RightFit
RecruitingPhase 2 / Phase 3

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
2 Years to 17 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests ozanimod, a medicine taken by mouth, in children with moderate to severe active ulcerative colitis (UC), which causes swelling and sores in the large intestine. It checks whether the medicine is safe and can bring symptoms under control and keep them controlled. It is for children whose UC has not improved enough with standard treatment.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have moderate to severe active UC diagnosed before the screening visit.
  • Have UC that spreads beyond the rectum, the last part of the large intestine, as shown by a test using a camera.
  • Have tried at least one of these UC treatments that did not work well enough, stopped working, or caused side effects they could not tolerate: oral aminosalicylates, steroids that act throughout the body, medicines that change the immune system, or biologic medicines.

Who can't join

  • Have Crohn’s disease or colitis whose type is unclear.
  • Have a recorded positive test for toxin-producing C. difficile, a germ that can cause bowel infection, or a positive stool PCR test for it.
  • Had apheresis, a procedure that removes parts of the blood, within 2 weeks before being assigned to a study group.
  • Have or have had an immune system deficiency, meaning the body cannot fight infections normally, or have a known genetic disorder that causes colitis.
  • Other study rules also apply.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (36)

AZ

CA

CT

DC

FL

GA

IA

IL

IN

MA

ME

MI

MN

MO

NC

NY

OH

OK

PA

SC

TX

WA

WI