Switching adults with Crohn's disease from Stelara (ustekinumab) to the biosimilar Uzpruvo
Acceptability and Therapeutic Maintenance of the Biosimilar Ustekinumab After Substitution
This will see if adults with stable Crohn's disease who switch from Stelara® to the biosimilar Uzpruvo® stay on the biosimilar and remain well over 12 months.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 246 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | EG Labo Industry-sponsored |
| Drugs / interventions | ustekinumab |
| Locations | 11 sites (Amiens and 10 other locations) |
| Trial ID | NCT07077681 on ClinicalTrials.gov |
What this trial studies
This is a prospective, open-label, multicenter observational cohort following adults with Crohn's disease whose physician and who have agreed to switch from Stelara® to the biosimilar Uzpruvo®. The switch is made as part of routine care, with physicians keeping full discretion over dosing and treatment decisions and patients completing online self-assessment questionnaires. The primary endpoint is maintenance on the biosimilar at 12 months without returning to the reference product, with secondary outcomes including quality of life, clinical remission rates, tolerability, patient satisfaction, and reasons for discontinuation. No extra medical procedures are mandated beyond standard follow-up.
Who should consider this trial
Good fit: Adults (18+) with moderate-to-severe Crohn's disease in stable remission on Stelara® (dosed every 8–12 weeks, stable dose for ≥24 weeks, no corticosteroids for ≥3 months) who agreed with their physician to switch to Uzpruvo® and can complete online questionnaires are ideal candidates.
Not a fit: Patients with active disease, injections at intervals under 8 weeks, prior intolerance to ustekinumab, unwillingness to switch, or inability to complete online follow‑up are unlikely to benefit from this observational switch pathway.
Why it matters
Potential benefit: If successful, this could show that patients can safely remain on the less expensive biosimilar for a year while keeping disease control, which may improve access and reduce costs.
How similar studies have performed: Switching from originator biologics to biosimilars has generally shown comparable safety and effectiveness for other biologics and indications, though long-term data specifically for Stelara® to Uzpruvo® remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient aged 18 years or older * Patient who has agreed to participate in the study and does not oppose the use of their health data * Patient with moderate to severe Crohn's disease treated with Stelara® in a pre-filled syringe according to the summary of product characteristics (SPC) with intervals of 8 or 12 weeks between injections * Patients presenting at least one of the following objective criteria: o PCR \< 5 mg/l o Calprotectin \< 250 μg/g o Harvey-Bradshaw index \< 5 * Patient in stable remission (defined by a stable ustekinumab dosage over the last 24 weeks and absence of corticosteroids for at least 3 months)• Patient for whom the investigator physician, prior to inclusion, has decided with their agreement, to replace Stelara® with Uzpruvo® * Patient having internet access enabling them to complete online questionnaires Exclusion Criteria: * Patient treated with ustekinumab with intervals between injections less than 8 weeks * Patients treated with ustekinumab in a pre-filled pen * Patient included in an interventional clinical trial at the time of inclusion * Patient refusing or unable to comply with the study follow-up procedures (patient unreachable by phone, unable to fill out the self-questionnaire or poorly speaking French...) * Patient under legal protection, under guardianship or under curatorship.
Where this trial is running
Amiens and 10 other locations
- Cabinet Medical — Amiens, France (Recruiting)
- Chu de La Côte Basque — Bayonne, France (Recruiting)
- Chu Besançon - Hopital Jean Minjoz — Besançon, France (Not_yet_recruiting)
- Chu La Cavale Blanche — Brest, France (Recruiting)
- Chu Montpellier - Hopital Saint Eloi — Montpellier, France (Recruiting)
- Chu Nantes — Nantes, France (Recruiting)
- Clinique Jules Verne — Nantes, France (Recruiting)
- Institut Des Mici Groupe Hospitalier — Neuilly-sur-Seine, France (Recruiting)
- Chu Lyon Sud — Pierre-Bénite, France (Recruiting)
- CHU Rouen Normandie — Rouen, France (Recruiting)
- Chu Nancy Brabois — Vandœuvre-lès-Nancy, France (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.