Trial · NCT05708677
A Long-Term Extension Study for Participants Previously Treated With EB-101 for the Treatment of RDEB
NCT05708677, Enrolling by invitation, Abeona Therapeutics, Inc
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Long-Term Extension Study for Participants Previously Treated With EB-101 for the Treatment of RDEB. Trials, record NCT05708677. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05708677
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Long-Term Extension Study for Participants Previously Treated With EB-101 for the Treatment of RDEB
- NCT number
- NCT05708677
- Status
- Enrolling by invitation
- Enrollment
- 22 participants, estimated
- Lead sponsor
- Abeona Therapeutics, Inc
- Conditions
- RDEB
- Interventions
- EB-101
- First posted
- 2023-02-01
- Last updated
- 2026-07-17
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Wound Closure | 5 years | Proportion of RDEB wounds with healing ≥50%, ≥75%, and 100% at all clinic visits up to Month 54 as determined by direct investigator assessment. |
| Primary | Pain Severity Scale (Wong-Baker FACES) | 5 years | Change in pain assessed by Wong-Baker FACES scale at all clinic visits up to Month 54. The minimum score value is 0 and the maximum score value is 10, with the higher scores being the worse outcome. |
| Primary | Itch Severity Scale | 5 years | Longitudinal change of Itch severity scores assessed at all clinic visits up to Week 54. The minimum score value is 0 and the maximum score value is 10, with the higher scores being the worse outcome. |
| Primary | Zarit Burden Interview Scale | 5 years | Longitudinal change of Zarit Burden Interview Short Form (ZBI-12) for caregiver scores related to wound care, assessed at all clinic visits up to Month 54. The minimum score value is 0 and the maximum score value is 4, with the higher scores being the worse outcome. |
| Primary | Quality of Life in Epidermolysis Bullosa | 5 years | Quality of Life in Epidermolysis Bullosa (QOLEB) responses will be assessed at all clinic visits up to Month 54. |
| Primary | Caregiver Global Impression of Change for Pain Scale | 5 years | Caregiver Global Impression of Change for Pain (CrGI-Pain) scores assessed at all clinic visits up to Month 54. The minimum score value is 1 and the maximum score value is 7, with the higher scores being the worse outcome. |
| Primary | Wound Infection and Adverse Events | 5 years | The number of participants and wounds that have an infection or any related adverse event. |
| Primary | The number of treatment-emergent adverse events. | 5 years | The number of treatment-emergent adverse events. |
| Primary | Serious Adverse Events | 5 years | The number of participants and wounds that result in hospitalization (serious adverse event \[SAE\]). |
| Primary | Incidence of squamous cell carcinoma. | 5 years | Incidence of squamous cell carcinoma. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05708677
GET https://conductscience.org/api/trials/v1/NCT05708677/registered