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Topical KB105 for the Treatment of TGM1-deficient Autosomal Recessive Congenital Ichthyosis (ARCI)

NCT05735158 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2023-02-23

No results posted yet for this study

Summary

KB105-02 is an intrasubject randomized, placebo-controlled, double-blind study to evaluate the safety and efficacy of KB105 in children and adults with autosomal recessive congenital ichthyosis (ARCI).

Conditions

  • Autosomal Recessive Ichthyosis

Interventions

BIOLOGICAL

KB105

Replication-defective, non-integrating HSV-1 vector expressing TGM1 formulated as a topical gel

OTHER

Placebo

Visually matched excipient gel

Sponsors & Collaborators

  • Krystal Biotech, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-31
Primary Completion
2024-03-31
Completion
2024-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05735158 on ClinicalTrials.gov