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RecruitingPhase 3

A Study Comparing KB803 and Matched Placebo in Patients With Dystrophic Epidermolysis Bullosa

Krystal Biotech, Inc. · NCT07016750

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 6 mo+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
16
US sites recruiting
5
Study start
June 20, 2025
Record last updated
March 12, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

KB803-EYE-01 is a Phase 3 double-blind, randomized, placebo-controlled, crossover study to evaluate the safety and efficacy of KB803 versus matched placebo in pediatric and adult subjects with recurrent corneal abrasions due to dystrophic epidermolysis bullosa (DEB).

Being studied: KB803; Placebo

Conditions: Dystrophic Epidermolysis Bullosa; DEB - Dystrophic Epidermolysis Bullosa; Recessive Dystrophic Epidermolysis Bullosa; Dominant Dystrophic Epidermolysis Bullosa

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • The subject and/or their parent/legal guardian must provide informed consent/assent and must be able to and willing to follow study procedures and instructions.
  • Age 6 months or older at time of informed consent/assent.
  • Confirmed diagnosis of DEB with a mutation in the COL7A1 gene.
  • Meets minimum corneal abrasion symptom frequency in the NHS study.

Exclusion Criteria

  • Initiation of any new treatment regimen or change in treatment for ocular disease during the run-in period except for preservative free topical antibiotics or artificial tears/lubricants associated with standard of care treatment of corneal abrasions.
  • Treatment with an investigational agent or off-label ophthalmic use of an approved product during the run-in period or planned use during the study (Exceptions may be approved by the medical monitor on a case-by-case basis).
  • Any condition that, in the opinion of the Investigator, would impact the completion of all study-related assessments, interfere with the administration of study drug, and/or poses an additional risk to the subject.
  • Women who are pregnant or nursing.
  • Subject who is unwilling to comply with contraception requirements per protocol.
  • Subject is known to be noncompliant or is unlikely to comply with the requirements of the study protocol in the opinion of the Investigator.

Recruiting US locations

  • Mission Dermatology Center

    Rancho Santa Margarita, CA 92688

    Site contact: Shireen Guide, MD · 949-858-3376 · admin@missiondermatology.com

  • Skin Research Institute

    Coral Gables, FL 33146

    Site contact: Alex Cazzaniga · 305-444-5770 · info@srinsitute.org

  • UMass Memorial Medical Center

    Worcester, MA 01605

    Site contact: Priscilla Romano, MD · 508-856-1706 · priscilla.romano@umassmed.edu

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, OH 45229

    Site contact: Bret Augsburger, CCRP · 513-636-2009 · Bret.Augsburger@cchmc.org

  • Texas Dermatology and Laser Specialists

    San Antonio, TX 78218

    Site contact: Jennifer Patterson · 210-852-2779 · jpatterson@texasdls.com

Study contacts (from the official record)

  • David Sweet, MD, PhD · 412-586-5830 · dsweet@krystalbio.com
  • Brittani Agostini, RN, CCRC · 412-586-5830 · bagostini@krystalbio.com
A Study Comparing KB803 and Matched Placebo in Patients With… (NCT07016750) | Bored Studies