Comparison · NCT04620811-sae
Main Study Active to Extension Study 3.0 mg/kg of Lirentelimab (AK002) vs Main Study Placebo to Extension Study 3.0 mg/kg of Lirentelimab (AK002): 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. Main Study Active to Extension Study 3.0 mg/kg of Lirentelimab (AK002) vs Main Study Placebo to Extension Study 3.0 mg/kg of Lirentelimab (AK002): serious adverse events. Trial comparisons, record NCT04620811-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04620811-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 | 0.167 | 0.102 | 0.261 | wilson | |
| Risk in group 2 | 0.08 | 0.0372 | 0.164 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0867 | -0.0192 | 0.19 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.08 | 0.843 | 5.15 | log | |
| Odds ratio, group 1 over group 2 | 2.3 | 0.836 | 6.33 | log | |
Number needed to harm, for one more participant with a serious adverse event on Main Study Active to Extension Study 3.0 mg/kg of Lirentelimab (AK002) than on Main Study Placebo to Extension Study 3.0 mg/kg of Lirentelimab (AK002) | 11.5 | 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 | Main Study Active to Extension Study 3.0 mg/kg of Lirentelimab (AK002) | Subjects in this arm received the active drug in the main study and were treated with up to 18 monthly doses (3mg/kg) of lirentelimab (AK002).~lirentelimab: Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8. | 14 | 84 | EG001 |
| Group 2 | Main Study Placebo to Extension Study 3.0 mg/kg of Lirentelimab (AK002) | Subjects in this arm received the placebo in the main study and were treated with up to 18 monthly doses (3mg/kg) of lirentelimab (AK002).~lirentelimab: Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8. | 6 | 75 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Through study completion, up to 21 months
Source ClinicalTrials.gov
Trial
- Title
- An Extension Study of Lirentelimab in Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis)
- NCT number
- NCT04620811
- Phases
- PHASE3
- Conditions
- Eosinophilic Gastritis, Eosinophilic Duodenitis
- Interventions
- lirentelimab
- Lead sponsor
- Allakos Inc.
- Results first posted
- 2024-04-18
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04620811?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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