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Taking people in United StatesPhase 3

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

Key facts

Who runs it
Krystal Biotech, Inc.
Where
Cincinnati, Coral Gables, Rancho Santa Margarita, San Antonio, and Worcester, United StatesSee the 5 sites
Trial code
Status
Recruiting
Phase
Phase 3
People taking part
16 people, planned
Started
20 Jun 2025
Expected to end
Dec 2026
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • KB803
  • Placebo
Record updated
12 March 2026

Who can take part

Age
6 months and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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)
  • 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
  • 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

Where in United States

  • Cincinnati Children's Hospital Medical CenterCincinnati, United StatesContact: Bret Augsburger, CCRPTaking people
  • Skin Research InstituteCoral Gables, United StatesContact: Alex CazzanigaTaking people
  • Mission Dermatology CenterRancho Santa Margarita, United StatesContact: Shireen Guide, MDTaking people
  • Texas Dermatology and Laser SpecialistsSan Antonio, United StatesContact: Jennifer PattersonTaking people
  • Umass Memorial Medical CenterWorcester, United StatesContact: Priscilla Romano, MDTaking people

About the trial

What the trial wants to find out

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).

The 2 groups in the trial

  • KB803Treatment being tested
  • PlaceboPlacebo, for comparison

    Vehicle

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Double-Blind Crossover of KB803 and Matched Placebo for the Treatment and Prevention of Corneal Abrasions in Dystrophic Epidermolysis Bullosa
Record updated
12 March 2026