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A Study of FCX-007 for Recessive Dystrophic Epidermolysis Bullosa

Study acronym: DEFI-RDEB
StatusActive, Not Recruiting
PhasePhase 3
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv25
  2. Results first posted: Apr 1, 2024v24
  3. Re-verified, no change to tracked fieldsv23
  4. Secondary endpoints revised (3)
    • Primary endpoint revised
    v22
  5. Primary completion date changed from estimate of Feb 2023 to Jan 17, 2023v21
Show 19 earlier versionsHide 19 earlier versions
  1. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 24 to confirmed 6
    • Primary completion date: Apr 2023 to Feb 2023
    • Site details revised at 5 of 5 sites
    v20
  2. Primary completion date: Apr 2022 to Apr 2023
    • Study completion date: Jul 2036 to Jul 2037
    v19
  3. Re-verified, no change to tracked fieldsv18
  4. Site details revised at 1 of 5 sitesv17
  5. Site contacts updated at 1 of 5 sitesv16
  6. Study sites: 4 to 5v15
  7. Interventions: FCX-007 (debcoemagene autoficel; see below for FCX-007 description) (Biological) to FCX-007 (dabocemagene autoficel; see below for FCX-007 description) (Biological)v14
  8. Site details revised at 1 of 4 sitesv13
  9. Study sites: 3 to 4v12
  10. Study completion date: Nov 2035 to Jul 2036
    • Site details revised at 1 of 3 sites
    v11
  11. Study description expanded, about 2 wordsv10
  12. Primary completion date: Dec 2020 to Apr 2022v9 Show 8 more changesShow less
    • Start date: Mar 30, 2020 to Jun 9, 2020
    • Primary endpoint revised
    • Enrollment target: 20 to 24
    • Study completion date: Mar 2021 to Nov 2035
    • Interventions: FCX-007 (no generic name is established; see below for FCX-007 description) (Biological) to FCX-007 (debcoemagene autoficel; see below for FCX-007 description) (Biological)
    • Eligibility criteria shortened, about 59 words
    • Secondary endpoints: 2 to 3
    • Study description expanded, about 59 words
  13. Site contacts updated at 1 of 3 sitesv8
  14. Start date changed from estimate of Mar 2020 to Mar 30, 2020
    • Site details revised at 1 of 3 sites
    v7
  15. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 3 of 3 sites
    v6
  16. Start date: Feb 2020 to Mar 2020
    • Collaborators shortened, about 4 words
    v5
  17. Start date: Jan 2020 to Feb 2020
    • Site contacts updated at 1 of 3 sites
    v4
  18. Re-verified, no change to tracked fieldsv3
  19. Secondary endpoints revised (2)v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT04213261
Lead Sponsor Castle Creek Biosciences, LLC.
Conditions
(from sponsor)		 Recessive Dystrophic Epidermolysis Bullosa
Related terms Epidermolysis Bullosa Dystrophica
Enrollment 6 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov