50. 皮膚筋炎／多発性筋炎 Dermatomyositis Clinical trials / Disease details
臨床試験数 : 182 / 薬物数 : 229 - (DrugBank : 88) / 標的遺伝子数 : 48 - 標的パスウェイ数 : 147
| 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 | EUCTR2019-002605-22-DE (EUCTR) | 11/03/2021 | 16/12/2019 | A study to evaluate the safety and efficacy of KZR-616 for the tretament of patients with active inflammations of the muscle and the skin (rheumatic disease) | A Phase 2 Randomized, Double-blind, Placebo-controlled,Crossover Multicenter Study to Evaluate the Safety and Efficacy ofKZR-616 in the Treatment of Patients with Active Polymyositis orDermatomyositis | Autoimmune Disorders Polymyositis and Dermatomyositis MedDRA version: 20.0;Level: HLGT;Classification code 10003816;Term: Autoimmune disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: KZR-616 INN or Proposed INN: KZR-616 Other descriptive name: KZR-616 maleate | Kezar Life Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 2 | United States;Czechia;Czech Republic;Poland;Germany | ||
| 2 | NCT04628936 (ClinicalTrials.gov) | November 4, 2020 | 2/11/2020 | Open-label Extension to the Phase 2 Crossover Study (PRESIDIO) Evaluating KZR-616 in Patients With PM and DM. | An Open-label Extension to the Phase 2 Randomized, Double-blind, Placebo-controlled, Crossover Multicenter Study to Evaluate the Safety and Efficacy of KZR-616 in the Treatment of Patients With Active Polymyositis or Dermatomyositis | Polymyositis;Dermatomyositis | Drug: KZR-616 | Kezar Life Sciences, Inc. | NULL | Enrolling by invitation | 18 Years | N/A | All | 24 | Phase 2 | United States |
| 3 | EUCTR2019-002605-22-CZ (EUCTR) | 28/01/2020 | 29/11/2019 | A study to evaluate the saftey and efficacy of KZR-616 for the tretament of patients with active inflammations of the muscle and the skin (rheumatic disease) | A Phase 2 Randomized, Double-blind, Placebo-controlled,Crossover Multicenter Study to Evaluate the Safety and Efficacy ofKZR-616 in the Treatment of Patients with Active Polymyositis orDermatomyositis | Autoimmune Disorders Polymyositis and Dermatomyositis MedDRA version: 20.0;Level: HLGT;Classification code 10003816;Term: Autoimmune disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: KZR-616 INN or Proposed INN: KZR-616 Other descriptive name: KZR-616 maleate Product Name: KZR-616 INN or Proposed INN: KZR-616 Other descriptive name: KZR-616 maleate | Kezar Life Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 24 | Phase 2 | United States;Czechia;Hungary;Czech Republic;Poland;Germany | ||
| 4 | NCT04033926 (ClinicalTrials.gov) | January 14, 2020 | 23/7/2019 | A Phase 2 Study of KZR-616 to Evaluate Safety and Efficacy in Patients With Active Polymyositis or Dermatomyositis | A Phase 2 Randomized, Double-blind, Placebo-controlled, Crossover Multicenter Study to Evaluate the Safety and Efficacy of KZR-616 in the Treatment of Patients With Active Polymyositis or Dermatomyositis | Polymyositis;Dermatomyositis | Drug: KZR-616;Drug: Placebo | Kezar Life Sciences, Inc. | NULL | Active, not recruiting | 18 Years | N/A | All | 24 | Phase 2 | United States;Czechia;Germany;Poland |