96. クローン病 Crohn disease Clinical trials / Disease details
臨床試験数 : 2,442 / 薬物数 : 1,278 - (DrugBank : 248) / 標的遺伝子数 : 142 - 標的パスウェイ数 : 209
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2017-004294-14-FR (EUCTR) | 02/12/2019 | 09/02/2018 | Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease | A 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 Sàrl | NULL | Authorised-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): no | 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;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 | ||
| 2 | EUCTR2017-004293-33-FR (EUCTR) | 12/11/2019 | 09/02/2018 | Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease | Induction 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 Sàrl | NULL | Authorised-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): no | Serbia;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 | ||
| 3 | EUCTR2017-004292-31-FR (EUCTR) | 05/11/2019 | 09/08/2019 | Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease | Induction 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 Sàrl | NULL | Authorised-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): no | Belarus;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 | ||
| 4 | EUCTR2017-004295-55-FR (EUCTR) | 08/10/2019 | 09/02/2018 | Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease | A 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 Sàrl | NULL | Authorised-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): no | 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;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 | ||
| 5 | EUCTR2017-004294-14-RO (EUCTR) | 11/04/2019 | 12/05/2022 | Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease | A 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 Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 485 | Phase 3 | Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Bosnia and Herzegovina;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;Germany;Norway;New Zealand;Japan | ||
| 6 | EUCTR2017-004295-55-PT (EUCTR) | 04/02/2019 | 01/10/2018 | Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease | A 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 Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | Portugal;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 | ||
| 7 | EUCTR2017-004292-31-RO (EUCTR) | 04/02/2019 | 25/02/2022 | Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease | Induction 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 Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | United 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 | ||
| 8 | EUCTR2017-004295-55-BE (EUCTR) | 13/12/2018 | 30/03/2018 | Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease | A 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 Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | 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;Japan;New Zealand | ||
| 9 | EUCTR2017-004294-14-DK (EUCTR) | 30/11/2018 | 27/08/2018 | Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease | A 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 Sàrl | NULL | Not 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): no | 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;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 | ||
| 10 | EUCTR2017-004295-55-DK (EUCTR) | 30/11/2018 | 27/08/2018 | Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease | A 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 Sàrl | NULL | Not 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): no | 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;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 | ||
| 11 | EUCTR2017-004295-55-SI (EUCTR) | 06/11/2018 | 13/02/2018 | Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease | A 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 Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | 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;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;New Zealand;Japan | ||
| 12 | EUCTR2017-004294-14-SI (EUCTR) | 06/11/2018 | 13/02/2018 | Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease | A 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 Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 485 | Phase 3 | Argentina;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 | ||
| 13 | EUCTR2017-004293-33-SI (EUCTR) | 06/11/2018 | 12/02/2018 | Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease | Induction 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 Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | Portugal;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 | ||
| 14 | EUCTR2017-004294-14-PT (EUCTR) | 29/10/2018 | 16/07/2018 | Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn¿s Disease | A 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 Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 485 | Phase 3 | Portugal;Belarus;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 | ||
| 15 | EUCTR2017-004294-14-NL (EUCTR) | 22/10/2018 | 12/03/2018 | Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease | A 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 Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 485 | Phase 3 | Belarus;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 | ||
| 16 | EUCTR2017-004293-33-NL (EUCTR) | 22/10/2018 | 12/03/2018 | Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease | Induction 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 Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | United 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 | ||
| 17 | EUCTR2017-004295-55-NL (EUCTR) | 22/10/2018 | 12/03/2018 | Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease | A 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 Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | Belarus;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 | ||
| 18 | EUCTR2017-004295-55-FI (EUCTR) | 10/10/2018 | 31/07/2018 | Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease | A 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 Sàrl | NULL | Authorised-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): no | 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;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 | ||
| 19 | EUCTR2017-004293-33-FI (EUCTR) | 10/10/2018 | 30/07/2018 | Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease | Induction 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 Sàrl | NULL | Authorised-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): no | Serbia;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 | ||
| 20 | EUCTR2017-004294-14-FI (EUCTR) | 10/10/2018 | 30/07/2018 | Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease | A 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 Sàrl | NULL | Authorised-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): no | 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;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 | ||
| 21 | EUCTR2017-004295-55-DE (EUCTR) | 21/09/2018 | 21/02/2018 | Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease | A 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 Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | 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;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;New Zealand;Japan | ||
| 22 | EUCTR2017-004294-14-BE (EUCTR) | 20/09/2018 | 28/03/2018 | Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease | A 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 Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 485 | Phase 3 | 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;Japan;New Zealand | ||
| 23 | EUCTR2017-004295-55-IE (EUCTR) | 10/09/2018 | 27/04/2018 | Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease | A 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 Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | 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;Korea, Republic of;Bosnia and Herzegovina;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland | ||
| 24 | EUCTR2017-004292-31-IE (EUCTR) | 10/09/2018 | 27/04/2018 | Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease | Induction 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 Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | Israel;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 | ||
| 25 | EUCTR2017-004292-31-BE (EUCTR) | 10/09/2018 | 23/03/2018 | Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease | Induction 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 Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | United 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 | ||
| 26 | EUCTR2017-004294-14-IE (EUCTR) | 10/09/2018 | 27/04/2018 | Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease | A 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 Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 485 | Phase 3 | Japan;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 | ||
| 27 | EUCTR2017-004292-31-DE (EUCTR) | 06/09/2018 | 06/02/2018 | Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease | Induction 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 Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | United 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 | ||
| 28 | EUCTR2017-004294-14-DE (EUCTR) | 23/08/2018 | 20/02/2018 | Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease | A 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 Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 485 | Phase 3 | 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;Japan;New Zealand | ||
| 29 | EUCTR2017-004295-55-SE (EUCTR) | 08/08/2018 | 08/03/2018 | Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease | A 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 Sàrl | NULL | Authorised-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): no | 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;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 | ||
| 30 | EUCTR2017-004294-14-SE (EUCTR) | 08/08/2018 | 08/03/2018 | Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease | A 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 Sàrl | NULL | Authorised-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): no | 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;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 | ||
| 31 | EUCTR2017-004293-33-PT (EUCTR) | 06/08/2018 | 27/03/2018 | Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn¿s Disease | Induction 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 Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | United 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 | ||
| 32 | EUCTR2017-004294-14-GB (EUCTR) | 13/07/2018 | 26/06/2018 | Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease | A 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 Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 485 | Phase 3 | Belarus;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 | ||
| 33 | EUCTR2017-004292-31-GB (EUCTR) | 13/07/2018 | 26/06/2018 | Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease | Induction 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 Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | United 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 | ||
| 34 | EUCTR2017-004292-31-DK (EUCTR) | 09/07/2018 | 09/04/2018 | Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease | Induction 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 Sàrl | NULL | Not 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): no | Belarus;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 | ||
| 35 | EUCTR2017-004295-55-HR (EUCTR) | 19/06/2018 | 07/12/2018 | Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease | A 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 Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | 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;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;New Zealand;Japan | ||
| 36 | EUCTR2017-004294-14-HR (EUCTR) | 18/06/2018 | 07/12/2018 | Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease | A 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 Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 485 | Phase 3 | 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;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;New Zealand;Japan | ||
| 37 | EUCTR2017-004292-31-HR (EUCTR) | 18/06/2018 | 07/12/2018 | Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease | Induction 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 Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | Belarus;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 | ||
| 38 | EUCTR2017-004295-55-BG (EUCTR) | 06/06/2018 | 20/02/2018 | Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease | A 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 Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Bosnia and Herzegovina;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;Germany;Norway;Japan;New Zealand | ||
| 39 | EUCTR2017-004292-31-BG (EUCTR) | 06/06/2018 | 20/02/2018 | Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease | Induction 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 Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | United States;Belarus;Taiwan;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Puerto Rico;Denmark;Australia;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 | ||
| 40 | EUCTR2017-004293-33-BG (EUCTR) | 06/06/2018 | 20/02/2018 | Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease | Induction 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 Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | Serbia;United States;Portugal;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 | ||
| 41 | EUCTR2017-004294-14-BG (EUCTR) | 06/06/2018 | 20/02/2018 | Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease | A 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 Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 485 | Phase 3 | Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Bosnia and Herzegovina;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;Germany;Norway;Japan;New Zealand | ||
| 42 | EUCTR2017-004295-55-ES (EUCTR) | 23/05/2018 | 01/03/2018 | Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease | A 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 Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | 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;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 | ||
| 43 | EUCTR2017-004293-33-SE (EUCTR) | 23/05/2018 | 08/03/2018 | Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease | Induction 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 Sàrl | NULL | Not Recruiting | Female: yes Male: yes | 675 | Phase 3 | Russian Federation;Singapore;Hong Kong;United States;Portugal;Greece;Saudi Arabia;Sweden;Austria;Netherlands;China;Korea, Republic of;Poland;Slovakia;Slovenia;Bulgaria;France;Lithuania;Serbia;Hungary;Ukraine;Spain;Canada;Turkey;Finland;Mexico;Georgia;Israel;Australia;Germany;South Africa | ||
| 44 | EUCTR2017-004292-31-LV (EUCTR) | 21/05/2018 | 31/01/2018 | Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease | Induction 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 Sàrl | NULL | Authorised-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): no | Belarus;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 | ||
| 45 | EUCTR2017-004295-55-LV (EUCTR) | 21/05/2018 | 31/01/2018 | Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease | A 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 Sàrl | NULL | Authorised-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): no | 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;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 | ||
| 46 | EUCTR2017-004294-14-LV (EUCTR) | 21/05/2018 | 31/01/2018 | Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease | A 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 Sàrl | NULL | Authorised-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): no | 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;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 | ||
| 47 | EUCTR2017-004295-55-GB (EUCTR) | 18/05/2018 | 27/06/2018 | Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease | A 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 Sàrl | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Phase 3 | Belarus;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 | ||
| 48 | EUCTR2017-004292-31-ES (EUCTR) | 10/05/2018 | 23/02/2018 | Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease | Induction 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 Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | Belarus;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 | ||
| 49 | EUCTR2017-004292-31-CZ (EUCTR) | 03/05/2018 | 31/01/2018 | Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease | Induction 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 Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | United 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 | ||
| 50 | EUCTR2017-004294-14-CZ (EUCTR) | 03/05/2018 | 01/02/2018 | Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease | A 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 Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 485 | Phase 3 | Belarus;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 | ||
| 51 | EUCTR2017-004294-14-GR (EUCTR) | 27/04/2018 | 28/02/2018 | Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease | A 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 Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 485 | Phase 3 | 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;Japan;New Zealand | ||
| 52 | EUCTR2017-004293-33-GR (EUCTR) | 27/04/2018 | 28/02/2018 | Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease | Induction 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 Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | United 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 | ||
| 53 | EUCTR2017-004295-55-GR (EUCTR) | 27/04/2018 | 01/03/2018 | Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease | A 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 Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | 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;Japan;New Zealand | ||
| 54 | EUCTR2017-004292-31-PL (EUCTR) | 26/04/2018 | 20/04/2018 | Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease | Induction 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 Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | Belarus;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 | ||
| 55 | EUCTR2017-004295-55-PL (EUCTR) | 26/04/2018 | 20/03/2018 | Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease | A 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 Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | 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;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 | ||
| 56 | EUCTR2017-004293-33-PL (EUCTR) | 26/04/2018 | 19/03/2018 | Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease | Induction 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 Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | Singapore;Bulgaria;Georgia;Serbia;United States;Portugal;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;Germany;Sweden | ||
| 57 | EUCTR2017-004294-14-PL (EUCTR) | 26/04/2018 | 20/03/2018 | Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease | A 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 Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 485 | Phase 3 | 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;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 | ||
| 58 | EUCTR2017-004294-14-ES (EUCTR) | 25/04/2018 | 02/03/2018 | Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease | A 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 Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 485 | Phase 3 | 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;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 | ||
| 59 | EUCTR2017-004293-33-ES (EUCTR) | 25/04/2018 | 02/03/2018 | Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease | Induction 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 Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | Serbia;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 | ||
| 60 | EUCTR2017-004295-55-AT (EUCTR) | 23/03/2018 | 14/02/2018 | Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease | A 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 Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Bosnia and Herzegovina;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;Germany;Norway;Japan;New Zealand | ||
| 61 | EUCTR2017-004293-33-AT (EUCTR) | 23/03/2018 | 14/02/2018 | Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease | Induction 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 Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | Serbia;United States;Portugal;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 | ||
| 62 | EUCTR2017-004294-14-AT (EUCTR) | 23/03/2018 | 14/02/2018 | Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease | A 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 Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 485 | Phase 3 | Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Bosnia and Herzegovina;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;Germany;Norway;Japan;New Zealand | ||
| 63 | EUCTR2017-004295-55-SK (EUCTR) | 16/03/2018 | 30/01/2018 | Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease | A 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 Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | 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;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 | ||
| 64 | EUCTR2017-004294-14-SK (EUCTR) | 16/03/2018 | 30/01/2018 | Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease | A 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 Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 485 | Phase 3 | 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;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 | ||
| 65 | EUCTR2017-004293-33-SK (EUCTR) | 16/03/2018 | 30/01/2018 | Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease | Induction 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 Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | Portugal;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 | ||
| 66 | EUCTR2017-004295-55-LT (EUCTR) | 12/03/2018 | 01/02/2018 | Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease | A 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 Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | 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;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;New Zealand;Japan | ||
| 67 | EUCTR2017-004293-33-LT (EUCTR) | 12/03/2018 | 01/02/2018 | Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease | Induction 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 Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | Portugal;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 | ||
| 68 | EUCTR2017-004294-14-LT (EUCTR) | 12/03/2018 | 01/02/2018 | Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease | A 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 Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 485 | Phase 3 | 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;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;New Zealand;Japan | ||
| 69 | EUCTR2017-004295-55-HU (EUCTR) | 08/03/2018 | 30/01/2018 | Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease | A 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 Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | Belarus;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 | ||
| 70 | EUCTR2017-004293-33-HU (EUCTR) | 06/03/2018 | 29/01/2018 | Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease | Induction 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 Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | United 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 | ||
| 71 | EUCTR2017-004294-14-HU (EUCTR) | 06/03/2018 | 30/01/2018 | Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease | A 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 Sàrl | NULL | Authorised-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): no | 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;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 | ||
| 72 | EUCTR2017-004293-33-DE (EUCTR) | 06/02/2018 | Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease | Induction 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 Sàrl | NULL | NA | Female: yes Male: yes | 600 | Phase 3 | Netherlands;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 | |||
| 73 | EUCTR2017-004295-55-CZ (EUCTR) | 05/02/2018 | Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease | A 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 Sàrl | NULL | NA | Female: yes Male: yes | 1200 | Phase 3 | Belarus;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 |