RECRUITING

A Study Assessing B-VEC Compared to Matching Placebo for the Treatment and Prevention of Corneal Abrasions in Dystrophic Epidermolysis Bullosa

Description

B-VEC-EYE-01 is a Phase 3 double-blind, intra-patient crossover study, to evaluate the safety and efficacy of ophthalmic Beremagene Geperpavec (B-VEC) versus matched placebo in pediatric and adult subjects with recurrent corneal abrasions due to dystrophic epidermolysis bullosa (DEB).

Study Overview

Study Details

Study overview

B-VEC-EYE-01 is a Phase 3 double-blind, intra-patient crossover study, to evaluate the safety and efficacy of ophthalmic Beremagene Geperpavec (B-VEC) versus matched placebo in pediatric and adult subjects with recurrent corneal abrasions due to dystrophic epidermolysis bullosa (DEB).

A Double-Blind Crossover of Ophthalmic Beremagene Geperpavec (B-VEC) and Matched Placebo, for the Treatment and Prevention of Corneal Abrasions in Dystrophic Epidermolysis Bullosa

A Study Assessing B-VEC Compared to Matching Placebo for the Treatment and Prevention of Corneal Abrasions in Dystrophic Epidermolysis Bullosa

Condition
Dystrophic Epidermolysis Bullosa
Intervention / Treatment

-

Contacts and Locations

Rancho Santa Margarita

Mission Dermatology Center, Rancho Santa Margarita, California, United States, 92688

Worcester

UMass Memorial Medical Center, Worcester, Massachusetts, United States, 01605

Cincinnati

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States, 45229

San Antonio

Texas Dermatology and Laser Specialists, San Antonio, Texas, United States, 78218

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 B-VEC-EYE-NHS study.
  • 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.

Ages Eligible for Study

6 Months to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Krystal Biotech, Inc.,

Study Record Dates

2026-03