Rpc1063 (equivalent to ozanimod hcl)    (DrugBank: Ozanimod)

1 disease
IDDisease name (Link within this page)Number of trials
96Crohn disease39

96. Crohn disease    [ 2,209 clinical trials,   1,276 drugs,   (DrugBank: 240 drugs),   166 drug target genes,   210 drug target pathways]
Searched query = "Crohn disease", "Terminal ileitis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
39 / 2,209 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2017-004295-55-PT
(EUCTR)
04/02/201901/10/2018Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1350Phase 3Portugal;Belarus;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand
2EUCTR2017-004294-14-SI
(EUCTR)
06/11/201813/02/2018Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
485Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand
3EUCTR2017-004293-33-SI
(EUCTR)
06/11/201812/02/2018Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s DiseaseInduction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3United States;Portugal;Serbia;Hong Kong;Saudi Arabia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;Hungary;Mexico;Canada;Poland;Singapore;Georgia;Bulgaria;Germany;Sweden
4EUCTR2017-004295-55-SI
(EUCTR)
06/11/201813/02/2018Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand
5EUCTR2017-004295-55-DE
(EUCTR)
21/09/201821/02/2018Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Georgia;Germany;Norway;Japan;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2017-004292-31-DE
(EUCTR)
06/09/201806/02/2018Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s DiseaseInduction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3United States;Belarus;Taiwan;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Puerto Rico;Denmark;Australia;Latvia;China;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Japan;New Zealand
7EUCTR2017-004294-14-DE
(EUCTR)
23/08/201820/02/2018Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
485Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Bosnia and Herzegovina;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand
8EUCTR2017-004293-33-PT
(EUCTR)
06/08/201827/03/2018Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn¿s DiseaseInduction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn¿s Disease Moderately to Severely Active Crohn¿s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
675Phase 3United States;Portugal;Serbia;Hong Kong;Saudi Arabia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;Hungary;Mexico;Canada;Poland;Singapore;Georgia;Bulgaria;Germany;Sweden
9EUCTR2017-004294-14-GB
(EUCTR)
13/07/201826/06/2018Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
485Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand
10EUCTR2017-004292-31-GB
(EUCTR)
13/07/201826/06/2018Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s DiseaseInduction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3United States;Belarus;Taiwan;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Puerto Rico;Denmark;Australia;Latvia;China;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Norway;Japan;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2017-004294-14-BG
(EUCTR)
06/06/201820/02/2018Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
485Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Bosnia and Herzegovina;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand
12EUCTR2017-004292-31-BG
(EUCTR)
06/06/201820/02/2018Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s DiseaseInduction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3United States;Belarus;Taiwan;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Puerto Rico;Denmark;Australia;Latvia;China;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Czechia;Turkey;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Japan;New Zealand
13EUCTR2017-004295-55-BG
(EUCTR)
06/06/201820/02/2018Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Bosnia and Herzegovina;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand
14EUCTR2017-004293-33-BG
(EUCTR)
06/06/201820/02/2018Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s DiseaseInduction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3United States;Portugal;Serbia;Hong Kong;Saudi Arabia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;Hungary;Mexico;Canada;Poland;Singapore;Georgia;Bulgaria;Germany;Sweden
15EUCTR2017-004295-55-ES
(EUCTR)
23/05/201801/03/2018Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Georgia;Germany;Norway;Japan;New Zealand;Mexico;Canada;Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2017-004295-55-GB
(EUCTR)
18/05/201827/06/2018Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLNot RecruitingFemale: yes
Male: yes
1200Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand
17EUCTR2017-004292-31-ES
(EUCTR)
10/05/201823/02/2018Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s DiseaseInduction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3Belarus;United States;Taiwan;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;Puerto Rico;Australia;Denmark;Latvia;Moldova, Republic of;China;Bosnia and Herzegovina;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Japan
18EUCTR2017-004293-33-GR
(EUCTR)
27/04/201828/02/2018Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s DiseaseInduction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3Serbia;Portugal;United States;Saudi Arabia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;Hungary;Mexico;Canada;Poland;Singapore;Bulgaria;Georgia;Germany;Sweden
19EUCTR2017-004295-55-GR
(EUCTR)
27/04/201801/03/2018Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Georgia;Germany;Norway;Japan;New Zealand
20EUCTR2017-004294-14-GR
(EUCTR)
27/04/201828/02/2018Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
485Phase 3Russian Federation;Switzerland;Australia;Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Georgia;Germany;Norway;Japan;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2017-004293-33-PL
(EUCTR)
26/04/201819/03/2018Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s DiseaseInduction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
675Phase 3United States;Portugal;Serbia;Hong Kong;Saudi Arabia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;Hungary;Mexico;Canada;Poland;Singapore;Georgia;Bulgaria;Germany;Sweden
22EUCTR2017-004295-55-PL
(EUCTR)
26/04/201820/03/2018Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1350Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Poland;Belgium;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand
23EUCTR2017-004292-31-PL
(EUCTR)
26/04/201820/04/2018Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s DiseaseInduction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
675Phase 3United States;Belarus;Taiwan;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Puerto Rico;Denmark;Australia;Latvia;China;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Japan;New Zealand
24EUCTR2017-004294-14-PL
(EUCTR)
26/04/201820/03/2018Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
535Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Poland;Belgium;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand
25EUCTR2017-004293-33-ES
(EUCTR)
25/04/201802/03/2018Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s DiseaseInduction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3Serbia;Portugal;United States;Saudi Arabia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;Hungary;Mexico;Canada;Poland;Singapore;Bulgaria;Georgia;Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2017-004294-14-ES
(EUCTR)
25/04/201802/03/2018Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
485Phase 3Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Georgia;Germany;Norway;Japan;New Zealand
27EUCTR2017-004295-55-AT
(EUCTR)
23/03/201814/02/2018Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Bosnia and Herzegovina;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand
28EUCTR2017-004293-33-AT
(EUCTR)
23/03/201814/02/2018Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s DiseaseInduction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3United States;Portugal;Serbia;Hong Kong;Saudi Arabia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;Hungary;Mexico;Canada;Poland;Singapore;Georgia;Bulgaria;Germany;Sweden
29EUCTR2017-004294-14-AT
(EUCTR)
23/03/201814/02/2018Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
485Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Bosnia and Herzegovina;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand
30EUCTR2017-004293-33-SK
(EUCTR)
16/03/201830/01/2018Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s DiseaseInduction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3United States;Portugal;Serbia;Hong Kong;Saudi Arabia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;Hungary;Mexico;Canada;Poland;Singapore;Georgia;Bulgaria;Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2017-004295-55-SK
(EUCTR)
16/03/201830/01/2018Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand
32EUCTR2017-004294-14-SK
(EUCTR)
16/03/201830/01/2018Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
485Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand
33EUCTR2017-004294-14-LT
(EUCTR)
12/03/201801/02/2018Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
485Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand
34EUCTR2017-004293-33-LT
(EUCTR)
12/03/201801/02/2018Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s DiseaseInduction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3United States;Portugal;Serbia;Hong Kong;Saudi Arabia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;Hungary;Mexico;Canada;Poland;Singapore;Georgia;Bulgaria;Germany;Sweden
35EUCTR2017-004295-55-LT
(EUCTR)
12/03/201801/02/2018Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2017-004292-31-IE
(EUCTR)
27/04/2018Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s DiseaseInduction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLNAFemale: yes
Male: yes
600Phase 3United States;Belarus;Taiwan;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Puerto Rico;Denmark;Australia;Latvia;China;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Czechia;Turkey;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Japan;New Zealand
37EUCTR2017-004293-33-DE
(EUCTR)
06/02/2018Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s DiseaseInduction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLNAFemale: yes
Male: yes
600Phase 3United States;Portugal;Serbia;Hong Kong;Saudi Arabia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;Hungary;Mexico;Canada;Poland;Singapore;Georgia;Bulgaria;Germany;Sweden
38EUCTR2017-004294-14-IE
(EUCTR)
27/04/2018Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLNAFemale: yes
Male: yes
485Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Bosnia and Herzegovina;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand
39EUCTR2017-004295-55-IE
(EUCTR)
27/04/2018Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLNAFemale: yes
Male: yes
1200Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Bosnia and Herzegovina;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand