NCT05725018Phase 3Active not recruiting

A Phase 3b Study for the Treatment of Dystrophic Epidermolysis Bullosa (DEB) in New and Previously EB-101 Treated Patients

Study sponsor: Abeona Therapeutics, Inc · ABEO

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2025-09-30Estimated

Enrollment · participants12Estimated

Source updated2025-06-27Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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No recorded changes are available for this view and time period. Our history may be incomplete; this does not establish that the trial stayed unchanged.

Study details

Conditions studied

Epidermolysis Bullosa; Recessive Dystrophic Epidermolysis Bullosa; RDEB

Treatments or interventions studied

EB-101 Surgical application of RDEB woundsBiologicalAlso known as pz-cel

Primary outcomes · main study measures

Read the study measures

measure: Safety Endpoint (number of treatment-related and treatment-emergent adverse events (AEs) and serious adverse events (SAEs); description: 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.; timeFrame: 6 months; measure: Safety Endpoint (number of patients and wounds that have an infection or any related adverse event.); description: The number of patients and wounds that have an infection or any related adverse event (AE).; timeFrame: 6 months; measure: Safety Endpoint (number of patients and wounds that result in hospitalization (serious adverse event ); description: The number of patients and wounds that result in hospitalization (SAE).; timeFrame: 6 months; measure: Safety Endpoint (Incidence of squamous cell carcinoma); description: The incidence of squamous cell carcinoma (SCC).; timeFrame: 6 months; measure: Safety Endpoint RCR status; description: Replication-competent retrovirus (RCR) status.; timeFrame: 6 months

History coverage

Imported research includes version dates later than the current official API record (2025-06-27). Disputed observations are retained for audit and excluded from trusted change feeds and sponsor statistics. Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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