Clinical trial Recruiting at 1 site Interventional Ages 6 to 17

Switching to ustekinumab for kids with Crohn's or ulcerative colitis who developed psoriasis after anti-TNF therapy

Official title: Digestive Evolution of Children With Crohn's Disease or Ulcerative Colitis Whose Anti-TNFα Was Switched to Ustekinumab Due to Paradoxical Psoriasis: Real Life Data

Run by Centre Hospitalier Universitaire de Nice · NCT07529236 · Data updated 2026-11-12

This study tests whether switching to ustekinumab helps children with inflammatory bowel disease who developed psoriasis while on anti-TNF drugs.

Quick facts

Study typeInterventional
Ages6 Years to 17 Years
SexAll
Enrollment40 (estimated)
SponsorCentre Hospitalier Universitaire de Nice
Academic / other
Drugs / interventionsUstekinumab, infliximab, adalimumab
Locations1 site (Nice, France)
StatusRecruiting
StartedApril 20, 2026
Main results expectedOctober 1, 2027
Study endsOctober 1, 2027
Registry record updatedJune 25, 2026
Trial IDNCT07529236 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are under 19 with confirmed IBD who developed severe paradoxical psoriasis while on an anti-TNF and who have already switched to ustekinumab.

Probably not a fit

Patients for whom psoriasis or IBD does not respond to ustekinumab, or who have >18 years of age, may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study focuses on pediatric patients with Crohn's disease or ulcerative colitis who have stopped an anti-TNF medication due to a paradoxical psoriasiform skin eruption. Eligible participants are under 19, have confirmed IBD, and have used an anti-TNF for at least three months with a dermatologist-confirmed severe psoriasis resistant to standard treatments. The intervention involves switching from the anti-TNF agent to ustekinumab and observing the effects on IBD symptoms and skin findings. The trial is conducted at CHU de Nice in Nice, France, led by Centre Hospitalier Universitaire de Nice, with no listed collaborators. Primary endpoints are not specified in the provided description, but the focus is on safety and clinical response after switching therapy.

Why it matters

Potential benefit: If successful, patients may experience both skin improvement and better control of IBD symptoms after switching to ustekinumab.

How similar studies have gone: There is precedent in European guidelines recommending ustekinumab after anti-TNF–related paradoxical psoriasis, with some supportive data in pediatric contexts, but the evidence base remains limited.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Patients capable of giving their non-opposition
2. Patient \<19 years
3. Diagnosis of IBD established
4. Having received an anti-TNFα for IBD for at least 3 months
5. Having stopped the anti-TNFα for a severe paradoxical psoriasis resistant to usual treatments (topical or systemic) diagnosed by a dermatologist
6. Having received Ustekinumab in relay of the anti-TNFα

Exclusion Criteria:

1. Patient \> 18 years
2. Diagnosis of IBD not confirmed
3. Discontinuation of anti-TNFα for a cause other than psoriasis

Where it's running

  • CHU de Nice
    Nice, France, France
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.