Status:
COMPLETED
Efficacy and Safety of Ustekinumab in Bullous Pemphigoid
Lead Sponsor:
CHU de Reims
Conditions:
Bullous Pemphigoid
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
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 format...
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
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
March 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 22 2023
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04117932
Start Date
March 11 2020
End Date
June 22 2023
Last Update
August 8 2023
Active Locations (1)
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1
Damien JOLLY
Reims, France