Efficacy and Safety of Ustekinumab in Bullous Pemphigoid

Who is this study for? Patients with Bullous Pemphigoid
What treatments are being studied? Ustekinumab
Status: Completed
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• patient with bullous pemphigoid

• patient aged between 18 and 90

• patient with Karnofsky Performance score \> 60%

• patient agreed to participate to the study

Locations
Other Locations
France
Damien JOLLY
Reims
Time Frame
Start Date: 2020-03-11
Completion Date: 2023-06-22
Participants
Target number of participants: 18
Treatments
Experimental: Arm ustekinumab
Patients with bullous pemphigoid, treated using ustekinumab in association during 8 weeks with superpotent topical corticosteroids
Related Therapeutic Areas
Sponsors
Leads: CHU de Reims

This content was sourced from clinicaltrials.gov