Comparison · NCT02004691-b28629c5
Olipudase Alfa vs Placebo: Number of Participants Who Developed Anti-Drug Antibodies (ADA) to Olipudase Alfa up to Week 52
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Olipudase Alfa vs Placebo: Number of Participants Who Developed Anti-Drug Antibodies (ADA) to Olipudase Alfa up to Week 52. Trial comparisons, record NCT02004691-b28629c5. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02004691-b28629c5
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.222 | 0.09 | 0.452 | wilson | |
| Risk in group 2 | 0.0556 | 0.00988 | 0.258 | wilson | |
| Risk difference, group 1 minus group 2 | 0.167 | -0.0748 | 0.401 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 4 | 0.494 | 32.4 | log | |
| Odds ratio, group 1 over group 2 | 4.86 | 0.486 | 48.6 | log | |
| Number needed to treat, for one more participant with the outcome on Olipudase Alfa than on Placebo | 6 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Olipudase Alfa | Participants received IV infusion of olipudase alfa once every 2 weeks up to Week 52. Each participant underwent a dose escalation according to the following paradigm: 0.1, 0.3, 0.3, 0.6, 0.6, 1.0, 2.0, 3.0, 3.0 mg/kg. Three (3) mg/kg was the target maintenance dose, which was maintained for the remaining duration of 52 weeks of PAP. Participants who completed PAP entered in ETP and continued the same treatment in ETP up to Year 5. | 4 | 18 | OG001 |
| Group 2 | Placebo | Participants received IV infusion of placebo (matched to olipudase alfa) once every 2 weeks up to Week 52. Participants who completed PAP entered in ETP and crossed over to olipudase alfa with a target maintenance dose of 3 mg/kg after dose escalation which was administered IV once every 2 weeks up to Year 5. | 1 | 18 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants Who Developed Anti-Drug Antibodies (ADA) to Olipudase Alfa up to Week 52
- Description
- Number of participants with treatment-emergent ADA are presented. Baseline was defined as the last non-missing value prior to the first infusion of study treatment.
- Time frame
- Baseline (Day 1) and Week 52
- Population
- The safety population was a subset of the randomized population and included randomized participants who received at least 1 infusion (partial or total).
Source ClinicalTrials.gov
Trial
- Title
- Efficacy, Safety, Pharmacodynamic, and Pharmacokinetics Study of Olipudase Alfa in Patients With Acid Sphingomyelinase Deficiency
- NCT number
- NCT02004691
- Phases
- PHASE2, PHASE3
- Conditions
- Sphingomyelin Lipidosis
- Interventions
- placebo (saline), Olipudase alfa
- Lead sponsor
- Genzyme, a Sanofi Company
- Results first posted
- 2022-05-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02004691?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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