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A Study of KB111 for Hailey-Hailey Disease

This study is looking at a treatment called KB111 for people with Hailey-Hailey Disease (HHD), a skin condition. KB111 is a gel applied to the skin that contains a modified virus designed to deliver a specific protein (ATP2C1) that is missing or not working correctly in HHD. The main goal is to see how safe KB111 is and if people can tolerate it over 12 weeks. Researchers will also look at how well it works to improve HHD lesions. You might be able to join if you are 12 years or older, have a confirmed diagnosis of HHD with genetic testing, and are willing to follow study procedures. This study is currently unclear on its recruitment status and plans to enroll up to 7 participants.

Study design
This is an open-label study, meaning both you and the study team will know you are receiving KB111. It will include up to 7 participants.
What's involved
You would apply KB111 to your skin at home for 12 weeks. The study team will contact you weekly to check for any side effects or changes.
Compensation
Not stated in the trial record.
Follow-up
There will be a safety follow-up visit 4 weeks after your treatment with KB111 stops.

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NCT07717346

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

Recruiting
EARLY_PHASE1Ages 12+InterventionalTreatment
Krystal Biotech, Inc.
~7 participants
Updated 2026-07-21 on ClinicalTrials.gov
What's tested:KB111

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To evaluate the safety and tolerability of KB111
Measured over 12 weeks

Conditions

Hailey Hailey Disease
Skin Diseases
Lesion Skin

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Where it's being run

1 sites across 1 states
Florida1

Who to contact

Brittani Agostini
[email protected]
412-586-5830
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • To evaluate the safety and tolerability of KB11112 weeks

    Number of subjects with treatment related adverse events as assessed by CTCAE v5