RECRUITING

Efficacy of Guselkumab in Treating Hailey Hailey Disease

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Hailey Hailey Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2025-01
Study Completion:2025-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06651489

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * A documented diagnosis of Hailey-Hailey disease confirmed with clinical, and histopathologic findings
  2. * Disease affecting more than one body site with at least moderate severity
  3. * 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.
  4. * Patients must be willing to have skin biopsies, blood collection, and total body photography and to comply with clinic visits
  1. * 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).
  2. * Patients known to be HIV or hepatitis B or C positive.
  3. * Patients planning to receive live vaccines during the duration of the study.
  4. * Patients with a positive tuberculin skin test or positive QuantiFERON TB test.
  5. * Patients with significant hepatic impairment (Child-Pugh class B and C).
  6. * 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.
  7. * 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.
  8. * Prior biologic use within the last 3 months.
  9. * Participant has known allergies, hypersensitivity, or intolerance to guselkumab or its excipients (refer to Investigator's brochure)
  10. * 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.
  11. * 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.
  12. * Symptomatic herpes zoster infection within 12 weeks of screening or recurrent or disseminated (even a single episode) herpes zoster.
  13. * Symptomatic herpes simplex or disseminated (even a single episode) herpes simplex at the Week 0 (baseline) visit.
  14. * 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.

Contacts and Locations

Study Contact

Caroline Echeandia-Francis, BA
CONTACT
203-785-2789
caroline.francis@yale.edu
Sheila Garcia, BS
CONTACT
475-321-0545
Sheila.garcia@yale.edu

Principal Investigator

Keith Choate, MD, PhD
PRINCIPAL_INVESTIGATOR
Yale School of Medicine

Study Locations (Sites)

Church Street Research Unit, Yale Center for Clinical Investigation
New Haven, Connecticut, 06520
United States

Collaborators and Investigators

Sponsor: Yale University

  • Keith Choate, MD, PhD, PRINCIPAL_INVESTIGATOR, Yale School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01
Study Completion Date2025-11

Study Record Updates

Study Start Date2025-01
Study Completion Date2025-11

Terms related to this study

Additional Relevant MeSH Terms

  • Hailey Hailey Disease