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
• 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
• 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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer

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

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting