96. クローン病
[臨床試験数:2,209,薬物数:1,276(DrugBank:240),標的遺伝子数:166,標的パスウェイ数:210

Searched query = "Crohn disease", "Terminal ileitis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
44 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2017-004295-55-PT
(EUCTR)
04/02/201901/10/2018Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1350Phase 3Portugal;Belarus;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand
2EUCTR2017-004293-33-SI
(EUCTR)
06/11/201812/02/2018Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s DiseaseInduction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3United States;Portugal;Serbia;Hong Kong;Saudi Arabia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;Hungary;Mexico;Canada;Poland;Singapore;Georgia;Bulgaria;Germany;Sweden
3EUCTR2017-004295-55-SI
(EUCTR)
06/11/201813/02/2018Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand
4EUCTR2017-004294-14-SI
(EUCTR)
06/11/201813/02/2018Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
485Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand
5EUCTR2017-004295-55-DE
(EUCTR)
21/09/201821/02/2018Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Georgia;Germany;Norway;Japan;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2017-004292-31-DE
(EUCTR)
06/09/201806/02/2018Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s DiseaseInduction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3United States;Belarus;Taiwan;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Puerto Rico;Denmark;Australia;Latvia;China;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Japan;New Zealand
7EUCTR2017-004294-14-DE
(EUCTR)
23/08/201820/02/2018Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
485Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Bosnia and Herzegovina;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand
8EUCTR2017-004293-33-PT
(EUCTR)
06/08/201827/03/2018Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn¿s DiseaseInduction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn¿s Disease Moderately to Severely Active Crohn¿s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
675Phase 3United States;Portugal;Serbia;Hong Kong;Saudi Arabia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;Hungary;Mexico;Canada;Poland;Singapore;Georgia;Bulgaria;Germany;Sweden
9EUCTR2017-004292-31-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
10EUCTR2017-004294-14-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2017-004294-14-BG
(EUCTR)
06/06/201820/02/2018Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
485Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Bosnia and Herzegovina;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand
12EUCTR2017-004292-31-BG
(EUCTR)
06/06/201820/02/2018Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s DiseaseInduction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3United States;Belarus;Taiwan;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Puerto Rico;Denmark;Australia;Latvia;China;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Czechia;Turkey;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Japan;New Zealand
13EUCTR2017-004295-55-BG
(EUCTR)
06/06/201820/02/2018Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Bosnia and Herzegovina;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand
14EUCTR2017-004293-33-BG
(EUCTR)
06/06/201820/02/2018Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s DiseaseInduction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3United States;Portugal;Serbia;Hong Kong;Saudi Arabia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;Hungary;Mexico;Canada;Poland;Singapore;Georgia;Bulgaria;Germany;Sweden
15EUCTR2017-004295-55-ES
(EUCTR)
23/05/201801/03/2018Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Georgia;Germany;Norway;Japan;New Zealand;Mexico;Canada;Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2017-004295-55-GB
(EUCTR)
18/05/201827/06/2018Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLNot RecruitingFemale: yes
Male: yes
1200Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand
17EUCTR2017-004292-31-ES
(EUCTR)
10/05/201823/02/2018Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s DiseaseInduction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3Belarus;United States;Taiwan;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;Puerto Rico;Australia;Denmark;Latvia;Moldova, Republic of;China;Bosnia and Herzegovina;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Japan
18EUCTR2017-004294-14-GR
(EUCTR)
27/04/201828/02/2018Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
485Phase 3Russian Federation;Switzerland;Australia;Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Georgia;Germany;Norway;Japan;New Zealand
19EUCTR2017-004293-33-GR
(EUCTR)
27/04/201828/02/2018Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s DiseaseInduction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3Serbia;Portugal;United States;Saudi Arabia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;Hungary;Mexico;Canada;Poland;Singapore;Bulgaria;Georgia;Germany;Sweden
20EUCTR2017-004295-55-GR
(EUCTR)
27/04/201801/03/2018Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Georgia;Germany;Norway;Japan;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2017-004294-14-PL
(EUCTR)
26/04/201820/03/2018Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
535Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Poland;Belgium;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand
22EUCTR2017-004293-33-PL
(EUCTR)
26/04/201819/03/2018Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s DiseaseInduction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
675Phase 3United States;Portugal;Serbia;Hong Kong;Saudi Arabia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;Hungary;Mexico;Canada;Poland;Singapore;Georgia;Bulgaria;Germany;Sweden
23EUCTR2017-004292-31-PL
(EUCTR)
26/04/201820/04/2018Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s DiseaseInduction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
675Phase 3United States;Belarus;Taiwan;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Puerto Rico;Denmark;Australia;Latvia;China;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Japan;New Zealand
24EUCTR2017-004295-55-PL
(EUCTR)
26/04/201820/03/2018Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1350Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Poland;Belgium;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand
25EUCTR2017-004294-14-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2017-004293-33-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
27EUCTR2017-004295-55-AT
(EUCTR)
23/03/201814/02/2018Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Bosnia and Herzegovina;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand
28EUCTR2017-004293-33-AT
(EUCTR)
23/03/201814/02/2018Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s DiseaseInduction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3United States;Portugal;Serbia;Hong Kong;Saudi Arabia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;Hungary;Mexico;Canada;Poland;Singapore;Georgia;Bulgaria;Germany;Sweden
29EUCTR2017-004294-14-AT
(EUCTR)
23/03/201814/02/2018Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
485Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Bosnia and Herzegovina;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand
30EUCTR2017-004295-55-SK
(EUCTR)
16/03/201830/01/2018Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2017-004293-33-SK
(EUCTR)
16/03/201830/01/2018Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s DiseaseInduction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3United States;Portugal;Serbia;Hong Kong;Saudi Arabia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;Hungary;Mexico;Canada;Poland;Singapore;Georgia;Bulgaria;Germany;Sweden
32EUCTR2017-004294-14-SK
(EUCTR)
16/03/201830/01/2018Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
485Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand
33EUCTR2017-004294-14-LT
(EUCTR)
12/03/201801/02/2018Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
485Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand
34EUCTR2017-004295-55-LT
(EUCTR)
12/03/201801/02/2018Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand
35EUCTR2017-004293-33-LT
(EUCTR)
12/03/201801/02/2018Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s DiseaseInduction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3United States;Portugal;Serbia;Hong Kong;Saudi Arabia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;Hungary;Mexico;Canada;Poland;Singapore;Georgia;Bulgaria;Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2016-003073-18-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]
Celgene International II SàrlNULLNot Recruiting Female: no
Male: yes
6Phase 1United Kingdom
37EUCTR2015-002025-19-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
38EUCTR2015-002025-19-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
39EUCTR2015-002025-19-HU
(EUCTR)
30/12/201529/10/2015An open-label study to assess improvement in patients with Moderate to Severe Crohn’s Disease taking RPC1063 orally 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]
Celgene International II Sarl (CISII) awholly owned subsidiary of Celgene CorporationNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
60Phase 2United States;Hungary;Canada;Poland;Ukraine
40NCT02531113
(ClinicalTrials.gov)
October 9, 201520/8/2015Efficacy and Safety Trial of RPC1063 for Moderate to Severe Crohn's DiseaseA Phase 2, Multi-Center, Open-Label Induction Trial With Extension Period to Access Endoscopic Improvement and Changes in Intestinal and Serum Biomarkers in Patients With Moderately to Severely Active Crohn's Disease Receiving Oral RPC1063 as Induction TherapyCrohn's DiseaseDrug: RPC1063CelgeneNULLCompleted18 Years75 YearsAll69Phase 2United States;Canada;Hungary;Poland;Ukraine;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41EUCTR2017-004295-55-IE
(EUCTR)
27/04/2018Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLNAFemale: yes
Male: yes
1200Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Bosnia and Herzegovina;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand
42EUCTR2017-004292-31-IE
(EUCTR)
27/04/2018Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s DiseaseInduction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLNAFemale: yes
Male: yes
600Phase 3United States;Belarus;Taiwan;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Puerto Rico;Denmark;Australia;Latvia;China;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Czechia;Turkey;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Japan;New Zealand
43EUCTR2017-004293-33-DE
(EUCTR)
06/02/2018Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s DiseaseInduction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLNAFemale: yes
Male: yes
600Phase 3United States;Portugal;Serbia;Hong Kong;Saudi Arabia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;Hungary;Mexico;Canada;Poland;Singapore;Georgia;Bulgaria;Germany;Sweden
44EUCTR2017-004294-14-IE
(EUCTR)
27/04/2018Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLNAFemale: yes
Male: yes
485Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Bosnia and Herzegovina;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand