Open-Label Extension Study to Evaluate the Safety of SD-101 Cream in Participants With Epidermolysis Bullosa
An Open Label Extension, Multi-Center, Study to Evaluate the Safety of SD-101 Cream in Subjects 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This PHASE2 trial investigates Epidermolysis Bullosa and is currently terminated or withdrawn. Amicus Therapeutics leads this study, which shows 12 recorded versions since 2014 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.
Status Flow
Change History
12 versions recorded-
Sep 2025 — Present [monthly]
Terminated PHASE2
-
Sep 2024 — Sep 2025 [monthly]
Terminated PHASE2
-
Jul 2024 — Sep 2024 [monthly]
Terminated PHASE2
-
Dec 2021 — Jul 2024 [monthly]
Terminated PHASE2
-
Jan 2021 — Dec 2021 [monthly]
Terminated PHASE2
▶ Show 7 earlier versions
-
Nov 2020 — Jan 2021 [monthly]
Terminated PHASE2
-
Dec 2019 — Nov 2020 [monthly]
Terminated PHASE2
Phase: NA → PHASE2
-
Dec 2018 — Dec 2019 [monthly]
Terminated NA
Status: Active Not Recruiting → Terminated
-
Jun 2018 — Dec 2018 [monthly]
Active Not Recruiting NA
-
May 2018 — Jun 2018 [monthly]
Active Not Recruiting NA
-
Feb 2017 — May 2018 [monthly]
Active Not Recruiting NA
-
Jan 2017 — Feb 2017 [monthly]
Active Not Recruiting NA
First recorded
Mar 2014
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Amicus Therapeutics
- Food and Drug Administration (FDA)
- Scioderm, Inc.
For direct contact, visit the study record on ClinicalTrials.gov .