Plain-English translation of NCT07071519 on ClinicalTrials.gov ↗ ·
Phase 3 — Testing in thousands of people, comparing the treatment against what doctors currently use. This is the last big step before approval.
This study is testing , a medication that helps calm the inflammation in the colon and rectum caused by ulcerative colitis. The trial will look at how the medication moves through children's bodies, how safe it is, and how well it works to reduce symptoms and disease activity. About 120 children ages 2 to 17 will participate at hospitals and clinics around the world.
is already approved for treating ulcerative colitis in adults, but there is limited information about how it works in children. This trial will help doctors understand the right doses and whether this medication is safe and effective for younger patients who haven't responded well to other treatments.
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The study is divided into three phases over about 5 years. First, you'll receive the medication by IV infusion weekly for 12 weeks. Then, you'll be randomly assigned to receive either a higher or lower maintenance dose given as injections under the skin every 4 weeks for one year. Finally, if you and your doctor think the medication is helping, you can continue receiving it in an extended phase for up to 4 more years. Throughout the study, you'll have regular visits to the hospital or clinic for blood tests, check-ups, and assessments of how well the medication is working.
AI-generated summary from trial data · Jun 28, 2026 · Not medical advice
United States