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NCT04213261 · ClinicalTrials.gov registry record · Phase 3
A Study of FCX-007 for Recessive Dystrophic Epidermolysis Bullosa
A Phase 3 study of Recessive Dystrophic Epidermolysis Bullosa, sponsored by Castle Creek Biosciences.
- Active
- Registry status
- Phase 3
- Development phase
- 6
- Enrollment target
- 5
- Study locations
NCT04213261: Active Phase 3 study of Recessive Dystrophic Epidermolysis Bullosa, sponsored by Castle Creek Biosciences.
NCT04213261 is a Phase 3 study of Recessive Dystrophic Epidermolysis Bullosa that is active but no longer recruiting, run by Castle Creek Biosciences. The registered enrollment target is 6 participants, below the 19-participant average among 5 other Recessive Dystrophic Epidermolysis Bullosa trials with a reported enrollment target (68% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04213261, a Phase 3 study of Recessive Dystrophic Epidermolysis Bullosa, is active but no longer recruiting, sponsored by Castle Creek Biosciences.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 6 participants
- Enrollment target
- 5
- Study locations
Study Summary
The purpose of this study is to determine whether administration of FCX-007 in addition to standard of care improves wound healing as compared to standard of care alone (control) in children, adolescents, and adults with Recessive Dystrophic Epidermolysis Bullosa. Funding Source - FDA OOPD
Primary Outcome
Complete wound closure of the first wound pair (treated vs. control)
Conditions Studied
Interventions
- BIOLOGICAL FCX-007 (dabocemagene autoficel; see below for FCX-007 description)
Study Locations (5)
California
- Stanford University - Stanford
Colorado
- Children's Hospital Colorado - Aurora
Florida
- Solutions Through Advanced Research, Inc. - Jacksonville
Minnesota
- Mayo Clinic - Rochester
Texas
- Dell Children's Medical Group - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2020-06-09 |
| Est. Completion | 2037-07 |
| Phase | Phase 3 |
What the registry record for NCT04213261 still lists
NCT04213261 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 19-participant average among 5 other Recessive Dystrophic Epidermolysis Bullosa trials with a reported enrollment target (68% lower).
The record links to 1 condition, with Recessive Dystrophic Epidermolysis Bullosa appearing as the primary indexed condition, and to 1 intervention - of which FCX-007 (dabocemagene autoficel; see below for FCX-007 description) is the first listed.
NCT04213261 lists 5 locations in 5 states (California, Colorado, Florida).
Frequently Asked Questions
What is clinical trial NCT04213261 about?
NCT04213261 is a clinical study titled "A Study of FCX-007 for Recessive Dystrophic Epidermolysis Bullosa". The purpose of this study is to determine whether administration of FCX-007 in addition to standard of care improves wound healing as compared to standard of care alone (control) in children, adolescents, and adults with Recessive Dystrophic Epidermolysis Bullosa. Funding Source - FDA OOPD
What is the current status of trial NCT04213261?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 6 participants. The study started on 2020-06-09. Estimated completion is 2037-07.
What conditions does trial NCT04213261 study?
This clinical trial studies the following conditions: Recessive Dystrophic Epidermolysis Bullosa.
What interventions are being tested in trial NCT04213261?
The interventions under investigation include: FCX-007 (dabocemagene autoficel; see below for FCX-007 description) (BIOLOGICAL).
Who is sponsoring clinical trial NCT04213261?
This trial is sponsored by Castle Creek Biosciences, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04213261 being conducted?
This trial has 5 study locations across California, Colorado, Florida, Minnesota, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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