Safety and Efficacy Trial of RPC1063 for Moderate to Severe Ulcerative Colitis
Purpose
The purpose of this study is to determine whether RPC1063 is effective in the treatment of Ulcerative Colitis (UC).
Condition
- Ulcerative Colitis
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Aged 18 to 75 years (at screening for Cohort 1 and 2) - UC confirmed on endoscopy - Moderately to severely active UC (May score 6-12) - Currently receiving treatment with aminosalisylate, prednisone, or budesonide - Can be receiving azathioprine, mercaptopurine, or methotrexate, but treatment will be stopped prior to randomization
Exclusion Criteria
- Have severe extensive colitis as evidence by: - Physician judgment that the patient is likely to require colectomy or ileostomy within 12 weeks of baseline. - Current or recent (within 3 months) evidence of fulminant colitis, toxic megacolon, or bowel perforation. - Diagnosis of CD, indeterminate colitis, or the presence of fistula consistent with CD or microscopic colitis, radiation colitis, or ischemic colitis - Clinically relevant cardiovascular conditions or other relevant diseases that could impact the implementation or interpretation of the trial, or put the patient at risk - History of uveitis or unknown macular edema - Pregnancy, lactation, or a positive serum β-human chorionic gonadotropin (β-hCG) measured during screening
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental RPC1063 (Ozanimod) |
1mg, daily oral administration during Induction and Maintenance periods. |
|
|
Placebo Comparator Placebo |
Daily oral administration during Induction and Maintenance periods. |
|
More Details
- Status
- Completed
- Sponsor
- Celgene
Study Contact
Detailed Description
The trial is composed of 2 periods: Induction and Maintenance. In the Induction Period (IP), patients will be entered into the trial in 2 separate cohorts (Cohort 1 and Cohort 2).Patients from Cohort 1 and 2 in clinical response at the end of the IP will proceed through to the Maintenance Period (MP). Patients from Cohort 1 and 2 who participate in this trial may also qualify to participate in an optional Open-Label Extension (OLE) trial.