Efficacy and Safety of Ustekinumab in Bullous Pemphigoid

Bullous Pemphigoid Clinical Trial

— PB-USTE  

Official title:

Efficacy and Safety of Ustekinumab in Bullous Pemphigoid

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04117932
• Other study ID #: PO19083
• Status: Completed
• Phase: Phase 2
• Start date: March 11, 2020
• Est. completion date: June 22, 2023

Study information

• Verified date: March 2022
• Source: CHU de Reims
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 22, 2023
• Est. primary completion date: December 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bullous Pemphigoid
• Pemphigoid, Bullous

Intervention

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).

Locations

Country	Name	City	State
France	Damien JOLLY	Reims

Sponsors (1)

Lead Sponsor	Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complete remission	Complete remission is defined as the absence of new or established lesions (bullae, eczematous lesions or urticarial lesions)	28 weeks