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NCT07016750 · ClinicalTrials.gov registry record · Phase 3
A Study Comparing KB803 and Matched Placebo in Patients With Dystrophic Epidermolysis Bullosa
A Phase 3 study of Dystrophic Epidermolysis Bullosa and Recessive Dystrophic Epidermolysis Bullosa, sponsored by Krystal Biotech.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 16
- Enrollment target
- 5
- Study locations
NCT07016750: Recruiting Phase 3 study of Dystrophic Epidermolysis Bullosa and Recessive Dystrophic Epidermolysis Bullosa, sponsored by Krystal Biotech.
NCT07016750 is a Phase 3 study of Dystrophic Epidermolysis Bullosa and Recessive Dystrophic Epidermolysis Bullosa that is actively recruiting participants, run by Krystal Biotech. The registered enrollment target is 16 participants, below the 18-participant average among 7 other Dystrophic Epidermolysis Bullosa trials with a reported enrollment target (11% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07016750, a Phase 3 study of Dystrophic Epidermolysis Bullosa and Recessive Dystrophic Epidermolysis Bullosa, is actively recruiting participants, sponsored by Krystal Biotech.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 16 participants
- Enrollment target
- 5
- Study locations
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).
Primary Outcome
Number of subjects with treatment related adverse events as assessed by CTCAE v5.
Conditions Studied
Interventions
- BIOLOGICAL KB803
- DRUG Placebo
Study Locations (5)
California
- Mission Dermatology Center - Rancho Santa Margarita
Florida
- Skin Research Institute - Coral Gables
Massachusetts
- UMass Memorial Medical Center - Worcester
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Texas
- Texas Dermatology and Laser Specialists - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2025-06-20 |
| Est. Completion | 2026-12 |
| Phase | Phase 3 |
What NCT07016750 shows while recruiting
NCT07016750 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 18-participant average among 7 other Dystrophic Epidermolysis Bullosa trials with a reported enrollment target (11% lower).
The record links to 4 conditions, with Dystrophic Epidermolysis Bullosa appearing as the primary indexed condition, and to 2 interventions - of which KB803 is the first listed.
NCT07016750 lists 5 locations in 5 states (California, Florida, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT07016750 about?
NCT07016750 is a clinical study titled "A Study Comparing KB803 and Matched Placebo in Patients With Dystrophic Epidermolysis Bullosa". 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).
What is the current status of trial NCT07016750?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 16 participants. The study started on 2025-06-20. Estimated completion is 2026-12.
What conditions does trial NCT07016750 study?
This clinical trial studies the following conditions: Dystrophic Epidermolysis Bullosa, Recessive Dystrophic Epidermolysis Bullosa, Dominant Dystrophic Epidermolysis Bullosa, DEB - Dystrophic Epidermolysis Bullosa.
What interventions are being tested in trial NCT07016750?
The interventions under investigation include: KB803 (BIOLOGICAL), Placebo (DRUG).
Who is sponsoring clinical trial NCT07016750?
This trial is sponsored by Krystal Biotech, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07016750 being conducted?
This trial has 5 study locations across California, Florida, Massachusetts, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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