Actively Recruiting
A Study Comparing KB803 and Matched Placebo in Patients With Dystrophic Epidermolysis Bullosa
Led by Krystal Biotech, Inc. · Updated on 2026-03-12
16
Participants Needed
5
Research Sites
75 weeks
Total Duration
On this page
AI-Summary
What this Trial 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).
CONDITIONS
Official Title
A Study Comparing KB803 and Matched Placebo in Patients With Dystrophic Epidermolysis Bullosa
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The participant or their parent/legal guardian must provide informed consent or assent and be willing to follow study procedures.
- Participant must be 6 months of age or older at the time of consent.
- Confirmed diagnosis of dystrophic epidermolysis bullosa (DEB) with a mutation in the COL7A1 gene.
- Participant must meet minimum corneal abrasion symptom frequency as recorded in the natural history study.
You will not qualify if you...
- Starting or changing any new treatment for eye disease during the run-in period, except preservative-free topical antibiotics or artificial tears/lubricants.
- Use of an investigational agent or off-label ophthalmic product during the run-in period or planned use during the study, unless approved case-by-case.
- Any condition that could interfere with study assessments, drug administration, or increase risk to the participant as judged by the investigator.
- Women who are pregnant or nursing.
- Participants unwilling to comply with contraception requirements.
- Participants known or expected to be noncompliant with study protocol.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Mission Dermatology Center
Rancho Santa Margarita, California, United States, 92688
Actively Recruiting
2
Skin Research Institute
Coral Gables, Florida, United States, 33146
Actively Recruiting
3
UMass Memorial Medical Center
Worcester, Massachusetts, United States, 01605
Actively Recruiting
4
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
5
Texas Dermatology and Laser Specialists
San Antonio, Texas, United States, 78218
Actively Recruiting
Research Team
D
David Sweet, MD, PhD
CONTACT
B
Brittani Agostini, RN, CCRC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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