Overview
Safety and Efficacy Trial of RPC1063 for Moderate to Severe Ulcerative Colitis
Status:
Completed
Completed
Trial end date:
2020-06-17
2020-06-17
Target enrollment:
0
0
Participant gender:
All
All
Summary
The purpose of this study is to determine whether RPC1063 is effective in the treatment of Ulcerative Colitis (UC).Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
CelgeneTreatments:
OzanimodCriteria
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