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NCT Number: NCT05076175

A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis

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.

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Key information

Conditions

Colitis, Ulcerative Colitis Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

The Children's Hospital at Westmead, Westmead, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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/exclusion criteria apply

Treatment and study plan

Ozanimod

Drug

Specified dose on specified days

Other names: RPC1063

Primary outcomes

  1. Proportion of participants who achieve clinical remission

    Time frame: At Week 52

Secondary outcomes

  1. Proportion of participants who achieve clinical remission

    Time frame: At Week 10

  2. Proportion of participants who achieve clinical response

    Time frame: At Week 52

  3. Proportion of participants who achieve clinical response

    Time frame: At Week 10

  4. Proportion of participants who achieve symptomatic remission

    Time frame: At Week 10 and Week 52

  5. Time to achievement of symptomatic remission

    Time frame: Up to 6 years

  6. Proportion of participants who achieve endoscopic improvement

    Time frame: At Week 10 and Week 52

  7. Proportion of participants who achieve corticosteroid free remission

    Time frame: At Week 52

  8. Incidence of Adverse Events (AEs)

    Time frame: Up to 6 years

  9. Incidence of Serious Adverse Events

    Time frame: Up to 6 years

  10. Incidence of AEs leading to discontinuation from treatment

    Time frame: Up to 6 years

  11. Incidence of AEs of special interest (AESIs)

    Time frame: Up to 6 years

  12. Steady state systemic exposure of ozanimod and CC112273

    Time frame: At Week 18 and throughout the study, up to 70 weeks

  13. Absolute change from baseline in Absolute Lymphocyte Count (ALC)

    Time frame: Up to 6 years

  14. Percent change from baseline in ALC

    Time frame: Up to 6 years

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

[email protected]

855-907-3286

First line of the email MUST contain NCT # and Site #.

CONTACT

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Phase 2/3, Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Oral Ozanimod (RPC1063) in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis With an Inadequate Response to Conventional Therapy

Important dates

Study start
2022
Primary completion
2032
Study completion
2032
First posted
Oct 13, 2021
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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