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

Part of paid clinical trials in Rancho Santa Margarita, California.

Sponsor
Krystal Biotech, Inc.
Study ID
NCT07016750
Phase
PHASE3
Status
Recruiting
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Conditions

  • DEB - Dystrophic Epidermolysis Bullosa
  • Dominant Dystrophic Epidermolysis Bullosa
  • Dystrophic Epidermolysis Bullosa
  • Recessive Dystrophic Epidermolysis Bullosa

Eligibility Criteria

Sex
ALL
Age
6 Months - N/A
Healthy Volunteers
Not accepted

Interventions

  • KB803 — BIOLOGICAL
    Ophthalmic suspension of replication-defective, non-integrating herpes simplex virus (HSV-1) expressing the human collagen VII protein
  • Placebo — DRUG
    Vehicle

Study Details

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).

Key Dates

Start date
Jun 20, 2025
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
16 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: KB803
    KB803
  • Placebo Comparator: Placebo
    Vehicle

Primary Outcome Measure

To evaluate the safety and tolerability of KB803. [ Time Frame: 24 weeks ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Mission Dermatology CenterRancho Santa MargaritaCalifornia92688
Shireen Guide, MD
[email protected]
949-858-3376
[email protected]
Skin Research InstituteCoral GablesFlorida33146
Alex Cazzaniga
[email protected]
305-444-5770
UMass Memorial Medical CenterWorcesterMassachusetts01605
Priscilla Romano, MD
[email protected]
508-856-1706
Isaac (Li-Chi) Chen, MD
[email protected]
774-455-4758
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229
Bret Augsburger, CCRP
[email protected]
513-636-2009
Texas Dermatology and Laser SpecialistsSan AntonioTexas78218
Jennifer Patterson
[email protected]
210-852-2779

Find similar trials in Rancho Santa Margarita, CA

By research site
Mission Dermatology Center· Rancho Santa Margarita, CASkin Research Institute· Coral Gables, FLUMass Memorial Medical Center· Worcester, MACincinnati Children's Hospital Medical Center· Cincinnati, OHTexas Dermatology and Laser Specialists· San Antonio, TX

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