Comparison · NCT04322604-7889e725
3 mg/kg of Lirentelimab (AK002) vs Placebo: Subjects Who Achieve ≥70% Reduction in TSS From Baseline to Weeks 23-24
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 mg/kg of Lirentelimab (AK002) vs Placebo: Subjects Who Achieve ≥70% Reduction in TSS From Baseline to Weeks 23-24. Trial comparisons, record NCT04322604-7889e725. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04322604-7889e725
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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 | 0.286 | 0.203 | 0.386 | wilson | |
| Risk in group 2 | 0.202 | 0.132 | 0.297 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0835 | -0.0424 | 0.206 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.41 | 0.836 | 2.39 | log | |
| Odds ratio, group 1 over group 2 | 1.58 | 0.792 | 3.14 | log | |
| Number needed to treat, for one more participant with the outcome on 3 mg/kg of Lirentelimab (AK002) than on Placebo | 12 | 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 mg/kg of Lirentelimab (AK002) | Subjects in this arm will receive 6 monthly doses of lirentelimab (AK002): a first dose of 1 mg/kg followed by 5 monthly doses of 3 mg/kg.~lirentelimab (AK002): Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8. | 26 | 91 | OG000 |
| Group 2 | Placebo | Placebo~Placebo: Placebo | 18 | 89 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Subjects Who Achieve ≥70% Reduction in TSS From Baseline to Weeks 23-24
- Description
The PRO Total Symptom Score (TSS) is a patient reported outcome (PRO) questionnaire comprises the following 6 symptoms: Abdominal pain intensity, Nausea intensity, Fullness before meal intensity, Loss of appetite intensity, Bloating intensity, and Abdominal cramping intensity. TSS scores can range from 0 to 60, with a lower score indicating less-severe symptoms.
- Time frame
- At Weeks 23-24
- Population
- Modified Intention-to-treat
Source ClinicalTrials.gov
Trial
- Title
- A Study to Assess AK002 in Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis)
- NCT number
- NCT04322604
- Phases
- PHASE3
- Conditions
- Eosinophilic Gastritis, Eosinophilic Duodenitis
- Interventions
- lirentelimab (AK002), Placebo
- Lead sponsor
- Allakos Inc.
- Results first posted
- 2024-01-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04322604?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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