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

56. ベーチェット病


臨床試験数 : 81 薬物数 : 107 - (DrugBank : 30) / 標的遺伝子数 : 36 - 標的パスウェイ数 : 116
No.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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size
PhaseCountries
1EUCTR2014-002108-25-GR
(EUCTR)
06/07/201608/06/2016Study 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
204Phase 3United States;France;Greece;Turkey;Israel;Germany;Japan;Italy;Korea, Republic of
2EUCTR2014-002108-25-DE
(EUCTR)
17/06/201525/11/2014Study 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.NULLNot RecruitingFemale: yes
Male: yes
204Phase 3France;United States;Greece;Turkey;Israel;Germany;Japan;Italy;Korea, Republic of
3EUCTR2014-002108-25-IT
(EUCTR)
24/02/201513/05/2015Study 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
204Phase 3United States;France;Greece;Turkey;Israel;Germany;Japan;Italy;Korea, Republic of
4NCT02307513
(ClinicalTrials.gov)
December 30, 20142/12/2014A Phase 3 Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Active Behçet's DiseaseA 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 DiseaseBehçet's SyndromeDrug: Apremilast;Drug: PlaceboAmgenNULLCompleted18 YearsN/AAll207Phase 3United States;France;Germany;Greece;Israel;Italy;Japan;Korea, Republic of;Lebanon;Turkey
5NCT00866359
(ClinicalTrials.gov)
August 1, 200918/3/2009A Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in the Treatment of Behçet DiseaseA 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 DiseaseBehcet SyndromeDrug: Apremilast (CC-10004);Drug: PlaceboAmgenNULLCompleted18 YearsN/AAll111Phase 2United States;Turkey