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 | EUCTR2015-000372-95-DE (EUCTR) | 08/10/2015 | 17/06/2015 | Study Evaluating ALX-0061 Administered Subcutaneously in Patients with Systemic Lupus Erythematosus | A Phase II Multicenter, Randomized, Double-blind, Placebo controlled, Dose-range Finding Study to Evaluate the Safety and Efficacy of ALX 0061 Administered Subcutaneously in Subjects with Moderate to Severe Active Systemic Lupus Erythematosus - STEADY | Moderate to Severe Active Systemic Lupus Erythematosus MedDRA version: 19.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ALX-0061 150 mg/mL INN or Proposed INN: vobarilizumab Other descriptive name: IL-6R nanobody | Ablynx N.V. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | Serbia;Portugal;United States;Philippines;Taiwan;Spain;Ukraine;Russian Federation;Chile;Czech Republic;Hungary;Mexico;Argentina;Poland;Peru;Germany;Korea, Republic of | ||
| 2 | EUCTR2015-000372-95-HU (EUCTR) | 24/09/2015 | 30/06/2015 | Study Evaluating ALX-0061 Administered Subcutaneously in Patients with Systemic Lupus Erythematosus | A Phase II Multicenter, Randomized, Double-blind, Placebo controlled, Dose-range Finding Study to Evaluate the Safety and Efficacy of ALX 0061 Administered Subcutaneously in Subjects with Moderate to Severe Active Systemic Lupus Erythematosus - STEADY | Moderate to Severe Active Systemic Lupus Erythematosus MedDRA version: 19.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ALX-0061 150 mg/mL INN or Proposed INN: vobarilizumab Other descriptive name: IL-6R nanobody | Ablynx N.V. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | Serbia;Portugal;United States;Philippines;Taiwan;Spain;Ukraine;Russian Federation;Chile;Hungary;Czech Republic;Mexico;Argentina;Poland;Peru;Germany;Korea, Republic of | ||
| 3 | EUCTR2015-000372-95-PT (EUCTR) | 11/09/2015 | 26/06/2015 | Study Evaluating ALX-0061 Administered Subcutaneously in Patients with Systemic Lupus Erythematosus | A Phase II Multicenter, Randomized, Double-blind, Placebo controlled, Dose-range Finding Study to Evaluate the Safety and Efficacy of ALX 0061 Administered Subcutaneously in Subjects with Moderate to Severe Active Systemic Lupus Erythematosus - STEADY | Moderate to Severe Active Systemic Lupus Erythematosus MedDRA version: 18.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ALX-0061 150 mg/mL INN or Proposed INN: N/A Other descriptive name: IL-6R nanobody | Ablynx N.V. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Philippines;Taiwan;Spain;Ukraine;Russian Federation;Chile;Czech Republic;Hungary;Mexico;Argentina;Poland;Peru;Germany;Korea, Republic of | ||
| 4 | EUCTR2015-000372-95-CZ (EUCTR) | 20/08/2015 | 16/06/2015 | Study Evaluating ALX-0061 Administered Subcutaneously in Patients with Systemic Lupus Erythematosus | A Phase II Multicenter, Randomized, Double-blind, Placebo controlled, Dose-range Finding Study to Evaluate the Safety and Efficacy of ALX 0061 Administered Subcutaneously in Subjects with Moderate to Severe Active Systemic Lupus Erythematosus - STEADY | Moderate to Severe Active Systemic Lupus Erythematosus MedDRA version: 20.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000017968;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ALX-0061 150 mg/mL INN or Proposed INN: vobarilizumab Other descriptive name: IL-6R nanobody | Ablynx N.V. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | Serbia;Portugal;United States;Philippines;Taiwan;Spain;Ukraine;Russian Federation;Chile;Czech Republic;Hungary;Mexico;Argentina;Poland;Peru;Germany;Korea, Republic of | ||
| 5 | EUCTR2015-000372-95-ES (EUCTR) | 07/08/2015 | 10/07/2015 | Study Evaluating ALX-0061 Administered Subcutaneously in Patients with Systemic Lupus Erythematosus | A Phase II Multicenter, Randomized, Double-blind, Placebo controlled, Dose-range Finding Study to Evaluate the Safety and Efficacy of ALX 0061 Administered Subcutaneously in Subjects with Moderate to Severe Active Systemic Lupus Erythematosus - STEADY | Moderate to Severe Active Systemic Lupus Erythematosus MedDRA version: 18.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ALX-0061 150 mg/mL INN or Proposed INN: N/A Other descriptive name: IL-6R nanobody | Ablynx N.V. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | Germany;Korea, Republic of;Serbia;Portugal;United States;Philippines;Taiwan;Spain;Ukraine;Russian Federation;Chile;Czech Republic;Hungary;Mexico;Argentina;Poland;Peru | ||
| 6 | NCT02437890 (ClinicalTrials.gov) | July 2015 | 29/4/2015 | A Phase II Study to Evaluate Safety and Efficacy of ALX-0061 in Subjects With Systemic Lupus Erythematosus | A Phase II Multicenter, Randomized, Double-blind, Placebo Controlled, Dose-range Finding Study to Evaluate the Safety and Efficacy of ALX-0061 Administered Subcutaneously in Subjects With Moderate to Severe Active Systemic Lupus Erythematosus | Lupus Erythematosus, Systemic | Biological: ALX-0061;Biological: Placebo | Ablynx | NULL | Completed | 18 Years | 64 Years | All | 312 | Phase 2 | United States;Argentina;Chile;Czechia;Germany;Hungary;Korea, Republic of;Mexico;Peru;Philippines;Poland;Portugal;Russian Federation;Serbia;Spain;Taiwan;Ukraine;Czech Republic |