Comparison · NCT03156621-ce8db5c3
Alirocumab 150 mg SC Q2W vs Placebo in DBTP: Number of Participants With Anti-Drug Antibodies (ADA) to REGN727 Over Time
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Alirocumab 150 mg SC Q2W vs Placebo in DBTP: Number of Participants With Anti-Drug Antibodies (ADA) to REGN727 Over Time. Trial comparisons, record NCT03156621-ce8db5c3. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03156621-ce8db5c3
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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 | 0.0227 | 0.00402 | 0.118 | wilson | |
| Risk in group 2 | 0.0417 | 0.00739 | 0.202 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0189 | -0.181 | 0.0824 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.545 | 0.0357 | 8.34 | log | |
| Odds ratio, group 1 over group 2 | 0.535 | 0.032 | 8.95 | log | |
| Number needed to treat, for one fewer participant with the outcome on Alirocumab 150 mg SC Q2W than on Placebo in DBTP | 52.8 | 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 | Alirocumab 150 mg SC Q2W | Participants in this arm received alirocumab 150 milligrams (mg) SC Q2W from baseline (Day 1) through Week 10 during the double-blind treatment period. Starting at Week 12, and continuing through Week 22, all participants received open-label alirocumab SC Q2W | 1 | 44 | OG001 |
| Group 2 | Placebo in DBTP | Participants received matching placebo subcutaneously (SC) every 2 weeks (Q2W) from baseline (Day 1) through Week 10 during the double-blind treatment period. Starting at Week 12, and continuing through Week 22, all participants received open-label alirocumab SC Q2W | 1 | 24 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Anti-Drug Antibodies (ADA) to REGN727 Over Time
- Description
- Time frame
- 26 weeks
- Population
- Here 'n' = number of evaluable participants at this time point
Source ClinicalTrials.gov
Trial
- Title
- Study in Participants With Homozygous Familial Hypercholesterolemia (HoFH)
- NCT number
- NCT03156621
- Phases
- PHASE3
- Conditions
- Homozygous Familial Hypercholesterolemia
- Interventions
- Alirocumab, Placebo
- Lead sponsor
- Regeneron Pharmaceuticals
- Results first posted
- 2021-06-29
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03156621?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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