Facebook Icon Print Created with Sketch. Twitter Icon Created with Sketch. Created with Sketch. LinkedIn Icon Green Check Icon Created with Sketch. YouTube Icon Right Arrow Icon Mobile Menu Icon Chevron Right Icon Phone Icon Health Study Area: AutoImmune Disease Health Study Area: Blood Cancer Health Study Area: Cardiovascular Disease Health Study Area: Fibrosis Health Study Area: Gastrointestinal Cancer Health Study Area: Genitourinary Health Study Area: Head and Neck Cancer Health Study Area: Lung Cancer Health Study Area: Melanoma Health Study Area: Women's Cancer Health Study Area: Breast Cancer For Caregivers For Clinicians Communities FAQs For Parents For Patients Chevron Icon Bookmark Icon Map Icon Share Icon Direction Arrow Icon Direction Arrow Icon Page Icon Location Icon Search Icon External Link Icon Help Icon Error Icon Glossary Email Icon Gender Both Gender Male Gender Female Created with Sketch. Created with Sketch. Health Study Area: NASH

Please Log In/Join Now first, and then use this function!


Open-Label Extension of RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis - RPC01-3102

Updated: 21 January, 2021   |   ClinicalTrials.gov

Print Friendly Summary

Print this page and the trial guide to help you talk with your doctor.
Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 3


  • Gender(s)

  • 12+

    Age Range

  • 18


  • Recruiting

Treatment Options

Study Arms
Experimental: RPC0163 (Ozanimod)
Drug: RPC1063

Key Eligibility Criteria

Inclusion Criteria: - Aged 18 to 75 years (at screening for Cohorts 1 and 2) - Male of Female adolescent patients aged 12 to < 18 years (at screening) with a body weight > or = 45kg (Cohort 3) - Ulcerative colitis confirmed on endoscopy - Moderately to severely active ulcerative colitis (Mayo score 6-12) - Currently receiving treatment with aminosalicylates, 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 evidenced by: - Physician judgement 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 Crohn's disease, indeterminate colitis, or the presence of a fistula consistent with Crohn's disease 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 known macular edema - Pregnancy, lactation, or a positive serum B-hCG measured during screening

We strongly recommend you contact BMS to report Side Effects (Adverse Events)
Side Effects (Adverse Events) and other reportable events are defined here
Report Side Effects (Adverse Events) or Product Quality Complaints: Medical Information

Have questions? Live support is available 24/7 - Call 855-907-3286 or email clinical.trials@bms.com

Have questions? Live support is available 24/7 -
Call 855-907-3286 or email clinical.trials@bms.com