96. クローン病 Crohn disease Clinical trials / Disease details


臨床試験数 : 2,400 薬物数 : 1,391 - (DrugBank : 267) / 標的遺伝子数 : 170 - 標的パスウェイ数 : 215

  
82 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2017-004294-14-FR
(EUCTR)
02/12/201909/02/2018Multicenter 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
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 finished Female: yes
Male: yes
535 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited 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;Serbia;Sweden;Romania;Croatia;Brazil;Canada;Mexico;Czech Republic;Turkey;Korea, Republic of;Bosnia and Herzegovina;Moldova, Republic of;Latvia;Denmark;Puerto Rico;France;Italy;Ukraine;Greece;Slovakia;Hong Kong;Taiwan;Portugal;Belarus
2EUCTR2017-004293-33-FR
(EUCTR)
12/11/201909/02/2018Multicenter 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 finished Female: yes
Male: yes
675 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;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
3EUCTR2017-004292-31-FR
(EUCTR)
05/11/201909/08/2019Multicenter 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 finished Female: yes
Male: yes
675 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noBelarus;United States;Taiwan;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Puerto Rico;Australia;Denmark;Latvia;Moldova, Republic of;China;Korea, Republic of;Bosnia and Herzegovina;Turkey;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Japan
4EUCTR2017-004295-55-FR
(EUCTR)
08/10/201909/02/2018Multicenter 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 finished Female: yes
Male: yes
1350 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noBelarus;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;New Zealand;Japan;Norway;Germany;Georgia;Bulgaria;Singapore;Poland;Belgium;Argentina;Hungary;United Kingdom;Austria;Lithuania;Finland;Slovenia;China;Netherlands;South Africa;Australia;Switzerland;Russian Federation
5EUCTR2017-004295-55-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
1200Phase 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;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand
6EUCTR2017-004295-55-BE
(EUCTR)
13/12/201830/03/2018Multicenter 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;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
7EUCTR2017-004294-14-DK
(EUCTR)
30/11/201827/08/2018Multicenter 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 SàrlNULLNot Recruiting Female: yes
Male: yes
535 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noBelarus;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
8EUCTR2017-004295-55-DK
(EUCTR)
30/11/201827/08/2018Multicenter 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 Recruiting Female: yes
Male: yes
1350 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noBelarus;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
9EUCTR2017-004294-14-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 3Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;New Zealand;Japan;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;United States;Serbia;Saudi Arabia;Spain;Ireland;Russian Federation;Israel;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary
10EUCTR2017-004293-33-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 3Portugal;Serbia;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;Georgia;Bulgaria;Germany;Sweden
11EUCTR2017-004295-55-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;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;United States;Serbia;Saudi Arabia;Spain;Ireland;Russian Federation;Israel;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;New Zealand;Japan
12EUCTR2017-004294-14-PT
(EUCTR)
29/10/201816/07/2018Multicenter 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 3Serbia;Saudi Arabia;Spain;Ireland;Russian Federation;Israel;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;New Zealand;Japan;United States;Sweden;Romania;Croatia;Brazil;Canada;Mexico;Czech Republic;Turkey;Korea, Republic of;Bosnia and Herzegovina;Moldova, Republic of;Latvia;Denmark;Puerto Rico;France;Italy;Ukraine;Greece;Slovakia;Hong Kong;Taiwan;Belarus;Portugal
13EUCTR2017-004293-33-NL
(EUCTR)
22/10/201812/03/2018Multicenter 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 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
14EUCTR2017-004294-14-NL
(EUCTR)
22/10/201812/03/2018Multicenter 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
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
15EUCTR2017-004295-55-NL
(EUCTR)
22/10/201812/03/2018Multicenter 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;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
16EUCTR2017-004295-55-FI
(EUCTR)
10/10/201831/07/2018Multicenter 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 finished Female: yes
Male: yes
1350 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noBelarus;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
17EUCTR2017-004293-33-FI
(EUCTR)
10/10/201830/07/2018Multicenter 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 finished Female: yes
Male: yes
675 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;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
18EUCTR2017-004294-14-FI
(EUCTR)
10/10/201830/07/2018Multicenter 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 finished Female: yes
Male: yes
535 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noBelarus;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
19EUCTR2017-004295-55-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;United States;Serbia;Saudi Arabia;Spain;Ireland;Russian Federation;Israel;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;New Zealand;Japan
20EUCTR2017-004294-14-BE
(EUCTR)
20/09/201828/03/2018Multicenter 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
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
21EUCTR2017-004295-55-IE
(EUCTR)
10/09/201827/04/2018Multicenter 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 SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3Israel;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;Belarus;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
22EUCTR2017-004292-31-IE
(EUCTR)
10/09/201827/04/2018Multicenter 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
600Phase 3Israel;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;United States;Belarus;Taiwan;Spain;Ukraine;Ireland;Russian Federation;Switzerland;Italy;France;Puerto Rico
23EUCTR2017-004292-31-BE
(EUCTR)
10/09/201823/03/2018Multicenter 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
24EUCTR2017-004294-14-IE
(EUCTR)
10/09/201827/04/2018Multicenter 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 SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
485Phase 3Japan;Belarus;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;New Zealand
25EUCTR2017-004292-31-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;Czechia;Turkey;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Japan;New Zealand
26EUCTR2017-004294-14-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;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;France;Italy;Ukraine;Greece;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand
27NCT03467958
(ClinicalTrials.gov)
August 22, 201812/3/2018An Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's DiseaseA Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's DiseaseCrohn DiseaseDrug: OzanimodCelgeneNULLRecruiting18 Years75 YearsAll1200Phase 3United States;Argentina;Australia;Austria;Belarus;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;China;Croatia;Czechia;Denmark;Finland;France;Georgia;Germany;Greece;Hungary;Ireland;Israel;Italy;Korea, Republic of;Latvia;Lithuania;Mexico;Moldova, Republic of;Netherlands;Norway;Poland;Portugal;Romania;Russian Federation;Saudi Arabia;Serbia;Slovakia;Slovenia;South Africa;Spain;Sweden;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;Brazil
28EUCTR2017-004295-55-SE
(EUCTR)
08/08/201808/03/2018Multicenter 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 finished Female: yes
Male: yes
1350 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noBelarus;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
29EUCTR2017-004294-14-SE
(EUCTR)
08/08/201808/03/2018Multicenter 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 finished Female: yes
Male: yes
535 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noBelarus;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
30EUCTR2017-004293-33-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
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
31EUCTR2017-004294-14-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
32EUCTR2017-004292-31-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
33EUCTR2017-004295-55-IT
(EUCTR)
12/07/201822/01/2021Multicenter 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 - Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s 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]
INN or Proposed INN: Ozanimod
Product Name: ozanimod
Product Code: [RPC1063 equiv to ozanimod HCI]
INN or Proposed INN: Ozanimod
CELGENE INTERNATIONAL II SàRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1350Phase 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;Russian Federation;Israel;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;New Zealand;Japan
34EUCTR2017-004294-14-IT
(EUCTR)
11/07/201814/06/2021Multicenter 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 - Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Ac 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 equiv. to ozanimod HCI]
INN or Proposed INN: Ozanimod hydrochloride
Other descriptive name: ozanimod
Product Name: ozanimod
Product Code: [RPC1063]
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;United States;Serbia;Saudi Arabia;Spain;Ireland;Russian Federation;Israel;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;New Zealand;Japan
35EUCTR2017-004292-31-DK
(EUCTR)
09/07/201809/04/2018Multicenter 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 SàrlNULLNot Recruiting Female: yes
Male: yes
675 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noBelarus;United States;Taiwan;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Puerto Rico;Australia;Denmark;Latvia;Moldova, Republic of;China;Bosnia and Herzegovina;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Japan
36NCT03464097
(ClinicalTrials.gov)
June 27, 201826/2/2018A Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for 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 DiseaseCrohn DiseaseDrug: Ozanimod;Other: PlaceboCelgeneNULLRecruiting18 Years75 YearsAll485Phase 3United States;Argentina;Australia;Austria;Belarus;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;China;Croatia;Czechia;Denmark;Finland;France;Georgia;Germany;Greece;Hungary;Ireland;Israel;Italy;Korea, Republic of;Latvia;Lithuania;Mexico;Moldova, Republic of;Netherlands;Norway;Poland;Portugal;Romania;Russian Federation;Saudi Arabia;Serbia;Slovakia;Slovenia;South Africa;Spain;Sweden;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;Brazil
37EUCTR2017-004295-55-HR
(EUCTR)
19/06/201807/12/2018Multicenter 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;United States;Serbia;Saudi Arabia;Spain;Ireland;Russian Federation;Israel;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;New Zealand;Japan
38EUCTR2017-004294-14-HR
(EUCTR)
18/06/201807/12/2018Multicenter 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;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;United States;Serbia;Saudi Arabia;Spain;Ireland;Russian Federation;Israel;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;New Zealand;Japan
39EUCTR2017-004292-31-HR
(EUCTR)
18/06/201807/12/2018Multicenter 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;Israel;Russian Federation;Switzerland;Italy;France;Puerto Rico;Australia;Denmark;Latvia;Moldova, Republic of;China;Korea, Republic of;Bosnia and Herzegovina;Czechia;Turkey;United Kingdom;Czech Republic;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Japan
40EUCTR2017-004293-33-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
41EUCTR2017-004292-31-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
42EUCTR2017-004294-14-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
43EUCTR2017-004295-55-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 3Korea, 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;Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of
44EUCTR2017-004293-33-SE
(EUCTR)
23/05/201808/03/2018Multicenter 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 SàrlNULLNot Recruiting Female: yes
Male: yes
675 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;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
45EUCTR2017-004295-55-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
46EUCTR2017-004295-55-LV
(EUCTR)
21/05/201831/01/2018Multicenter 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 finished Female: yes
Male: yes
1200 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noBelarus;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
47EUCTR2017-004292-31-LV
(EUCTR)
21/05/201831/01/2018Multicenter 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 finished Female: yes
Male: yes
600 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noBelarus;United States;Taiwan;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Puerto Rico;Australia;Denmark;Latvia;Moldova, Republic of;China;Korea, Republic of;Bosnia and Herzegovina;Turkey;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Japan
48EUCTR2017-004294-14-LV
(EUCTR)
21/05/201831/01/2018Multicenter 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 finished Female: yes
Male: yes
485 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noBelarus;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
49EUCTR2017-004295-55-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
50EUCTR2017-004292-31-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
51EUCTR2017-004292-31-IT
(EUCTR)
08/05/201802/02/2021Multicenter 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 - Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Acti 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]
INN or Proposed INN: Ozanimod
Product Name: ozanimod
Product Code: [RPC1063]
INN or Proposed INN: Ozanimod
CELGENE INTERNATIONAL II SàRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
675Phase 3Belarus;United States;Taiwan;Spain;Ukraine;Ireland;Israel;Russian Federation;Switzerland;Italy;France;Puerto Rico;Australia;Denmark;Latvia;Moldova, Republic of;China;Korea, Republic of;Bosnia and Herzegovina;Czechia;Turkey;United Kingdom;Czech Republic;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Japan
52EUCTR2017-004294-14-CZ
(EUCTR)
03/05/201801/02/2018Multicenter 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
53EUCTR2017-004292-31-CZ
(EUCTR)
03/05/201831/01/2018Multicenter 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;Romania;Croatia;Bulgaria;Germany;Norway;Japan;New Zealand
54EUCTR2017-004293-33-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 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
55EUCTR2017-004294-14-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
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
56EUCTR2017-004295-55-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;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
57EUCTR2017-004295-55-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
1200Phase 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;Romania;Croatia;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;Bulgaria;Georgia;Norway;Germany;Japan;New Zealand
58EUCTR2017-004292-31-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
600Phase 3Belarus;United States;Taiwan;Spain;Ukraine;Ireland;Israel;Russian Federation;Switzerland;Italy;France;Puerto Rico;Australia;Denmark;Latvia;Moldova, Republic of;China;Korea, Republic of;Bosnia and Herzegovina;Czechia;Turkey;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Japan
59EUCTR2017-004293-33-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
600Phase 3United States;Serbia;Portugal;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;Bulgaria;Georgia;Germany;Sweden
60EUCTR2017-004294-14-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
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;United States;Serbia;Saudi Arabia;Spain;Ireland;Russian Federation;Israel;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Poland;Belgium;Singapore;Georgia;Bulgaria;Germany;Norway;New Zealand;Japan
61EUCTR2017-004294-14-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
62EUCTR2017-004293-33-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
63EUCTR2017-004295-55-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;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;Russian Federation;Israel;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;New Zealand;Japan
64EUCTR2017-004294-14-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
65EUCTR2017-004293-33-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 3Portugal;Serbia;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;Georgia;Bulgaria;Germany;Sweden
66EUCTR2017-004293-33-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 3Portugal;Serbia;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;Georgia;Bulgaria;Germany;Sweden
67EUCTR2017-004294-14-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;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;Russian Federation;Israel;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;New Zealand;Japan
68EUCTR2017-004295-55-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;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;Russian Federation;Israel;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;New Zealand;Japan
69EUCTR2017-004295-55-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;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;United States;Serbia;Saudi Arabia;Spain;Ireland;Russian Federation;Israel;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;New Zealand;Japan
70EUCTR2017-004293-33-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 3Portugal;Serbia;United States;Saudi Arabia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;Austria;Hungary;Mexico;Canada;Poland;Singapore;Georgia;Bulgaria;Germany;Sweden
71EUCTR2017-004294-14-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;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;United States;Serbia;Saudi Arabia;Spain;Ireland;Russian Federation;Israel;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;New Zealand;Japan
72EUCTR2017-004295-55-HU
(EUCTR)
08/03/201830/01/2018Multicenter 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;Bulgaria;Georgia;Germany;Norway;Japan;New Zealand
73NCT03440385
(ClinicalTrials.gov)
March 7, 201814/2/2018Induction Study #2 of Oral Ozanimod as Induction Therapy for 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 DiseaseCrohn DiseaseDrug: Ozanimod;Other: PlaceboCelgeneNULLRecruiting18 Years75 YearsAll600Phase 3United States;Australia;Austria;Bulgaria;Canada;China;Finland;France;Georgia;Germany;Greece;Hungary;Israel;Korea, Republic of;Lithuania;Netherlands;Poland;Portugal;Russian Federation;Serbia;Slovakia;Slovenia;South Africa;Spain;Sweden;Taiwan;Turkey;Ukraine;Brazil
74EUCTR2017-004294-14-HU
(EUCTR)
06/03/201830/01/2018Multicenter 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
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
485 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noBelarus;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
75EUCTR2017-004293-33-HU
(EUCTR)
06/03/201829/01/2018Multicenter 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;Serbia;Portugal;Saudi Arabia;Hong Kong;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;Bulgaria;Georgia;Germany;Sweden
76NCT03440372
(ClinicalTrials.gov)
February 27, 201814/2/2018Induction Study #1 of Oral Ozanimod as Induction Therapy for 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 DiseaseCrohn DiseaseDrug: Ozanimod;Other: PlaceboCelgeneNULLRecruiting18 Years75 YearsAll600Phase 3United States;Argentina;Australia;Belarus;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Croatia;Czechia;Denmark;Finland;France;Germany;Ireland;Israel;Italy;Korea, Republic of;Latvia;Mexico;Moldova, Republic of;Norway;Poland;Romania;Russian Federation;Saudi Arabia;Spain;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;Brazil
77EUCTR2016-003073-18-GB
(EUCTR)
29/09/201616/09/2016A study designed to investigate how radiolabelled RPC1063 is taken up, broken down and removed from the bodyA Phase I, Single-Centre, Single Dose Oral Excretion Balance Study of [14C]-RPC1063 in Healthy Male Adults - ADME study of [14C]-RPC1063 in healthy male subjects (QCL117686) The drug is a potential treatment for adult patients with relapsing multiple sclerosis (RMS) and for adult patients with moderately to severely active inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn’s disease (CD).
MedDRA version: 19.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 19.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: [14C]-RPC1063 Solution (0.1 mg/mL) for Oral Administration
INN or Proposed INN: Ozanimod hydrochloride
Celgene International II SàrlNULLNot Recruiting Female: no
Male: yes
6 Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited Kingdom
78EUCTR2015-002025-19-IT
(EUCTR)
17/05/201605/11/2020An open-label study to assess improvement in patients with Moderate to Severe Crohn’s Disease taking RPC1063 orallyA Phase 2, Multi-Center, Open-Label Induction Trial with Extension Period to Assess Endoscopic Improvement and Changes in Intestinal and Serum Biomarkers in Patients with Moderately to Severely Active Crohn's Disease Receiving Oral RPC1063 as Induction Therapy - Open-Label Endoscopic Improvement Trial of RPC1063 for Moderate to Severe Crohn’s Disease Moderately to Severely Active Crohn's Disease
MedDRA version: 20.1;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856
MedDRA version: 22.1;Classification code 10011403;Term: Crohn's disease aggravated;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: RPC1063
Product Code: [RPC1063]
INN or Proposed INN: Ozanimod
Product Name: RPC0163
Product Code: [RPC0163]
INN or Proposed INN: Ozanimod
CELGENE INTERNATIONAL II SàRLNULLNot RecruitingFemale: yes
Male: yes
60Phase 2United States;Hungary;Canada;Poland;Ukraine;Italy
79EUCTR2015-002025-19-PL
(EUCTR)
28/01/201621/12/2015An open-label study to assess improvement in patients with Moderate to Severe Crohn’s Disease taking RPC1063 orallyA Phase 2, Multi-Center, Open-Label Induction Trial with Extension Period to Assess Endoscopic Improvement and Changes in Intestinal and Serum Biomarkers in Patients with Moderately to Severely Active Crohn's Disease Receiving Oral RPC1063 as Induction Therapy - Open-Label Endoscopic Improvement Trial of RPC1063 for Moderate to Severe Crohn’s Disease Moderately to Severely Active Crohn's Disease
MedDRA version: 20.1;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10011402;Term: Crohn's disease (colon);Classification code 10011403;Term: Crohn's disease aggravated;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: 0.25 mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod
Other descriptive name: RPC1063
Product Name: 1mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod
Other descriptive name: RPC1063
Celgene International II Sàrl (CIS II), a wholly owned subsidiary of Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
60Phase 2United States;Hungary;Canada;Poland;Ukraine
80EUCTR2015-002025-19-HU
(EUCTR)
30/12/201529/10/2015A Phase 2, Multi-Center, Open-Label Induction Trial with Extension Period to Assess Endoscopic Improvement and Changes in Intestinal and Serum Biomarkers in Patients with Moderately to Severely Active Crohn's Disease Receiving Oral RPC1063 as Induction Therapy - Open-Label Endoscopic Improvement Trial of RPC1063 for Moderate to Severe Crohn’s Disease A Phase 2, Multi-Center, Open-Label Induction Trial with Extension Period to Assess Endoscopic Improvement and Changes in Intestinal and Serum Biomarkers in Patients with Moderately to Severely Active Crohn's Disease Receiving Oral RPC1063 as Induction Therapy - Open-Label Endoscopic Improvement Trial of RPC1063 for Moderate to Severe Crohn’s Disease Moderately to Severely Active Crohn's Disease
MedDRA version: 20.1;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10011402;Term: Crohn's disease (colon);Classification code 10011403;Term: Crohn's disease aggravated;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: 0,25 mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod
Other descriptive name: RPC1063
Product Name: 1mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod
Other descriptive name: RPC1063
Celgene International II Sarl (CISII) awholly owned subsidiary of Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
60Phase 2United States;Hungary;Canada;Poland;Ukraine;Italy
81EUCTR2017-004293-33-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 3Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;Hungary;Mexico;Canada;Poland;Singapore;Georgia;Bulgaria;Germany;Sweden;United States;Portugal;Serbia;Hong Kong;Saudi Arabia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;France;Australia;South Africa
82EUCTR2017-004295-55-CZ
(EUCTR)
05/02/2018Multicenter 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 SàrlNULLNAFemale: 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