Open-Label Evaluation of KB111 Safety and Early Effectiveness for Treating Hailey-Hailey Disease in Patients Aged 12 and Older

What this Trial Is About

Researchers are evaluating the safety, tolerability, and early effectiveness of KB111, a topical treatment, in both pediatric and adult participants with Hailey-Hailey Disease HHD. This open-label study aims to better understand how KB111 works for managing HHD skin lesions by directly applying the investigational treatment and monitoring its effects over time. Up to 7 participants aged 12 years and older will apply KB111, a gel containing a non-integrating herpes simplex virus vector with the functional ATP2C1 protein, to their skin lesions for 12 weeks. The treatment will be administered at home by a trained person. Throughout the study, investigators or designees will contact participants weekly to check for any side effects or changes in their health or treatments. After the 12-week treatment, participants will have a safety follow-up visit 4 weeks later. During the study, participants will be assessed through investigator evaluations, patient-reported impressions of lesion severity, and molecular analysis of skin biopsies to measure how the treatment affects their condition. Safety and tolerability of KB111 will be monitored closely throughout the treatment and follow-up periods. The total study duration includes 12 weeks of treatment plus the 4-week safety follow-up, with frequent contact to support participant safety and collect data on treatment effects.

A Study to Investigate Safety and Efficacy of KB111 for the Treatment of Hailey-Hailey Disease