A Phase 3b Study for the Treatment of Dystrophic Epidermolysis Bullosa (DEB) in New and Previously EB-101 Treated Patients
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Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
12estimated
Sites
2
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2023-04-02 | actual | When the study began enrolling |
| Primary completion | 2025-09-30 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-09-30 | estimated | The whole study's end, after follow-up |
| First posted | 2023-02-13 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-06-27 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Epidermolysis Bullosa
- Recessive Dystrophic Epidermolysis Bullosa
- RDEB
Intervention
- Biological: EB-101 Surgical application of RDEB wounds — also filed as pz-cel
Primary outcomes
what the primary-completion date above is the date OFSafety Endpoint (number of treatment-related and treatment-emergent adverse events (AEs) and serious adverse events (SAEs)
measured 6 months
Safety Endpoint (number of patients and wounds that have an infection or any related adverse event.)
measured 6 months
Safety Endpoint (number of patients and wounds that result in hospitalization (serious adverse event )
measured 6 months
Safety Endpoint (Incidence of squamous cell carcinoma)
measured 6 months
Safety Endpoint RCR status
measured 6 months
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