96. クローン病 Crohn disease Clinical trials / Disease details
臨床試験数 : 2,442 / 薬物数 : 1,278 - (DrugBank : 248) / 標的遺伝子数 : 142 - 標的パスウェイ数 : 209
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2017-004294-14-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 | ||
| 2 | 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 |