Trials / Completed
CompletedNCT02531113
Efficacy and Safety Trial of RPC1063 for Moderate to Severe Crohn's Disease
A Phase 2, Multi-Center, Open-Label Induction Trial With Extension Period to Access 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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 69 (actual)
- Sponsor
- Celgene · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose is to determine whether RPC1063 is effective in the treatment of Crohn's disease.
Detailed description
This open-label trial is composed of two periods: Induction and Extension. All eligible patients will be enrolled into the 12-Week Induction period and receive study medication. Patients who complete the Induction period may then be eligible to enter the 100-Week Extension period where they will continue to receive study medication.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | RPC1063 |
Timeline
- Start date
- 2015-10-09
- Primary completion
- 2019-09-12
- Completion
- 2019-11-28
- First posted
- 2015-08-24
- Last updated
- 2021-01-22
- Results posted
- 2020-10-08
Locations
28 sites across 5 countries: United States, Canada, Hungary, Poland, Ukraine
Source: ClinicalTrials.gov record NCT02531113. Inclusion in this directory is not an endorsement.