QGE031 ( DrugBank: - )
1 disease
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 162 | 類天疱瘡（後天性表皮水疱症を含む。） | 4 |
162. 類天疱瘡（後天性表皮水疱症を含む。）
臨床試験数 : 83 / 薬物数 : 128 - (DrugBank : 51) / 標的遺伝子数 : 33 - 標的パスウェイ数 : 142
| 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 | EUCTR2012-003370-10-FR (EUCTR) | 24/05/2013 | 28/09/2015 | Safety, efficacy and PK/PD of QGE031 vs. placebo in patients with active bullous phemphigoid despite oral steroid treatment. | A randomized, double-blind, placebo controlled, parallel group study evaluating the efficacy, safety, pharmacokinetics and pharmacodynamics of QGE031 in the treatment of patients with bullous pemphigoid with disease refractory to oral steroid treatment | refractory bullous pemphigoid MedDRA version: 18.0;Level: LLT;Classification code 10006567;Term: Bullous pemphigoid;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: QGE031 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 42 | Phase 2 | United States;France;Taiwan;Austria;Germany | ||
| 2 | EUCTR2012-003370-10-DE (EUCTR) | 23/01/2013 | 23/10/2012 | Safety, efficacy and PK/PD of QGE031 vs. placebo in patients with active bullous phemphigoid despite oral steroid treatment. | A randomized, double-blind, placebo controlled, parallel group study evaluating the efficacy, safety, pharmacokinetics and pharmacodynamics of QGE031 in the treatment of patients with bullous pemphigoid with disease refractory to oral steroid treatment | Refractory Bullous Pemphigoid MedDRA version: 16.1;Level: LLT;Classification code 10006567;Term: Bullous pemphigoid;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: QGE031 INN or Proposed INN: QGE031 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 42 | United States;Taiwan;Austria;Germany | |||
| 3 | NCT01688882 (ClinicalTrials.gov) | January 2013 | 17/9/2012 | Safety, Efficacy and PK/PD of QGE031 vs. Placebo in Patients With Active Bullous Pemphigoid Despite Oral Steroid Treatment | A Randomized, Double-blind, Placebo Controlled, Parallel Group Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of QGE031 in the Treatment of Patients With Bullous Pemphigoid With Disease Refractory to Oral Steroid Treatment | Bullous Pemphigoid | Drug: QGE031;Drug: Placebo | Novartis Pharmaceuticals | NULL | Terminated | 20 Years | 80 Years | All | 20 | Phase 2 | United States;Austria;France;Germany;Japan;Taiwan |
| 4 | EUCTR2012-003370-10-AT (EUCTR) | 13/11/2012 | 03/10/2012 | Safety, efficacy and PK/PD of QGE031 vs. placebo in patients with active bullous phemphigoid despite oral steroid treatment. | A randomized, double-blind, placebo controlled, parallel group study evaluating the efficacy, safety, pharmacokinetics and pharmacodynamics of QGE031 in the treatment of patients with bullous pemphigoid with disease refractory to oral steroid treatment | Refractory Bullous Pemphigoid MedDRA version: 15.0;Level: LLT;Classification code 10006567;Term: Bullous pemphigoid;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: QGE031 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 42 | United States;Taiwan;Austria;Germany |