A Study Comparing KB801 Verse Placebo in Patients With Stage 2 or 3 Neurotrophic Keratitis

Part of paid clinical trials in Irvine, California.

Sponsor: Krystal Biotech, Inc.
Study ID: NCT06999733
Phase: PHASE1/PHASE2
Status: Recruiting

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Conditions

Neurotrophic Keratitis

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

KB801 — BIOLOGICAL
Ophthalmic suspension of replication-defective, non-integrating herpes simplex virus type 1 (HSV-1)-based vector delivering functional, full-length human nerve growth factor (NGF)
Placebo — DRUG
Vehicle

Study Details

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.

Key Dates

Start date: Jul 7, 2025
Status verified: Feb 2026
Primary completion: Dec 31, 2026
Completion: Dec 31, 2027

Study Design

Enrollment: 60 participants (estimated)
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Arms

Experimental: KB801
Placebo Comparator: Placebo

Primary Outcome Measure

To evaluate safety and tolerability of KB801 based upon assessment of adverse events (frequency, severity, relatedness). [ Time Frame: 8 weeks ]

Central Contacts

David Sweet, MD, PhD
412-586-5830
[email protected]
Brittani Agostini, RN, CCRC
412-586-5830
[email protected]

Locations (9)

Facility	City	State	ZIP	Site coordinators
UC Irvine Alpha Clinic	Irvine	California	92617	UC Irvine Alpha Clinic [email protected] 949-824-3990
Azul Vision - California Eye Specialists Medical Group Inc.	Pasadena	California	91107	Kaci Taylor [email protected] 626-792-1074
Midwest Cornea Associates	Carmel	Indiana	46290	Chris Bartizal, BS [email protected] 317-805-4527
Vance Thompson Vision	Alexandria	Minnesota	56308	Miranda Danielson [email protected] 320-762-2166 Bailee Larson [email protected] 320-762-2166
Minnesota Eye Consultants	Minnetonka	Minnesota	55305	Allison Dreyer [email protected] 952-567-6111
St. Louis Eye Institute	Town and Country	Missouri	63017	Abigail Carpenter [email protected] 314-254-3818 Main Office 314-326-4800
Metropolitan Eye Research and Surgery Institute	Palisades Park	New Jersey	07650	Sachi Desai [email protected] 201-461-3970
Vance Thompson Vision	West Fargo	North Dakota	58078	Hannah Christensen [email protected] 701-369-9022 McKenzie Schueller [email protected] 701-205-0935
UPMC Vision Institute	Pittsburgh	Pennsylvania	15219	UPMC Vision Institute Clinical Trials Team [email protected] 412-642-7888

Find similar trials in Irvine, CA

By research site

UC Irvine Alpha Clinic· Irvine, CA Azul Vision - California Eye Specialists Medical Group Inc.· Pasadena, CA Midwest Cornea Associates· Carmel, IN Vance Thompson Vision· Alexandria, MN Minnesota Eye Consultants· Minnetonka, MN St. Louis Eye Institute· Town and Country, MO

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