deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT04491604

Ph 3 Efficacy and Safety of B-VEC for the Treatment of DEB (GEM-3)

A Phase III Efficacy and Safety Study of Beremagene Geperpavec (B-VEC, Previously KB103) for the Treatment of Dystrophic Epidermolysis Bullosa (DEB)

Sponsor: Krystal Biotech, Inc.

Conditions Dominant Dystrophic Epidermolysis Bullosa Dystrophic Epidermolysis Bullosa Recessive Dystrophic Epidermolysis Bullosa
Interventions Placebo Topical Beremagene Geperpavec
Updated 8 times since 2020 Last updated: Jan 25, 2023 Started: Aug 17, 2020 Primary completion: Oct 29, 2021 Completion: Jan 14, 2022
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE3 clinical study on Dominant Dystrophic Epidermolysis Bullosa and Dystrophic Epidermolysis Bullosa, this trial is completed. The trial is conducted by Krystal Biotech, Inc. and has accumulated 8 data snapshots since 2020. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

~Aug 2020 – ~Jan 2021 · 5 months · monthly snapshot~Jan 2021 – ~May 2021 · 4 months · monthly snapshot~May 2021 – ~Oct 2021 · 5 months · monthly snapshot~Oct 2021 – ~Sep 2022 · 11 months · monthly snapshotActive Not Recruiting~Sep 2022 – ~Mar 2023 · 6 months · monthly snapshotCompleted~Mar 2023 – ~Jul 2024 · 16 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – present · 24 months · monthly snapshotCompleted

Change History

8 versions recorded

  1. Sep 2024 — Present [monthly]

    Completed PHASE3

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  3. Mar 2023 — Jul 2024 [monthly]

    Completed PHASE3

  4. Sep 2022 — Mar 2023 [monthly]

    Completed PHASE3

    Status: Active Not Recruiting → Completed

  5. Oct 2021 — Sep 2022 [monthly]

    Active Not Recruiting PHASE3

▶ Show 3 earlier versions

  1. May 2021 — Oct 2021 [monthly]

    Active Not Recruiting PHASE3

    Status: Recruiting → Active Not Recruiting

  2. Jan 2021 — May 2021 [monthly]

    Recruiting PHASE3

  3. Aug 2020 — Jan 2021 [monthly]

    Recruiting PHASE3

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Krystal Biotech, Inc.
Data source: Krystal Biotech, Inc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations