deltatrials
Completed PHASE2/PHASE3 INTERVENTIONAL 2-arm NCT02004691

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

Updated 35 times since 2017 Last updated: Oct 16, 2024 Started: Dec 18, 2015 Primary completion: Mar 15, 2021 Completion: Oct 19, 2023
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

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

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Mar 2017 · 28 days · monthly snapshot~Mar 2017 – ~Jun 2017 · 3 months · monthly snapshot~Jun 2017 – ~Aug 2017 · 2 months · monthly snapshot~Aug 2017 – ~Dec 2017 · 4 months · monthly snapshot~Dec 2017 – ~Feb 2018 · 2 months · monthly snapshot~Feb 2018 – ~May 2018 · 3 months · monthly snapshot~May 2018 – ~Jun 2018 · 31 days · monthly snapshot~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshot~Jul 2018 – ~Aug 2018 · 31 days · monthly snapshot~Aug 2018 – ~Sep 2018 · 31 days · monthly snapshot~Sep 2018 – ~Oct 2018 · 30 days · monthly snapshot~Oct 2018 – ~Nov 2018 · 31 days · monthly snapshot~Nov 2018 – ~Dec 2018 · 30 days · monthly snapshot~Dec 2018 – ~Jan 2019 · 31 days · monthly snapshot~Jan 2019 – ~Feb 2019 · 31 days · monthly snapshot~Feb 2019 – ~May 2019 · 3 months · monthly snapshot~May 2019 – ~Sep 2019 · 4 months · monthly snapshot~Sep 2019 – ~Oct 2019 · 30 days · monthly snapshot~Oct 2019 – ~Nov 2019 · 31 days · monthly snapshot~Nov 2019 – ~Dec 2019 · 30 days · monthly snapshot~Dec 2019 – ~Jan 2020 · 31 days · monthly snapshot~Jan 2020 – ~Nov 2020 · 10 months · monthly snapshot~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshot~Jan 2021 – ~Sep 2021 · 8 months · monthly snapshot~Sep 2021 – ~Nov 2021 · 2 months · monthly snapshot~Nov 2021 – ~Apr 2022 · 5 months · monthly snapshot~Apr 2022 – ~Jun 2022 · 2 months · monthly snapshot~Jun 2022 – ~Oct 2023 · 16 months · monthly snapshot~Oct 2023 – ~Jan 2024 · 3 months · monthly snapshot~Jan 2024 – ~Jul 2024 · 6 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Dec 2024 · 3 months · monthly snapshot~Dec 2024 – ~Sep 2025 · 9 months · monthly snapshot~Sep 2025 – present · 10 months · monthly snapshot

Change History

35 versions recorded
  1. Sep 2025 — Present [monthly]

    Completed PHASE2/PHASE3

  2. Dec 2024 — Sep 2025 [monthly]

    Completed PHASE2/PHASE3

  3. Sep 2024 — Dec 2024 [monthly]

    Completed PHASE2/PHASE3

  4. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2/PHASE3

    Phase: PHASE2_PHASE3PHASE2/PHASE3

  5. Jan 2024 — Jul 2024 [monthly]

    Completed PHASE2_PHASE3

    Status: Active Not RecruitingCompleted

Show 30 earlier versions
  1. Oct 2023 — Jan 2024 [monthly]

    Active Not Recruiting PHASE2_PHASE3

  2. Jun 2022 — Oct 2023 [monthly]

    Active Not Recruiting PHASE2_PHASE3

  3. Apr 2022 — Jun 2022 [monthly]

    Active Not Recruiting PHASE2_PHASE3

  4. Nov 2021 — Apr 2022 [monthly]

    Active Not Recruiting PHASE2_PHASE3

  5. Sep 2021 — Nov 2021 [monthly]

    Active Not Recruiting PHASE2_PHASE3

  6. Jan 2021 — Sep 2021 [monthly]

    Active Not Recruiting PHASE2_PHASE3

  7. Nov 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE2_PHASE3

  8. Jan 2020 — Nov 2020 [monthly]

    Active Not Recruiting PHASE2_PHASE3

  9. Dec 2019 — Jan 2020 [monthly]

    Active Not Recruiting PHASE2_PHASE3

  10. Nov 2019 — Dec 2019 [monthly]

    Active Not Recruiting PHASE2_PHASE3

  11. Oct 2019 — Nov 2019 [monthly]

    Active Not Recruiting PHASE2_PHASE3

  12. Sep 2019 — Oct 2019 [monthly]

    Active Not Recruiting PHASE2_PHASE3

  13. May 2019 — Sep 2019 [monthly]

    Active Not Recruiting PHASE2_PHASE3

  14. Feb 2019 — May 2019 [monthly]

    Active Not Recruiting PHASE2_PHASE3

    Status: RecruitingActive Not Recruiting

  15. Jan 2019 — Feb 2019 [monthly]

    Recruiting PHASE2_PHASE3

  16. Dec 2018 — Jan 2019 [monthly]

    Recruiting PHASE2_PHASE3

  17. Nov 2018 — Dec 2018 [monthly]

    Recruiting PHASE2_PHASE3

  18. Oct 2018 — Nov 2018 [monthly]

    Recruiting PHASE2_PHASE3

  19. Sep 2018 — Oct 2018 [monthly]

    Recruiting PHASE2_PHASE3

  20. Aug 2018 — Sep 2018 [monthly]

    Recruiting PHASE2_PHASE3

  21. Jul 2018 — Aug 2018 [monthly]

    Recruiting PHASE2_PHASE3

  22. Jun 2018 — Jul 2018 [monthly]

    Recruiting PHASE2_PHASE3

  23. May 2018 — Jun 2018 [monthly]

    Recruiting PHASE2_PHASE3

  24. Feb 2018 — May 2018 [monthly]

    Recruiting PHASE2_PHASE3

  25. Dec 2017 — Feb 2018 [monthly]

    Recruiting PHASE2_PHASE3

  26. Aug 2017 — Dec 2017 [monthly]

    Recruiting PHASE2_PHASE3

  27. Jun 2017 — Aug 2017 [monthly]

    Recruiting PHASE2_PHASE3

  28. Mar 2017 — Jun 2017 [monthly]

    Recruiting PHASE2_PHASE3

  29. Feb 2017 — Mar 2017 [monthly]

    Recruiting PHASE2_PHASE3

  30. 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

Sponsor contact:
  • Genzyme, a Sanofi Company
Data source: Sanofi

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