Clinical trial NCT05076175: A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Colitis, Ulcerative
Keywords: Ulcerative Colitis
Ozanimod
Pediatric
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2021-10-13
Enrollment: 120
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Proportion of participants who achieve clinical remission
timeFrame: At Week 52
Secondary outcomes:
measure: Proportion of participants who achieve clinical remission
timeFrame: At Week 10
measure: Proportion of participants who achieve clinical response
timeFrame: At Week 52
measure: Proportion of participants who achieve clinical response
timeFrame: At Week 10
measure: Proportion of participants who achieve symptomatic remission
timeFrame: At Week 10 and Week 52
measure: Time to achievement of symptomatic remission
timeFrame: Up to 6 years
measure: Proportion of participants who achieve endoscopic improvement
timeFrame: At Week 10 and Week 52
measure: Proportion of participants who achieve corticosteroid free remission
timeFrame: At Week 52
measure: Incidence of Adverse Events (AEs)
timeFrame: Up to 6 years
measure: Incidence of Serious Adverse Events
timeFrame: Up to 6 years
measure: Incidence of AEs leading to discontinuation from treatment
timeFrame: Up to 6 years
measure: Incidence of AEs of special interest (AESIs)
timeFrame: Up to 6 years
measure: Steady state systemic exposure of ozanimod and CC112273
timeFrame: At Week 18 and throughout the study, up to 70 weeks
measure: Absolute change from baseline in Absolute Lymphocyte Count (ALC)
timeFrame: Up to 6 years
measure: Percent change from baseline in ALC
timeFrame: Up to 6 years
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Local Institution - 0041
state: Arizona
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Garden Grove
country: United States
facility: Local Institution - 0052
state: California
city: Loma Linda
country: United States
facility: Local Institution - 0087
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Palo Alto
country: United States
facility: Lucile Packard Children's Hospital
state: California
city: Sacramento
country: United States
facility: Local Institution - 0096
state: California
city: Hartford
country: United States
facility: Local Institution - 0007
state: Connecticut
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Orlando
country: United States
facility: Local Institution - 0075
state: Florida
city: Atlanta
country: United States
facility: Local Institution - 0016
state: Georgia
city: Indianapolis
country: United States
facility: Local Institution - 0100
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Portland
country: United States
facility: Maine Medical Partners
state: Maine
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Springfield
country: United States
facility: Local Institution - 0042
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Chan Medical School
state: Massachusetts
city: Detroit
country: United States
facility: Children's Hospital of Michigan
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic in Rochester, Minnesota
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: New York
country: United States
facility: Local Institution - 0028
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: New York
country: United States
facility: Local Institution - 0023
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina Medical Center
state: North Carolina
city: Charlotte
country: United States
facility: Local Institution - 0047
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Oklahoma City
country: United States
facility: Local Institution - 0062
state: Oklahoma
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Charleston
country: United States
facility: Local Institution - 0099
state: South Carolina
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
city: Seattle
country: United States
facility: Local Institution - 0091
state: Washington
city: Tacoma
country: United States
facility: MultiCare Health System
state: Washington
city: Milwaukee
country: United States
facility: Children's Wisconsin
state: Wisconsin
city: Westmead
country: Australia
facility: Local Institution - 0094
state: New South Wales
city: Clayton
country: Australia
facility: Monash Health
state: Victoria
city: Murdoch
country: Australia
facility: Local Institution - 0086
state: Western Australia
city: Brussels
country: Belgium
facility: Local Institution - 0076
state: Bruxelles-Capitale, Région De
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams-Brabant
city: Brussels
country: Belgium
facility: UZ Brussel
city: Edegem
country: Belgium
facility: Local Institution - 0063
city: Liège
country: Belgium
facility: Centre Hospitalier Régional de la Citadelle
city: Liège
country: Belgium
facility: Local Institution - 0071
city: Hamilton
country: Canada
facility: Local Institution - 0083
state: Ontario
city: Toronto
country: Canada
facility: Local Institution - 0082
state: Ontario
city: Toulouse
country: France
facility: CHU de Toulouse - Hôpital des Enfants
state: Haute-Garonne
city: Bron
country: France
facility: Hospices Civils de Lyon - Hôpital Femme Mère Enfant
city: Caen
country: France
facility: Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre
city: Paris
country: France
facility: Hôpital Universitaire Necker Enfants Malades
city: Paris
country: France
facility: Local Institution - 0073
city: München
country: Germany
facility: Klinikum der Ludwig-Maximilians-Universitaet Muenchen
state: Bayern
city: Leipzig
country: Germany
facility: Local Institution - 0097
state: Sachsen
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus Dresden
city: Petah-Tikva
country: Israel
facility: Schneider Children's Medical Center
state: HaMerkaz
city: Haifa
country: Israel
facility: Rambam Health Care Campus
state: HaTsafon
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
state: Yerushalayim
city: Obu
country: Japan
facility: Aichi Children's Health and Medical Center
state: Aichi
city: Kurume-shi
country: Japan
facility: Kurume University Hospital
state: Fukuoka
city: Komatsu
country: Japan
facility: Komatsu Municipal Hospital
state: Ishikawa
city: Yokohama-shi
country: Japan
facility: Saiseikai Yokohamashi Tobu Hospital
state: Kanagawa
city: Takatsuki
country: Japan
facility: Osaka Medical and Pharmaceutical University Hospital
state: Osaka
city: Bunkyo-Ku
country: Japan
facility: Institute of Science Tokyo Hospital
state: Tokyo
city: Setagaya-ku
country: Japan
facility: National Center for Child Health and Development
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Medical University Hospital
state: Tokyo
city: Hiroshima
country: Japan
facility: Hiroshima University Hospital
city: Tokyo
country: Japan
facility: Juntendo University Hospital
city: Wrocław
country: Poland
facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
state: Dolnośląskie
city: Warsaw
country: Poland
facility: WIP Warsaw IBD Point Profesor Kierkuś
state: Mazowieckie
city: Warsaw
country: Poland
facility: Centrum Zdrowia Dziecka w Warszawie
state: Mazowieckie
city: Krakow
country: Poland
facility: Local Institution - 0084
state: Małopolskie
city: Rzeszów
country: Poland
facility: Local Institution - 0015
state: Podkarpackie
city: Gdansk
country: Poland
facility: Local Institution - 0013
state: Pomorskie
city: Gdansk
country: Poland
facility: Local Institution - 0079
state: Pomorskie
city: Szczecin
country: Poland
facility: Twoja Przychodnia SCM
state: Zachodniopomorskie
city: Lodz
country: Poland
facility: Local Institution - 0092
state: Łódzkie
city: San Juan
country: Puerto Rico
facility: Local Institution - 0098
city: Moscow
country: Russian Federation
facility: Local Institution
city: Moskva
country: Russian Federation
facility: Local Institution
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
state: Barcelona [Barcelona]
city: Esplugues de Llobregat
country: Spain
facility: Hospital Sant Joan de Déu
state: Barcelona [Barcelona]
city: Madrid
country: Spain
facility: Hospital Infantil Universitario Niño Jesús
state: Madrid, Comunidad De
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
city: Madrid
country: Spain
facility: Local Institution - 0050
city: Birmingham
country: United Kingdom
facility: Local Institution - 0054
state: England
city: London
country: United Kingdom
facility: King's College Hospital
state: Greater London
city: London
country: United Kingdom
facility: Barts Health NHS Trust
state: London, City Of
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: