa-Kinoid in adult subjects with Systemic Lupus Erythematosus. - IFN-Kinoid in Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Product Name: IFN-a2b Kinoid Product Code: IFN-K INN or Proposed INN: Not assigned yet Other descriptive name: IFN-a 2b Kinoid Drug Substance | Neovacs SA | NULL | Not Recruiting | Female: yes Male: yes | 28 | Phase 1;Phase 2 | France;Belgium;Bulgaria;Germany | ||
| 11 | NCT01058343 (ClinicalTrials.gov) | March 2010 | 27/1/2010 | Safety of IFNa Kinoid in Systemic Lupus Erythematosus | A Phase I-II, Randomized, Double-blind, Placebo-controlled, Dose Escalation Study of Neovacs' IFNa-Kinoid in Adult Subjects With Systemic Lupus Erythematosus. | Systemic Lupus Erythematosus | Biological: IFN-K | Neovacs | NULL | Completed | 18 Years | 50 Years | All | 28 | Phase 1/Phase 2 | Belgium;Bulgaria;Croatia;France;Germany;Switzerland;Romania;Spain |
| 12 | EUCTR2009-012059-47-BE (EUCTR) | 28/01/2010 | 05/01/2010 | A phase I-II, randomized, double-blind, placebo-controlled, dose escalation study of Neovacs’ IFNa-Kinoid in adult subjects with Systemic Lupus Erythematosus. - IFN-Kinoid in Systemic Lupus Erythematosus | A phase I-II, randomized, double-blind, placebo-controlled, dose escalation study of Neovacs’ IFNa-Kinoid in adult subjects with Systemic Lupus Erythematosus. - IFN-Kinoid in Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Product Name: IFN-a2b Kinoid Product Code: IFN-K INN or Proposed INN: Not assigned yet Other descriptive name: IFN-a 2b Kinoid Drug Substance | Neovacs SA | NULL | Not Recruiting | Female: yes Male: yes | 28 | Phase 1;Phase 2 | France;Belgium;Bulgaria;Germany |