[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hailey-hailey-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hailey-hailey-disease":68},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100648038","early-phase-1-a-study-to-investigate-safety-and-efficacy-of-kb111-for-the-treatment-of-hailey-hailey-disease-100648038",false,"NCT07717346","A Study to Investigate Safety and Efficacy of KB111 for the Treatment of Hailey-Hailey Disease","An Open-Label Study to Investigate Safety and Preliminary Efficacy of KB111 for the Treatment of Hailey-Hailey Disease","HALITE-1","Inclusion Criteria:\n\n* The participant must have read, understood, and signed an Institutional Review Board (IRB)- approved Informed Consent Form and must be willing and able to comply with study procedures and instructions\n* Aged ≥ 12 years of age at the time of informed consent\u002Fassent\n* Documented clinical diagnosis of HHD with confirmed ATP2C1 variant by genetic testing\n* A negative pregnancy test prior to initial dose for subjects of child-bearing potential\n* If taking systemic therapies, subject must be on a stable dosing regimen 1 month prior to Screening and throughout the 12-week treatment period\n* An acceptable form of contraception must be taken from the first dose (Week 1) through 3 months after the last dose of IP for subjects of childbearing potential\n\nExclusion Criteria:\n\n* Participation in another clinical study or treatment with an investigational agent 30 days or 5 half-lives, whichever is longer, prior to initial dosing in Week 1\n* Participant who is pregnant or nursing\n* Participant who is unwilling to comply with contraception requirements per protocol (for subjects of child-bearing potential)\n* Participant who is known to be non-compliant or is unlikely to comply with the requirements of the study protocol, in the opinion of the Investigator\n* Presence of any dermatologic or systemic condition that might hinder the efficacy of the study treatment or its evaluation, could possibly interfere with the interpretation of study results, or could be judged by the Investigator to be incompatible with the study visit schedule or conduct","ALL","12 Years",{"count":20,"type":21},7,"ESTIMATED","INTERVENTIONAL",[24],"EARLY_PHASE1","An open-label study to evaluate the safety and efficacy of KB111 in pediatric and adult subjects with Hailey-Hailey Disease",[27,28,29],"Hailey Hailey Disease","Skin Diseases","Lesion Skin","RECRUITING","2026-07-16",{"date":33,"type":34},"2026-07-21","ACTUAL",{"date":36,"type":34},"2026-05-06",{"date":38,"type":21},"2026-12",{"name":40,"class":41},"Krystal Biotech, Inc.","INDUSTRY",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":50,"sex":17,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":65,"locationsCount":42},"100566154","phase-2-efficacy-of-guselkumab-in-treating-hailey-hailey-disease-100566154","NCT06651489","Efficacy of Guselkumab in Treating Hailey Hailey Disease","Efficacy of Guselkumab in the Treatment of Hailey Hailey Disease: An Open-label, Proof of Concept Study","Inclusion Criteria:\n\n* A documented diagnosis of Hailey-Hailey disease confirmed with clinical, and histopathologic findings\n* Disease affecting more than one body site with at least moderate severity\n* 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.\n* Patients must be willing to have skin biopsies, blood collection, and total body photography and to comply with clinic visits\n\nExclusion Criteria:\n\n* 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).\n* Patients known to be HIV or hepatitis B or C positive.\n* Patients planning to receive live vaccines during the duration of the study.\n* Patients with a positive tuberculin skin test or positive QuantiFERON TB test.\n* Patients with significant hepatic impairment (Child-Pugh class B and C).\n* 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.\n* 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.\n* Prior biologic use within the last 3 months.\n* Participant has known allergies, hypersensitivity, or intolerance to guselkumab or its excipients (refer to Investigator's brochure)\n* 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.\n* 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.\n* Symptomatic herpes zoster infection within 12 weeks of screening or recurrent or disseminated (even a single episode) herpes zoster.\n* Symptomatic herpes simplex or disseminated (even a single episode) herpes simplex at the Week 0 (baseline) visit.\n* 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.",true,"18 Years","90 Years",{"count":54,"type":21},10,[56],"PHASE2","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.\n\nSeveral treatment options have been proposed for this chronic and disabling disorder, however, there is no reproducibly effective therapeutic for it.\n\nThe 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.",[27],"2026-06-17",{"date":61,"type":34},"2026-06-22",{"date":63,"type":34},"2025-03-13",{"date":38,"type":21},{"name":66,"class":67},"Yale University","OTHER","Hailey-Hailey Disease"]