Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2025-12-31 @ 11:35 PM
Study NCT ID:
NCT06999733
Status:
RECRUITING
Last Update Posted:
2025-05-31
First Post:
2025-05-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Assessing KB801 for the Treatment of Stage 2 or 3 Neurotrophic Keratitis
Sponsor:
Krystal Biotech, Inc.
Organization:
Study Overview
Official Title:
A Phase 1/2, Multicenter, Double-Masked, Placebo-Controlled Study of KB801 in Subjects With Stage 2 or 3 Neurotrophic Keratitis
Status:
RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EMERALD-1
Brief Summary:
The Sponsor is developing KB801, a replication-defective, non-integrating herpes simplex virus type 1 (HSV-1)-derived vector engineered to deliver functional full-length human nerve growth factor (NGF) to the corneas of people with Stage 2 or 3 neurotrophic keratitis (NK) via topical application. This is a Phase 1/2, multicenter, double-masked, placebo-controlled study to evaluate the safety, tolerability, and preliminary efficacy of KB801 in these subjects.
Detailed Description:
Subjects will will be randomized 2:1 to receive KB801 or placebo (vehicle) topically to the study eye twice weekly for 8 weeks. Subjects will return for follow-up visits 2- and 12-weeks after finishing treatment to monitor for safety and durability of corneal healing. Safety follow-up visits will then occur every 3 months up to 1 year on study.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: