NCT05735158

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

A Phase 2, Randomized, Placebo-controlled Study of Topical KB105, a Replication-defective, Non-integrating HSV-1 Vector Expressing Human Transglutaminase 1 (TGM1) for the Treatment of TGM1-deficient Autosomal Recessive Congenital Ichthyosis (ARCI)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Krystal Biotech, Inc. · Industry
• Sex: All
• Age: 6 Months
• Healthy volunteers: Not accepted

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

Type	Name	Description
BIOLOGICAL	KB105	Replication-defective, non-integrating HSV-1 vector expressing TGM1 formulated as a topical gel
OTHER	Placebo	Visually matched excipient gel

Timeline

• Start date: 2023-03-01
• Primary completion: 2024-03-01
• Completion: 2024-04-01
• First posted: 2023-02-21
• Last updated: 2023-02-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study