A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis
To evaluate the efficacy and safety of ozanimod in pediatric participants with moderately to severely active UC.
- Moderately to severely active Ulcerative Colitis (UC) diagnosed prior to the Screening Visit
- Evidence of UC extending beyond the rectum, as determined by baseline colonoscopy
- 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, or other immunomodulatory treatments for UC (such as tofacitinib)
- 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 (blood withdrawal treatment) 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 description/explanation of participation:
- This study is designed to determine the safety and effectiveness of the oral investigational study drug, ozanimod, in achieving symptom remission in pediatric patients (ages 2-17 years old) with active Ulcerative disease symptoms. All participants will receive a dose of active study drug. Participation in this clinical study is expected to last 52 weeks (about 1 year).
- Depending on response and the study doctor's recommendation, participants may have the opportunity to continue participation in the extension study. An extension study means you may be able to continue taking the investigational study drug, if you qualify and choose to participate.
Description of treatment or intervention:
- We are studying ozanimod to see if it acts on the immune system by encouraging certain types of white blood cells called lymphocytes, which include T cells, to stay in the lymph nodes and other places in the body, thereby keeping them away from sites of inflammation.
- Lymphocytes, which act as the body's mechanism to fight off invaders, are responsible for initiating the immune response. However, in Ulcerative Colitis disease, lymphocytes misread the inflammation caused by the disease as an area where their help is needed.
Patient participation requirements:
- Over the course of participation in the study, will require approximately 10 clinic visits.
- A variety of assessments such as lab tests, ECGs, vital signs, physical exams, eye exams, colonoscopies and pulmonary function tests will be performed.
- Participants will need to complete some questionnaires during visits to the trial site, and to keep a study diary (e-diary) daily.
If you/your child are living with active Ulcerative Colitis and experiencing symptoms, you may want to discuss this study with a participating trial site where the study will be explained to you in greater detail and you will be given an opportunity to ask any questions
Possible risks and side effects:
- Ozanimod is still being studied, so not all of its side effects are known. The most common known side effects of ozanimod treatment can include upper respiratory tract infection, increase in blood pressure, elevated liver enzymes, and headache. Ozanimod lowers the number of lymphocytes (white blood cells) in the blood, which may increase the risk of infection.
- If you/your child qualifies for the trial, more information will be given to you by the study site doctor or a member of their staff.
Please note that we will continue to update the contact section with more sites as the information for them becomes available. Be sure to bookmark this page and check back regularly to find the site recruiting nearest to you.