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Ulcerative ColitisSeptember 2021Summary reviewed June 2026

What True North Found — Ozanimod for Ulcerative Colitis

Researchers tested ozanimod, a pill taken once daily, in adults with moderate to severe ulcerative colitis. After 10 weeks, 18% of patients taking ozanimod were in remission compared to 6% taking a placebo. After one year of continued treatment, 37% were in remission compared to 19% on placebo.

What the trial was testing

The TRUE NORTH enrolled 1,012 patients with ulcerative colitis. The study was sponsored by Celgene and tracked outcomes across the full group of patients who matched the trial's eligibility profile.

It was a large trial designed to confirm whether the treatment works well enough for wider use. Trials at this stage are designed to produce evidence regulators and physicians can act on — not just observations to follow up later.

What the results showed

Nearly 4 in 10 patients taking ozanimod were in remission after one year of treatment.

The New England journal of medicine · 2021 · NCT02435992

These findings — that more than one in three patients had no symptoms after a year of treatment — were published in the The New England journal of medicine and represent the headline result of the study.

Researchers tracked outcomes across 1,012 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.

What this means for patients

For patients with ulcerative colitis, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.

What you can do now

Ozanimod is FDA-approved for ulcerative colitis under the brand name Zeposia. It's a daily pill that helps reduce inflammation in the colon. If your symptoms aren't controlled with your current treatment, ask your doctor if ozanimod might be right for you. Your doctor will monitor your liver function while you take it.

Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.

Open ulcerative colitis trials

RecruitingPost-approval monitoring

A Study of Vedolizumab With Tofacitinib in Adults With Ulcerative Colitis (UC)

The main aim of this study is to learn about the effect of treatment with vedolizumab IV (vedolizumab) together with tofacitinib in adults with moderate and severe ulcerative colitis (UC). Another aim is to learn about treatment with Vedolizumab alone after the double treatment. All participants will receive vedolizumab together with tofacitinib for 8 weeks and will be checked for response. Participants who show a response to the treatment after 8 weeks will be treated with vedolizumab alone for an additional 44 weeks. Each participant will be followed up for at least 26 weeks after the last dose of vedolizumab.

Dothan, Alabama, United States +24 more
RecruitingObservational study

Analysis of Barriers and Facilitators to Adapted Physical Activity for Pediatric Patients With Chronic Inflammatory Bowel Diseases

This study aims to identify perceived barriers and facilitators to regular physical activity among children and adolescents with inflammatory bowel disease (IBD) followed in pediatric gastroenterology. Approximately 60 participants aged 10-17 years will complete two self-administered questionnaires (CAPAS-Q for physical activity/sedentary behavior and IMPACT-III for health-related quality of life) and take part in a single semi-structured interview exploring experiences, obstacles, and levers to support sustainable physical activity. Relevant clinical data (disease characteristics, treatment and selected routine clinical parameters) will be extracted from the medical record. Participation is limited to one visit (about 45-60 minutes) during a routine hospital appointment, with no additional intervention or follow-up required.

Nice, France