Comparison · NCT05088460-cb09c06e
Arm 2 Combined Cohort A + B: REGN4461 to REGN4461 vs Arm 1 Combined Cohort A + B: Placebo to REGN4461: Number of Participants With Treatment-emergent Anti-drug Antibody (ADA) Response
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. Arm 2 Combined Cohort A + B: REGN4461 to REGN4461 vs Arm 1 Combined Cohort A + B: Placebo to REGN4461: Number of Participants With Treatment-emergent Anti-drug Antibody (ADA) Response. Trial comparisons, record NCT05088460-cb09c06e. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05088460-cb09c06e
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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 | 0 | 0.278 | wilson | |
| Risk in group 2 | 0 | 0 | 0.278 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.278 | 0.278 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat | from the risk difference interval | the two groups' risks are equal |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Arm 2 Combined Cohort A + B: REGN4461 to REGN4461 | Arm 2 Cohort A and Arm 2 Cohort B combined | 0 | 10 | OG001 |
| Group 2 | Arm 1 Combined Cohort A + B: Placebo to REGN4461 | Arm 1 Cohort A and Arm 1 Cohort B combined | 0 | 10 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Treatment-emergent Anti-drug Antibody (ADA) Response
- Description
- Time frame
- Up to Day 281
- Population
- The ADA analysis set included all treated participants who received any amount of study drug and had at least one non-missing anti-drug antibody result following the first dose of study drug.
Source ClinicalTrials.gov
Trial
- Title
- A Study to Examine the Effects of the Leptin Receptor (LEPR) Agonist Antibody REGN4461 in Adult Patients With Familial Partial Lipodystrophy (FPLD)
- NCT number
- NCT05088460
- Phases
- PHASE2
- Conditions
- Familial Partial Lipodystrophy, Metabolic Abnormalities
- Interventions
- REGN4461, Matching Placebo
- Lead sponsor
- Regeneron Pharmaceuticals
- Results first posted
- 2025-07-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT05088460?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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