StudyFinder
A Study Comparing KB803 and Matched Placebo in Patients With Dystrophic Epidermolysis Bullosa
RECRUITING
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).
ALL
6 month(s) and over
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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).
- 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.
- 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 requirements of the study protocol in the opinion of the Investigator.
BIOLOGICAL: KB803, DRUG: Placebo
Dystrophic Epidermolysis Bullosa, DEB - Dystrophic Epidermolysis Bullosa, Recessive Dystrophic Epidermolysis Bullosa, Dominant Dystrophic Epidermolysis Bullosa
Dystrophic Epidermolysis Bullosa, DEB, Corneal Abrasions