Otezla ( DrugBank: - )


3 diseases
IDDisease name (Link within this page)Number of trials
56Behcet disease6
107Juvenile idiopathic arthritis8
162Pemphigoid1

56. Behcet disease


Clinical trials : 81 Drugs : 107 - (DrugBank : 30) / Drug target genes : 36 - Drug target pathways : 116
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2022-003024-41-ES
(EUCTR)
25/01/202325/11/2022Apremilast study in children with active oral ulcers associated with Behçet's Disease or Juvenile Psoriatic ArthritisA Phase 3, Multicenter, Open-label, Long-term Extension Study of Apremilast in Children 2 Years of Age or Older With Oral Ulcers Associated With Behçet’s Disease or 5 Years of Age or Older With Juvenile Psoriatic Arthritis Subjects with active Behçet's Disease or Juvenile Psoriatic Arthritis
MedDRA version: 21.1;Level: LLT;Classification code 10004212;Term: Behcet's disease;System Organ Class: 100000004866
MedDRA version: 20.0;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Otezla
Product Name: Apremilast 20 mg
Product Code: AMG 407
INN or Proposed INN: Apremilast
Trade Name: Otezla
Product Name: Apremilast 30 mg
Product Code: AMG 407
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: AMG 407
INN or Proposed INN: Apremilast
Amgen IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
48Phase 3France;Greece;Spain;Turkey;Israel;United Kingdom;Italy;Switzerland
2EUCTR2019-002787-27-IT
(EUCTR)
24/05/202107/06/2021Apremilast study in children with active oral ulcers associated with Behçet's DiseaseA Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled,Parallel Group Study, Followed by an Active Treatment Phase to Evaluate the Efficacy and Safety of Apremilast in Children From 2 to Less Than 18 Years of Age With Active Oral Ulcers Associated With Behçet's Disease (BEAN) - BEAN 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 - 10 MG + 20 MG + 30 MG COMPRESSA RIVESTITA CON FILM USO ORALE - BLISTER (PVC/ALU) IN UN ASTUCCIO - 4 COMPRESSE DA 10 MG + 4 COMPRESSE DA 20 MG +19 COMPRESSE DA 30 MG
Product Name: Apremilast
Product Code: [AMG407]
INN or Proposed INN: Apremilast
Trade Name: OTEZLA - 10 MG + 20 MG + 30 MG COMPRESSA RIVESTITA CON FILM USO ORALE - BLISTER (PVC/ALU) IN UN ASTUCCIO - 4 COMPRESSE DA 10 MG + 4 COMPRESSE DA 20 MG +19 COMPRESSE DA 30 MG
Product Name: Apremilast
Product Code: [AMG407]
INN or Proposed INN: Apremilast
Trade Name: OTEZLA - 10 MG + 20 MG + 30 MG COMPRESSA RIVESTITA CON FILM USO ORALE - BLISTER (PVC/ALU) IN UN ASTUCCIO - 4 COMPRESSE DA 10 MG + 4 COMPRESSE DA 20 MG +19 COMPRESSE DA 30 MG
Product Name: Apremilast
Product Code: [AMG 407]
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: [AMG407]
INN or Proposed INN: Apremilast
AMGEN INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 3France;Greece;Israel;Netherlands;Switzerland;Italy
3EUCTR2019-002787-27-GR
(EUCTR)
20/05/202107/05/2021Apremilast study in children with active oral ulcers associated with Behçet’s DiseaseA Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study, Followed by an Active Treatment Phase to Evaluate the Efficacy and Safety of Apremilast in Children From 2 to Less Than 18 Years of Age With Active Oral Ulcers Associated With Behçet’s Disease (BEAN) 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 10 mg
Product Code: AMG-407
INN or Proposed INN: Apremilast
Trade Name: Otezla
Product Name: Apremilast 20 mg
Product Code: AMG-407
INN or Proposed INN: Apremilast
Trade Name: Otezla
Product Name: Apremilast 30 mg
Product Code: AMG-407
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: AMG407
INN or Proposed INN: Apremilast
Amgen Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 3France;Greece;Israel;Netherlands;Switzerland
4EUCTR2014-002108-25-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
5EUCTR2019-002787-27-FR
(EUCTR)
18/12/2020Apremilast study in children with active oral ulcers associated with Behçet’s DiseaseA Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study, Followed by an Active Treatment Phase to Evaluate the Efficacy and Safety of Apremilast in Children From 2 to Less Than 18 Years of Age With Active Oral Ulcers Associated With Behçet’s Disease (BEAN) 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 10 mg
Product Code: AMG-407
INN or Proposed INN: Apremilast
Trade Name: Otezla
Product Name: Apremilast 20 mg
Product Code: AMG-407
INN or Proposed INN: Apremilast
Trade Name: Otezla
Product Name: Apremilast 30 mg
Product Code: AMG-407
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: AMG407
INN or Proposed INN: Apremilast
Amgen Inc.NULLNAFemale: yes
Male: yes
60Phase 3France;Israel;Netherlands;Switzerland
6EUCTR2019-002787-27-NL
(EUCTR)
11/02/2021Apremilast study in children with active oral ulcers associated with Behçet’s DiseaseA Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study, Followed by an Active Treatment Phase to Evaluate the Efficacy and Safety of Apremilast in Children From 2 to Less Than 18 Years of Age With Active Oral Ulcers Associated With Behçet’s Disease (BEAN) 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 10 mg
Product Code: AMG-407
INN or Proposed INN: Apremilast
Trade Name: Otezla
Product Name: Apremilast 20 mg
Product Code: AMG-407
INN or Proposed INN: Apremilast
Trade Name: Otezla
Product Name: Apremilast 30 mg
Product Code: AMG-407
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: AMG407
INN or Proposed INN: Apremilast
Amgen Inc.NULLNAFemale: yes
Male: yes
60Phase 3France;Greece;Spain;Israel;Netherlands;United Kingdom;Switzerland;Italy

107. Juvenile idiopathic arthritis


Clinical trials : 447 Drugs : 297 - (DrugBank : 57) / Drug target genes : 52 - Drug target pathways : 146
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2022-003024-41-ES
(EUCTR)
25/01/202325/11/2022Apremilast study in children with active oral ulcers associated with Behçet's Disease or Juvenile Psoriatic ArthritisA Phase 3, Multicenter, Open-label, Long-term Extension Study of Apremilast in Children 2 Years of Age or Older With Oral Ulcers Associated With Behçet’s Disease or 5 Years of Age or Older With Juvenile Psoriatic Arthritis Subjects with active Behçet's Disease or Juvenile Psoriatic Arthritis
MedDRA version: 21.1;Level: LLT;Classification code 10004212;Term: Behcet's disease;System Organ Class: 100000004866
MedDRA version: 20.0;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Otezla
Product Name: Apremilast 20 mg
Product Code: AMG 407
INN or Proposed INN: Apremilast
Trade Name: Otezla
Product Name: Apremilast 30 mg
Product Code: AMG 407
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: AMG 407
INN or Proposed INN: Apremilast
Amgen IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
48Phase 3France;Greece;Spain;Turkey;Israel;United Kingdom;Italy;Switzerland
2EUCTR2019-002788-88-GR
(EUCTR)
14/04/202201/02/2022Apremilast Study in Children with Active Juvenile Psoriatic ArthritisA Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Apremilast in Children From 5 to Less Than 18 Years of Age With Active Juvenile Psoriatic Arthritis (PEAPOD) Juvenile psoriatic arthritis
MedDRA version: 20.0;Level: LLT;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Otezla
Product Name: Apremilast 10 mg
Product Code: AMG-407
INN or Proposed INN: Apremilast
Trade Name: Otezla
Product Name: Apremilast 20 mg
Product Code: AMG-407
INN or Proposed INN: Apremilast
Trade Name: Otezla
Product Name: Apremilast 30 mg
Product Code: AMG-407
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: AMG407
INN or Proposed INN: Apremilast
Amgen Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 3France;Greece;Poland;Belgium;Austria;Netherlands;Italy
3EUCTR2019-002788-88-NL
(EUCTR)
23/09/202118/02/2021Apremilast Study in Children with Active Juvenile Psoriatic ArthritisA Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Apremilast in Children From 5 to Less Than 18 Years of Age With Active Juvenile Psoriatic Arthritis (PEAPOD) Juvenile psoriatic arthritis
MedDRA version: 20.0;Level: LLT;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Otezla
Product Name: Apremilast 10 mg
Product Code: AMG-407
INN or Proposed INN: Apremilast
Trade Name: Otezla
Product Name: Apremilast 20 mg
Product Code: AMG-407
INN or Proposed INN: Apremilast
Trade Name: Otezla
Product Name: Apremilast 30 mg
Product Code: AMG-407
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: AMG407
INN or Proposed INN: Apremilast
Amgen Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 3France;Belgium;Austria;Netherlands;Italy
4EUCTR2019-002788-88-FR
(EUCTR)
15/04/202118/12/2020Apremilast Study in Children with Active Juvenile Psoriatic ArthritisA Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Apremilast in Children From 5 to Less Than 18 Years of Age With Active Juvenile Psoriatic Arthritis (PEAPOD) Juvenile psoriatic arthritis
MedDRA version: 20.0;Level: LLT;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Otezla
Product Name: Apremilast 10 mg
Product Code: AMG-407
INN or Proposed INN: Apremilast
Trade Name: Otezla
Product Name: Apremilast 20 mg
Product Code: AMG-407
INN or Proposed INN: Apremilast
Trade Name: Otezla
Product Name: Apremilast 30 mg
Product Code: AMG-407
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: AMG407
INN or Proposed INN: Apremilast
Amgen Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 3France;Belgium;Austria;Netherlands
5EUCTR2019-002788-88-IT
(EUCTR)
11/03/202120/05/2021Apremilast Study in Children with Active Juvenile Psoriatic ArthritisA Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Apremilast in Children From 5 to Less Than 18 Years of Age With Active Juvenile Psoriatic Arthritis (PEAPOD) - PEAPOD Juvenile psoriatic arthritis
MedDRA version: 20.0;Level: LLT;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: OTEZLA - 10 MG + 20 MG + 30 MG COMPRESSA RIVESTITA CON FILM USO ORALE - BLISTER (PVC/ALU) IN UN ASTUCCIO - 4 COMPRESSE DA 10 MG + 4 COMPRESSE DA 20 MG +19 COMPRESSE DA 30 MG
Product Name: Apremilast 20 mg
Product Code: [AMG407]
INN or Proposed INN: Apremilast
Trade Name: OTEZLA - 30 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PVC/ALU) - 56 COMPRESSE
Product Name: Apremilast 30 mg
Product Code: [AMG407]
INN or Proposed INN: Apremilast
Trade Name: OTEZLA - 10 MG + 20 MG + 30 MG COMPRESSA RIVESTITA CON FILM USO ORALE - BLISTER (PVC/ALU) IN UN ASTUCCIO - 4 COMPRESSE DA 10 MG + 4 COMPRESSE DA 20 MG +19 COMPRESSE DA 30 MG
Product Name: Apremilast 10 mg
Product Code: [AMG407]
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: [AMG407]
INN or Proposed INN: Apremilast
AMGEN INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 3France;Spain;Belgium;Austria;Netherlands;Germany;Italy
6EUCTR2019-002788-88-AT
(EUCTR)
11/01/202105/11/2020Apremilast Study in Children with Active Juvenile Psoriatic ArthritisA Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Apremilast in Children From 5 to Less Than 18 Years of Age With Active Juvenile Psoriatic Arthritis (PEAPOD) Juvenile psoriatic arthritis
MedDRA version: 20.0;Level: LLT;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Otezla
Product Name: Apremilast 10 mg
Product Code: AMG-407
INN or Proposed INN: Apremilast
Trade Name: Otezla
Product Name: Apremilast 20 mg
Product Code: AMG-407
INN or Proposed INN: Apremilast
Trade Name: Otezla
Product Name: Apremilast 30 mg
Product Code: AMG-407
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: AMG407
INN or Proposed INN: Apremilast
Amgen Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 3France;Greece;Poland;Belgium;Austria;Netherlands;Italy
7EUCTR2019-002788-88-PL
(EUCTR)
28/01/2022Apremilast Study in Children with Active Juvenile Psoriatic ArthritisA Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Apremilast in Children From 5 to Less Than 18 Years of Age With Active Juvenile Psoriatic Arthritis (PEAPOD) Juvenile psoriatic arthritis
MedDRA version: 20.0;Level: LLT;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Otezla
Product Name: Apremilast 10 mg
Product Code: AMG-407
INN or Proposed INN: Apremilast
Trade Name: Otezla
Product Name: Apremilast 20 mg
Product Code: AMG-407
INN or Proposed INN: Apremilast
Trade Name: Otezla
Product Name: Apremilast 30 mg
Product Code: AMG-407
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: AMG407
INN or Proposed INN: Apremilast
Amgen Inc.NULLNAFemale: yes
Male: yes
60Phase 3France;Belgium;Poland;Austria;Netherlands;Italy
8EUCTR2019-002788-88-BE
(EUCTR)
15/12/2020Apremilast Study in Children with Active Juvenile Psoriatic ArthritisA Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Apremilast in Children From 5 to Less Than 18 Years of Age With Active Juvenile Psoriatic Arthritis (PEAPOD) Juvenile psoriatic arthritis
MedDRA version: 20.0;Level: LLT;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Otezla
Product Name: Apremilast 10 mg
Product Code: AMG-407
INN or Proposed INN: Apremilast
Trade Name: Otezla
Product Name: Apremilast 20 mg
Product Code: AMG-407
INN or Proposed INN: Apremilast
Trade Name: Otezla
Product Name: Apremilast 30 mg
Product Code: AMG-407
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: AMG407
INN or Proposed INN: Apremilast
Amgen Inc.NULLNAFemale: yes
Male: yes
60Phase 3Belgium;Austria;Netherlands

162. Pemphigoid


Clinical trials : 90 Drugs : 122 - (DrugBank : 47) / Drug target genes : 34 - Drug target pathways : 144
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2018-002564-10-NL
(EUCTR)
23/04/201923/04/2019PDE4 inhibitor (apremilast) in pemphigoid.Short-term safety, efficacy and mode of action of apremilast in mild to moderate cutaneous pemphigoid: a phase IIa open label single arm study. - SAMP trial Pemphigoid;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]Trade Name: Otezla
Product Name: Apremilast
Product Code: CC-10004
Universitair Medisch Centrum GroningenNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
10 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noNetherlands