Phase
Condition
Epidermolysis Bullosa
Treatment
KB803
Placebo
Ophthalmic Beremagene Geperpavec (B-VEC)
Clinical Study ID
Ages > 6 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
The subject and/or their parent/legal guardian must provide informed consent/assentand 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.
Exclusion
Exclusion Criteria:
Initiation of any new treatment regimen or change in treatment for ocular diseaseduring the run-in period except for preservative free topical antibiotics orartificial tears/lubricants associated with standard of care treatment of cornealabrasions.
Treatment with an investigational agent or off-label ophthalmic use of an approvedproduct during the run-in period or planned use during the study (Exceptions may beapproved by the medical monitor on a case-by-case basis).
Any condition that, in the opinion of the Investigator, would impact the completionof 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 requirementsof the study protocol in the opinion of the Investigator.
Study Design
Study Description
Connect with a study center
Mission Dermatology Center
Rancho Santa Margarita, California 92688
United StatesActive - Recruiting
Mission Dermatology Center
Rancho Santa Margarita 5386082, California 5332921 92688
United StatesSite Not Available
Skin Research Institute
Coral Gables, Florida 33146
United StatesActive - Recruiting
Skin Research Institute
Coral Gables 4151871, Florida 4155751 33146
United StatesSite Not Available
UMass Memorial Medical Center
Worcester, Massachusetts 01605
United StatesActive - Recruiting
UMass Memorial Medical Center
Worcester 4956184, Massachusetts 6254926 01605
United StatesSite Not Available
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45229
United StatesActive - Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati 4508722, Ohio 5165418 45229
United StatesSite Not Available
Texas Dermatology and Laser Specialists
San Antonio, Texas 78218
United StatesActive - Recruiting
Texas Dermatology and Laser Specialists
San Antonio 4726206, Texas 4736286 78218
United StatesSite Not Available

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