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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Dystrophic Epidermolysis Bullosa, DEB - Dystrophic Epidermolysis Bullosa, Recessive Dystrophic Epidermolysis Bullosa, Dominant Dystrophic Epidermolysis Bullosa

In brief

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).

Key facts

Study ID

NCT07016750

Run by

Krystal Biotech, Inc.

People needed

16

Starts

2025-06-20

Expected to finish

2026-12-01

Last updated by the study team

2026-03-12

Who can join

Age: 1 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Skin Research Institute — Coral Gables, Florida, United States (enrolling)
• Mission Dermatology Center — Rancho Santa Margarita, California, United States (enrolling)
• UMass Memorial Medical Center — Worcester, Massachusetts, United States (enrolling)
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (enrolling)
• Texas Dermatology and Laser Specialists — San Antonio, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.