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Gene Therapy

EB-101 for Epidermolysis Bullosa

Phase 3
Recruiting
Research Sponsored by Abeona Therapeutics, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Two confirmed RDEB C7 mutations with recessive inheritance patterns (or confirmation that parents don't have any evidence of dominant disease)
Must have at least one wound site that meets all of the following criteria: An area ≥20 cm2, Present for ≥6 months, Stage 2 wound defined as an open skin wound with partial thickness loss of dermis that has not extended through the dermis into subcutaneous tissue
Must not have
Evidence of systemic infection
Receipt of chemical or biological investigational therapy for the specific treatment of RDEB in the 3 months prior to EB-101 application
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial studies the safety of a new treatment for wounds in people with a certain skin disorder.

Who is the study for?
This trial is for patients aged 6 and older with Recessive Dystrophic Epidermolysis Bullosa (RDEB) who have stable pain medication regimens and at least one wound larger than 20 cm2 that's been present for over six months. Participants must not be pregnant, use reliable birth control, and cannot have a history of certain allergies or recent investigational therapies.
What is being tested?
The trial tests EB-101, which are engineered skin sheets applied surgically to treat wounds caused by RDEB. It aims to assess the safety of this treatment in both new patients and those previously treated with EB-101.
What are the potential side effects?
While specific side effects aren't listed here, potential risks may include reactions related to surgery, anesthesia complications, infection risk at the wound site, or possible immune responses against the introduced C7 protein.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have two confirmed RDEB C7 mutations inherited recessively.
Select...
I have a wound larger than 20 cm2, present for over 6 months, and it's a stage 2 wound.
Select...
I can safely receive anesthesia for EB-101 treatment.
Select...
I have been diagnosed with RDEB.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have an infection that affects my whole body.
Select...
I haven't had experimental treatments for RDEB in the last 3 months.
Select...
I cannot or do not want to provide tissue samples for testing.
Select...
I have or had squamous cell carcinoma in the area where EB-101 will be applied.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety Endpoint (Incidence of squamous cell carcinoma)
Safety Endpoint (number of patients and wounds that have an infection or any related adverse event.)
Safety Endpoint (number of patients and wounds that result in hospitalization (serious adverse event )
+2 more
Other study objectives
Change in Caregiver Global Impression of Pain
Change in Quality of Life in Epidermolysis Bullosa
Comparison of how circulating C7 antibody status relates to wound healing and safety profile
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: EB-101 Surgical application of RDEB woundsExperimental Treatment1 Intervention
New or Previously Treated RDEB Patients

Find a Location

Who is running the clinical trial?

Abeona Therapeutics, IncLead Sponsor
11 Previous Clinical Trials
1,089 Total Patients Enrolled
2 Trials studying Epidermolysis Bullosa
23 Patients Enrolled for Epidermolysis Bullosa
Sarah Abdelwahab, MDStudy DirectorAbeona Therapeutics, Inc
1 Previous Clinical Trials
22 Total Patients Enrolled
Angela Iheanacho, MSStudy DirectorAbeona Therapeutics, Inc
1 Previous Clinical Trials
22 Total Patients Enrolled
Dmitriy Grachev, MD, PhDStudy DirectorAbeona Therapeutics, Inc

Media Library

EB-101 (Gene Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05725018 — Phase 3
Epidermolysis Bullosa Research Study Groups: EB-101 Surgical application of RDEB wounds
Epidermolysis Bullosa Clinical Trial 2023: EB-101 Highlights & Side Effects. Trial Name: NCT05725018 — Phase 3
EB-101 (Gene Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05725018 — Phase 3
~2 spots leftby Mar 2025
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