KB801 for Keratitis

(EMERALD-1 Trial)

Recruiting at 5 trial locations

Overseen By Brittani Agostini, RN, CCRC

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Krystal Biotech, Inc.

Must not be taking: Topical treatments

Disqualifiers: Active ocular infection, Corneal ulceration, Diabetes, Autoimmune disease, others

Compensation: Varies

Number of Visits: 2

Duration: 8 weeks

27 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for adults over 18 with Stage 2 or 3 Neurotrophic Keratitis, a condition affecting the cornea. Participants must have persistent corneal defects and decreased sensitivity but no active infections or inflammation unrelated to NK. They should not be pregnant, nursing, or unwilling to use contraception and must agree to follow study procedures.

Inclusion Criteria

A negative pregnancy test at Screening 1 and Day 1 for women of child-bearing potential

The subject 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

PCED at Screening 1 must have a minimum of 1 mm of any linear measurement of defect

Exclusion Criteria

I do not have an active eye infection or inflammation unrelated to my condition.

I haven't used any disallowed treatments for my condition.

PCED at Screening 1 or 2 of > 8 mm maximum linear measurement in any eye

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive KB801 or placebo topically to the study eye twice weekly for 8 weeks

8 weeks

Follow-up

Participants are monitored for safety and durability of corneal healing after treatment

12 weeks

Follow-up visits at 2 and 12 weeks after treatment, then every 3 months up to 1 year

Treatment Details

Interventions

• KB801

Trial Overview KB801, a new treatment using a modified herpes virus to deliver nerve growth factor to the eye's surface, is being tested against a placebo in people with advanced neurotrophic keratitis. This double-masked study means neither participants nor researchers know who receives the real treatment.

Participant Groups

Group I: KB801 Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Krystal Biotech, Inc.

Lead Sponsor

Trials

15

Recruited

770+