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NCT04227106 · ClinicalTrials.gov registry record · Phase 3
Phase 3, Open-label Clinical Trial of EB-101 for the Treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB)
A Phase 3 study of Epidermolysis Bullosa and Recessive Dystrophic Epidermolysis Bullosa, sponsored by Abeona Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 11
- Enrollment target
- 2
- Study locations
NCT04227106: Completed Phase 3 study of Epidermolysis Bullosa and Recessive Dystrophic Epidermolysis Bullosa, sponsored by Abeona Therapeutics.
NCT04227106 is a Phase 3 study of Epidermolysis Bullosa and Recessive Dystrophic Epidermolysis Bullosa that has completed, run by Abeona Therapeutics. The registered enrollment target is 11 participants, below the 19-participant average among 10 other Epidermolysis Bullosa trials with a reported enrollment target (42% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04227106, a Phase 3 study of Epidermolysis Bullosa and Recessive Dystrophic Epidermolysis Bullosa, has completed, sponsored by Abeona Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 11 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this trial is to evaluate safety and efficacy of surgical application of EB-101 (autologous, gene-corrected keratinocyte sheets) as a treatment of recessive dystrophic epidermolysis bullosa (RDEB).
Primary Outcome
Proportion of RDEB wound sites with ≥50% healing from Baseline in treated versus untreated wounds
Conditions Studied
Interventions
- BIOLOGICAL EB-101
Study Locations (2)
California
- Stanford University - Redwood City
Massachusetts
- University of Massachusetts Medical School - Worcester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2020-01-10 |
| Est. Completion | 2022-10-18 |
| Phase | Phase 3 |
What the finished NCT04227106 record still lists
NCT04227106 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 19-participant average among 10 other Epidermolysis Bullosa trials with a reported enrollment target (42% lower).
The record links to 2 conditions, with Epidermolysis Bullosa appearing as the primary indexed condition, and to 1 intervention - of which EB-101 is the first listed.
NCT04227106 reports a single indexed study location in California, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04227106 about?
NCT04227106 is a clinical study titled "Phase 3, Open-label Clinical Trial of EB-101 for the Treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB)". The purpose of this trial is to evaluate safety and efficacy of surgical application of EB-101 (autologous, gene-corrected keratinocyte sheets) as a treatment of recessive dystrophic epidermolysis bullosa (RDEB).
What is the current status of trial NCT04227106?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 11 participants. The study started on 2020-01-10. Estimated completion is 2022-10-18.
What conditions does trial NCT04227106 study?
This clinical trial studies the following conditions: Epidermolysis Bullosa, Recessive Dystrophic Epidermolysis Bullosa.
What interventions are being tested in trial NCT04227106?
The interventions under investigation include: EB-101 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04227106?
This trial is sponsored by Abeona Therapeutics, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04227106 being conducted?
This trial has 2 study locations across California, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Epidermolysis Bullosa
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04227106's enrollment target sits among peer trials
11 8th of 10 higher than 3 of 10 other Epidermolysis Bullosa trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Epidermolysis Bullosa trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Phase 3b Study for the Treatment of Dystrophic Epidermolysis Bullosa (DEB) in New and Previously EB-101 Treated Patients
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