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Recruiting NCT05076175

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

Phase II / Phase III Interventional Colitis, Ulcerative

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ozanimod.
Who it may be relevant to
Registry conditions: Colitis, Ulcerative. Basic parameters: 2 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia, Belgium, Canada, France +8
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug Ozanimod
    Specified dose on specified days

Primary outcome measures

  • Proportion of participants who achieve clinical remission [Time frame: At Week 52]
Secondary outcome measures (12)
  • Proportion of participants who achieve clinical remission [Time frame: At Week 10]
  • Proportion of participants who achieve clinical response [Time frame: At Week 52]
  • Proportion of participants who achieve clinical response [Time frame: At Week 10]
  • Proportion of participants who achieve symptomatic remission [Time frame: At Week 10 and Week 52]
  • Time to achievement of symptomatic remission [Time frame: Up to 6 years]
  • Proportion of participants who achieve endoscopic improvement [Time frame: At Week 10 and Week 52]
  • Proportion of participants who achieve corticosteroid free remission [Time frame: At Week 52]
  • Incidence of Adverse Events (AEs) [Time frame: Up to 6 years]
  • Incidence of Serious Adverse Events [Time frame: Up to 6 years]
  • Incidence of AEs leading to discontinuation from treatment [Time frame: Up to 6 years]
  • Incidence of AEs of special interest (AESIs) [Time frame: Up to 6 years]
  • Steady state systemic exposure of ozanimod and CC112273 [Time frame: At Week 18 and throughout the study, up to 70 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 36 centers
  • Local Institution - 0041 — Phoenix
  • University of Arizona — Tucson
  • Local Institution - 0052 — Garden Grove
  • Loma Linda University Health System — Loma Linda
  • Cedars-Sinai Medical Center — Los Angeles
  • Lucile Packard Children's Hospital — Palo Alto
  • University of California Davis Health — Sacramento
  • Local Institution - 0007 — Hartford
  • … and 28 more centers
Japan · 10 centers
  • Aichi Children's Health and Medical Center — Ōbu
  • Kurume University Hospital — Kurume-shi
  • Komatsu Municipal Hospital — Komatsu
  • Saiseikai Yokohamashi Tobu Hospital — Yokohama
  • Osaka Medical and Pharmaceutical University Hospital — Takatsuki
  • Institute of Science Tokyo Hospital — Bunkyo-Ku
  • National Center for Child Health and Development — Setagaya-ku
  • Tokyo Medical University Hospital — Shinjuku-ku
  • … and 2 more centers
Poland · 9 centers
  • Local Institution - 0084 — Krakow
  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu — Wroclaw
  • WIP Warsaw IBD Point Profesor Kierkuś — Warsaw
  • Centrum Zdrowia Dziecka w Warszawie — Warsaw
  • Local Institution - 0015 — Rzeszów
  • Local Institution - 0013 — Gdansk
  • Local Institution - 0079 — Gdansk
  • Twoja Przychodnia SCM — Szczecin
  • … and 1 more center
Belgium · 6 centers
  • Local Institution - 0076 — Brussels
  • UZ Leuven — Leuven
  • Local Institution - 0056 — Brussels
  • Local Institution - 0063 — Edegem
  • Centre Hospitalier Régional de la Citadelle — Liège
  • Local Institution - 0071 — Liège
France · 5 centers
  • CHU de Toulouse - Hôpital des Enfants — Toulouse
  • Local Institution - 0022 — Bron
  • Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre — Caen
  • Local Institution - 0017 — Paris
  • Local Institution - 0073 — Paris
Spain · 5 centers

Center list to be confirmed — check the primary protocol.

United Kingdom · 4 centers

Center list to be confirmed — check the primary protocol.

Australia · 3 centers
  • The Children's Hospital at Westmead — Westmead
  • Monash Health — Clayton
  • Local Institution - 0086 — Murdoch
Canada · 3 centers
  • Local Institution - 0083 — Hamilton
  • Local Institution - 0104 — Toronto
  • Local Institution - 0082 — Toronto
Germany · 3 centers
  • Local Institution - 0032 — München
  • Universitätsklinikum Leipzig — Leipzig
  • Local Institution - 0031 — Dresden
Israel · 3 centers
  • Schneider Children's Medical Center — Petah Tikva
  • Shaare Zedek Medical Center — Jerusalem
  • Rambam Health Care Campus — Haifa
Russia · 2 centers
  • Local Institution — Moscow
  • … and 1 more center
Puerto Rico · 1 center
  • Clinical Research Puerto Rico — San Juan

Identifiers

NCT: NCT05076175 · IM047-001 · 2023-509248-86

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗