A Study Comparing KB803 and Matched Placebo in Patients With Dystrophic Epidermolysis Bullosa

Ki vehet részt

• 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

Ki nem vehet részt

• 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)
• 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
• 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