WHO ICTRP trial
An open-label study to assess improvement in patients with Moderate to Severe…
EUCTR2015-002025-19-PL · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2015-002025-19-PL |
|---|---|
| Public title | An open-label study to assess improvement in patients with Moderate to Severe Crohn’s Disease taking RPC1063 orally |
| Scientific title | 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… |
| Primary sponsor | Celgene International II Sàrl (CIS II), a wholly owned subsidiary of Celgene Corporation |
| Registry | EU Clinical Trials Register |
| Recruitment status | Not Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no |
| Countries | United States;Hungary;Canada;Poland;Ukraine |
| Conditions | 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 Level: LLT Classification code 10011402… |
| Interventions | Product Name: 0.25 mg RPC1063 Product Code: RPC1063 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Ozanimod CAS Number: 1306760-87-1 Other descriptive name: RPC1063 Concentration unit: mg milligram(s) Concentration type: equal… |
| Registration date | Dec 21, 2015 |
| Target size | 60 |
| Secondary IDs | RPC01-2201;NCT02531113;126,740;2015-002025-19-HU |
| Registry page | clinicaltrialsregister.eu |
At a glance
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: