drugset / Trial / NCT04117932

Efficacy and Safety of Ustekinumab in Bullous Pemphigoid

NCT04117932

Phase 2 Completed 18 enrolled Reims University Hospital
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2020-03-11
Primary completion
2022-12-22
Completion
2023-06-22

Drugs

EvaluationDrugModalityDoseRoute
Subject Ustekinumab Monoclonal antibody 90 mg Subcutaneous

Indications