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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 2 Years - 17 Years
Gender All
More Inclusion & Exclusion Criteria

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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05470985
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2/Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Bristol-Myers Squibb
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Bristol-Myers Squibb
Principal Investigator Affiliation Bristol-Myers Squibb
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Australia, Belgium, Canada, Hungary, Poland, Spain, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Crohn Disease
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: Ozanimod Dose Level 1

Experimental: Ozanimod Dose Level 2

Interventions

Drug: - Ozanimod

Specific dose on specific days

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Valley View Wellness Medical Center, Garden Grove, California

Status

Recruiting

Address

Valley View Wellness Medical Center

Garden Grove, California, 92845-2032

Site Contact

Michael Kurtz, Site 0010

Clinical.Trials@bms.com

855-907-3286

UC Davis Medical Center, Sacramento, California

Status

Active, not recruiting

Address

UC Davis Medical Center

Sacramento, California, 95817-2207

UCSF Medical Center- Mission Bay, San Francisco, California

Status

Not yet recruiting

Address

UCSF Medical Center- Mission Bay

San Francisco, California, 94158

Site Contact

Sofia Verstraete, Site 0009

Clinical.Trials@bms.com

415-502-3741

Children's Hospital Colorado, Aurora, Colorado

Status

Withdrawn

Address

Children's Hospital Colorado

Aurora, Colorado, 80045-7106

Connecticut Children's Medical Center, Hartford, Connecticut

Status

Not yet recruiting

Address

Connecticut Children's Medical Center

Hartford, Connecticut, 06106-3322

Site Contact

Jeffrey Hyams, Site 0011

Clinical.Trials@bms.com

860-545-8125

Orlando, Florida

Status

Not yet recruiting

Address

AdventHealth (Florida Hospital) Medical Group - Pediatric Gastroenterology - Orlando

Orlando, Florida, 32803-1469

Site Contact

Regino Gonzalez-Peralta, Site 0044

Clinical.Trials@bms.com

352-514-7349

Orlando, Florida

Status

Not yet recruiting

Address

Arnold Palmer Hospital for Children - Center for Digestive Health and Nutrition - Downtown Orlando

Orlando, Florida, 32806

Site Contact

Jeffrey Bornstein, Site 0037

Clinical.Trials@bms.com

919-684-2052

Emory-Children's Center, Atlanta, Georgia

Status

Not yet recruiting

Address

Emory-Children's Center

Atlanta, Georgia, 30302

Site Contact

Subramaniam Kugathasan, Site 0053

Clinical.Trials@bms.com

855-907-3286

Iowa City, Iowa

Status

Withdrawn

Address

University of Iowa Stead Family Children's Hospital

Iowa City, Iowa, 52242-1009

Boston Children's Hospital, Boston, Massachusetts

Status

Not yet recruiting

Address

Boston Children's Hospital

Boston, Massachusetts, 02115-5724

Site Contact

Athos Bousvaros, Site 0032

Clinical.Trials@bms.com

855-907-3286

Children's Hospital of Michigan, Detroit, Michigan

Status

Not yet recruiting

Address

Children's Hospital of Michigan

Detroit, Michigan, 48201-2196

Site Contact

Kristen Cares, Site 0006

Clinical.Trials@bms.com

313-745-5585

Lebanon, New Hampshire

Status

Not yet recruiting

Address

Dartmouth-Hitchcock Medical Center (DHMC) - Children's Hospital at Dartmouth (CHaD) - Lebanon

Lebanon, New Hampshire, 03756-1000

Site Contact

Amer Al-Nimr, Site 0071

Clinical.Trials@bms.com

603-653-9666

Morristown Medical Center, Morristown, New Jersey

Status

Withdrawn

Address

Morristown Medical Center

Morristown, New Jersey, 07960-6136

Paramus, New Jersey

Status

Not yet recruiting

Address

Valley Medical Group (VMG) - Pediatric Gastroenterology

Paramus, New Jersey, 07652

Site Contact

Jose Antonio Quiros, Site 0043

Clinical.Trials@bms.com

201-389-0815

Children'S Hospital At Montefiore, Bronx, New York

Status

Withdrawn

Address

Children'S Hospital At Montefiore

Bronx, New York, 10467-2403

New York, New York

Status

Withdrawn

Address

Icahn School of Medicine - The Mount Sinai Hospital - The Susan and Leonard Feinstein IBD Center

New York, New York, 10029-5204

Cleveland, Ohio

Status

Withdrawn

Address

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106

Cook Children's Gastroenterology, Fort Worth, Texas

Status

Not yet recruiting

Address

Cook Children's Gastroenterology

Fort Worth, Texas, 76104-2710

Site Contact

Clifton Huang, Site 0075

Clinical.Trials@bms.com

559-353-5746

International Sites

Local Institution - 0029, Sydney, New South Wales, Australia

Status

Not yet recruiting

Address

Local Institution - 0029

Sydney, New South Wales, 2145

Site Contact

Site 0029

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0023, Leuven, VBR, Belgium

Status

Not yet recruiting

Address

Local Institution - 0023

Leuven, VBR, 3000

Site Contact

Site 0023

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0062, Liege, Belgium

Status

Not yet recruiting

Address

Local Institution - 0062

Liege, , 4000

Site Contact

Site 0062

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0001, London, Ontario, Canada

Status

Not yet recruiting

Address

Local Institution - 0001

London, Ontario, N6A 5W9

Site Contact

Site 0001

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0054, Montréal, Quebec, Canada

Status

Not yet recruiting

Address

Local Institution - 0054

Montréal, Quebec, H3T 1C5

Site Contact

Site 0054

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0019, Miskolc, BZ, Hungary

Status

Withdrawn

Address

Local Institution - 0019

Miskolc, BZ, 3526

Local Institution - 0061, Lodz, Lodzkie, Poland

Status

Not yet recruiting

Address

Local Institution - 0061

Lodz, Lodzkie, 91-738

Site Contact

Site 0061

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0052, Rzeszow, PK, Poland

Status

Not yet recruiting

Address

Local Institution - 0052

Rzeszow, PK, 35-302

Site Contact

Site 0052

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0031, Warszawa, Poland

Status

Not yet recruiting

Address

Local Institution - 0031

Warszawa, , 4730

Site Contact

Site 0031

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0021, Madrid, Spain

Status

Withdrawn

Address

Local Institution - 0021

Madrid, , 28009

Local Institution - 0013, Madrid, Spain

Status

Withdrawn

Address

Local Institution - 0013

Madrid, , 28046

Local Institution - 0050, London, LND, United Kingdom

Status

Active, not recruiting

Address

Local Institution - 0050

London, LND, WC1N 3JH

Local Institution - 0049, London, United Kingdom

Status

Active, not recruiting

Address

Local Institution - 0049

London, , SE5 9RS