Comparison · NCT04856891-8bf444da
3.0 mg/kg of Lirentelimab (AK002) vs Placebo: Number of Treatment Responders
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. 3.0 mg/kg of Lirentelimab (AK002) vs Placebo: Number of Treatment Responders. Trial comparisons, record NCT04856891-8bf444da. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04856891-8bf444da
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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 | 0.457 | 0.322 | 0.598 | wilson | |
| Risk in group 2 | 0.0213 | 0.00377 | 0.111 | wilson | |
| Risk difference, group 1 minus group 2 | 0.435 | 0.273 | 0.578 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 21.5 | 3.01 | 153 | log | |
| Odds ratio, group 1 over group 2 | 38.6 | 4.9 | 304 | log | |
| Number needed to treat, for one more participant with the outcome on 3.0 mg/kg of Lirentelimab (AK002) than on Placebo | 2.3 | 1.73 | 3.66 | from the risk difference interval |
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. | 21 | 46 | OG000 |
| Group 2 | Placebo | Subjects in this arm will receive 6 monthly doses of placebo at 3 mg/kg.~Placebo: Placebo | 1 | 47 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Treatment Responders
- Description
- Treatment responders defined by \>30% improvement in TSS and eosinophil count ≤15 cells per hpf in 3 duodenal hpf
- Time frame
- At Weeks 23-24 and Week 24, Respectively
- Population
- Modified Intention-to-treat
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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