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RECRUITING
NCT06651489
PHASE2

Efficacy of Guselkumab in Treating Hailey Hailey Disease

Sponsor: Yale University

View on ClinicalTrials.gov

Summary

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.

Official title: Efficacy of Guselkumab in the Treatment of Hailey Hailey Disease: An Open-label, Proof of Concept Study

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2025-03-13

Completion Date

2026-04

Last Updated

2025-12-04

Healthy Volunteers

Yes

Interventions

DRUG

Guselkumab

Subcutaneous injection of 100 mg at Weeks 0, 4, 12, and 20

Locations (1)

Church Street Research Unit, Yale Center for Clinical Investigation

New Haven, Connecticut, United States