Efficacy and Safety of Ustekinumab, a Human Monoclonal Anti-IL-12/IL-23 Antibody, in Patients With Behçet Disease
- Sponsor
- Assistance Publique - Hôpitaux de Paris
- Study ID
- NCT02648581
- Phase
- PHASE2
- Status
- Completed
Conditions
- Behçet Disease
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Subcutaneous Ustekinumab — DRUGInjections of ustekinumab at 90 mg at week 0, week 4 and week 16. Patients in treatment failure at week 24 will terminate the study. Responder patients at week 24 will receive additional 2 injections of ustekinumab at week 28 and week 40 with a final evaluation at week 52.
Study Details
The purpose of this study is to evaluate the proof of concept of efficacy of ustekinumab in subjects with Behçet disease, including patients with oral ulcers (STELABEC-1) and patients with active posterior uveitis or panuveitis (STELABEC-2)
Key Dates
- Start date
- Jun 14, 2017
- Status verified
- Sep 2025
- Primary completion
- May 7, 2019
- Completion
- Nov 19, 2019
Study Design
- Enrollment
- 16 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Subcutaneous Ustekinumab
Primary Outcome Measure
Number of oral ulcers at week 24 compared to baseline [ Time Frame: 24 weeks ]