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Children's Hospital Colorado | Pediatric Infectious Disease

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A Study to Evaluate the Efficacy, Safety, and Drug Levels of Oral Ozanimod in Pediatric Participants With Moderately to Severely Active Crohn's Disease With an Inadequate Response to Conventional Therapy

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status and phase

Enrolling
Phase 3
Phase 2

Conditions

Crohn Disease

Treatments

Drug: Ozanimod

Study type

Interventional

Funder types

Industry

Identifiers

NCT05470985
2021-005019-30 (EudraCT Number)
IM047-023

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy, safety, drug levels, and drug effects of ozanimod in pediatric participants with moderately to severely active Crohn's Disease.

Enrollment

120 estimated patients

Sex

All

Ages

2 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Participants must have a Pediatric Crohn's Disease Activity Index (PCDAI) score ≥ 30 and a Simple Endoscopic Score for Crohn's Disease (SES-CD) score ≥ 6 (or SES-CD ≥ 4 in participants with isolated ileal disease)

  • Participant has an inadequate response, intolerance, or loss of response to at least 1 of the following treatments for Crohn's Disease (CD):

    i) corticosteroids ii) immunomodulators iii) biologic therapy iv) other systemic immunomodulatory therapies for CD

Exclusion criteria

  • Participant is likely to require, in the physician's judgment, bowel resection within 12 weeks of entry into the study
  • Participant has current stoma, ileal-anal pouch anastomosis, fistula that is likely to require, in the physician's judgment, surgical or medical intervention within 12 weeks of entry into the study or need for ileostomy or colostomy
  • Participant has extensive small bowel resection (> 100 cm) or known diagnosis of short bowel syndrome or participant requires total parenteral nutrition

Other protocol-defined inclusion/exclusion criteria apply.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

120 participants in 2 patient groups

Ozanimod Dose Level 1
Experimental group
Treatment:
Drug: Ozanimod
Ozanimod Dose Level 2
Experimental group
Treatment:
Drug: Ozanimod

Trial contacts and locations

82

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Central trial contact

BMS Study Connect Contact Center http://www.bmsstudyconnect.com; First line of the email MUST contain NCT # and Site #.

Data sourced from clinicaltrials.gov

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