Actively Recruiting
Efficacy of Guselkumab in Treating Hailey Hailey Disease
Led by Yale University · Updated on 2025-12-04
10
Participants Needed
1
Research Sites
54 weeks
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
J
Janssen Scientific Affairs, LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy of Guselkumab in Treating Hailey Hailey Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Documented diagnosis of Hailey-Hailey disease confirmed by clinical and histopathologic findings
- Disease affects more than one body site with at least moderate severity
- Stable dose of other systemic therapies for HHD (antibiotics, prednisone) for at least 3 months with no planned changes for 6 months, except for antibiotics, methotrexate, or low-dose prednisone (<5 mg daily)
- Willingness to have skin biopsies, blood collection, total body photography, and comply with clinic visits
You will not qualify if you...
- History of malignancy except treated basal or squamous cell skin carcinoma over 6 months before study drug
- Known HIV or hepatitis B or C infection
- Plans to receive live vaccines during study
- Positive tuberculin skin test or QuantiFERON TB test
- Significant hepatic impairment (Child-Pugh class B or C)
- Use of immunosuppressive or biologic medications other than methotrexate, low-dose prednisone, or TNF-alpha inhibitors
- Pregnant, nursing, planning pregnancy, or planning to father a child during study or for 12 weeks after last dose
- Biologic use within last 3 months
- Known allergy or intolerance to guselkumab or its ingredients
- Significant uncontrolled or abnormal medical conditions posing risk or interfering with data
- Active untreated infection or immunocompromise posing unacceptable risk
- Symptomatic herpes zoster within 12 weeks before screening or recurrent/disseminated herpes zoster
- Symptomatic or disseminated herpes simplex at baseline
- History or risk of keloid formation (3 or more keloids)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Church Street Research Unit, Yale Center for Clinical Investigation
New Haven, Connecticut, United States, 06520
Actively Recruiting
Research Team
C
Caroline Echeandia-Francis, BA
CONTACT
S
Sheila Garcia, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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