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A Study Assessing KB801 for the Treatment of Stage 2 or 3 Neurotrophic Keratitis

(EMERALD-1)

Sponsored by Krystal Biotech, Inc.

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Current Status

Recruiting

Auto-verified from ClinicalTrials.gov

Verified Feb 27, 2026

Phase

Clinical Trial

Sponsor

Krystal Biotech, Inc.

Enrollment Target

27

Start Date

May 2025

๐Ÿ“Š
1 of 27 participants interested
4% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

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.

Who Can Participate

Inclusion Criteria

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. 2. Aged โ‰ฅ 18 years at the time of informed consent. 3. Diagnosis of Stage 2 or Stage 3 NK, as defined by the Mackie criteria. 4. Persistent corneal epithelial defect (PCED) of at least 2 weeks duration without clinical improvement during that time. PCED is defined as a focal loss of the cornea's outermost cell layer and can include involvement of the deeper stromal layers (i.e., corneal ulcer). 5. PCED at Screening 1 must have a minimum of 1 mm of any linear measurement of defect. 6. Decreased corneal sensitivity (โ‰ค 4 cm using the Cochet-Bonnet esthesiometer \[CBE\]) within the area of the PCED and in at least one corneal quadrant outside of the area of the defect. 7. A negative pregnancy test at Screening 1 and Day 1 for women of child-bearing potential.

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

๐Ÿ“‹

Study Type

INTERVENTIONAL

๐Ÿ‘ฅ

Target Enrollment

27 participants

โšง

Gender

ALL

๐Ÿข

Sponsor

Krystal Biotech, Inc.

Study Locations

Choose your preferred location or select flexible during enrollment

NOT_YET_RECRUITING

Irvine

California

Location available
View Irvine location page
RECRUITING

Pasadena

California

Location available
View Pasadena location page
RECRUITING

Carmel

Indiana

Location available
View Carmel location page
RECRUITING

Alexandria

Minnesota

Location available
View Alexandria location page
RECRUITING

Minnetonka

Minnesota

Location available
View Minnetonka location page
RECRUITING

Town and Country

Missouri

Location available
View Town and Country location page
RECRUITING

Palisades Park

New Jersey

Location available
View Palisades Park location page
RECRUITING

West Fargo

North Dakota

Location available
View West Fargo location page
NOT_YET_RECRUITING

Pittsburgh

Pennsylvania

Location available
View Pittsburgh location page

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

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Looking for Neurotrophic Keratitis Treatment in Irvine?

Join others in California exploring innovative treatment options through clinical research

Neurotrophic Keratitis Treatment Options in Irvine, California

If you're searching for Neurotrophic Keratitis treatment in Irvine, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Irvine, Pasadena, Carmel and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Neurotrophic Keratitis. All study-related care is provided at no cost to participants.

Local Sites
3 locations in California
Now Enrolling
Up to 27 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Neurotrophic Keratitis?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Neurotrophic Keratitis

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Neurotrophic Keratitis Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06999733. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.