Comparison · NCT04856891-sae
3.0 mg/kg of Lirentelimab (AK002) 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
Cite this record
ConductScience Library. 3.0 mg/kg of Lirentelimab (AK002) vs Placebo: serious adverse events. Trial comparisons, record NCT04856891-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04856891-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 | 0.0435 | 0.012 | 0.145 | wilson | |
| Risk in group 2 | 0.0213 | 0.00377 | 0.111 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0222 | -0.073 | 0.126 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.04 | 0.192 | 21.8 | log | |
| Odds ratio, group 1 over group 2 | 2.09 | 0.183 | 23.9 | log | |
| Number needed to harm, for one more participant with a serious adverse event on 3.0 mg/kg of Lirentelimab (AK002) than on Placebo | 45 | 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 | 3.0 mg/kg of Lirentelimab (AK002) | Subjects in this arm will receive 6 monthly doses of lirentelimab (AK002) at 3 mg/kg.~AK002: Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1(IgG1) monoclonal antibody directed against Siglec-8. | 2 | 46 | EG000 |
| Group 2 | Placebo | Subjects in this arm will receive 6 monthly doses of placebo at 3 mg/kg.~Placebo: Placebo | 1 | 47 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Baseline up to Day 225
Source ClinicalTrials.gov
Trial
- Title
- A Study of Lirentelimab (AK002) in Patients With Active Eosinophilic Duodenitis
- NCT number
- NCT04856891
- Phases
- PHASE3
- Conditions
- Eosinophilic Duodenitis, Eosinophilic Gastroenteritis
- Interventions
- AK002, Placebo
- Lead sponsor
- Allakos Inc.
- Results first posted
- 2024-01-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04856891?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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