olipudase alfa: Clinical Trials

4 trials of olipudase alfa, newest first

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4 completed. 4 Phase 2, 1 Phase 1, 1 Phase 3.

By phase and status

PhaseTrialsStatus
Phase 24Completed 4
Phase 11Completed 1
Phase 31Completed 1

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Trials (filtered) newest first · largest first

All 4 trials

Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.

TrialPhaseStatusSponsorEnrollmentStartUpdated
A Study to Evaluate Safety and Tolerability of Olipudase Alfa in Pediatric and Adult Participants With Acid Sphingomyelinase Deficiency (ASMD) Who Completed the DFI12712 or the LTS13632 Study in France
Olipudase alfa - Acid Sphingomyelinase Deficiency
Phase 2CompletedSanofi32021-11-182026-04-13
Efficacy, Safety, Pharmacodynamic, and Pharmacokinetics Study of Olipudase Alfa in Patients With Acid Sphingomyelinase Deficiency
placebo (saline), Olipudase alfa - Sphingomyelin Lipidosis
Phase 2 / Phase 3CompletedGenzyme, a Sanofi Company362015-12-182024-11-07
Safety, Tolerability, PK, and Efficacy Evaluation of Repeat Ascending Doses of Olipudase Alfa in Pediatric Patients <18 Years of Age With Acid Sphingomyelinase Deficiency
Olipudase alfa - Sphingomyelin Lipidosis
Phase 1 / Phase 2CompletedGenzyme, a Sanofi Company202015-05-012022-03-23
A Long-Term Study of Olipudase Alfa in Patients With Acid Sphingomyelinase Deficiency
GZ402665 - Sphingomyelin Lipidosis
Phase 2CompletedGenzyme, a Sanofi Company252013-12-042024-07-03

Conditions studied

Niemann-Pick Disease, Type A (3)  ·  Niemann-Pick Diseases (1)

Sponsors

Genzyme, a Sanofi Company (3)  ·  Sanofi (1)

Countries

France (4)  ·  Brazil (3)  ·  Germany (3)  ·  Italy (3)  ·  United Kingdom (3)  ·  United States (3)  ·  Belgium (2)  ·  Argentina (1)  ·  Australia (1)  ·  Bulgaria (1)  ·  Chile (1)  ·  Japan (1)  ·  Netherlands (1)  ·  Portugal (1)  ·  Spain (1)

Results publications

PMID 29305734, PMID 32620536, PMID 33875845, PMID 37098529, PMID 38042851, PMID 39774103, PMID 40937531

NIH funding

2015 (1)