Comparison · NCT04202679-sae
Dupilumab 300 mg Q2W vs Placebo: serious adverse events
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. Dupilumab 300 mg Q2W vs Placebo: serious adverse events. Trial comparisons, record NCT04202679-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04202679-sae
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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 | 0.026 | 0.00715 | 0.0898 | wilson | |
| Risk in group 2 | 0.0488 | 0.0191 | 0.119 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0228 | -0.0953 | 0.0476 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.532 | 0.1 | 2.82 | log | |
| Odds ratio, group 1 over group 2 | 0.52 | 0.0925 | 2.92 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Dupilumab 300 mg Q2W than on Placebo | 43.8 | 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 | Dupilumab 300 mg Q2W | Participants received dupilumab at a loading dose of 600 mg, SC on Day 1 followed by dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose. | 2 | 77 | EG001 |
| Group 2 | Placebo | Participants received placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose. | 4 | 82 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From the first IMP administration to the last IMP administration + 14 weeks (i.e., up to 36 weeks)
Source ClinicalTrials.gov
Trial
- Title
- Study of Dupilumab for the Treatment of Patients With Prurigo Nodularis, Inadequately Controlled on Topical Prescription Therapies or When Those Therapies Are Not Advisable (PRIME2)
- NCT number
- NCT04202679
- Phases
- PHASE3
- Conditions
- Neurodermatitis
- Interventions
- Dupilumab SAR231893, Placebo, Moisturizers, Low to medium potent topical corticosteroids, Topical calcineurin inhibitors
- Lead sponsor
- Sanofi
- Results first posted
- 2022-09-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04202679?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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