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NCT05076175 Clinical Trial

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

Colitis, Ulcerative Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05076175
Other study ID # IM047-001
Secondary ID 2021-002308-11
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date May 30, 2022
Est. completion date August 14, 2031

Study information
Verified date May 2024
Source Bristol-Myers Squibb
Contact BMS Study Connect Contact Center www.BMSStudyConnect.com
Phone 855-907-3286
Email Clinical.Trials@bms.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 120
Est. completion date August 14, 2031
Est. primary completion date May 22, 2026
Accepts healthy volunteers No
Gender All
Age group 2 Years to 17 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Ozanimod
Specified dose on specified days

Locations
Country Name City State
Australia Local Institution - 0085 Clayton Victoria
Australia Local Institution - 0086 Murdoch Western Australia
Australia Local Institution - 0094 Westmead New South Wales
Belgium Local Institution - 0056 Brussels
Belgium Local Institution - 0076 Brussels Bruxelles-Capitale, Région De
Belgium Local Institution - 0063 Edegem
Belgium Local Institution - 0059 Leuven Vlaams-Brabant
Belgium Local Institution - 0061 Liège
Belgium Local Institution - 0071 Liège
Canada Local Institution - 0083 Hamilton Ontario
Canada Local Institution - 0082 Toronto Ontario
France Hospices Civils de Lyon - Hôpital Femme Mère Enfant Bron
France Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre Caen
France Hôpital Universitaire Necker Enfants Malades Paris
France Local Institution - 0073 Paris
France CHU de Toulouse - Hôpital des Enfants Toulouse Haute-Garonne
Germany Universitaetsklinikum Carl Gustav Carus Dresden Dresden Sachsen
Germany Klinikum der Ludwig-Maximilians-Universitaet Muenchen München Bayern
Israel Local Institution - 0018 Haifa HaTsafon
Israel Local Institution - 0019 Jerusalem Yerushalayim
Israel Schneider Children's Medical Center Petah-Tikva HaMerkaz
Japan Local Institution - 0024 Bunkyo Tokyo
Japan Local Institution - 0069 Hiroshima
Japan Local Institution - 0068 Komatsu Ishikawa
Japan Local Institution - 0011 Kurume-shi Fukuoka
Japan Local Institution - 0025 Obu Aichi
Japan National Center for Child Health and Development Setagaya-ku Tokyo
Japan Local Institution - 0033 Shinjuku-ku Tokyo
Japan Osaka Medical and Pharmaceutical University Hospital Takatsuki Osaka
Japan Local Institution - 0010 Tokyo
Japan Local Institution - 0038 Yokohama-shi Kanagawa
Poland Local Institution - 0013 Gdansk Pomorskie
Poland Local Institution - 0079 Gdansk Pomorskie
Poland Local Institution - 0084 Krakow Malopolskie
Poland Local Institution - 0092 Lodz Lódzkie
Poland Local Institution - 0015 Rzeszów Podkarpackie
Poland Twoja Przychodnia SCM Szczecin Zachodniopomorskie
Poland Centrum Zdrowia Dziecka w Warszawie Warsaw Mazowieckie
Poland Local Institution - 0043 Warsaw Mazowieckie
Poland Local Institution - 0012 Wroclaw Dolnoslaskie
Russian Federation Local Institution Moscow
Russian Federation Local Institution Moskva
Spain Local Institution - 0048 Badalona Barcelona [Barcelona]
Spain Local Institution - 0051 Esplugues de Llobregat Barcelona [Barcelona]
Spain Local Institution - 0044 Madrid Madrid, Comunidad De
Spain Local Institution - 0050 Madrid
Spain Local Institution - 0057 Madrid
United Kingdom Local Institution - 0054 Birmingham England
United Kingdom Local Institution - 0026 London London, City Of
United Kingdom Local Institution - 0066 London London, City Of
United States Local Institution - 0016 Atlanta Georgia
United States Boston Children's Hospital Boston Massachusetts
United States University of North Carolina Medical Center Chapel Hill North Carolina
United States Atrium Health - Carolinas Medical Center Charlotte North Carolina
United States Local Institution - 0036 Cleveland Ohio
United States Local Institution - 0093 Detroit Michigan
United States Local Institution - 0052 Garden Grove California
United States Local Institution - 0007 Hartford Connecticut
United States Penn State Milton S. Hershey Medical Center Hershey Pennsylvania
United States Texas Children's Hospital Houston Texas
United States University of Iowa Iowa City Iowa
United States Loma Linda University Health System Loma Linda California
United States Cedars-Sinai Medical Center Los Angeles California
United States Children's Wisconsin Milwaukee Wisconsin
United States Local Institution - 0023 New York New York
United States Local Institution - 0028 New York New York
United States Local Institution - 0040 New York New York
United States Local Institution - 0062 Oklahoma City Oklahoma
United States AdventHealth Orlando Orlando Florida
United States Lucile Packard Children's Hospital Palo Alto California
United States Local Institution - 0041 Phoenix Arizona
United States Maine Medical Partners Portland Maine
United States Mayo Clinic in Rochester, Minnesota Rochester Minnesota
United States Washington University Saint Louis Missouri
United States Seattle Children's Hospital Seattle Washington
United States Swedish Medical Center Seattle Washington
United States Local Institution - 0042 Springfield Massachusetts
United States MultiCare Health System Tacoma Washington
United States University of Arizona Tucson Arizona
United States Children's National Medical Center Washington District of Columbia

Sponsors (1)
Lead Sponsor Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  France,  Germany,  Israel,  Japan,  Poland,  Russian Federation,  Spain,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of participants who achieve clinical remission At Week 52
Secondary Proportion of participants who achieve clinical remission At Week 10
Secondary Proportion of participants who achieve clinical response At Week 52
Secondary Proportion of participants who achieve clinical response At Week 10
Secondary Proportion of participants who achieve symptomatic remission At Week 10 and Week 52
Secondary Time to achievement of symptomatic remission Up to 6 years
Secondary Proportion of participants who achieve endoscopic improvement At Week 10 and Week 52
Secondary Proportion of participants who achieve corticosteroid free remission At Week 52
Secondary Incidence of Adverse Events (AEs) Up to 6 years
Secondary Incidence of Serious Adverse Events Up to 6 years
Secondary Incidence of AEs leading to discontinuation from treatment Up to 6 years
Secondary Incidence of AEs of special interest (AESIs) Up to 6 years
Secondary Steady state systemic exposure of ozanimod and CC112273 At Week 18 and throughout the study, up to 70 weeks
Secondary Absolute change from baseline in Absolute Lymphocyte Count (ALC) Up to 6 years
Secondary Percent change from baseline in ALC Up to 6 years
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Recruiting NCT05611671 - A Study to Evaluate MORF-057 in Adults With Moderately to Severely Active UC Phase 2
Active, not recruiting NCT03596645 - A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis Phase 3
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