49. 全身性エリテマトーデス Systemic lupus erythematosus Clinical trials / Disease details
臨床試験数 : 946 / 薬物数 : 722 - (DrugBank : 186) / 標的遺伝子数 : 117 - 標的パスウェイ数 : 199
| 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 | 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 | ||
| 2 | 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 | ||
| 3 | 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 | ||
| 4 | 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 |