Efficacy, Safety, Pharmacodynamic, and Pharmacokinetics Study of Olipudase Alfa in Patients With Acid Sphingomyelinase Deficiency (ASCEND)
A Phase 2/3, Multicenter, Randomized, Double-blinded, Placebo-controlled, Repeat-dose Study to Evaluate the Efficacy, Safety, Pharmacodynamics, and Pharmacokinetics of Olipudase Alfa in Patients With Acid Sphingomyelinase Deficiency
Sponsor: Genzyme, a Sanofi Company
A PHASE2/PHASE3 clinical study on Sphingomyelin Lipidosis, this trial is completed. The trial is conducted by Genzyme, a Sanofi Company and has accumulated 35 data snapshots since 2015. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.
Status Flow
Change History
35 versions recorded-
Sep 2025 — Present [monthly]
Completed PHASE2/PHASE3
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Dec 2024 — Sep 2025 [monthly]
Completed PHASE2/PHASE3
-
Sep 2024 — Dec 2024 [monthly]
Completed PHASE2/PHASE3
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE2/PHASE3
Phase: PHASE2_PHASE3 → PHASE2/PHASE3
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Jan 2024 — Jul 2024 [monthly]
Completed PHASE2_PHASE3
Status: Active Not Recruiting → Completed
▶ Show 30 earlier versions
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Oct 2023 — Jan 2024 [monthly]
Active Not Recruiting PHASE2_PHASE3
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Jun 2022 — Oct 2023 [monthly]
Active Not Recruiting PHASE2_PHASE3
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Apr 2022 — Jun 2022 [monthly]
Active Not Recruiting PHASE2_PHASE3
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Nov 2021 — Apr 2022 [monthly]
Active Not Recruiting PHASE2_PHASE3
-
Sep 2021 — Nov 2021 [monthly]
Active Not Recruiting PHASE2_PHASE3
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Jan 2021 — Sep 2021 [monthly]
Active Not Recruiting PHASE2_PHASE3
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Nov 2020 — Jan 2021 [monthly]
Active Not Recruiting PHASE2_PHASE3
-
Jan 2020 — Nov 2020 [monthly]
Active Not Recruiting PHASE2_PHASE3
-
Dec 2019 — Jan 2020 [monthly]
Active Not Recruiting PHASE2_PHASE3
-
Nov 2019 — Dec 2019 [monthly]
Active Not Recruiting PHASE2_PHASE3
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Oct 2019 — Nov 2019 [monthly]
Active Not Recruiting PHASE2_PHASE3
-
Sep 2019 — Oct 2019 [monthly]
Active Not Recruiting PHASE2_PHASE3
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May 2019 — Sep 2019 [monthly]
Active Not Recruiting PHASE2_PHASE3
-
Feb 2019 — May 2019 [monthly]
Active Not Recruiting PHASE2_PHASE3
Status: Recruiting → Active Not Recruiting
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Jan 2019 — Feb 2019 [monthly]
Recruiting PHASE2_PHASE3
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Dec 2018 — Jan 2019 [monthly]
Recruiting PHASE2_PHASE3
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Nov 2018 — Dec 2018 [monthly]
Recruiting PHASE2_PHASE3
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Oct 2018 — Nov 2018 [monthly]
Recruiting PHASE2_PHASE3
-
Sep 2018 — Oct 2018 [monthly]
Recruiting PHASE2_PHASE3
-
Aug 2018 — Sep 2018 [monthly]
Recruiting PHASE2_PHASE3
-
Jul 2018 — Aug 2018 [monthly]
Recruiting PHASE2_PHASE3
-
Jun 2018 — Jul 2018 [monthly]
Recruiting PHASE2_PHASE3
-
May 2018 — Jun 2018 [monthly]
Recruiting PHASE2_PHASE3
-
Feb 2018 — May 2018 [monthly]
Recruiting PHASE2_PHASE3
-
Dec 2017 — Feb 2018 [monthly]
Recruiting PHASE2_PHASE3
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Aug 2017 — Dec 2017 [monthly]
Recruiting PHASE2_PHASE3
-
Jun 2017 — Aug 2017 [monthly]
Recruiting PHASE2_PHASE3
-
Mar 2017 — Jun 2017 [monthly]
Recruiting PHASE2_PHASE3
-
Feb 2017 — Mar 2017 [monthly]
Recruiting PHASE2_PHASE3
-
Jan 2017 — Feb 2017 [monthly]
Recruiting PHASE2_PHASE3
First recorded
Dec 2015
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Genzyme, a Sanofi Company
For direct contact, visit the study record on ClinicalTrials.gov .