Recruiting
Early Phase 1

KB111

Sponsor:

Krystal Biotech, Inc.

Code:

NCT07717346

Conditions

Hailey Hailey Disease

Skin Diseases

Lesion Skin

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Interventions

KB111

Study Details

Brief summary:

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

Conditions

Hailey Hailey Disease

Skin Diseases

Lesion Skin

Study ID

NCT07717346

Start date

May 6, 2026

Status verified date

Jul, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Participant who is pregnant or nursing
  • Participant who is unwilling to comply with contraception requirements per protocol (for subjects of child-bearing potential)
  • 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
  • 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

Study Design

Enrollment

7 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: KB111

KB111

Interventions

KB111

KB111 is a replication-defective, non-integrating herpes simplex virus (HSV-1)-based vector encoding functional, full-length human ATP2C1 protein combined with a gel for topical application.

Primary outcome measure

  • To evaluate the safety and tolerability of KB111 [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Brittani Agostini

412-586-5830CNE@krystalbio.com

Locations

Pediatric Skin Research

Recruiting

Miami, Florida, United States, 33156

Contacts

Jean Marco Varanese

+1 786-585-5774

More Information

Sponsor

Krystal Biotech, Inc.

Last update posted

Jul 21, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-22. This information was provided to ClinicalTrials.gov by Krystal Biotech, Inc. on 2026-07-21.