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

NCT07016750 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2026-03-12

No results posted yet for this 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).

Conditions

Interventions

BIOLOGICAL

KB803

Ophthalmic suspension of replication-defective, non-integrating herpes simplex virus (HSV-1) expressing the human collagen VII protein

DRUG

Placebo

Vehicle

Sponsors & Collaborators

  • Krystal Biotech, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-20
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07016750 on ClinicalTrials.gov