Colitis, Ulcerative
Conditions
Keywords
Ulcerative Colitis, Ozanimod, Pediatric
Brief summary
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.
Interventions
DRUGOzanimod
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
No
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 * 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 therapy
Exclusion criteria
* Diagnosis of Crohn's disease or indeterminate colitis * Has documentation of positive test for toxin producing Clostridium difficile, or polymerase chain reaction examination of the stool * Apheresis within 2 weeks of randomization * History of or currently active primary or secondary immunodeficiency, or participants with known genetic disorders as a cause for colitis * Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants who achieve clinical remission | At Week 52 |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of participants who achieve clinical remission | At Week 10 |
| Proportion of participants who achieve clinical response | At Week 52 |
| Proportion of participants who achieve symptomatic remission | At Week 10 and Week 52 |
| Time to achievement of symptomatic remission | Up to 6 years |
| Proportion of participants who achieve endoscopic improvement | At Week 10 and Week 52 |
| Proportion of participants who achieve corticosteroid free remission | At Week 52 |
| Incidence of Adverse Events (AEs) | Up to 6 years |
| Incidence of Serious Adverse Events | Up to 6 years |
| Incidence of AEs leading to discontinuation from treatment | Up to 6 years |
| Incidence of AEs of special interest (AESIs) | Up to 6 years |
| Steady state systemic exposure of ozanimod and CC112273 | At Week 18 and throughout the study, up to 70 weeks |
| Absolute change from baseline in Absolute Lymphocyte Count (ALC) | Up to 6 years |
| Percent change from baseline in ALC | Up to 6 years |
Countries
Australia, Belgium, Canada, France, Germany, Israel, Japan, Poland, Puerto Rico, Russia, Spain, United Kingdom, United States
Contacts
CONTACTBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACTFirst line of the email MUST contain NCT # and Site #.
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed