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

NCT05470985 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: IM047-0232021-005019-30
• Study Type: interventional
• Target: 5
• Locations: 9 countries
• Sites: 46

Brief Summary

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.

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants Who Achieve Pediatric Crohn's Disease Activity Index (PCDAI) Score < 10 at Week 64

  The PCDAI is an instrument that was developed and validated for numerical assessment of disease activity in children and adolescents with CD. The PCDAI consists of the following 11 variables: Abdominal pain, stools per day, wellbeing, weight, height velocity, abdominal tenderness, peri-rectal disease, extra-intestinal manifestation, hematocrit, erythrocyte sedimentation rate and albumin. The category of severity for each index item is assigned a score: 0=normal;5=mild abnormality; 10= severe abnormality. For hematocrit and erythrocyte SR, the maximum score =5. For albumin level, the maximum score = 10. The PCDAI score is average of 11 variables scoring range of 0 to 100. Mild disease corresponds to scores of 11 to 30; moderate to severe disease corresponds to scores \> 30. Remission (no disease activity) is defined as a PCDAI score \< 10.

  Week 64

• Percentage of Participants Achieving Simple Endoscopic Score for Crohn's Disease (SES-CD) ≤ 2 or SES-CD ≤ 4 Points With no SES-CD Subscore > 1 Point at Week 64

  SES-CD assesses the degree of inflammation on the basis of 4 components: size of ulcers, ulcerated surface, affected surface, and presence of narrowing. Each of these 4 components are assessed in the five segments of the ileum and colon: ileum, right colon, transverse colon, left (descending and sigmoid) colon, and rectum, and is scored on a scale of severity 0 (Normal) to 3 (High). Sub-scores for each segment will be derived by adding component scores within segments. Total SES-CD score is the sum of the sub-scores across the five segments. The sum of each component across all segments ranges from 0 to 15, except for the presence of narrowing where it varies from 0 to 11. The range of the overall SES-CD score is 0-56, with larger scores indicating greater severity of disease.

  Week 64

Secondary Outcomes (21)

• Percentage of Participants Who Achieve Pediatric Crohn's Disease Activity Index (PCDAI) < 10 at Week 12 Based on Data as Observed

  Week 12

• Percentage of Participants Who Achieve Simple Endoscopic Score for Crohn's Disease (SES-CD) Decrease From Baseline of ≥ 50% (ER-50) at Week 64

  Week 64

• Percentage of Participants Who Achieve Simple Endoscopic Score for Crohn's Disease (SES-CD) Decrease From Baseline of ≥ 50% (ER-50) at Week 12 Based on Data as Observed

  Week 12

• Percentage of Participants Who Achieve Reduction in Pediatric Crohn's Disease Activity Index (PCDAI) Score ≥ 12.5 and a Total PCDAI Score of < 30 Points at Week 64

  Week 64

• Percentage of Participants Who Achieve Reduction in Pediatric Crohn's Disease Activity Index (PCDAI) Score ≥ 12.5 and a Total PCDAI Score of < 30 Points at Week 12 Based on Data as Observed

  Week 12

Study Arms (2)

Ozanimod Dose Level 1

EXPERIMENTAL

Drug: Ozanimod

Ozanimod Dose Level 2

EXPERIMENTAL

Drug: Ozanimod

Interventions

Ozanimod DRUG

Specific dose on specific days

Also known as: BMS-986374, RPC1063

Ozanimod Dose Level 1; Ozanimod Dose Level 2

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (46)

Local Institution - 0010

Garden Grove, California, 92845-2032, United States

Location

Local Institution - 0028

Los Angeles, California, 90027-6062, United States

Location

Local Institution - 0002

Sacramento, California, 95817-2207, United States

Location

Local Institution - 0009

San Francisco, California, 94158, United States

Location

Local Institution - 0011

Hartford, Connecticut, 06106-3322, United States

Location

Local Institution - 0044

Orlando, Florida, 32803-1469, United States

Location

Local Institution - 0037

Orlando, Florida, 32806, United States

Location

Local Institution - 0053

Atlanta, Georgia, 30302, United States

Location

Local Institution - 0059

Indianapolis, Indiana, 46202-5109, United States

Location

Local Institution - 0038

Springfield, Massachusetts, 01199, United States

Location

Local Institution - 0006

Detroit, Michigan, 48201-2196, United States

Location

Local Institution - 0003

Rochester, Minnesota, 55905-0001, United States

Location

Local Institution - 0016

St Louis, Missouri, 63110-1002, United States

Location

Local Institution - 0071

Lebanon, New Hampshire, 03756-1000, United States

Location

Local Institution - 0060

New York, New York, 10032, United States

Location

Local Institution - 0075

Fort Worth, Texas, 76104-2710, United States

Location

Local Institution - 0070

Houston, Texas, 77030-2316, United States

Location

Local Institution - 0008

Seattle, Washington, 98105-3901, United States

Location

Local Institution - 0040

Tacoma, Washington, 98405-3720, United States

Location

Local Institution - 0045

Joonladup, Western Australia, 6027, Australia

Location

Local Institution - 0058

Brussels, BRU, 1020, Belgium

Location

Local Institution - 0023

Leuven, VBR, 3000, Belgium

Location

Local Institution - 0048

Liège, WLG, 4000, Belgium

Location

Local Institution - 0062

Liège, WLG, 4000, Belgium

Location

Local Institution - 0047

Brussels, 1090, Belgium

Location

Local Institution - 0055

Brussels, 1200, Belgium

Location

Local Institution - 0014

Halifax, Nova Scotia, B3K 6R8, Canada

Location

Local Institution - 0001

London, Ontario, N6A 5W9, Canada

Location

Local Institution - 0054

Montreal, Quebec, H3T 1C5, Canada

Location

Local Institution - 0066

Bron, 69500, France

Location

Local Institution - 0065

Caen, 14033, France

Location

Local Institution - 0072

Paris, 75015, France

Location

Local Institution - 0063

Toulouse, 31059, France

Location

Local Institution - 0057

Dresden, Saxony, 01307, Germany

Location

Local Institution - 0067

Leipzig, Saxony, 04103, Germany

Location

Local Institution - 0015

Miskolc, 3526, Hungary

Location

Local Institution - 0026

Szeged, 6720, Hungary

Location

Local Institution - 0007

Warsaw, Masovian Voivodeship, 00-728, Poland

Location

Local Institution - 0052

Rzeszów, Podkarpackie Voivodeship, 35-302, Poland

Location

Local Institution - 0061

Lodz, 91-738, Poland

Location

Local Institution - 0031

Warsaw, 00-635, Poland

Location

Local Institution - 0033

Warsaw, 04-746, Poland

Location

Local Institution - 0025

Barcelona, B, 8950, Spain

Location

Local Institution - 0030

Badalona, 08916, Spain

Location

Local Institution - 0035

Barcelona, 08035, Spain

Location

Local Institution - 0017

Madrid, 28009, Spain

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Crohn Disease

Interventions

ozanimod

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2022
• First Posted: July 22, 2022
• Study Start: August 22, 2023
• Primary Completion: September 13, 2024
• Study Completion: September 13, 2024
• Last Updated: April 22, 2025
• Results First Posted: April 22, 2025

Record last verified: 2025-04

Locations

DE (2); PL (5); ES (4); US (19); HU (2); FR (4); AU (1); CA (3); BE (6)