Efficacy of Guselkumab in Treating Hailey Hailey Disease
Part of paid clinical trials in New Haven, Connecticut.
- Sponsor
- Yale University
- Study ID
- NCT06651489
- Phase
- PHASE2
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 90 Years
- Healthy Volunteers
- Accepted
Interventions
- Guselkumab — DRUGSubcutaneous injection of 100 mg at Weeks 0, 4, 12, and 20
Study Details
Hailey-Hailey disease (HHD) is a debilitating genetic skin disorder, affecting mainly body folds with erythema and painful erosions and blisters. Histopathological findings include epidermal hyperplasia, suprabasilar clefting, dyskeratosis and acantholysis of keratinocytes. A final diagnosis of HHD is usually confirmed based on clinical and histopathological findings in line with genetic testing. Several treatment options have been proposed for this chronic and disabling disorder, however, there is no reproducibly effective therapeutic for it. The primary objective is to evaluate the treatment response of guselkumab. Single-center, non-randomized, single-arm, open-label, phase II trial to evaluate the efficacy and safety of guselkumab for the treatment of patients with HHD.
Key Dates
- Start date
- Mar 13, 2025
- Status verified
- Dec 2025
- Primary completion
- Apr 30, 2026
- Completion
- Apr 30, 2026
Study Design
- Enrollment
- 10 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: GuselkumabParticipants with HHD with be given guselkumab
Primary Outcome Measure
Change in Physician's Global Assessment (PGA) score [ Time Frame: baseline and week 24 ]
Central Contacts
- Caroline Echeandia-Francis, BA203-785-2789
- Sheila Garcia, BS475-321-0545
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Church Street Research Unit, Yale Center for Clinical Investigation | New Haven | Connecticut | 06520 | - |