A Double-Blind Crossover of KB803 and Matched Placebo, for the Treatment and Prevention of Corneal Abrasions in Dystrophic Epidermolysis Bullosa
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Biological, Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
KB803-EYE-01 is a Phase 3 double-blind, intra-patient 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
Participation Requirements
Sex: All
Minimum Age: 6 months
Healthy Volunteers: f
View:
• 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.
Locations
United States
California
Mission Dermatology Center
RECRUITING
Rancho Santa Margarita
Massachusetts
UMass Memorial Medical Center
NOT_YET_RECRUITING
Worcester
Ohio
Cincinnati Children's Hospital Medical Center
NOT_YET_RECRUITING
Cincinnati
Texas
Texas Dermatology and Laser Specialists
RECRUITING
San Antonio
Contact Information
Primary
David Sweet, MD, PhD
dsweet@krystalbio.com
412-586-5830
Backup
Brittani Agostini, RN, CCRC
bagostini@krystalbio.com
412-586-5830
Time Frame
Start Date: 2025-06-20
Estimated Completion Date: 2026-03
Participants
Target number of participants: 16
Treatments
Experimental: KB803
KB803
Placebo_comparator: Placebo
Vehicle
Related Therapeutic Areas
Sponsors
Leads: Krystal Biotech, Inc.