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New treatment option for Colitis, Ulcerative
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 medicine, given as a pill taken by mouth, being studied as a potential treatment for colitis, ulcerative.
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 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.
- 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's taking place
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- Garden Grove, California, United States
- Loma Linda, California, United States
- Los Angeles, California, United States
- Palo Alto, California, United States
- Sacramento, California, United States
- Hartford, Connecticut, United States
- Washington D.C., District of Columbia, United States
- Orlando, Florida, United States
- Atlanta, Georgia, United States
- Park Ridge, Illinois, United States
- Indianapolis, Indiana, United States
- Iowa City, Iowa, United States
- Portland, Maine, United States
- Boston, Massachusetts, United States
- Springfield, Massachusetts, United States
- Worcester, Massachusetts, United States
- Detroit, Michigan, United States
- Rochester, Minnesota, United States
+ 60 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 - 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?
Study sites include Phoenix, Arizona, United States; Tucson, Arizona, United States; Garden Grove, California, United States; Loma Linda, California, United States; Los Angeles, California, United States; Palo Alto, California, United States and 74 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.