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 type | Interventional |
|---|---|
| Ages | 6 Years to 17 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Centre Hospitalier Universitaire de Nice Academic / other |
| Drugs / interventions | Ustekinumab, infliximab, adalimumab |
| Locations | 1 site (Nice, France) |
| Status | Recruiting |
| Started | April 20, 2026 |
| Main results expected | October 1, 2027 |
| Study ends | October 1, 2027 |
| Registry record updated | June 25, 2026 |
| Trial ID | NCT07529236 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
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CHU de Nice
Nice, France, France Recruiting
Study contacts
- Principal investigator: Christine CHIAVERINI — Centre Hospitalier Universitaire de Nice
- Study coordinator: Christine Chiaverini, Dr
- Email: chiaverini.c@chu-nice.fr
- Phone: 04 92 03 47 02
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Guselkumab after Ustekinumab in adults with moderate-to-severe psoriasis in routine care
This study looks at how well guselkumab works for people with moderate-to-severe psoriasis after switching from ustekinumab in everyday clinical practice.
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Guselkumab for adults with Crohn's disease after ustekinumab failure
This study will try guselkumab for adults with moderate to severe Crohn's disease who did not respond to or could not tolerate ustekinumab to see if they reach remission after 52 weeks.
-
Guselkumab vs Ustekinumab for stricturing Crohn's disease
This study will follow adults with moderate-to-severe Crohn's disease and confirmed intestinal strictures to see if treatment with guselkumab or ustekinumab better controls obstructive symptoms and disease activity.
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Guselkumab for Chinese patients with Crohn's disease who stopped responding to ustekinumab
This study tests whether guselkumab can help Chinese patients with active Crohn's disease who initially responded to ustekinumab but later lost response.
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Reducing ustekinumab dosing for Crohn's disease and ulcerative colitis
This will try giving ustekinumab less often—changing from every 4 or 8 weeks to every 8 or 12 weeks—to see if people with Crohn's disease or ulcerative colitis in deep remission can stay well.
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Switching to guselkumab for adults with active IBD after ustekinumab
We will try guselkumab (Tremfya) in adults with active IBD whose symptoms didn't improve enough on ustekinumab.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.