OZANIMOD ( DrugBank: Ozanimod )
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 | 36 |
| 96 | クローン病 | 85 |
| 97 | 潰瘍性大腸炎 | 39 |
13. 多発性硬化症／視神経脊髄炎
臨床試験数 : 3,340 / 薬物数 : 2,163 - (DrugBank : 383) / 標的遺伝子数 : 241 - 標的パスウェイ数 : 238
| 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 | NCT05319093 (ClinicalTrials.gov) | April 2022 | 1/4/2022 | Observational Study of the Effect of Ozanimod on Fatigue in Multiple Sclerosis Patients | Observational Study of the Effect of Ozanimod on Fatigue in Multiple Sclerosis Patients | Fatigue;Multiple Sclerosis | Drug: Ozanimod | Brigham and Women's Hospital | Bristol-Myers Squibb | Not yet recruiting | 18 Years | N/A | All | 40 | NULL | |
| 2 | NCT05028634 (ClinicalTrials.gov) | October 27, 2021 | 25/8/2021 | Safety Study to Evaluate Immune Response of Vaccines in Participants With Relapsing Forms of Multiple Sclerosis Who Receive Ozanimod Compared to Non-Pegylated Interferon (IFN)-ß or No Disease Modifying Therapy | A Phase 3b, Multicenter, Open-label Study to Evaluate the Immune Response to, and the Safety of, Vaccines in Participants With Relapsing Forms of Multiple Sclerosis Who Receive Oral Ozanimod Compared to Non-pegylated Interferon (IFN)-ß or No Disease Modifying Therapy | Multiple Sclerosis;Multiple Sclerosis, Relapsing-Remitting | Biological: Tetanus, diphtheria, and acellular pertussis vaccine;Biological: Pneumococcal polysaccharide vaccine;Biological: Seasonal influenza vaccine | Celgene | NULL | Recruiting | 18 Years | 65 Years | All | 60 | Phase 3 | United States;Germany |
| 3 | NCT04140305 (ClinicalTrials.gov) | January 16, 2020 | 24/10/2019 | Study Describing Cognitive Processing Speed Changes in Relapsing Multiple Sclerosis Subjects Treated With Ozanimod (RPC-1063) | A Multicenter, Longitudinal, Open-Label, Single-Arm Study Describing Cognitive Processing Speed Changes in Relapsing Multiple Sclerosis Subjects Treated With Ozanimod (RPC-1063) | Multiple Sclerosis | Drug: RPC-1063 | Celgene | NULL | Active, not recruiting | 18 Years | 65 Years | All | 250 | Phase 3 | United States;Canada;Puerto Rico |
| 4 | EUCTR2015-002500-91-SE (EUCTR) | 01/06/2017 | 27/06/2016 | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study | Relapsing Multiple Sclerosis MedDRA version: 20.0;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: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCl Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCl | Celgene International II Sàrl (CIS II) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2495 | Phase 3 | Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden;United States;Belarus;Portugal;Serbia | ||
| 5 | EUCTR2016-003073-18-GB (EUCTR) | 29/09/2016 | 16/09/2016 | A study designed to investigate how radiolabelled RPC1063 is taken up, broken down and removed from the body | A Phase I, Single-Centre, Single Dose Oral Excretion Balance Study of [14C]-RPC1063 in Healthy Male Adults - ADME study of [14C]-RPC1063 in healthy male subjects (QCL117686) | The drug is a potential treatment for adult patients with relapsing multiple sclerosis (RMS) and for adult patients with moderately to severely active inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn’s disease (CD). MedDRA version: 19.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 19.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: [14C]-RPC1063 Solution (0.1 mg/mL) for Oral Administration INN or Proposed INN: Ozanimod hydrochloride | Celgene International II Sàrl | NULL | Not Recruiting | Female: no Male: yes | 6 | Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 6 | EUCTR2015-002500-91-HR (EUCTR) | 13/06/2016 | 06/07/2016 | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study | Relapsing Multiple Sclerosis MedDRA version: 20.0;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: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCl Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCl | Celgene International II Sàrl (CIS II) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2496 | Phase 3 | United States;Belarus;Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden | ||
| 7 | EUCTR2015-002500-91-PT (EUCTR) | 06/06/2016 | 13/04/2016 | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis. - Open Label Extension (OLE) study | Relapsing Multiple Sclerosis MedDRA version: 20.0;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: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCI Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCI | Celgene International II Sàrl (CIS II) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2496 | Phase 3 | United States;Belarus;Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden | ||
| 8 | EUCTR2015-002500-91-LT (EUCTR) | 31/05/2016 | 17/03/2016 | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study | Relapsing Multiple Sclerosis MedDRA version: 20.0;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: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCl Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCl | Celgene International II Sàrl (CIS II) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2495 | Phase 3 | United States;Serbia;Belarus;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Belgium;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden | ||
| 9 | EUCTR2015-002500-91-LV (EUCTR) | 20/04/2016 | 19/02/2016 | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study | Relapsing Multiple Sclerosis MedDRA version: 20.0;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: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCl Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCl | Celgene International II Sàrl (CIS II) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2495 | Phase 3 | United States;Serbia;Belarus;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Belgium;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden | ||
| 10 | EUCTR2015-002500-91-EE (EUCTR) | 04/04/2016 | 07/03/2016 | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study | Relapsing Multiple Sclerosis MedDRA version: 20.0;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: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCl Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCl | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 2495 | Phase 3 | United States;Belarus;Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden | ||
| 11 | EUCTR2015-002500-91-IT (EUCTR) | 09/02/2016 | 22/01/2021 | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study | Relapsing Multiple Sclerosis MedDRA version: 20.0;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: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCL Product Name: 1.0mg RPC1063 Product Code: RPC1063 | CELGENE INTERNATIONAL II SàRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2496 | Phase 3 | United States;Serbia;Belarus;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Mexico;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden | ||
| 12 | EUCTR2015-002500-91-SK (EUCTR) | 22/01/2016 | 28/10/2015 | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study | Relapsing Multiple Sclerosis MedDRA version: 20.0;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: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCl Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCl | Celgene International II Sàrl (CIS II) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2496 | Phase 3 | United States;Serbia;Belarus;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;Peru;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Belgium;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;New Zealand;Sweden | ||
| 13 | EUCTR2015-002500-91-PL (EUCTR) | 20/01/2016 | 01/12/2015 | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study | Relapsing Multiple Sclerosis MedDRA version: 20.0;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: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCl Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCl | Celgene International II Sàrl (CIS II) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2496 | Phase 3 | United States;Serbia;Belarus;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Colombia;Italy;Peru;South Africa;Latvia;Netherlands;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden | ||
| 14 | EUCTR2015-002500-91-BG (EUCTR) | 13/01/2016 | 20/10/2015 | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study | Relapsing Multiple Sclerosis MedDRA version: 20.0;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: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCl Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCl | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 2496 | Phase 3 | Sweden;United States;Serbia;Belarus;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;Peru;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Belgium;Poland;Romania;Croatia;Georgia;Bulgaria;Germany;New Zealand | ||
| 15 | EUCTR2015-002500-91-ES (EUCTR) | 24/11/2015 | 05/10/2015 | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study | Relapsing Multiple Sclerosis MedDRA version: 18.0;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: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod | Receptos, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2350 | Serbia;Portugal;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Colombia;Italy;Peru;South Africa;Netherlands;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;New Zealand;Sweden | |||
| 16 | EUCTR2015-002500-91-GR (EUCTR) | 18/11/2015 | 04/11/2015 | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study | Relapsing Multiple Sclerosis MedDRA version: 20.0;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: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCI Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCI | Celgene International II Sàrl (CIS II) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2496 | Phase 3 | United States;Belarus;Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;New Zealand;Sweden | ||
| 17 | EUCTR2015-002500-91-GB (EUCTR) | 10/11/2015 | 18/09/2015 | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study | Relapsing Multiple Sclerosis MedDRA version: 20.0;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: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 2496 | Phase 3 | United States;Belarus;Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Mexico;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden | ||
| 18 | EUCTR2015-002500-91-BE (EUCTR) | 10/11/2015 | 02/09/2015 | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study | Relapsing Multiple Sclerosis MedDRA version: 20.0;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: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCl Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCl | Celgene International II Sàrl (CIS II) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2496 | Phase 3 | United States;Serbia;Belarus;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Belgium;Poland;Romania;Croatia;Georgia;Bulgaria;Germany;New Zealand;Sweden | ||
| 19 | EUCTR2015-002500-91-HU (EUCTR) | 12/10/2015 | 26/08/2015 | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study | Relapsing Multiple Sclerosis MedDRA version: 20.0;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: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod | Celgene International II Sàrl (CIS II) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2496 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Belgium;Serbia;Belarus;United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden | ||
| 20 | EUCTR2014-002320-27-NL (EUCTR) | 15/09/2015 | 08/01/2015 | 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 3, multi-center, randomized, Double-Blind, double-dummy, active controlled, parallel group study to evaluate the efficacy and safety of RPC1063 administered orally to relapsing multiple sclerosis patients. | 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: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: RPC1063 Product Name: 0.5mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: RPC1063 Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: RPC1063 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Interferon beta-1a Other descriptive name: INTERFERON BETA-1A | Receptos, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Phase 3 | Serbia;Portugal;Belarus;United States;Estonia;Spain;Ukraine;Russian Federation;Colombia;Switzerland;Peru;South Africa;Netherlands;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden | ||
| 21 | EUCTR2014-002320-27-HR (EUCTR) | 27/07/2015 | 01/10/2015 | 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 3, multi-center, randomized, Double-Blind, double-dummy, active controlled, parallel group study to evaluate the efficacy and safety of RPC1063 administered orally to relapsing multiple sclerosis patients. | 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: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Product Name: 0.5mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Interferon beta-1a Other descriptive name: INTERFERON BETA-1A | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 1346 | Phase 3 | Serbia;Belarus;United States;Portugal;Estonia;Spain;Ukraine;Russian Federation;Switzerland;Latvia;Netherlands;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden | ||
| 22 | EUCTR2014-002320-27-GB (EUCTR) | 22/07/2015 | 17/06/2015 | 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 3, multi-center, randomized, Double-Blind, double-dummy, active controlled, parallel group study to evaluate the efficacy and safety of RPC1063 administered orally to relapsing multiple sclerosis patients. | 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: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Product Name: 0.5mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Product Name: 1.0mg RPC1063 Product Code: 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 | 1200 | Phase 3 | Serbia;Portugal;Belarus;United States;Estonia;Spain;Ukraine;Russian Federation;Colombia;Switzerland;Peru;South Africa;Netherlands;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;New Zealand;Sweden | ||
| 23 | EUCTR2014-002320-27-HU (EUCTR) | 03/07/2015 | 11/05/2015 | A Phase 3, multi-center, randomized, Double-Blind, double-dummy, active controlled, parallel group study to evaluate the efficacy and safety of RPC1063 administered orally to relapsing multiple sclerosis patients. | A Phase 3, multi-center, randomized, Double-Blind, double-dummy, active controlled, parallel group study to evaluate the efficacy and safety of RPC1063 administered orally to relapsing multiple sclerosis patients. | 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: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Product Name: 0.5mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Interferon beta-1a Other descriptive name: INTERFERON BETA-1A | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 1346 | Phase 3 | Belarus;Portugal;Serbia;United States;Estonia;Spain;Ukraine;Russian Federation;Switzerland;Netherlands;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden | ||
| 24 | EUCTR2014-002320-27-LT (EUCTR) | 09/06/2015 | 17/04/2015 | 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 3, multi-center, randomized, Double-Blind, double-dummy, active controlled, parallel group study to evaluate the efficacy and safety of RPC1063 administered orally to relapsing multiple sclerosis patients. | 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: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: RPC1063 Product Name: 0.5mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: RPC1063 Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: RPC1063 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Interferon beta-1a Other descriptive name: INTERFERON BETA-1A | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 1346 | Phase 3 | Serbia;Belarus;United States;Portugal;Estonia;Spain;Ukraine;Russian Federation;Switzerland;Latvia;Netherlands;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden | ||
| 25 | EUCTR2014-002320-27-ES (EUCTR) | 21/04/2015 | 09/02/2015 | 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 3, multi-center, randomized, Double-Blind, double-dummy, active controlled, parallel group study to evaluate the efficacy and safety of RPC1063 administered orally to relapsing multiple sclerosis patients. - Sunbeam | Relapsing Multiple Sclerosis MedDRA version: 18.0;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: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Product Name: 0.5mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Interferon beta-1a Other descriptive name: INTERFERON BETA-1A | Receptos, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Phase 3 | Serbia;Portugal;Belarus;United States;Estonia;Spain;Ukraine;Russian Federation;Colombia;Switzerland;Peru;South Africa;Latvia;Netherlands;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden | ||
| 26 | EUCTR2014-002320-27-BG (EUCTR) | 19/03/2015 | 21/01/2015 | 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 3, multi-center, randomized, Double-Blind, double-dummy, active controlled, parallel group study to evaluate the efficacy and safety of RPC1063 administered orally to relapsing multiple sclerosis patients. | 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: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: RPC1063 Product Name: 0.5mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Interferon beta-1a Other descriptive name: INTERFERON BETA-1A | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 1346 | Phase 3 | Serbia;Portugal;Belarus;United States;Estonia;Spain;Ukraine;Russian Federation;Switzerland;South Africa;Latvia;Netherlands;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;New Zealand;Sweden | ||
| 27 | EUCTR2014-002320-27-PL (EUCTR) | 01/03/2015 | 27/01/2015 | 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 3, multi-center, randomized, Double-Blind, double-dummy, active controlled, 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: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: SUB175614 Product Name: 0.5mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: SUB175614 Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: SUB175614 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Interferon beta-1a Other descriptive name: INTERFERON BETA-1A | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 1346 | Phase 3 | Belarus;United States;Portugal;Serbia;Estonia;Spain;Ukraine;Russian Federation;Switzerland;Netherlands;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden | ||
| 28 | EUCTR2014-002320-27-SE (EUCTR) | 12/02/2015 | 08/12/2014 | 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 3, multi-center, randomized, Double-Blind, double-dummy, active controlled, parallel group study to evaluate the efficacy and safety of RPC1063 administered orally to relapsing multiple sclerosis patients. | 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: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Product Name: 0.5mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Interferon beta-1a Other descriptive name: INTERFERON BETA-1A | Receptos, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Phase 3 | Serbia;Portugal;Belarus;United States;Estonia;Spain;Ukraine;Russian Federation;Colombia;Switzerland;Peru;South Africa;Latvia;Netherlands;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden | ||
| 29 | EUCTR2014-002320-27-LV (EUCTR) | 23/01/2015 | 30/10/2014 | 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 3, multi-center, randomized, Double-Blind, double-dummy, active controlled, parallel group study to evaluate the efficacy and safety of RPC1063 administered orally to relapsing multiple sclerosis patients. | 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: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Product Name: 0.5mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Product Name: 1.0mg RPC1063 Product Code: 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 | 1346 | Phase 3 | Belarus;United States;Portugal;Serbia;Estonia;Spain;Ukraine;Russian Federation;Switzerland;South Africa;Latvia;Netherlands;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Canada;Brazil;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden | ||
| 30 | NCT02294058 (ClinicalTrials.gov) | December 3, 2014 | 5/8/2014 | Study of Ozanimod (RPC1063) in Relapsing Multiple Sclerosis (MS) | A Phase 3, Multi-Center, Randomized, Double-Blind, Double-Dummy, Active Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of RPC1063 Administered Orally To Relapsing Multiple Sclerosis Patients | Multiple Sclerosis | Drug: Ozanimod;Drug: Interferon beta-1a;Drug: Placebo to ozanimod;Drug: Placebo to interferon beta-1a | Celgene | NULL | Completed | 18 Years | 55 Years | All | 1346 | Phase 3 | United States;Belarus;Bosnia and Herzegovina;Bulgaria;Canada;Croatia;Czechia;Estonia;Georgia;Germany;Hungary;Latvia;Lithuania;Moldova, Republic of;Netherlands;New Zealand;Poland;Portugal;Romania;Russian Federation;Serbia;Spain;Sweden;Ukraine;United Kingdom;Argentina;Austria;Colombia;Czech Republic;Mexico;Peru |
| 31 | EUCTR2014-002320-27-PT (EUCTR) | 21/11/2014 | 08/10/2014 | 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 3, multi-center, randomized, Double-Blind, double-dummy, active controlled, 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: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Product Name: 0.5mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Interferon beta-1a Other descriptive name: INTERFERON BETA-1A | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 1346 | Phase 3 | Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden;Estonia;Spain;Ukraine;Russian Federation;Switzerland;Peru;Netherlands;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Serbia;Belarus;United States;Portugal | ||
| 32 | EUCTR2014-002320-27-EE (EUCTR) | 21/11/2014 | 08/10/2014 | 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 3, multi-center, randomized, Double-Blind, double-dummy, active controlled, parallel group study to evaluate the efficacy and safety of RPC1063 administered orally to relapsing multiple sclerosis patients. | 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: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: RPC1063 Product Name: 0.5mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: RPC1063 Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: 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 | 1346 | Phase 3 | United States;Belarus;Portugal;Serbia;Estonia;Spain;Ukraine;Russian Federation;Switzerland;South Africa;Latvia;Netherlands;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Brazil;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden | ||
| 33 | NCT02047734 (ClinicalTrials.gov) | December 3, 2013 | 26/1/2014 | Efficacy and Safety Study of Ozanimod in Relapsing Multiple Sclerosis (Radiance Study) | 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 | Drug: Ozanimod 0.5 mg;Drug: Ozanimod 1 mg;Drug: Ozanimod placebo;Drug: Interferon ß-1a;Drug: IFN ß-1a placebo | Celgene | NULL | Completed | 18 Years | 55 Years | All | 1320 | Phase 3 | United States;Belarus;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Croatia;Georgia;Greece;Hungary;Italy;Moldova, Republic of;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Ukraine;United Kingdom |
| 34 | 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 | ||
| 35 | 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 | ||
| 36 | 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 : 2,442 / 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 | NCT05470985 (ClinicalTrials.gov) | March 10, 2023 | 12/7/2022 | A Study to Evaluate the Efficacy, Safety, and Drug Levels of Oral Ozanimod in Pediatric Participants With Moderately to Severely Active Crohn's Disease With an Inadequate Response to Conventional Therapy | A Phase 2/3, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Oral Ozanimod (RPC1063) in Pediatric Participants With Moderately to Severely Active Crohn's Disease With an Inadequate Response to Conventional Therapy | Crohn Disease | Drug: Ozanimod | Bristol-Myers Squibb | NULL | Recruiting | 2 Years | 17 Years | All | 120 | Phase 2/Phase 3 | United States;Australia;Belgium;Canada;Hungary;Poland;Spain;United Kingdom |
| 2 | 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 | ||
| 3 | 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 | ||
| 4 | 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 | ||
| 5 | 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 | ||
| 6 | 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 | ||
| 7 | 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 | ||
| 8 | 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 | ||
| 9 | 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 | ||
| 10 | 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 | ||
| 11 | 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 | ||
| 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 | EUCTR2017-004295-55-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 | ||
| 15 | 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 | ||
| 16 | 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 | ||
| 17 | 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 | ||
| 18 | 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 | ||
| 19 | 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 | ||
| 20 | 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 | ||
| 21 | 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 | ||
| 22 | 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 | ||
| 23 | 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 | ||
| 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 | EUCTR2017-004294-14-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 | ||
| 26 | 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 | ||
| 27 | 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 | ||
| 28 | 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 | ||
| 29 | NCT03467958 (ClinicalTrials.gov) | August 24, 2018 | 12/3/2018 | An Extension Study of Oral Ozanimod for 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 | Crohn Disease | Drug: Ozanimod | Celgene | NULL | Recruiting | 18 Years | 75 Years | All | 1200 | Phase 3 | United States;Argentina;Australia;Austria;Belarus;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Chile;China;Colombia;Croatia;Czechia;Denmark;Finland;France;Georgia;Germany;Greece;Hong Kong;Hungary;Ireland;Israel;Italy;Korea, Republic of;Latvia;Lithuania;Mexico;Moldova, Republic of;Netherlands;Poland;Portugal;Romania;Russian Federation;Saudi Arabia;Senegal;Serbia;Slovakia;Slovenia;South Africa;Spain;Sweden;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;Brazil;Norway |
| 30 | 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 | ||
| 31 | 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 | ||
| 32 | 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 | ||
| 33 | 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 | ||
| 34 | 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 | ||
| 35 | 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 | ||
| 36 | EUCTR2017-004295-55-IT (EUCTR) | 12/07/2018 | 22/01/2021 | 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 - Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: [RPC1063] INN or Proposed INN: Ozanimod Product Name: ozanimod Product Code: [RPC1063 equiv to ozanimod HCI] INN or Proposed INN: Ozanimod | CELGENE INTERNATIONAL II SàRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1350 | 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 | ||
| 37 | EUCTR2017-004294-14-IT (EUCTR) | 11/07/2018 | 14/06/2021 | 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 - Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Ac | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Ozanimod Product Code: [RPC1063 equiv. to ozanimod HCI] INN or Proposed INN: Ozanimod hydrochloride Other descriptive name: ozanimod Product Name: ozanimod Product Code: [RPC1063] Other descriptive name: Ozanimod | CELGENE INTERNATIONAL II 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 | ||
| 38 | 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 | ||
| 39 | NCT03464097 (ClinicalTrials.gov) | June 27, 2018 | 26/2/2018 | A Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for 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 | Crohn Disease | Drug: Ozanimod;Other: Placebo | Celgene | NULL | Recruiting | 18 Years | 75 Years | All | 485 | Phase 3 | United States;Argentina;Australia;Austria;Belarus;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Chile;China;Colombia;Croatia;Czechia;Denmark;Finland;France;Georgia;Germany;Greece;Hong Kong;Hungary;Ireland;Israel;Italy;Korea, Republic of;Latvia;Lithuania;Mexico;Moldova, Republic of;Netherlands;Poland;Portugal;Romania;Russian Federation;Saudi Arabia;Senegal;Serbia;Slovakia;Slovenia;South Africa;Spain;Sweden;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;Brazil;Norway |
| 40 | 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 | ||
| 41 | 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 | ||
| 42 | 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 | ||
| 43 | 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 | ||
| 44 | 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 | ||
| 45 | 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 | ||
| 46 | 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 | ||
| 47 | 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 | ||
| 48 | 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 | ||
| 49 | 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 | ||
| 50 | 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 | ||
| 51 | 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 | ||
| 52 | 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 | ||
| 53 | 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 | ||
| 54 | EUCTR2017-004292-31-IT (EUCTR) | 08/05/2018 | 02/02/2021 | 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 - Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Acti | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: [RPC1063] INN or Proposed INN: Ozanimod Product Name: ozanimod Product Code: [RPC1063] INN or Proposed INN: Ozanimod | CELGENE INTERNATIONAL II SàRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 675 | 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 | ||
| 55 | 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 | ||
| 56 | 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 | ||
| 57 | 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 | ||
| 58 | 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 | ||
| 59 | 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 | ||
| 60 | 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 | ||
| 61 | 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 | ||
| 62 | 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 | ||
| 63 | 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 | ||
| 64 | 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 | ||
| 65 | 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 | ||
| 66 | 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 | ||
| 67 | 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 | ||
| 68 | 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 | ||
| 69 | 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 | ||
| 70 | 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 | ||
| 71 | 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 | ||
| 72 | 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 | ||
| 73 | 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 | ||
| 74 | 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 | ||
| 75 | 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 | ||
| 76 | NCT03440385 (ClinicalTrials.gov) | March 7, 2018 | 14/2/2018 | Induction Study #2 of Oral Ozanimod as Induction Therapy for 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 | Crohn Disease | Drug: Ozanimod;Other: Placebo | Celgene | NULL | Recruiting | 18 Years | 75 Years | All | 600 | Phase 3 | United States;Australia;Austria;Bulgaria;Canada;China;Colombia;Finland;France;Georgia;Germany;Greece;Hong Kong;Hungary;Israel;Korea, Republic of;Lithuania;Netherlands;Poland;Portugal;Russian Federation;Senegal;Serbia;Slovakia;Slovenia;South Africa;Spain;Sweden;Taiwan;Turkey;Ukraine;Brazil |
| 77 | 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 | ||
| 78 | 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 | ||
| 79 | NCT03440372 (ClinicalTrials.gov) | February 27, 2018 | 14/2/2018 | Induction Study #1 of Oral Ozanimod as Induction Therapy for 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 | Crohn Disease | Drug: Ozanimod;Other: Placebo | Celgene | NULL | Recruiting | 18 Years | 75 Years | All | 600 | Phase 3 | United States;Argentina;Australia;Belarus;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Chile;Croatia;Czechia;Denmark;Finland;France;Germany;Ireland;Israel;Italy;Korea, Republic of;Latvia;Mexico;Moldova, Republic of;Poland;Romania;Russian Federation;Saudi Arabia;Spain;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;Brazil;Norway |
| 80 | EUCTR2016-003073-18-GB (EUCTR) | 29/09/2016 | 16/09/2016 | A study designed to investigate how radiolabelled RPC1063 is taken up, broken down and removed from the body | A Phase I, Single-Centre, Single Dose Oral Excretion Balance Study of [14C]-RPC1063 in Healthy Male Adults - ADME study of [14C]-RPC1063 in healthy male subjects (QCL117686) | The drug is a potential treatment for adult patients with relapsing multiple sclerosis (RMS) and for adult patients with moderately to severely active inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn’s disease (CD). MedDRA version: 19.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 19.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: [14C]-RPC1063 Solution (0.1 mg/mL) for Oral Administration INN or Proposed INN: Ozanimod hydrochloride | Celgene International II Sàrl | NULL | Not Recruiting | Female: no Male: yes | 6 | Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 81 | EUCTR2015-002025-19-IT (EUCTR) | 17/05/2016 | 05/11/2020 | 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);System Organ Class: 100000004856 MedDRA version: 22.1;Classification code 10011403;Term: Crohn's disease aggravated;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: RPC1063 Product Code: [RPC1063] INN or Proposed INN: Ozanimod Product Name: RPC0163 Product Code: [RPC0163] INN or Proposed INN: Ozanimod | CELGENE INTERNATIONAL II SàRL | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United States;Hungary;Canada;Poland;Ukraine;Italy | ||
| 82 | 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 | ||
| 83 | EUCTR2015-002025-19-HU (EUCTR) | 30/12/2015 | 29/10/2015 | 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 | A Phase 2, Multi-Center, Open-Label Induction Trial with Extension Period to Assess Endoscopic Improvement and Changes in Intestinal and Serum Biomarkers in Patients with Moderately to Severely Active Crohn's Disease Receiving Oral RPC1063 as Induction Therapy - Open-Label Endoscopic Improvement Trial of RPC1063 for Moderate to Severe Crohn’s Disease | Moderately to Severely Active Crohn's Disease MedDRA version: 20.1;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10011402;Term: Crohn's disease (colon);Classification code 10011403;Term: Crohn's disease aggravated;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0,25 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: RPC1063 Product Name: 1mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: RPC1063 | Celgene International II Sarl (CISII) awholly owned subsidiary of Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United States;Hungary;Canada;Poland;Ukraine;Italy | ||
| 84 | 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 | |||
| 85 | 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 |
97. 潰瘍性大腸炎
臨床試験数 : 2,630 / 薬物数 : 1,459 - (DrugBank : 265) / 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 | NCT05702879 (ClinicalTrials.gov) | April 1, 2023 | 18/1/2023 | Combined Microbiota and Metabolic Signature in Ulcerative Colitis Predicts Anti-Inflammatory Therapy Success | An Early Combined Microbiota and Metabolic Signature in Ulcerative Colitis Patients Predict the Clinical Success of Anti-inflammatory Therapy | Ulcerative Colitis | Drug: Ozanimod;Drug: TNF Inhibitor;Drug: Steroids;Drug: Vedolizumab;Drug: Ustekinumab | University Hospital Inselspital, Berne | Bristol-Myers Squibb | Not yet recruiting | 18 Years | 80 Years | All | 240 | NULL | |
| 2 | NCT05369832 (ClinicalTrials.gov) | December 16, 2022 | 6/5/2022 | An Open-label Study of Ozanimod in Moderate to Severe Ulcerative Colitis in Clinical Practice | A Phase 4, Prospective, Open-label Study of Ozanimod to Explore the Safety, Efficacy, Quality of Life, and Biomarker Response in Participants With Moderate to Severe Ulcerative Colitis in Clinical Practice | Colitis, Ulcerative | Drug: Ozanimod | Bristol-Myers Squibb | NULL | Recruiting | 18 Years | N/A | All | 415 | Phase 4 | United States;Puerto Rico |
| 3 | NCT05644665 (ClinicalTrials.gov) | December 9, 2022 | 1/12/2022 | A Study to Evaluate Efficacy and Long-term Safety of Oral Ozanimod in Chinese Participants With Moderately to Severely Active Ulcerative Colitis (UC) | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of Oral Ozanimod to Evaluate Efficacy and Long-term Safety in Chinese Participants With Moderately to Severely Active Ulcerative Colitis (UC) | Ulcerative Colitis | Drug: Ozanimod;Drug: Placebo | Bristol-Myers Squibb | NULL | Recruiting | 18 Years | 75 Years | All | 240 | Phase 3 | China;Taiwan |
| 4 | EUCTR2021-002308-11-ES (EUCTR) | 21/07/2022 | 21/07/2022 | A phase 2/3, multicenter, randomized, double-blind study to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of oral ozanimod (RPC1063) in pediatric subjects with moderately to severely active ulcerative colitis with an inadequate response to conventional therapy. | A phase 2/3, multicenter, randomized, double-blind study to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of oral ozanimod (RPC1063) in pediatric subjects with moderately to severely active ulcerative colitis with an inadequate response to conventional therapy. | 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: Ozanimod HCL Product Code: RPC1063 INN or Proposed INN: Ozanimod HCL Other descriptive name: RPC1063 Product Name: Ozanimod HCL Product Code: RPC1063 INN or Proposed INN: Ozanimod HCL Other descriptive name: RPC1063 Product Name: Ozanimod HCL Product Code: RPC1063 INN or Proposed INN: Ozanimod HCL Other descriptive name: RPC1063 | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 2;Phase 3 | France;United States;Canada;Belgium;Poland;Spain;Russian Federation;Israel;Germany;Netherlands;United Kingdom;Japan | ||
| 5 | JPRN-jRCT2021220013 | 01/07/2022 | 18/06/2022 | A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis | A Phase 2/3, Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Oral Ozanimod (RPC1063) in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis with an Inadequate Response to Conventional Therapy | Ulcerative Colitis (UC) | Ozanimod High Dose Ozanimod Low Dose | Liu W. Jerry | NULL | Pending | >= 2age old | <= 17age old | Both | 120 | Phase 2-3 | France;United States;Japan |
| 6 | NCT05076175 (ClinicalTrials.gov) | May 30, 2022 | 4/10/2021 | A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis | A Phase 2/3, Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Oral Ozanimod (RPC1063) in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis With an Inadequate Response to Conventional Therapy | Colitis, Ulcerative | Drug: Ozanimod | Bristol-Myers Squibb | NULL | Recruiting | 2 Years | 17 Years | All | 120 | Phase 2/Phase 3 | United States;Belgium;France;Germany;Israel;Japan;Poland;Russian Federation;Spain;United Kingdom |
| 7 | NCT03915769 (ClinicalTrials.gov) | June 3, 2019 | 12/4/2019 | To Evaluate Efficacy and Long-term Safety of Ozanimod in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis | A Phase 2/3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of Oral Ozanimod to Evaluate Efficacy and Long-term Safety in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis | Colitis, Ulcerative | Drug: Ozanimod;Other: Placebo | Celgene | NULL | Active, not recruiting | 18 Years | 75 Years | All | 195 | Phase 3 | Japan |
| 8 | 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 | ||
| 9 | 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 | ||
| 10 | 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 | ||
| 11 | 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 | ||
| 12 | EUCTR2015-000319-41-ES (EUCTR) | 12/07/2018 | 21/05/2018 | 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 Induction and 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: 0.25mg 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 | France;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand | ||
| 13 | 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 | 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 | ||
| 14 | EUCTR2015-000319-41-LV (EUCTR) | 22/06/2018 | 13/04/2018 | 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: 0.25mg RPC103 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 RPC103 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 | ||
| 15 | EUCTR2015-000319-41-AT (EUCTR) | 25/05/2018 | 17/04/2018 | 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 Induction and 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: 0.25mg RPC103 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 RPC103 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 | ||
| 16 | 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 | ||
| 17 | EUCTR2015-000319-41-HR (EUCTR) | 17/01/2017 | 05/06/2017 | 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: 0.25mg RPC103 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 RPC103 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;Serbia;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 | ||
| 18 | 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 | ||
| 19 | EUCTR2016-003073-18-GB (EUCTR) | 29/09/2016 | 16/09/2016 | A study designed to investigate how radiolabelled RPC1063 is taken up, broken down and removed from the body | A Phase I, Single-Centre, Single Dose Oral Excretion Balance Study of [14C]-RPC1063 in Healthy Male Adults - ADME study of [14C]-RPC1063 in healthy male subjects (QCL117686) | The drug is a potential treatment for adult patients with relapsing multiple sclerosis (RMS) and for adult patients with moderately to severely active inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn’s disease (CD). MedDRA version: 19.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 19.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: [14C]-RPC1063 Solution (0.1 mg/mL) for Oral Administration INN or Proposed INN: Ozanimod hydrochloride | Celgene International II Sàrl | NULL | Not Recruiting | Female: no Male: yes | 6 | Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 20 | 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 | ||
| 21 | EUCTR2015-000319-41-NL (EUCTR) | 26/01/2016 | 01/07/2015 | 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: 0.25mg RPC103 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 RPC103 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 | 1050 | 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;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand | ||
| 22 | 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 | ||
| 23 | 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 | ||
| 24 | EUCTR2015-000319-41-IT (EUCTR) | 19/11/2015 | 29/01/2021 | 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 Induction and 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 RPC103 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 RPC103 Product Code: RPC1063 INN or Proposed INN: NA 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 | 900 | Phase 3 | United States;Belarus;Slovakia;Greece;Spain;Ukraine;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 | ||
| 25 | 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 | ||
| 26 | EUCTR2015-000319-41-SK (EUCTR) | 22/10/2015 | 04/06/2015 | 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 Induction and 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: 0.25mg RPC103 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 RPC103 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 | 1050 | 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;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;New Zealand | ||
| 27 | 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 | United States;Belarus;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Germany;New Zealand | ||
| 28 | 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 | ||
| 29 | 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 | ||
| 30 | EUCTR2015-000319-41-BE (EUCTR) | 06/10/2015 | 24/07/2015 | 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: 0.25mg RPC103 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 RPC103 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;Serbia;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 | ||
| 31 | 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 | ||
| 32 | EUCTR2015-000319-41-DE (EUCTR) | 18/09/2015 | 02/06/2015 | 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: 0.25mg RPC103 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 RPC103 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 | 1050 | Phase 3 | Belarus;United States;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand | ||
| 33 | EUCTR2015-000319-41-CZ (EUCTR) | 14/09/2015 | 16/06/2015 | 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: 0.25mg RPC103 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 RPC103 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 | Belarus;United States;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand | ||
| 34 | EUCTR2015-000319-41-GB (EUCTR) | 10/08/2015 | 13/07/2015 | 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: 0.25mg RPC103 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 RPC103 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 | 900 | Phase 3 | Belarus;United States;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand | ||
| 35 | EUCTR2015-000319-41-HU (EUCTR) | 10/08/2015 | 05/06/2015 | 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: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25mg RPC103 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 RPC103 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 | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | Belarus;United States;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand | ||
| 36 | NCT01647516 (ClinicalTrials.gov) | December 26, 2012 | 19/7/2012 | Efficacy and Safety Study of Ozanimod in 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 | Ulcerative Colitis | Drug: Ozanimod;Drug: Placebo | Celgene | NULL | Completed | 18 Years | 73 Years | All | 199 | Phase 2 | United States;Australia;Belgium;Bulgaria;Canada;Greece;Hungary;Israel;Korea, Republic of;Netherlands;New Zealand;Poland;Russian Federation;Slovakia;Ukraine |
| 37 | 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 | |||
| 38 | EUCTR2015-000319-41-PL (EUCTR) | 16/09/2015 | 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: 0.25mg RPC103 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 RPC103 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;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Slovenia;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand | |||
| 39 | EUCTR2015-000319-41-BG (EUCTR) | 12/08/2015 | 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: 0.25mg RPC103 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 RPC103 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 | 1050 | Phase 3 | Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Romania;Croatia;Bulgaria;Georgia;Germany;New Zealand |