NCT02648581

Efficacy and Safety of Ustekinumab, a Human Monoclonal Anti-IL-12/IL-23 Antibody, in Patients With Behçet Disease

A Phase 2 Open-Label Study to Evaluate the Efficacy and Safety of Ustekinumab, a Human Monoclonal Anti-IL-12/IL-23 Antibody, in Patients With Behçet Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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)

Detailed description

Behçet disease (BD) is a chronic systemic inflammatory disorder at the crossroad between autoimmune and autoinflammatory syndromes. Two recent large genome-wide association studies (GWAS) conducted in Turkey and Japan reported association between single nucleotide polymorphism (SNP) of interleukin (IL)-10 and IL-23R/IL-12RB2 genes and BD. Interleukin-12 and interleukin-23, cytokines that induce naive CD4+ lymphocytes to differentiate into type 1 helper T cells (Th1 cells) and type 17 helper T cells (Th17 cells), respectively, have been identified as key mediators of BD. Promotion of Th1 and Th17 responses and suppression of regulatory T cells correlate with BD activity. Due to the lack of an etiologic agent, the treatment is symptomatic without consensus. The goals are the functional recovery of a visceral involvement (eye, central nervous system) and prevention of relapse(s). The risks of BD are an increased mortality especially in case of arterial involvement, and a high morbidity due to the cumulative sequelae of ocular and neurological involvement. Steroids are the corner stone of the antiinflammatory agents administered topically or systemically. Relapses are frequently seen after discontinuation of steroids, and corticodependence is frequently observed leading to the use of immunosuppressive drugs. Biologic agents that selectively block steps in the inflammatory cascade could provide additional therapies for BD.

Conditions

• Behçet Disease

Interventions

Type	Name	Description
DRUG	Subcutaneous Ustekinumab	Injections 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.

Timeline

• Start date: 2017-06-14
• Primary completion: 2019-05-07
• Completion: 2019-11-19
• First posted: 2016-01-07
• Last updated: 2025-09-08

Locations

1 site across 1 country: France