Trial · NCT04322708
A Study of Lirentelimab (AK002) in Patients With Active Eosinophilic Esophagitis
NCT04322708, Phase 2, Phase 3, Completed, Allakos Inc.; results first posted 2024-01-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Lirentelimab (AK002) in Patients With Active Eosinophilic Esophagitis. Trials, record NCT04322708. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04322708
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Lirentelimab (AK002) in Patients With Active Eosinophilic Esophagitis
- NCT number
- NCT04322708
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 277 participants, actual
- Lead sponsor
- Allakos Inc.
- Conditions
- Eosinophilic Esophagitis
- Interventions
- Placebo, lirentelimab (AK002)
- First posted
- 2020-03-26
- Last updated
- 2024-01-02
- Results first posted
- 2024-01-02
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Subjects Who Achieve a Peak Esophageal Intraepithelial Count of ≤6 Eosinophils/Hpf at Week 24 | At Week 24 | Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies. |
| Primary | Change in Dysphagia Symptom Questionnaire (DSQ) Score From Baseline to Weeks 23-24. | Baseline to Weeks 23-24 | The DSQ is used to measure the frequency and intensity of dysphagia. DSQ scores can range from 0 to 84, with a lower score indicating less-frequent or less-severe dysphagia. |
| Secondary | Percent Change in Peak Esophageal Intraepithelial Eosinophil Count From Baseline to Week 24 | Baseline to Week 24 | Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies. A greater esophageal intraepithelial eosinophil count from baseline indicates worsening disease. |
| Secondary | Subjects Achieving Peak Esophageal Intraepithelial Eosinophil Count of ≤1 Eosinophil/Hpf at Week 24 | At Week 24 | Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies. |
| Secondary | Subjects Achieving Peak Esophageal Intraepithelial Eosinophil Count of <15 Eosinophils/Hpf at Week 24 | At Week 24 | Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies. |
| Secondary | Number of Treatment Responders | At Weeks 23-24 and Week 24, Respectively | Treatment responders defined by \>30% improvement in symptoms (DSQ) at Weeks 23-24 and peak intraepithelial eosinophilic count of ≤6 cells/hpf at Week 24 |
| Secondary | Subjects Who Achieve >50% Reduction in DSQ Score From Baseline to Weeks 23-24 | Weeks 23-24 | The DSQ is used to measure the frequency and intensity of dysphagia. DSQ scores can range from 0 to 84, with a lower score indicating less-frequent or less-severe dysphagia. |
| Secondary | Percent Change in DSQ Score From Baseline to Weeks 23-24 | Baseline to Weeks 23-24 | The DSQ is used to measure the frequency and intensity of dysphagia. DSQ scores can range from 0 to 84, with a lower score indicating less-frequent or less-severe dysphagia. |
| Secondary | Change in Biweekly Mean DSQ Over Time Using MMRM | Baseline to Weeks 23-24 | The DSQ is used to measure the frequency and intensity of dysphagia. DSQ scores can range from 0 to 84, with a lower score indicating less-frequent or less-severe dysphagia. |
| Secondary | Change in EoE Reference Score for Endoscopic Abnormalities (EREFS) From Baseline to Week 24 | Baseline to Week 24 | EoE esophageal characteristics analyzed based on the EoE-EREFS, a scoring system for inflammatory and remodeling features of disease. The overall total score ranges from 0 to 18 with higher number indicating worse disease. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Subjects Who Achieve a Peak Esophageal Intraepithelial Count of ≤6 Eosinophils/Hpf at Week 24 | At Week 24 | Modified Intention-to-treat | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Change in Dysphagia Symptom Questionnaire (DSQ) Score From Baseline to Weeks 23-24. | Baseline to Weeks 23-24 | Modified Intention-to-treat | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change in Peak Esophageal Intraepithelial Eosinophil Count From Baseline to Week 24 | Baseline to Week 24 | Modified Intention-to-treat | Percentage of Change | MEAN |
| SECONDARY | Subjects Achieving Peak Esophageal Intraepithelial Eosinophil Count of ≤1 Eosinophil/Hpf at Week 24 | At Week 24 | Modified Intention-to-treat | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Subjects Achieving Peak Esophageal Intraepithelial Eosinophil Count of <15 Eosinophils/Hpf at Week 24 | At Week 24 | Modified Intention-to-treat | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Treatment Responders | At Weeks 23-24 and Week 24, Respectively | Modified Intention-to-treat | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Subjects Who Achieve >50% Reduction in DSQ Score From Baseline to Weeks 23-24 | Weeks 23-24 | Modified Intention-to-treat | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percent Change in DSQ Score From Baseline to Weeks 23-24 | Baseline to Weeks 23-24 | Modified Intention-to-treat | Percentage of Change | MEAN |
| SECONDARY | Change in Biweekly Mean DSQ Over Time Using MMRM | Baseline to Weeks 23-24 | Modified Intention-to-treat | Score on a Scale | MEAN |
| SECONDARY | Change in EoE Reference Score for Endoscopic Abnormalities (EREFS) From Baseline to Week 24 | Baseline to Week 24 | Modified Intention-to-treat | Score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group63
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Subjects Who Achieve a Peak Esophageal Intraepithelial Count of ≤6 Eosinophils/Hpf at Week 24 | 1 mg/kg of Lirentelimab (AK002) | 86 | Participants | ||
| Proportion of Subjects Who Achieve a Peak Esophageal Intraepithelial Count of ≤6 Eosinophils/Hpf at Week 24 | 3 mg/kg of Lirentelimab (AK002) | 80 | Participants | ||
| Proportion of Subjects Who Achieve a Peak Esophageal Intraepithelial Count of ≤6 Eosinophils/Hpf at Week 24 | Placebo | 10 | Participants | ||
| Change in Dysphagia Symptom Questionnaire (DSQ) Score From Baseline to Weeks 23-24. | 1 mg/kg of Lirentelimab (AK002) | -11.9 | Standard Error 1.8 | Score on a scale | |
| Change in Dysphagia Symptom Questionnaire (DSQ) Score From Baseline to Weeks 23-24. | 3 mg/kg of Lirentelimab (AK002) | -17.4 | Standard Error 1.8 | Score on a scale | |
| Change in Dysphagia Symptom Questionnaire (DSQ) Score From Baseline to Weeks 23-24. | Placebo | -14.6 | Standard Error 1.8 | Score on a scale | |
| Percent Change in Peak Esophageal Intraepithelial Eosinophil Count From Baseline to Week 24 | 1 mg/kg of Lirentelimab (AK002) | -98.9 | Standard Deviation 5.6 | Percentage of Change | |
| Percent Change in Peak Esophageal Intraepithelial Eosinophil Count From Baseline to Week 24 | 3 mg/kg of Lirentelimab (AK002) | -99.6 | Standard Deviation 1.0 | Percentage of Change | |
| Percent Change in Peak Esophageal Intraepithelial Eosinophil Count From Baseline to Week 24 | Placebo | -3.1 | Standard Deviation 76.0 | Percentage of Change | |
| Subjects Achieving Peak Esophageal Intraepithelial Eosinophil Count of ≤1 Eosinophil/Hpf at Week 24 | 1 mg/kg of Lirentelimab (AK002) | 82 | Participants |
1 to 10 of 63Source ClinicalTrials.gov
See all 63 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 92 | |
| Overall Study | STARTED | 1 mg/kg of Lirentelimab (AK002) | 93 | |
| Overall Study | STARTED | 3 mg/kg of Lirentelimab (AK002) | 91 | |
| Overall Study | COMPLETED | Placebo | 89 | |
| Overall Study | COMPLETED | 1 mg/kg of Lirentelimab (AK002) | 89 | |
| Overall Study | COMPLETED | 3 mg/kg of Lirentelimab (AK002) | 85 | |
| Overall Study | NOT COMPLETED | Placebo | 3 | |
| Overall Study | NOT COMPLETED | 1 mg/kg of Lirentelimab (AK002) | 4 | |
| Overall Study | NOT COMPLETED | 3 mg/kg of Lirentelimab (AK002) | 6 |
Source ClinicalTrials.gov
Adverse events48
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | 1 mg/kg of Lirentelimab (AK002) | 4 | 93 | 4 |
| other | Nausea | Gastrointestinal disorders | 3 mg/kg of Lirentelimab (AK002) | 4 | 91 | 6 |
| other | Nausea | Gastrointestinal disorders | Placebo | 8 | 92 | 12 |
| other | Vomiting | Gastrointestinal disorders | 1 mg/kg of Lirentelimab (AK002) | 1 | 93 | 1 |
| other | Vomiting | Gastrointestinal disorders | 3 mg/kg of Lirentelimab (AK002) | 5 | 91 | 6 |
| other | Vomiting | Gastrointestinal disorders | Placebo | 7 | 92 | 8 |
| other | Fatigue | General disorders | 1 mg/kg of Lirentelimab (AK002) | 3 | 93 | 7 |
| other | Fatigue | General disorders | 3 mg/kg of Lirentelimab (AK002) | 3 | 91 | 3 |
| other | Fatigue | General disorders | Placebo | 5 | 92 | 6 |
| other | Infusion related reaction | Injury, poisoning and procedural complications | 1 mg/kg of Lirentelimab (AK002) | 24 | 93 | 36 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 1 mg/kg of Lirentelimab (AK002) | 0 | 93 |
| Total, all-cause mortality | 3 mg/kg of Lirentelimab (AK002) | 0 | 91 |
| Total, all-cause mortality | Placebo | 0 | 92 |
| Total, other adverse events | 1 mg/kg of Lirentelimab (AK002) | 37 | 93 |
| Total, other adverse events | 3 mg/kg of Lirentelimab (AK002) | 39 | 91 |
| Total, other adverse events | Placebo | 23 | 92 |
| Total, serious adverse events | 1 mg/kg of Lirentelimab (AK002) | 4 | 93 |
| Total, serious adverse events | 3 mg/kg of Lirentelimab (AK002) | 3 | 91 |
| Total, serious adverse events | Placebo | 2 | 92 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04322708
GET https://conductscience.org/api/trials/v1/NCT04322708/results?page=2