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Phase 4 — The treatment has already been approved. Researchers are tracking how it works in a large number of people over time.
This study is testing , a biologic medication that reduces inflammation in the digestive system, in children with Crohn's disease who have never received this type of treatment before. The trial uses a different dosing schedule than is typically given—a higher starting dose followed by smaller doses given more frequently—to see if this approach helps children achieve better disease control. Researchers want to understand whether this approach keeps medication levels in the blood at the right range to work effectively.
Children with Crohn's disease often have more severe disease than adults, but current dosing for this medication is based mainly on adult studies. Recent research suggests children may not get enough medication with standard dosing, especially younger children, which can allow the disease to progress. This trial aims to find a better dosing approach specifically designed for children.
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You will receive the medication by intravenous infusion (through an IV) at several visits during the first few months. The treatment starts with a higher dose at week 0, then continues with smaller doses at weeks 2, 4, and 8. After that, you'll continue receiving maintenance infusions every 6 weeks. Throughout the trial, your doctor will monitor how well the medication is working, check your blood levels to see how your body is processing the drug, and watch for any side effects.
AI-generated summary from trial data · Jun 5, 2026 · Not medical advice
Netherlands