Frontlight ResearchEarly access
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
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData 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