Efficacy and Safety of Ustekinumab in Bullous Pemphigoid

Phase 2

Completed

• Conditions: Bullous Pemphigoid
• Interventions: Drug: Ustekinumab

• Registration Number: NCT04117932
• Lead Sponsor: CHU de Reims

Brief 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.

Detailed 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

Study Timeline

• Study First Submitted: 2019-10-04
• Study First Submitted QC: 2019-10-04
• Study First Posted: 2019-10-07
• Study Start: 2020-03-11
• Status Verified: 2022-03
• Primary Completion: 2022-12-22
• Study Completion: 2023-06-22
• Last Update Submitted: 2023-08-07
• Last Update Posted: 2023-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm "ustekinumab"	Ustekinumab	Patients with bullous pemphigoid, treated using ustekinumab in association during 8 weeks with superpotent topical corticosteroids

Primary Outcome Measures

Name	Time	Method
complete remission	28 weeks	Complete remission is defined as the absence of new or established lesions (bullae, eczematous lesions or urticarial lesions)

Trial Locations

Locations (1)

Damien JOLLY; 🇫🇷 Reims, France