An Open-Label Study to Investigate Safety and Preliminary Efficacy of KB111 for the Treatment of Hailey-Hailey Disease

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

An open-label study to evaluate the safety and efficacy of KB111 in pediatric and adult subjects with Hailey-Hailey Disease

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:

• 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

• Aged ≥ 12 years of age at the time of informed consent/assent

• Documented clinical diagnosis of HHD with confirmed ATP2C1 variant by genetic testing

• A negative pregnancy test prior to initial dose for subjects of child-bearing potential

• If taking systemic therapies, subject must be on a stable dosing regimen 1 month prior to Screening and throughout the 12-week treatment period

• 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

Locations
United States
Florida
Pediatric Skin Research
RECRUITING
Miami
Contact Information
Primary
Brittani Agostini
CNE@krystalbio.com
412-586-5830
Time Frame
Start Date: 2026-05-06
Estimated Completion Date: 2026-12
Participants
Target number of participants: 7
Treatments
Experimental: KB111
KB111
Related Therapeutic Areas
Sponsors
Leads: Krystal Biotech, Inc.

This content was sourced from clinicaltrials.gov