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NCT05725018 · ClinicalTrials.gov registry record · Phase 3
A Phase 3b Study for the Treatment of Dystrophic Epidermolysis Bullosa (DEB) in New and Previously EB-101 Treated Patients
A Phase 3 study of Epidermolysis Bullosa and Recessive Dystrophic Epidermolysis Bullosa, sponsored by Abeona Therapeutics.
- Active
- Registry status
- Phase 3
- Development phase
- 12
- Enrollment target
- 2
- Study locations
NCT05725018: Active Phase 3 study of Epidermolysis Bullosa and Recessive Dystrophic Epidermolysis Bullosa, sponsored by Abeona Therapeutics.
NCT05725018 is a Phase 3 study of Epidermolysis Bullosa and Recessive Dystrophic Epidermolysis Bullosa that is active but no longer recruiting, run by Abeona Therapeutics. The registered enrollment target is 12 participants, below the 19-participant average among 10 other Epidermolysis Bullosa trials with a reported enrollment target (37% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05725018, a Phase 3 study of Epidermolysis Bullosa and Recessive Dystrophic Epidermolysis Bullosa, is active but no longer recruiting, sponsored by Abeona Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 12 participants
- Enrollment target
- 2
- Study locations
Study Summary
To evaluate and further characterize the safety of EB-101 (LZRSE-Col7A1 gene-corrected keratinocyte sheets with type VII collagen \[C7\] expression) for the treatment of large, chronic DEB wounds in new and previously EB-101 treated patients 12 months and older.
Primary Outcome
The number of treatment-related and treatment-emergent adverse events (TEAEs), treatment-emergent wound adverse events (TEWAEs), and serious adverse events (SAEs), including systemic and wound-specific adverse events.
Conditions Studied
Interventions
- BIOLOGICAL EB-101 Surgical application of RDEB wounds
Study Locations (2)
California
- Stanford University - Redwood City
Massachusetts
- University of Massachusetts Medical School - Worcester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2023-04-02 |
| Est. Completion | 2025-09-30 |
| Phase | Phase 3 |
What the registry record for NCT05725018 still lists
NCT05725018 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 19-participant average among 10 other Epidermolysis Bullosa trials with a reported enrollment target (37% lower).
The record links to 3 conditions, with Epidermolysis Bullosa appearing as the primary indexed condition, and to 1 intervention - of which EB-101 Surgical application of RDEB wounds is the first listed.
NCT05725018 reports a single indexed study location in California, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05725018 about?
NCT05725018 is a clinical study titled "A Phase 3b Study for the Treatment of Dystrophic Epidermolysis Bullosa (DEB) in New and Previously EB-101 Treated Patients". To evaluate and further characterize the safety of EB-101 (LZRSE-Col7A1 gene-corrected keratinocyte sheets with type VII collagen \[C7\] expression) for the treatment of large, chronic DEB wounds in new and previously EB-101 treated patients 12 months and older.
What is the current status of trial NCT05725018?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 12 participants. The study started on 2023-04-02. Estimated completion is 2025-09-30.
What conditions does trial NCT05725018 study?
This clinical trial studies the following conditions: Epidermolysis Bullosa, Recessive Dystrophic Epidermolysis Bullosa, RDEB.
What interventions are being tested in trial NCT05725018?
The interventions under investigation include: EB-101 Surgical application of RDEB wounds (BIOLOGICAL).
Who is sponsoring clinical trial NCT05725018?
This trial is sponsored by Abeona Therapeutics, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05725018 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 NCT05725018's enrollment target sits among peer trials
12 6th of 10 higher than 4 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
-
Allogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of Epidermolysis Bullosa (Phase III)
ACTIVE NOT RECRUITING · Phase 3
-
Phase 3, Open-label Clinical Trial of EB-101 for the Treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB)
COMPLETED · Phase 3
-
Targeting Collagen VII Antibodies With IV IgG in Dystrophic Epidermolysis Bullosa
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-
Characterization of the Microbiome in Colonized Dystrophic and Junctional Epidermolysis Bullosa Wounds Before and After Use of APR-TD011 ® Spray Solution
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-
Study of Effectiveness and Safety of SD-101 in Participants With Epidermolysis Bullosa
COMPLETED · Phase 2
-
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