Colitis, Ulcerative
Oral Ozanimod for Children With Moderate to Severe Active Ulcerative Colitis
This Phase 2/3 study is investigating the effectiveness, safety, and body processing of two oral ozanimod dose levels in participants ages 2 to 17 with moderate to severe active ulcerative colitis and an inadequate response to conventional therapy.
Registry title: A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis
18 recruiting U.S. sites ↓Study at a glance
- Age
- 2 Years–17 Years
- Treatment
- Ozanimod
- Design
- Randomized · Quadruple
- Central study contact
- BMS Clinical Trials Contact Center www.BMSClinicalTrials.com855-907-3286Clinical.Trials@bms.com
- Sponsor
- Bristol-Myers Squibb
Research question
Can oral ozanimod achieve and maintain clinical remission, with an acceptable safety profile, in children and adolescents with moderate to severe active ulcerative colitis that has not responded adequately to conventional therapy?
Participant snapshot
Who the study is looking for
- The study is looking for children and adolescents ages 2 through 17.
- Participants must have moderately to severely active ulcerative colitis diagnosed before the screening visit.
- Ulcerative colitis must extend beyond the rectum, as determined by baseline endoscopy.
- Participants must have had an inadequate response, lost response, or been unable to tolerate at least one listed ulcerative colitis treatment.
Participation overview
What participation may involve
Participants receive oral ozanimod in either a high-dose or low-dose group and undergo assessments of remission, disease response, safety, drug exposure, and absolute lymphocyte count. What participation may involve: - Take oral ozanimod at the study-specified dose on specified days. - Undergo assessments of clinical response, clinical remission, and symptoms at reported study time points. - Undergo endoscopic assessment, including a baseline endoscopy used to confirm disease extending beyond the rectum. - Be monitored for adverse events, including serious events, events leading to treatment discontinuation, and events of special interest. - Provide samples for measurement of ozanimod exposure and absolute lymphocyte count.
Study interventions
What participants may receive or do
- Ozanimod: Ozanimod, also called RPC1063, is taken by mouth at a specified dose on specified days. The registry lists separate high-dose and low-dose study groups but does not provide the dose amounts.
Study design
How the comparison works
This is a Phase 2/3 interventional treatment study in which an estimated 120 participants are assigned in parallel to a high-dose or low-dose ozanimod group. Participants are assigned randomly between the study groups; the registry does not report the allocation ratio. The study uses quadruple masking: participants, care providers, investigators, and outcome assessors are masked to treatment assignment. The registry lists two experimental groups receiving different ozanimod dose levels, allowing the researchers to compare the high-dose and low-dose groups. No placebo or sham intervention is listed; both registry arms receive ozanimod.
Reported activities
Procedures and tests
- Baseline endoscopy is used to determine whether ulcerative colitis extends beyond the rectum.
- Endoscopic improvement is assessed at Weeks 10 and 52.
- Clinical remission is assessed at Weeks 10 and 52.
- Clinical response and symptomatic remission are assessed at reported study time points.
- Safety monitoring includes adverse events, serious adverse events, events causing treatment discontinuation, and events of special interest.
- Ozanimod and CC112273 systemic exposure is measured at Week 18 and at other times through up to 70 weeks.
- Absolute lymphocyte count is measured for absolute and percentage changes from baseline.
- Screening may involve confirming the absence of toxin-producing Clostridium difficile through a toxin test or stool polymerase chain reaction test.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- Ulcerative colitis must be moderately to severely active and diagnosed before the screening visit.
- Baseline endoscopy must show that ulcerative colitis extends beyond the rectum.
- There must have been an inadequate response, loss of response, or intolerance to at least one of these ulcerative colitis treatments: oral aminosalicylates, systemic corticosteroids, immunomodulators, or biologic therapy.
- The registry age range is 2 through 17 years.
Possible reasons someone may not be able to join
- A diagnosis of Crohn's disease or indeterminate colitis is exclusionary.
- Documentation of a positive test for toxin-producing Clostridium difficile, or a positive stool polymerase chain reaction examination, is exclusionary.
- Apheresis within two weeks before randomization is exclusionary.
- A history of, or currently active, primary or secondary immunodeficiency is exclusionary.
- A known genetic disorder that causes colitis is exclusionary.
- Additional protocol-defined eligibility criteria apply but are not listed in the registry record.
Important unknowns
What the record does not make clear
- The registry reports several assessment time points but does not provide the number, frequency, length, or format of study visits.
- Outcome time frames extend as far as six years, but the registry does not clearly state how long each participant remains in the study.
- The registry does not explain which current ulcerative colitis medicines may continue during the study.
- Apart from the two-week restriction on apheresis, medication washout requirements are not reported.
- The registry does not describe rescue treatment if ulcerative colitis worsens during the study.
- A baseline endoscopy and endoscopic assessments at Weeks 10 and 52 are referenced, but preparation, sedation, biopsy requirements, and whether additional endoscopies may occur are not described.
- The registry does not state which study-related or routine-care costs are paid by the sponsor or billed to insurance.
- Compensation or reimbursement is not described.
- The registry lists study locations but does not describe travel or lodging support.
- The registry does not say whether any visits or assessments may be completed remotely.
- The registry does not describe access to ozanimod after study treatment ends.
- The study is recruiting overall, but individual locations have recruiting, not-yet-recruiting, completed, and withdrawn statuses.
- The registry identifies high-dose and low-dose groups but does not report the dose amounts, dosing schedule, allocation ratio, or rules for dose changes.
Before contacting the site
Questions for the study team
- What are the complete protocol-defined inclusion and exclusion criteria that are not shown in the registry?
- What are the full visit schedule and expected time commitments for the participant and caregiver?
- How long does each participant receive ozanimod and remain in follow-up?
- What are the exact high and low ozanimod doses, how are they scheduled, and what is the chance of assignment to each group?
- Which current ulcerative colitis treatments can continue, and are any washout periods required?
- How many endoscopies, blood draws, stool tests, and other sample collections are required?
- What happens if ulcerative colitis worsens, including available rescue treatment and rules for stopping study treatment?
- Which costs are covered, and are compensation, travel reimbursement, or lodging assistance available?
Before changing care
Questions for your gastroenterologist
- Would changing or pausing any current ulcerative colitis treatment create concerns about disease stability?
- How stable is the child's ulcerative colitis now, and what signs would make trial screening or participation medically inappropriate to consider?
- What approved treatment alternatives are available now, and how do their known monitoring needs compare with what this study requires?
- Are there clinical concerns about ozanimod, repeated endoscopy, lymphocyte monitoring, or the study's long follow-up in this child's specific medical context?
- How should the gastroenterology team and research team coordinate routine care, laboratory monitoring, flares, and urgent decisions?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
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.
Study design and administration
- Organization
- Bristol-Myers Squibb
- Organization class
- Industry
- Organization study ID
- IM047-001
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor class
- Industry
- Enrollment type
- Estimated
- Allocation
- Randomized
- Intervention model
- Parallel
- Primary purpose
- Treatment
- Masking
- Quadruple
- Who is masked
- Participant, Care Provider, Investigator, Outcomes Assessor
- Standard age groups
- Child
Study arms
Experimental
Ozanimod High Dose
Interventions: Drug: Ozanimod
Experimental
Ozanimod Low Dose
Interventions: Drug: Ozanimod
Interventions
Drug
Ozanimod
Specified dose on specified days
Eligibility
2 Years–17 Years
All
Not accepted
Inclusion criteria (3)
- Moderately to severely active Ulcerative Colitis (UC) diagnosed prior to the Screening VisitRegistry-derived · unreviewed
- Evidence of UC extending beyond the rectum, as determined by baseline endoscopyRegistry-derived · unreviewed
- Has had an inadequate response, loss of response to, or is intolerant to at least 1 of the following treatments for UC: oral aminosalicylates, systemic corticosteroids, immunomodulators, biologic therapyRegistry-derived · unreviewed
Exclusion criteria (4)
- Diagnosis of Crohn's disease or indeterminate colitisRegistry-derived · unreviewed
- Has documentation of positive test for toxin producing Clostridium difficile, or polymerase chain reaction examination of the stoolRegistry-derived · unreviewed
- Apheresis within 2 weeks of randomizationRegistry-derived · unreviewed
- History of or currently active primary or secondary immunodeficiency, or participants with known genetic disorders as a cause for colitisRegistry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
Proportion of participants who achieve clinical remission
Time frame: At Week 52
Secondary outcome
Proportion of participants who achieve clinical remission
Time frame: At Week 10
Secondary outcome
Proportion of participants who achieve clinical response
Time frame: At Week 52
Secondary outcome
Proportion of participants who achieve clinical response
Time frame: At Week 10
Secondary outcome
Proportion of participants who achieve symptomatic remission
Time frame: At Week 10 and Week 52
Secondary outcome
Time to achievement of symptomatic remission
Time frame: Up to 6 years
Secondary outcome
Proportion of participants who achieve endoscopic improvement
Time frame: At Week 10 and Week 52
Secondary outcome
Proportion of participants who achieve corticosteroid free remission
Time frame: At Week 52
Secondary outcome
Incidence of Adverse Events (AEs)
Time frame: Up to 6 years
Secondary outcome
Incidence of Serious Adverse Events
Time frame: Up to 6 years
Secondary outcome
Incidence of AEs leading to discontinuation from treatment
Time frame: Up to 6 years
Secondary outcome
Incidence of AEs of special interest (AESIs)
Time frame: Up to 6 years
Secondary outcome
Steady state systemic exposure of ozanimod and CC112273
Time frame: At Week 18 and throughout the study, up to 70 weeks
Secondary outcome
Absolute change from baseline in Absolute Lymphocyte Count (ALC)
Time frame: Up to 6 years
Secondary outcome
Percent change from baseline in ALC
Time frame: Up to 6 years
Recruiting locations in the United States
Loma Linda University Health System
RecruitingLoma Linda, California, 92354, United States
Kalyan Ray Parashette, Site 0087505-274-0704
Cedars-Sinai Medical Center
RecruitingLos Angeles, California, 90048, United States
Shervin Rabizadeh, Site 0074310-423-7100
Lucile Packard Children's Hospital
Not Yet RecruitingPalo Alto, California, 94304, United States
Jonathan Moses, Site 0080650-721-2250
University of California Davis Health
RecruitingSacramento, California, 95817, United States
Trinh Truong, Site 0096310-597-1251
Local Institution - 0101
Not Yet RecruitingPark Ridge, Illinois, 60068, United States
Site 0101
Local Institution - 0100
Not Yet RecruitingIndianapolis, Indiana, 46202, United States
Site 0100
Maine Medical Partners
Not Yet RecruitingPortland, Maine, 04102, United States
Noah Hoffman, Site 0090207-662-5522
Boston Children's Hospital
RecruitingBoston, Massachusetts, 02115, United States
Athos Bousvaros, Site 0005617-699-1021
University of Massachusetts Chan Medical School
RecruitingWorcester, Massachusetts, 01655, United States
Basavaraj Kerur, Site 0095774-441-8082
Mayo Clinic in Rochester, Minnesota
RecruitingRochester, Minnesota, 55905, United States
Michael Stephens, Site 0070111111
Washington University
RecruitingSt Louis, Missouri, 63110, United States
Charles Samson, Site 0053513-518-8949
Columbia University Medical Center
RecruitingNew York, New York, 10032, United States
JOSEPH PICORARO, Site 0040212-305-5903
Local Institution - 0099
Not Yet RecruitingCharleston, South Carolina, 29425, United States
Site 0099
Local Institution - 0103
Not Yet RecruitingFort Worth, Texas, 76104, United States
Site 0103
Texas Children's Hospital
RecruitingHouston, Texas, 77030, United States
Lina Karam, Site 0067832-822-3612
Seattle Children's Hospital
RecruitingSeattle, Washington, 98105, United States
Ghassan Wahbeh, Site 0060111111
MultiCare Health System
RecruitingTacoma, Washington, 98405, United States
Raghu Varier, Site 0046503-847-4748
This study also lists 54 locations outside the United States. They are not shown here.
Central study contacts
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Contact
First line of the email MUST contain NCT # and Site #.
Contact
Registry dates
- First posted
- Oct 13, 2021
- Primary completion
- Jul 12, 2032
- Overall completion
- Jul 12, 2032
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.