Plain-English translation of NCT05043870 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Read our Crohn Disease research guide →Phase 4 — The treatment has already been approved. Researchers are tracking how it works in a large number of people over time.
This trial is testing whether using together with a second immune-suppressing medication works better than using alone for children with Crohn's disease. is a medication that helps calm down the inflammation in the gut that causes Crohn's disease symptoms. The study will compare how well the treatment works and how safe it is when the medication is used by itself versus when it's combined with another drug.
Doctors want to find the best way to treat Crohn's disease in children, especially those whose disease hasn't improved enough with initial treatments like nutritional therapy or steroids. This research will help determine whether combining treatments might give children better results and faster relief from their symptoms.
You likely qualify if…
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You would be randomly assigned to receive either the medication alone or the medication combined with a second drug. The main medication is given as an infusion (through an IV) at specific timepoints over several weeks, then every 8 weeks after that. If you're in the combination group, you'll also take a daily oral medication. You'll have regular clinic visits and tests to see how well the treatment is working and to monitor for any side effects.
AI-generated summary from trial data · Jun 5, 2026 · Not medical advice
China
Phase
Post-approval monitoring
Sponsor
Children's Hospital of Fudan University
Enrollment target
~128 participants
Started
October 2022
Primary completion
October 2026
Age range
6 Years – 18 Years
Last updated on clinicaltrials.gov in March 2026.
Reach out to the team running this trial. Response times vary — some teams are faster than others.
Central contact
Lin Wang
Children's Hospital of Fudan University
Tell us you're interested and we'll help connect you with the research team. We'll walk you through what to expect first — no email needed to get started.