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

Study Purpose

The purpose of this study is to evaluate the effectiveness and safety of ozanimod (RPC1063) in causing 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.

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:

  • - 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

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.

NCT05076175
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 France, Israel, Japan, Poland, Russian Federation, United States
Conditions

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

Colitis, Ulcerative
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: Ozanimod High Dose

Experimental: Ozanimod Low Dose

Interventions

Drug: - Ozanimod

Specified dose on specified 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.

Local Institution, Phoenix, Arizona

Status

Not yet recruiting

Address

Local Institution

Phoenix, Arizona, 85016

Site Contact

Site 0041

Clinical.Trials@bms.com

855-907-3286

Local Institution, Los Angeles, California

Status

Not yet recruiting

Address

Local Institution

Los Angeles, California, 90048

Site Contact

Site 0006

Clinical.Trials@bms.com

855-907-3286

Local Institution, Hartford, Connecticut

Status

Not yet recruiting

Address

Local Institution

Hartford, Connecticut, 06106

Site Contact

Site 0007

Clinical.Trials@bms.com

855-907-3286

Local Institution, Atlanta, Georgia

Status

Not yet recruiting

Address

Local Institution

Atlanta, Georgia, 30342

Site Contact

Site 0016

Clinical.Trials@bms.com

855-907-3286

Local Institution, Boston, Massachusetts

Status

Not yet recruiting

Address

Local Institution

Boston, Massachusetts, 02115

Site Contact

Site 0005

Clinical.Trials@bms.com

855-907-3286

Local Institution, Springfield, Massachusetts

Status

Not yet recruiting

Address

Local Institution

Springfield, Massachusetts, 01107

Site Contact

Site 0042

Clinical.Trials@bms.com

855-907-3286

Local Institution, New York, New York

Status

Not yet recruiting

Address

Local Institution

New York, New York, 10021

Site Contact

Site 0023

Clinical.Trials@bms.com

855-907-3286

Local Institution, New York, New York

Status

Not yet recruiting

Address

Local Institution

New York, New York, 10029

Site Contact

Site 0028

Clinical.Trials@bms.com

855-907-3286

Local Institution, New York, New York

Status

Not yet recruiting

Address

Local Institution

New York, New York, 10032

Site Contact

Site 0040

Clinical.Trials@bms.com

855-907-3286

Local Institution, Cleveland, Ohio

Status

Not yet recruiting

Address

Local Institution

Cleveland, Ohio, 44195

Site Contact

Site 0036

Clinical.Trials@bms.com

855-907-3286

Local Institution, Philadelphia, Pennsylvania

Status

Not yet recruiting

Address

Local Institution

Philadelphia, Pennsylvania, 19134

Site Contact

Site 0035

Clinical.Trials@bms.com

855-907-3286

Local Institution, Wauwatosa, Wisconsin

Status

Not yet recruiting

Address

Local Institution

Wauwatosa, Wisconsin, 53226

Site Contact

Site 0037

Clinical.Trials@bms.com

855-907-3286

International Sites

Local Institution, Bron, France

Status

Not yet recruiting

Address

Local Institution

Bron, , 69500

Site Contact

Site 0022

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0030, Caen, France

Status

Recruiting

Address

Local Institution - 0030

Caen, , 14033

Site Contact

Site 0030

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0017, Paris, France

Status

Recruiting

Address

Local Institution - 0017

Paris, , 75015

Site Contact

Site 0017

Clinical.Trials@bms.com

855-907-3286

Local Institution, Haifa, Israel

Status

Not yet recruiting

Address

Local Institution

Haifa, , 3109601

Site Contact

Site 0018

Clinical.Trials@bms.com

855-907-3286

Local Institution, Jerusalem, Israel

Status

Not yet recruiting

Address

Local Institution

Jerusalem, , 9103102

Site Contact

Site 0019

Clinical.Trials@bms.com

855-907-3286

Local Institution, Petah Tikva, Israel

Status

Not yet recruiting

Address

Local Institution

Petah Tikva, , 4920235

Site Contact

Site 0020

Clinical.Trials@bms.com

855-907-3286

Local Institution, Obu-shi, Aichi, Japan

Status

Not yet recruiting

Address

Local Institution

Obu-shi, Aichi,

Site Contact

Site 0025

Clinical.Trials@bms.com

855-907-3286

Local Institution, Kurume-shi, Fukuoka, Japan

Status

Not yet recruiting

Address

Local Institution

Kurume-shi, Fukuoka, 830-0011

Site Contact

Site 0011

Clinical.Trials@bms.com

855-907-3286

Local Institution, Yokohama, Kanagawa, Japan

Status

Not yet recruiting

Address

Local Institution

Yokohama, Kanagawa, 230-0304

Site Contact

Site 0038

Clinical.Trials@bms.com

855-907-3286

Local Institution, Takatsuki, Osaka, Japan

Status

Not yet recruiting

Address

Local Institution

Takatsuki, Osaka, 569-8686

Site Contact

Site 0021

Clinical.Trials@bms.com

855-907-3286

Local Institution, Bunkyo-ku, Tokyo, Japan

Status

Not yet recruiting

Address

Local Institution

Bunkyo-ku, Tokyo, 1138431

Site Contact

Site 0010

Clinical.Trials@bms.com

855-907-3286

Local Institution, Setagaya-ku, Tokyo, Japan

Status

Not yet recruiting

Address

Local Institution

Setagaya-ku, Tokyo, 1570074

Site Contact

Site 0009

Clinical.Trials@bms.com

855-907-3286

Local Institution, Shinjuku-ku, Tokyo, Japan

Status

Not yet recruiting

Address

Local Institution

Shinjuku-ku, Tokyo, 1600023

Site Contact

Site 0033

Clinical.Trials@bms.com

855-907-3286

Local Institution, Tokyo, Japan

Status

Not yet recruiting

Address

Local Institution

Tokyo, , 113-8519

Site Contact

Site 0024

Clinical.Trials@bms.com

855-907-3286

Local Institution, Gdansk, Poland

Status

Not yet recruiting

Address

Local Institution

Gdansk, , 80-803

Site Contact

Site 0013

Clinical.Trials@bms.com

855-907-3286

Local Institution, Rzeszow, Poland

Status

Not yet recruiting

Address

Local Institution

Rzeszow, , 35-302

Site Contact

Site 0015

Clinical.Trials@bms.com

855-907-3286

Local Institution, Warszawa, Poland

Status

Not yet recruiting

Address

Local Institution

Warszawa, , 04-745

Site Contact

Site 0014

Clinical.Trials@bms.com

855-907-3286

Local Institution, Wroclaw, Poland

Status

Not yet recruiting

Address

Local Institution

Wroclaw, , 50-369

Site Contact

Site 0012

Clinical.Trials@bms.com

855-907-3286

Local Institution, Moscow, Russian Federation

Status

Withdrawn

Address

Local Institution

Moscow, , 119991

Local Institution, Moskva, Russian Federation

Status

Withdrawn

Address

Local Institution

Moskva, , 119571

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation. For a full description of terms please refer to our Terms, Conditions & Privacy.