KB803: Ophthalmic suspension of replication-defective, non-integrating herpes simplex virus (HSV-1) expressing the human collagen VII protein
Placebo: Vehicle
Study summary
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).
Eligibility
Sex
ALL
Min age
6 Months
Max age
—
Healthy volunteers
No
Inclusion 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 NHS study.
Exclusion Criteria:
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.
Primary outcome measure(s)
To evaluate the safety and tolerability of KB803. — 24 weeks Number of subjects with treatment related adverse events as assessed by CTCAE v5.
To evaluate the effect of ophthalmic KB803 on frequency of corneal abrasion symptoms. — 24 weeks Average number of days per month with corneal abrasion symptoms.
Trial sites (5)
Facility
City
Region
Status
Mission Dermatology Center
Rancho Santa Margarita
California
Recruiting
Skin Research Institute
Coral Gables
Florida
Recruiting
UMass Memorial Medical Center
Worcester
Massachusetts
Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati
Ohio
Recruiting
Texas Dermatology and Laser Specialists
San Antonio
Texas
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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