At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Ozanimod (drug)
- How long the study runs
- Study runs about 122 months (dates as stated)
- About the drug or intervention
- Ozanimod — drug: Specified dose on specified days
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 2 Years to 17 Years
- Who
- All
- Number of participants
- 120
- Started
- 2022-05-30
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for colitis, ulcerative
- • Phase2/Phase3 - 120 participants
- • The purpose of this study is to evaluate the effectiveness and safety of ozanimod (RPC1063) in achieving and maintaining clinical remission
Who can take part?
- • Ages 2 Years to 17 Years
- • Diagnosed with colitis, ulcerative
Where?
- • Birmingham - Birmingham Children's Hospital
- • London - King's College Hospital
- • London - Local Institution - 0105
- • London - Barts Health NHS Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The purpose of this study is to evaluate the effectiveness and safety of ozanimod (RPC1063) in achieving and maintaining clinical remission. Ozanimod will be administered orally to pediatric participants with moderate to severe active ulcerative colitis (UC) who have had an inadequate response to conventional therapy.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 2 Years - 17 Years
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Inclusion Criteria
- ✓Moderately to severely active Ulcerative Colitis (UC) diagnosed prior to the Screening Visit
- ✓Evidence of UC extending beyond the rectum, as determined by baseline endoscopy
- ✓Exclusion Criteria
- ✓Diagnosis of Crohn's disease or indeterminate colitis
See the full criteria
Where Is This Study? (4 UK sites)
Birmingham Children's Hospital
Birmingham B4 6NH, United Kingdom
King's College Hospital
London SE5 9RS, United Kingdom
Local Institution - 0105
London SW10 9NH, United Kingdom
Barts Health NHS Trust
London E1 1BB, United Kingdom
How to Get in Touch
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Sponsor contactCONTACT
First line of the email MUST contain NCT # and Site #.
Sponsor contactCONTACT
