Colitis, Ulcerative study: Ozanimod
Official title A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis
ClinicalTrials.gov ID: NCT05076175
What this study is testing
What is Ozanimod?
Ozanimod is an investigational oral medicine being studied for moderate to severe ulcerative colitis in children.
Also referred to as RPC1063.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see if ozanimod is effective and safe for getting and keeping kids with moderate to severe ulcerative colitis in remission.
- Who it's for
- Pediatric patients with moderate to severe active ulcerative colitis who have not responded well to standard therapy.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 17
You may be able to join if
- 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...
You likely can't join if
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Loma Linda, California, United States
- Los Angeles, California, United States
- Sacramento, California, United States
- Boston, Massachusetts, United States
- Worcester, Massachusetts, United States
- Rochester, Minnesota, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Houston, Texas, United States
- Seattle, Washington, United States
- Tacoma, Washington, United States
- Westmead, New South Wales, Australia
- Clayton, Victoria, Australia
- Leuven, Vlaams-Brabant, Belgium
- Liège, Belgium
- Toronto, Ontario, Canada
- Toulouse, Haute-Garonne, France
- Caen, France
- Leipzig, Saxony, Germany
+ 20 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Loma Linda, California, United States; Los Angeles, California, United States; Sacramento, California, United States; Boston, Massachusetts, United States; Worcester, Massachusetts, United States; Rochester, Minnesota, United States and 34 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.