Efficacy and Safety of Ustekinumab in Bullous Pemphigoid

Sponsor
CHU de Reims
Study ID
NCT04117932
Phase
PHASE2
Status
Completed

Conditions

  • Bullous Pemphigoid

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • 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).

Study Details

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.

Key Dates

Start date
Mar 11, 2020
Status verified
Mar 2022
Primary completion
Dec 22, 2022
Completion
Jun 22, 2023

Study Design

Enrollment
18 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm "ustekinumab"
    Patients with bullous pemphigoid, treated using ustekinumab in association during 8 weeks with superpotent topical corticosteroids

Primary Outcome Measure

complete remission [ Time Frame: 28 weeks ]

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