0.25 mg RPC1063 ( DrugBank: - )
3 diseases
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 13 | 多発性硬化症／視神経脊髄炎 | 9 |
| 96 | クローン病 | 1 |
| 97 | 潰瘍性大腸炎 | 23 |
13. 多発性硬化症／視神経脊髄炎
臨床試験数 : 3,342 / 薬物数 : 2,355 - (DrugBank : 406) / 標的遺伝子数 : 269 - 標的パスウェイ数 : 241
| 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 | EUCTR2012-002714-40-HR (EUCTR) | 17/10/2014 | 05/11/2014 | A CLINICAL STUDY TO EVALUATE IN A BLINDED AND SCIENTIFIC WAY THE EFFICACY AND SAFETY OF THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS | A PHASE 2/3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED (PART A) AND DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE CONTROLLED (PART B), PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF RPC1063 ADMINISTERED ORALLY TO RELAPSING MULTIPLE SCLEROSIS PATIENTS - Radiance | RELAPSING MULTIPLE SCLEROSIS MedDRA version: 17.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 0.5 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 1 mg RPC1063 INN or Proposed INN: RPC1063 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A | Receptos, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1410 | Phase 2;Phase 3 | Serbia;United States;Belarus;Slovakia;Slovenia;Greece;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Croatia;Georgia;South Africa;Bulgaria;Moldova, Republic of;Bosnia and Herzegovina | ||
| 2 | EUCTR2012-002714-40-SK (EUCTR) | 02/06/2014 | 12/03/2014 | A CLINICAL STUDY TO EVALUATE IN A BLINDED AND SCIENTIFIC WAY THE EFFICACY AND SAFETY OF THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS | A PHASE 2/3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED (PART A) AND DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE CONTROLLED (PART B), PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF RPC1063 ADMINISTERED ORALLY TO RELAPSING MULTIPLE SCLEROSIS PATIENTS - Radiance | RELAPSING MULTIPLE SCLEROSIS MedDRA version: 18.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 0.5 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 1 mg RPC1063 INN or Proposed INN: RPC1063 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 1578 | Phase 2;Phase 3 | Serbia;United States;Belarus;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Hungary;Canada;Poland;Belgium;Romania;Croatia;South Africa;Bulgaria;Georgia;Moldova, Republic of;Bosnia and Herzegovina | ||
| 3 | EUCTR2012-002714-40-GB (EUCTR) | 29/05/2014 | 28/02/2014 | A CLINICAL STUDY TO EVALUATE IN A BLINDED AND SCIENTIFIC WAY THE EFFICACY AND SAFETY OF THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS | A PHASE 2/3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED (PART A) AND DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE CONTROLLED (PART B), PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF RPC1063 ADMINISTERED ORALLY TO RELAPSING MULTIPLE SCLEROSIS PATIENTS - Radiance | RELAPSING MULTIPLE SCLEROSIS MedDRA version: 18.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 0.5 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 1 mg RPC1063 INN or Proposed INN: RPC1063 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 1265 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Belarus;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Hungary;Canada;Poland;Belgium;Romania;Croatia;South Africa;Bulgaria;Georgia;Moldova, Republic of;Bosnia and Herzegovina | ||
| 4 | EUCTR2012-002714-40-ES (EUCTR) | 02/08/2013 | 09/04/2013 | A CLINICAL STUDY TO EVALUATE IN A BLINDED AND SCIENTIFIC WAY THE EFFICACY AND SAFETY OF THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS | A PHASE 2/3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED (PART A) AND DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE CONTROLLED (PART B), PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF RPC1063 ADMINISTERED ORALLY TO RELAPSING MULTIPLE SCLEROSIS PATIENTS - | RELAPSING MULTIPLE SCLEROSIS MedDRA version: 14.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 0.5 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 1 mg RPC1063 INN or Proposed INN: RPC1063 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A | Receptos, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1280 | Phase 2;Phase 3 | Serbia;United States;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Romania;Georgia;Bulgaria;Sweden | ||
| 5 | EUCTR2012-002714-40-GR (EUCTR) | 10/07/2013 | 17/05/2013 | A CLINICAL STUDY TO EVALUATE IN A BLINDED AND SCIENTIFIC WAY THE EFFICACY AND SAFETY OF THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS | A PHASE 2/3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED (PART A) AND DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE CONTROLLED (PART B), PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF RPC1063 ADMINISTERED ORALLY TO RELAPSING MULTIPLE SCLEROSIS PATIENTS | RELAPSING MULTIPLE SCLEROSIS MedDRA version: 16.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 0.5 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 1 mg RPC1063 INN or Proposed INN: RPC1063 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A | Receptos, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1280 | Phase 2;Phase 3 | Serbia;United States;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Romania;Georgia;Bulgaria;Sweden | ||
| 6 | EUCTR2012-002714-40-HU (EUCTR) | 10/06/2013 | 02/05/2013 | A CLINICAL STUDY TO EVALUATE IN A BLINDED AND SCIENTIFIC WAY THE EFFICACY AND SAFETY OF THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS | A PHASE 2/3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED (PART A) AND DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE CONTROLLED (PART B), PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF RPC1063 ADMINISTERED ORALLY TO RELAPSING MULTIPLE SCLEROSIS PATIENTS - Radiance | RELAPSING MULTIPLE SCLEROSIS MedDRA version: 19.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25 mg RPC1063 INN or Proposed INN: Ozanimod Product Name: 0.5 mg RPC1063 INN or Proposed INN: Ozanimod Product Name: 1 mg RPC1063 INN or Proposed INN: Ozanimod Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 1578 | Phase 2;Phase 3 | Serbia;United States;Belarus;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Hungary;Canada;Poland;Belgium;Romania;Croatia;Georgia;South Africa;Bulgaria;Moldova, Republic of;Bosnia and Herzegovina | ||
| 7 | EUCTR2012-002714-40-BG (EUCTR) | 17/05/2013 | 08/05/2013 | A CLINICAL STUDY TO EVALUATE IN A BLINDED AND SCIENTIFIC WAY THE EFFICACY AND SAFETY OF THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS | A PHASE 2/3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED (PART A) AND DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE CONTROLLED (PART B), PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF RPC1063 ADMINISTERED ORALLY TO RELAPSING MULTIPLE SCLEROSIS PATIENTS | RELAPSING MULTIPLE SCLEROSIS MedDRA version: 19.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25 mg RPC1063 INN or Proposed INN: Ozanimod Product Name: 0.5 mg RPC1063 INN or Proposed INN: Ozanimod Product Name: 1 mg RPC1063 INN or Proposed INN: Ozanimod Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 1578 | Phase 2;Phase 3 | Serbia;United States;Belarus;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Croatia;Georgia;Bulgaria;South Africa;Moldova, Republic of;Bosnia and Herzegovina | ||
| 8 | EUCTR2012-002714-40-IT (EUCTR) | 09/05/2013 | 08/03/2013 | A CLINICAL STUDY TO EVALUATE IN A BLINDED AND SCIENTIFIC WAY THE EFFICACY AND SAFETY OF THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS | A PHASE 2/3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED (PART A) AND DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE CONTROLLED (PART B), PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF RPC1063 ADMINISTERED ORALLY TO RELAPSING MULTIPLE SCLEROSIS PATIENTS | RELAPSING MULTIPLE SCLEROSIS MedDRA version: 14.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 0.5 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 1 mg RPC1063 INN or Proposed INN: RPC1063 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A | Receptos, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1280 | Phase 2;Phase 3 | Serbia;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;Hungary;Canada;Belgium;Croatia;Georgia;Bulgaria | ||
| 9 | EUCTR2012-002714-40-BE (EUCTR) | 29/04/2013 | 14/03/2013 | A CLINICAL STUDY TO EVALUATE IN A BLINDED AND SCIENTIFIC WAY THE EFFICACY AND SAFETY OF THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS | A PHASE 2/3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED (PART A) AND DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE CONTROLLED (PART B), PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF RPC1063 ADMINISTERED ORALLY TO RELAPSING MULTIPLE SCLEROSIS PATIENTS - Radiance | RELAPSING MULTIPLE SCLEROSIS MedDRA version: 18.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25 mg RPC1063 INN or Proposed INN: Ozanimod Product Name: 0.5 mg RPC1063 INN or Proposed INN: Ozanimod Product Name: 1 mg RPC1063 INN or Proposed INN: Ozanimod Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 1578 | Phase 2;Phase 3 | Serbia;United States;Belarus;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Croatia;Georgia;South Africa;Bulgaria;Moldova, Republic of;Sweden;Bosnia and Herzegovina |
96. クローン病
臨床試験数 : 2,400 / 薬物数 : 1,391 - (DrugBank : 267) / 標的遺伝子数 : 170 - 標的パスウェイ数 : 215
| 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 | EUCTR2015-002025-19-PL (EUCTR) | 28/01/2016 | 21/12/2015 | An open-label study to assess improvement in patients with Moderate to Severe Crohn’s Disease taking RPC1063 orally | A Phase 2, Multi-Center, Open-Label Induction Trial with Extension Period to Assess Endoscopic Improvement and Changes in Intestinal and Serum Biomarkers in Patients with Moderately to Severely Active Crohn's Disease Receiving Oral RPC1063 as Induction Therapy - Open-Label Endoscopic Improvement Trial of RPC1063 for Moderate to Severe Crohn’s Disease | Moderately to Severely Active Crohn's Disease MedDRA version: 20.1;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10011402;Term: Crohn's disease (colon);Classification code 10011403;Term: Crohn's disease aggravated;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: RPC1063 Product Name: 1mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: RPC1063 | Celgene International II Sàrl (CIS II), a wholly owned subsidiary of Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United States;Hungary;Canada;Poland;Ukraine |
97. 潰瘍性大腸炎
臨床試験数 : 2,527 / 薬物数 : 1,465 - (DrugBank : 259) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202
| 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 | EUCTR2015-001600-64-AT (EUCTR) | 25/07/2018 | 17/04/2018 | The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of long-term RPC1063 in Ulcerative Colitis | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride | Celgene International II Sàrl | NULL | Not Recruiting | 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;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand | ||
| 2 | EUCTR2015-000319-41-GR (EUCTR) | 23/07/2018 | 18/04/2018 | The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Inductionand Maintenance Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of RPC1063 in Ulcerative Colitis | ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Belarus;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand | ||
| 3 | EUCTR2015-001600-64-GR (EUCTR) | 23/07/2018 | 19/04/2018 | The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of long-term RPC1063 in Ulcerative Colitis | ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand | ||
| 4 | EUCTR2015-001600-64-ES (EUCTR) | 12/07/2018 | 21/05/2018 | The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of long-term RPC1063 in Ulcerative Colitis | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride | Celgene International II Sàrl | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Phase 3 | Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand | ||
| 5 | EUCTR2015-001600-64-LV (EUCTR) | 22/06/2018 | 13/04/2018 | The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of long-term RPC1063 in Ulcerative Colitis | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride | 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 | Bulgaria;Croatia;Poland;Belgium;Argentina;Canada;Hungary;Czech Republic;United Kingdom;Austria;Korea, Republic of;Netherlands;Latvia;South Africa;Australia;France;Italy;Israel;Russian Federation;Ukraine;Spain;Greece;Slovakia;United States;Belarus;Germany;New Zealand | ||
| 6 | EUCTR2015-001600-64-HR (EUCTR) | 19/01/2017 | 05/06/2017 | The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of long-term RPC1063 in Ulcerative Colitis | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1350 | Phase 3 | United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand | ||
| 7 | EUCTR2015-001600-64-BG (EUCTR) | 13/10/2016 | 01/10/2015 | The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of long-term RPC1063 in Ulcerative Colitis | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: ZEPOSIA® (ozanimod) Product Name: 0.25 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Trade Name: ZEPOSIA® (ozanimod) Product Name: 1.0 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1350 | Phase 3 | United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand | ||
| 8 | EUCTR2015-001600-64-NL (EUCTR) | 28/04/2016 | 13/10/2015 | The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of long-term RPC1063 in Ulcerative Colitis | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: ZEPOSIA® (ozanimod) Product Name: 0.25 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Trade Name: ZEPOSIA® (ozanimod) Product Name: 1.0 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;New Zealand | ||
| 9 | EUCTR2015-001600-64-IT (EUCTR) | 05/01/2016 | 28/01/2021 | The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 asTherapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of long-term RPC1063 in Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5- yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5- yl)-2-isopropoxybenzonitrile hydrochloride | CELGENE INTERNATIONAL II SàRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1350 | Phase 3 | Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Czechia;Korea, Democratic People's Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand | ||
| 10 | EUCTR2015-001600-64-BE (EUCTR) | 30/11/2015 | 01/03/2016 | The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of long-term RPC1063 in Ulcerative Colitis | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: ZEPOSIA® (ozanimod) Product Name: 0.25 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Trade Name: ZEPOSIA® (ozanimod) Product Name: 1.0 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1350 | Phase 3 | Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand | ||
| 11 | EUCTR2015-001600-64-DE (EUCTR) | 13/11/2015 | 04/08/2015 | The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of long-term RPC1063 in Ulcerative Colitis | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: ZEPOSIA® (ozanimod) Product Name: 0.25 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Trade Name: ZEPOSIA® (ozanimod) Product Name: 1.0 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride | Celgene International II Sàrl (CIS II) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1350 | Phase 3 | Belarus;United States;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Czechia;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand | ||
| 12 | EUCTR2015-001600-64-CZ (EUCTR) | 14/10/2015 | 31/07/2015 | The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of long-term RPC1063 in Ulcerative Colitis | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1350 | Phase 3 | Belarus;United States;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Czechia;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand | ||
| 13 | EUCTR2015-001600-64-SK (EUCTR) | 13/10/2015 | 27/08/2015 | The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of long-term RPC1063 in Ulcerative Colitis | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: ZEPOSIA® (ozanimod) Product Name: 0.25 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Trade Name: ZEPOSIA® (ozanimod) Product Name: 1.0 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1350 | Phase 3 | United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;Australia;South Africa;Djibouti;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand | ||
| 14 | EUCTR2015-001600-64-HU (EUCTR) | 12/10/2015 | 01/09/2015 | The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of long-term RPC1063 in Ulcerative Colitis | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride | Celgene International II Sárl (CIS II) | 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 | Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;New Zealand | ||
| 15 | EUCTR2015-001600-64-GB (EUCTR) | 28/09/2015 | 06/08/2015 | The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis (Clinical Study”) - Efficacy and Safety Study of long-term RPC1063 in Ulcerative Colitis | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxyben Product Name: 1.0 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxyben | Celgene International II Sàrl | NULL | Not Recruiting | Female: yes Male: yes | 1350 | Phase 3 | United States;Belarus;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand | ||
| 16 | EUCTR2012-003123-38-NL (EUCTR) | 29/10/2013 | 27/05/2013 | A CLINICAL EFFICACY AND SAFETY STUDY TO EVALUATE IN A BLINDED WAY THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS | A PHASE 2, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PARALLEL-GROUP STUDY TO EVALUATE THE CLINICAL EFFICACY AND SAFETY OF INDUCTION THERAPY WITH RPC1063 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS | Moderately to severely active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 0.5 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 1 mg RPC1063 INN or Proposed INN: RPC1063 | Celgene International II Sàrl (CIS II). | NULL | Not Recruiting | Female: yes Male: yes | 86 | Phase 2 | United States;Hungary;Slovakia;Greece;Poland;Belgium;Ukraine;Russian Federation;Israel;Bulgaria;Netherlands;Korea, Republic of | ||
| 17 | EUCTR2012-003123-38-GR (EUCTR) | 25/06/2013 | 10/05/2013 | A CLINICAL EFFICACY AND SAFETY STUDY TO EVALUATE IN A BLINDED WAY THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS | A PHASE 2, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PARALLEL-GROUP STUDY TO EVALUATE THE CLINICAL EFFICACY AND SAFETY OF INDUCTION THERAPY WITH RPC1063 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS | Moderately to severely active Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 0.5 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 1 mg RPC1063 INN or Proposed INN: RPC1063 | Receptos, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Slovakia;Greece;Russian Federation;Israel;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Bulgaria;Netherlands;Germany;New Zealand;Korea, Republic of | ||
| 18 | EUCTR2012-003123-38-BG (EUCTR) | 24/04/2013 | 05/03/2013 | A CLINICAL EFFICACY AND SAFETY STUDY TO EVALUATE IN A BLINDED WAY THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS | A PHASE 2, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PARALLEL-GROUP STUDY TO EVALUATE THE CLINICAL EFFICACY AND SAFETY OF INDUCTION THERAPY WITH RPC1063 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS | Moderately to severely active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 0.5 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 1 mg RPC1063 INN or Proposed INN: RPC1063 | Celgene International II Sàrl (CIS II). | NULL | Not Recruiting | Female: yes Male: yes | 86 | Phase 2 | United States;Hungary;Slovakia;Greece;Poland;Belgium;Ukraine;Russian Federation;Israel;Bulgaria;Netherlands;Korea, Republic of | ||
| 19 | EUCTR2012-003123-38-HU (EUCTR) | 12/02/2013 | 04/12/2012 | A CLINICAL EFFICACY AND SAFETY STUDY TO EVALUATE IN A BLINDED WAY THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS | A PHASE 2, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PARALLEL-GROUP STUDY TO EVALUATE THE CLINICAL EFFICACY AND SAFETY OF INDUCTION THERAPY WITH RPC1063 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS | Moderately to severely active Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 0.5 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 1 mg RPC1063 INN or Proposed INN: RPC1063 | Celgene International II Sàrl (CIS II). | NULL | Not Recruiting | Female: yes Male: yes | 113 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Hungary;Slovakia;Greece;Poland;Belgium;Ukraine;Russian Federation;Israel;Bulgaria;Netherlands;Korea, Republic of | ||
| 20 | EUCTR2012-003123-38-PL (EUCTR) | 10/02/2013 | 15/01/2013 | A CLINICAL EFFICACY AND SAFETY STUDY TO EVALUATE IN A BLINDED WAY THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS | A PHASE 2, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PARALLEL-GROUP STUDY TO EVALUATE THE CLINICAL EFFICACY AND SAFETY OF INDUCTION THERAPY WITH RPC1063 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS | Moderately to severely active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 0.5 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 1 mg RPC1063 INN or Proposed INN: RPC1063 | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 86 | Phase 2 | United States;Slovakia;Greece;Ukraine;Israel;Russian Federation;Czech Republic;Hungary;Poland;Belgium;Bulgaria;Netherlands;Korea, Republic of | ||
| 21 | EUCTR2012-003123-38-SK (EUCTR) | 28/01/2013 | 04/03/2013 | A CLINICAL EFFICACY AND SAFETY STUDY TO EVALUATE IN A BLINDED WAY THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS | A PHASE 2, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PARALLEL-GROUP STUDY TO EVALUATE THE CLINICAL EFFICACY AND SAFETY OF INDUCTION THERAPY WITH RPC1063 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS | Moderately to severely active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 0.5 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 1 mg RPC1063 INN or Proposed INN: RPC1063 | Celgene International II Sàrl (CIS II). | NULL | Not Recruiting | Female: yes Male: yes | 86 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Hungary;Slovakia;Greece;Poland;Belgium;Ukraine;Russian Federation;Israel;Bulgaria;Netherlands;Korea, Republic of | ||
| 22 | EUCTR2012-003123-38-BE (EUCTR) | 11/12/2012 | 10/10/2012 | A CLINICAL EFFICACY AND SAFETY STUDY TO EVALUATE IN A BLINDED WAY THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS | A PHASE 2, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PARALLEL-GROUP STUDY TO EVALUATE THE CLINICAL EFFICACY AND SAFETY OF INDUCTION THERAPY WITH RPC1063 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS | Moderately to severely active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 0.5 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 1 mg RPC1063 INN or Proposed INN: RPC1063 | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 86 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Hungary;Slovakia;Greece;Poland;Belgium;Ukraine;Russian Federation;Israel;Bulgaria;Netherlands;Korea, Republic of | ||
| 23 | EUCTR2015-001600-64-PL (EUCTR) | 03/12/2015 | The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of long-term RPC1063 in Ulcerative Colitis | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride | Celgene International II Sàrl (CIS II) | NULL | NA | Female: yes Male: yes | 1350 | Phase 3 | Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Korea, Republic of;Slovenia;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;New Zealand |