Can a higher dose of ustekinumab rescue Crohn's patients who lost response?

NCT ID NCT04245215

Completed Disease control Sponsor: Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jul 02, 2026 · Updated 3 times

Summary

This study looked at 108 adults with Crohn's disease whose symptoms returned while on standard ustekinumab treatment. Researchers gave them a re-induction infusion and then split them into two groups: one continued the usual shot every 8 weeks, the other got a shot every 4 weeks. The goal was to see if the higher dose could bring back remission and reduce gut inflammation.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: ustekinumab (a biologic drug given as an infusion or injection)
What this could lead to: If successful, this could show that increasing the dose of ustekinumab helps regain control of Crohn's disease in people who stopped responding to the standard dose.
What could go wrong: This is a small, completed Phase 3 trial with only 108 participants. The results may not apply to all Crohn's patients, and dose escalation can increase side effects like infections.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

Crohn disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

CROHN DISEASE

Contacts and locations

Locations

Ingrid Arijs

Zaventem, 1930, Belgium

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