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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 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.

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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.

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

FieldValue
Enrollment Target 12 participants
Start Date 2023-04-02
Est. Completion 2025-09-30
Phase Phase 3

Sponsor

Abeona Therapeutics

8 total trials

What the Registry Record Tells You About NCT05725018

The ClinicalTrials.gov registry entry for NCT05725018 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 19-participant average among 10 other Epidermolysis Bullosa trials with a reported enrollment target (37% lower). The listed sponsor is Abeona Therapeutics, which has 8 total studies on file at ClinicalTrials.gov.

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 2 study locations spanning 2 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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