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

Sponsor

CHU de Reims (Other)

Overall Status

Recruiting

CT.gov ID

NCT04117932

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bullous Pemphigoid	Drug: Ustekinumab	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

18 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Efficacy and Safety of Ustekinumab in Bullous Pemphigoid

Actual Study Start Date :

Mar 11, 2020

Anticipated Primary Completion Date :

Oct 11, 2023

Anticipated Study Completion Date :

Apr 11, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm "ustekinumab" Patients with bullous pemphigoid, treated using ustekinumab in association during 8 weeks with superpotent topical corticosteroids	Drug: Ustekinumab 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).

Arm

Intervention/Treatment

Experimental: Arm "ustekinumab"

Patients with bullous pemphigoid, treated using ustekinumab in association during 8 weeks with superpotent topical corticosteroids

Drug: Ustekinumab

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).

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.