Efficacy and Safety of Ustekinumab in Bullous Pemphigoid (PB-USTE)

• ClinicalTrials.gov Identifier: NCT04117932
• Recruitment Status: Completed
• First Posted: October 7, 2019
• Last Update Posted: August 8, 2023
• Sponsor: CHU de Reims
• Information provided by (Responsible Party): CHU de Reims

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 (Clinical Trial)
• Actual 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: March 11, 2020
• Actual Primary Completion Date: December 22, 2022
• Actual Study Completion Date: June 22, 2023

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).

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

France

Damien JOLLY

Reims, France

Sponsors and Collaborators

CHU de Reims

More Information

• Responsible Party: CHU de Reims
• ClinicalTrials.gov Identifier: NCT04117932
• Other Study ID Numbers: PO19083
• First Posted: October 7, 2019
• Last Update Posted: August 8, 2023
• Last Verified: March 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by CHU de Reims:

bullous pemphigoid; ustekinumab; superpotent topical corticosteroids; efficacy; safety

Additional relevant MeSH terms:

Pemphigoid, Bullous; Skin Diseases, Vesiculobullous; Skin Diseases; Autoimmune Diseases; Immune System Diseases; Ustekinumab; Dermatologic Agents