Efficacy and Safety of Ustekinumab in Bullous Pemphigoid

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Bullous Pemphigoid Autoimmune Diseases Immune System Diseases Pemphigoid, Bullous Skin Diseases Skin Diseases, Vesiculobullous Skin and Connective Tissue Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Damien JOLLY

Reims, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

patient with bullous pemphigoid
patient aged between 18 and 90
patient with Karnofsky Performance score > 60%
patient agreed to participate to the study

Exclusion criteria

patient with allergy to corticosteroids
patient with allergy to ustekinumab
patient with any severe medical condition at time of inclusion including stroke, heart failure, renal failure, high blood pressure and diabetes mellitus
malignancy < 5 years prior to inclusion
pregnant or nursing (lactating) women, or women of child-bearing potential
active infection or with recent history of clinically significant infection within 4 weeks prior to inclusion
history or presence of infection with hepatitis B or C.
history or presence of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.

Treatment and study plan

Ustekinumab

Drug

Ustekinumab (90 mg subcutaneously at weeks 0, 4, 16), in association with topical superpotent corticosteroid (10-30 g per day during the first 4 weeks, then every other day during 4 weeks).

Primary outcomes

complete remission

Time frame: 28 weeks

Complete remission is defined as the absence of new or established lesions (bullae, eczematous lesions or urticarial lesions)

Sponsors and collaborators

Lead sponsor

CHU de Reims

Other

Registry information

Acronym: PB-USTE

Important dates

Study start: 2020
Primary completion: 2022
Study completion: 2023
First posted: Oct 7, 2019
Registry last updated: Aug 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed