Efficacy and Safety of Ustekinumab in Bullous Pemphigoid (PB-USTE)
Primary Purpose
Bullous Pemphigoid
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Ustekinumab
Sponsored by
About this trial
This is an interventional treatment trial for Bullous Pemphigoid focused on measuring bullous pemphigoid, ustekinumab, superpotent topical corticosteroids, efficacy, safety
Eligibility 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.
Sites / Locations
- Damien JOLLY
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm "ustekinumab"
Arm Description
Patients with bullous pemphigoid, treated using ustekinumab in association during 8 weeks with superpotent topical corticosteroids
Outcomes
Primary Outcome Measures
complete remission
Complete remission is defined as the absence of new or established lesions (bullae, eczematous lesions or urticarial lesions)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04117932
Brief Title
Efficacy and Safety of Ustekinumab in Bullous Pemphigoid
Acronym
PB-USTE
Official Title
Efficacy and Safety of Ustekinumab in Bullous Pemphigoid
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
March 11, 2020 (Actual)
Primary Completion Date
December 22, 2022 (Actual)
Study Completion Date
June 22, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Reims
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bullous Pemphigoid
Keywords
bullous pemphigoid, ustekinumab, superpotent topical corticosteroids, efficacy, safety
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm "ustekinumab"
Arm Type
Experimental
Arm Description
Patients with bullous pemphigoid, treated using ustekinumab in association during 8 weeks with superpotent topical corticosteroids
Intervention Type
Drug
Intervention Name(s)
Ustekinumab
Intervention Description
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 Outcome Measure Information:
Title
complete remission
Description
Complete remission is defined as the absence of new or established lesions (bullae, eczematous lesions or urticarial lesions)
Time Frame
28 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Damien JOLLY
City
Reims
Country
France
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Ustekinumab in Bullous Pemphigoid
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