Efficacy and Safety of Ustekinumab in Bullous Pemphigoid — PB-USTE  

Bullous Pemphigoid Clinical Trial

Official title: Efficacy and Safety of Ustekinumab in Bullous Pemphigoid

Status Completed

Clinical Trial Summary

Bullous pemphigoid (BP) is an autoimmune subepidermal blistering disease and typically affects the elderly. Clinically, BP is an intensely pruritic erythematous eruption with widespread blister formation. BP is usually a chronic disease, with spontaneous exacerbations and remissions, which may be accompanied by significant morbidity.

BP usually requires on average a 1-year duration of treatment. Superpotent topical corticosteroids have been demonstrated to be effective. Despite their high efficacy, topical corticosteroids are often considered as poorly convenient, requiring the assistance of patients' relatives or a nurse to apply the topical treatment on a long period of time.

Overall, whereas BP lesions can be adequately and rapidly controlled with either topical corticosteroids, there is a high need for a safe maintenance therapy to avoid treatment side effects due to cumulative doses of corticosteroids over months.

Newer therapeutic agents such as ustekinumab targeting molecules involved in the inflammatory cascade associated with BP represent future alternatives to classical immunosuppressant drugs for maintenance therapy.

Clinical Trial Description

The aim of the study is to evaluate efficacy of ustekinumab in association during 8 weeks with superpotent topical corticosteroids in patients with bullous pemphigoid ;

Related Conditions & MeSH terms

• Bullous Pemphigoid
• Pemphigoid, Bullous

• NCT number: NCT04117932
• Study type: Interventional
• Source: CHU de Reims
• Status: Completed
• Phase: Phase 2
• Start date: March 11, 2020
• Completion date: June 22, 2023