Guselkumab treatment for Hailey-Hailey disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the efficacy and safety of guselkumab, a medication typically used for psoriasis, in treating Hailey-Hailey disease, a chronic genetic skin disorder. Participants will receive guselkumab at a standard dosage and will be monitored through clinical follow-ups at 4, 12, and 24 weeks after treatment initiation. The study includes laboratory monitoring and the collection of skin biopsies and blood samples to assess treatment response and safety. This is a single-center, non-randomized, open-label phase II trial.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* A documented diagnosis of Hailey-Hailey disease confirmed with clinical, and histopathologic findings
* Disease affecting more than one body site with at least moderate severity
* If patients are taking other systemic therapies for their HHD (antibiotics, prednisone), they must be taking a stable dose of the other medication(s) for at least 3 months with no plans to change the regimen in the next 6 months. With the exception of antibiotics, methotrexate or low dose prednisone (less than 5 mg daily), use of concomitant immunosuppressants, e.g. azathioprine, etc. and biologics other than TNF-α inhibitors will not be permitted.
* Patients must be willing to have skin biopsies, blood collection, and total body photography and to comply with clinic visits

Exclusion Criteria:

* Patients with a history of malignancy (except history of successfully treated basal cell or squamous cell carcinoma of the skin over six months prior to first study drug administration).
* Patients known to be HIV or hepatitis B or C positive.
* Patients planning to receive live vaccines during the duration of the study.
* Patients with a positive tuberculin skin test or positive QuantiFERON TB test.
* Patients with significant hepatic impairment (Child-Pugh class B and C).
* Patients taking immunosuppressive and biologic medications, except for methotrexate, low-dose prednisone, and TNF-α inhibitors, including but not limited to mycophenolate mofetil, azathioprine, tacrolimus, and cyclosporine.
* Are pregnant, nursing, or planning a pregnancy while enrolled in the study or for 12 weeks after the study agent injection for women or are planning to father a child while enrolled in the study or for 12 weeks after the last study agent injection.
* Prior biologic use within the last 3 months.
* Participant has known allergies, hypersensitivity, or intolerance to guselkumab or its excipients (refer to Investigator's brochure)
* Presence of significant uncontrolled respiratory, hepatic, renal, endocrine, hematologic, neurologic, or neuropsychiatric disorders, or abnormal laboratory screening values that, in the opinion of the investigator, pose an unacceptable risk to the subject if participating in the study or of interfering with the interpretation of the data.
* Active, untreated, acute infection, or immunocompromised to an extent that participation in the study would pose an unacceptable risk to the subject based on the investigator's clinical assessment.
* Symptomatic herpes zoster infection within 12 weeks of screening or recurrent or disseminated (even a single episode) herpes zoster.
* Symptomatic herpes simplex or disseminated (even a single episode) herpes simplex at the Week 0 (baseline) visit.
* Patients with the potential for keloid formation, e.g. patients with a propensity for keloid formation, defined as a personal history of 3 or more keloids.

Where it's running

• Church Street Research Unit, Yale Center for Clinical Investigation
  New Haven, Connecticut, United States Recruiting

Study contacts

• Principal investigator: Keith Choate, MD, PhD — Yale University
• Study coordinator: Caroline Echeandia-Francis, BA
• Email: caroline.francis@yale.edu
• Phone: 203-785-2789

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Long-Term Guselkumab Use in Adults with Inflammatory Bowel Disease

  This study looks at how long adults with Crohn's disease or ulcerative colitis stay on guselkumab in real-world care.

  Recruiting Janssen Research & Development, LLC · Amiens · NCT07822529

• Colonic delivery of two antibodies to see if they reach the bloodstream in healthy people

  This early study tests whether guselkumab and adalimumab given directly into the colon can enter the body in healthy adults.

  Recruiting Phase 1 Surmount Services, Inc. · Maroochydore, Queensland · NCT07788807

• Guselkumab after Ustekinumab in adults with moderate-to-severe psoriasis in routine care

  This study looks at how well guselkumab works for people with moderate-to-severe psoriasis after switching from ustekinumab in everyday clinical practice.

  Recruiting Janssen-Cilag Kft. · Budapest · NCT07746583

• Guselkumab in Moderate-to-Severe Ulcerative Colitis: Real-World Experience

  This real-world study tests whether guselkumab helps adults with moderate-to-severe ulcerative colitis and how safe it is for them.

  Recruiting Second Affiliated Hospital of Wenzhou Medical University · Wenzhou, Zhejiang · NCT07726888

• Topical KB111 for Hailey-Hailey Disease (early phase, kids and adults)

  This study tests whether a topical KB111 treatment is safe and helps with lesions in people with Hailey-Hailey disease, including adolescents and adults.

  Recruiting Early Phase 1 Krystal Biotech, Inc. · Miami, Florida · NCT07717346

• Guselkumab in Crohn's Disease: Optimising Care for Real-World Patients (OPTIM Study A)

  This study tests whether guselkumab can help adults with Crohn's disease, including those who have had prior therapies or partial responses, when used in real-world clinical settings.

  Recruiting Phase 4 Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives · Amiens · NCT07616687

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.