Open Label Extension Study to Evaluate the Long-term Safety of Zorblisa (SD-101-6.0) in Patients With Epidermolysis Bullosa
An Open Label Multi-Center Extension Study to Evaluate the Long-term Safety of Zorblisa™ (SD-101-6.0) in Patients With Epidermolysis Bullosa
Sponsor: Amicus Therapeutics
Terminated
The Sponsor voluntarily recalled SD-101 and terminated the study due to GMP deficiencies identified during an FDA inspection at the site of the manufacturer.
Other terminated trials from Amicus Therapeutics
Other Epidermolysis Bullosa trials with similar outcome
This PHASE3 trial investigates Epidermolysis Bullosa and is currently terminated or withdrawn. Amicus Therapeutics leads this study, which shows 13 recorded versions since 2015 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.
Status Flow
Change History
13 versions recorded-
Sep 2025 — Present [monthly]
Terminated PHASE3
-
Sep 2024 — Sep 2025 [monthly]
Terminated PHASE3
-
Jul 2024 — Sep 2024 [monthly]
Terminated PHASE3
-
Dec 2021 — Jul 2024 [monthly]
Terminated PHASE3
-
Jan 2021 — Dec 2021 [monthly]
Terminated PHASE3
▶ Show 8 earlier versions
-
Nov 2020 — Jan 2021 [monthly]
Terminated PHASE3
-
Oct 2019 — Nov 2020 [monthly]
Terminated PHASE3
-
Sep 2019 — Oct 2019 [monthly]
Terminated PHASE3
Phase: NA → PHASE3
-
Nov 2018 — Sep 2019 [monthly]
Terminated NA
Status: Active Not Recruiting → Terminated
-
Jun 2018 — Nov 2018 [monthly]
Active Not Recruiting NA
-
May 2017 — Jun 2018 [monthly]
Active Not Recruiting NA
-
Feb 2017 — May 2017 [monthly]
Active Not Recruiting NA
-
Jan 2017 — Feb 2017 [monthly]
Active Not Recruiting NA
First recorded
Jun 2015
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Amicus Therapeutics
- Scioderm, Inc.
For direct contact, visit the study record on ClinicalTrials.gov .