Apremilast (cc-10004) (DrugBank: Apremilast)
1 disease| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 56 | ベーチェット病 | 5 |
| 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 | EUCTR2014-002108-25-GR (EUCTR) | 06/07/2016 | 08/06/2016 | Study to test whether apremilast is better than placebo (inactive substance in the same form as the drug) for the treatment of active Behçet’s disease (oral ulcers). This study also tests how well the body tolerates apremilast. The study is conducted in several centers in different countries. | A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY, FOLLOWED BY AN ACTIVE-TREATMENT PHASE TO EVALUATE THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) IN THE TREATMENT OF SUBJECTS WITH ACTIVE BEHÇET’S DISEASE | SUBJECTS WITH ACTIVE BEHÇET’S DISEASE MedDRA version: 19.0;Level: LLT;Classification code 10004212;Term: Behcet's disease;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: APREMILAST Other descriptive name: APREMILAST Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: APREMILAST Other descriptive name: APREMILAST Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: APREMILAST Other descriptive name: APREMILAST | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 204 | Phase 3 | United States;France;Greece;Turkey;Israel;Germany;Japan;Italy;Korea, Republic of | ||
| 2 | EUCTR2014-002108-25-DE (EUCTR) | 17/06/2015 | 25/11/2014 | Study to test whether apremilast is better than placebo (inactive substance in the same form as the drug) for the treatment of active Behçet’s disease (oral ulcers). This study also tests how well the body tolerates apremilast. The study is conducted in several centers in different countries. | A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY, FOLLOWED BY AN ACTIVE-TREATMENT PHASE TO EVALUATE THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) IN THE TREATMENT OF SUBJECTS WITH ACTIVE BEHÇET’S DISEASE | SUBJECTS WITH ACTIVE BEHÇET’S DISEASE MedDRA version: 21.1;Level: LLT;Classification code 10004212;Term: Behcet's disease;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Otezla Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: APREMILAST Other descriptive name: APREMILAST Trade Name: Otezla Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: APREMILAST Other descriptive name: APREMILAST Trade Name: Otezla Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: APREMILAST Other descriptive name: APREMILAST | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 204 | Phase 3 | France;United States;Greece;Turkey;Israel;Germany;Japan;Italy;Korea, Republic of | ||
| 3 | EUCTR2014-002108-25-IT (EUCTR) | 24/02/2015 | 13/05/2015 | Study to test whether apremilast is better than placebo (inactive substance in the same form as the drug) for the treatment of active Behçet’s disease (oral ulcers). This study also tests how well the body tolerates apremilast. The study is conducted in several centers in different countries. | A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY, FOLLOWED BY AN ACTIVE-TREATMENT PHASE TO EVALUATE THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) IN THE TREATMENT OF SUBJECTS WITH ACTIVE BEHÇET’S DISEASE - NA | SUBJECTS WITH ACTIVE BEHÇET’S DISEASE MedDRA version: 18.0;Level: LLT;Classification code 10004212;Term: Behcet's disease;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: APREMILAST Other descriptive name: APREMILAST Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: APREMILAST Other descriptive name: APREMILAST Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: APREMILAST Other descriptive name: APREMILAST | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 204 | Phase 3 | United States;France;Greece;Turkey;Israel;Germany;Japan;Italy;Korea, Republic of | ||
| 4 | NCT02307513 (ClinicalTrials.gov) | December 30, 2014 | 2/12/2014 | A Phase 3 Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Active Behçet's Disease | A Phase 3, Multicenter, Randomized, Doubleblind, Placebo-controlled, Parallel Group Study, Followed by an Active-treatment Phase to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in the Treatment of Subjects With Active Behcet's Disease | Behçet's Syndrome | Drug: Apremilast;Drug: Placebo | Amgen | NULL | Completed | 18 Years | N/A | All | 207 | Phase 3 | United States;France;Germany;Greece;Israel;Italy;Japan;Korea, Republic of;Lebanon;Turkey |
| 5 | NCT00866359 (ClinicalTrials.gov) | August 1, 2009 | 18/3/2009 | A Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in the Treatment of Behçet Disease | A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Followed by an Active-Treatment Extension to Evaluate the Efficacy and Safety of Apremilast(CC-10004) in the Treatment of Behçet Disease | Behcet Syndrome | Drug: Apremilast (CC-10004);Drug: Placebo | Amgen | NULL | Completed | 18 Years | N/A | All | 111 | Phase 2 | United States;Turkey |