Ozanimod HCL ( DrugBank: Ozanimod )


2 diseases
IDDisease name (Link within this page)Number of trials
13Multiple sclerosis/Neuromyelitis optica10
97Ulcerative colitis1

13. Multiple sclerosis/Neuromyelitis optica


Clinical trials : 3,340 Drugs : 2,163 - (DrugBank : 383) / Drug target genes : 241 - Drug target pathways : 238
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2015-002500-91-SE
(EUCTR)
01/06/201727/06/2016A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple SclerosisA Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study Relapsing Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: 0.25mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod HCl
Product Name: 1.0mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod HCl
Celgene International II Sàrl (CIS II)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2495Phase 3Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden;United States;Belarus;Portugal;Serbia
2EUCTR2015-002500-91-HR
(EUCTR)
13/06/201606/07/2016A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple SclerosisA Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study Relapsing Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: 0.25mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod HCl
Product Name: 1.0mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod HCl
Celgene International II Sàrl (CIS II)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2496Phase 3United States;Belarus;Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden
3EUCTR2015-002500-91-LT
(EUCTR)
31/05/201617/03/2016A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple SclerosisA Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study Relapsing Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: 0.25mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod HCl
Product Name: 1.0mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod HCl
Celgene International II Sàrl (CIS II)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2495Phase 3United States;Serbia;Belarus;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Belgium;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden
4EUCTR2015-002500-91-LV
(EUCTR)
20/04/201619/02/2016A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple SclerosisA Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study Relapsing Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: 0.25mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod HCl
Product Name: 1.0mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod HCl
Celgene International II Sàrl (CIS II)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2495Phase 3United States;Serbia;Belarus;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Belgium;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden
5EUCTR2015-002500-91-EE
(EUCTR)
04/04/201607/03/2016A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple SclerosisA Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study Relapsing Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: 0.25mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod HCl
Product Name: 1.0mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod HCl
Celgene International II Sàrl (CIS II)NULLNot RecruitingFemale: yes
Male: yes
2495Phase 3United States;Belarus;Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden
6EUCTR2015-002500-91-IT
(EUCTR)
09/02/201622/01/2021A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple SclerosisA Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study Relapsing Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: 0.25mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod HCL
Product Name: 1.0mg RPC1063
Product Code: RPC1063
CELGENE INTERNATIONAL II SàRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2496Phase 3United States;Serbia;Belarus;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Mexico;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden
7EUCTR2015-002500-91-SK
(EUCTR)
22/01/201628/10/2015A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple SclerosisA Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study Relapsing Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: 0.25mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod HCl
Product Name: 1.0mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod HCl
Celgene International II Sàrl (CIS II)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2496Phase 3United States;Serbia;Belarus;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;Peru;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Belgium;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;New Zealand;Sweden
8EUCTR2015-002500-91-PL
(EUCTR)
20/01/201601/12/2015A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple SclerosisA Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study Relapsing Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: 0.25mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod HCl
Product Name: 1.0mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod HCl
Celgene International II Sàrl (CIS II)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2496Phase 3United States;Serbia;Belarus;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Colombia;Italy;Peru;South Africa;Latvia;Netherlands;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden
9EUCTR2015-002500-91-BG
(EUCTR)
13/01/201620/10/2015A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple SclerosisA Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study Relapsing Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: 0.25mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod HCl
Product Name: 1.0mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod HCl
Celgene International II Sàrl (CIS II)NULLNot RecruitingFemale: yes
Male: yes
2496Phase 3Sweden;United States;Serbia;Belarus;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;Peru;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Belgium;Poland;Romania;Croatia;Georgia;Bulgaria;Germany;New Zealand
10EUCTR2015-002500-91-BE
(EUCTR)
10/11/201502/09/2015A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple SclerosisA Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study Relapsing Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: 0.25mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod HCl
Product Name: 1.0mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod HCl
Celgene International II Sàrl (CIS II)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2496Phase 3United States;Serbia;Belarus;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Belgium;Poland;Romania;Croatia;Georgia;Bulgaria;Germany;New Zealand;Sweden

97. Ulcerative colitis


Clinical trials : 2,630 Drugs : 1,459 - (DrugBank : 265) / Drug target genes : 144 - Drug target pathways : 202
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2021-002308-11-ES
(EUCTR)
21/07/202221/07/2022A phase 2/3, multicenter, randomized, double-blind study to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of oral ozanimod (RPC1063) in pediatric subjects with moderately to severely active ulcerative colitis with an inadequate response to conventional therapy.A phase 2/3, multicenter, randomized, double-blind study to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of oral ozanimod (RPC1063) in pediatric subjects with moderately to severely active ulcerative colitis with an inadequate response to conventional therapy. Moderately to Severely Active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Ozanimod HCL
Product Code: RPC1063
INN or Proposed INN: Ozanimod HCL
Other descriptive name: RPC1063
Product Name: Ozanimod HCL
Product Code: RPC1063
INN or Proposed INN: Ozanimod HCL
Other descriptive name: RPC1063
Product Name: Ozanimod HCL
Product Code: RPC1063
INN or Proposed INN: Ozanimod HCL
Other descriptive name: RPC1063
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 2;Phase 3France;United States;Canada;Belgium;Poland;Spain;Russian Federation;Israel;Germany;Netherlands;United Kingdom;Japan