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Clinical Trials in the USA / NCT07016750
Recruiting Phase 3

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

NCT07016750 · tracked via the Priya Life Science USA tracker
Sponsor
Krystal Biotech, Inc.
Phase
Phase 3
Started
2025-06-20
Last updated
2026-03-12

Condition(s) studied

Dystrophic Epidermolysis BullosaDEB - Dystrophic Epidermolysis BullosaRecessive Dystrophic Epidermolysis BullosaDominant Dystrophic Epidermolysis Bullosa

Investigational drug(s) / intervention(s)

KB803Placebo

KB803: Ophthalmic suspension of replication-defective, non-integrating herpes simplex virus (HSV-1) expressing the human collagen VII protein

Placebo: Vehicle

Study summary

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).

Eligibility

Sex
ALL
Min age
6 Months
Max age
Healthy volunteers
No
Inclusion Criteria: 1. 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. 2. Age 6 months or older at time of informed consent/assent. 3. Confirmed diagnosis of DEB with a mutation in the COL7A1 gene. 4. Meets minimum corneal abrasion symptom frequency in the NHS study. Exclusion Criteria: 1. 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. 2. 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). 3. 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. 4. Women who are pregnant or nursing. 5. Subject who is unwilling to comply with contraception requirements per protocol. 6. Subject is known to be noncompliant or is unlikely to comply with the requirements of the study protocol in the opinion of the Investigator.

Primary outcome measure(s)

Trial sites (5)

FacilityCityRegionStatus
Mission Dermatology Center Rancho Santa Margarita California Recruiting
Skin Research Institute Coral Gables Florida Recruiting
UMass Memorial Medical Center Worcester Massachusetts Recruiting
Cincinnati Children's Hospital Medical Center Cincinnati Ohio Recruiting
Texas Dermatology and Laser Specialists San Antonio Texas Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07016750 on ClinicalTrials.gov ↗ ← All trials in the USA