Trial · NCT04856891
A Study of Lirentelimab (AK002) in Patients With Active Eosinophilic Duodenitis
NCT04856891, 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 Duodenitis. Trials, record NCT04856891. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04856891
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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 Duodenitis
- NCT number
- NCT04856891
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 94 participants, actual
- Lead sponsor
- Allakos Inc.
- Conditions
- Eosinophilic Duodenitis, Eosinophilic Gastroenteritis
- Interventions
- AK002, Placebo
- First posted
- 2021-04-23
- Last updated
- 2024-01-02
- Results first posted
- 2024-01-02
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Tissue Eosinophil Responders at Week 24 | At Week 24 | A tissue eosinophil responder is defined as mean eosinophil count \<=15 cells/HPF in 3 duodenal HPFs |
| Primary | Change in PRO Total Symptom Score (TSS) From Baseline to Weeks 23-24 | Baseline to Weeks 23 - 24 | 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. |
| Secondary | Percent Change in Tissue Eosinophils From Baseline to Week 24 | Baseline to Week 24 | Tissue eosinophil count obtained in biopsy specimens from the duodenum using esophago-gastro-duodenoscopy (EGD) |
| Secondary | Subjects Achieving Eosinophils Count ≤1 Cell/Hpf in 3 Highest Duodenal Hpf at Week 24 | At Week 24 | Tissue eosinophil count obtained in biopsy specimens from the duodenum using esophago-gastro-duodenoscopy (EGD) |
| Secondary | Number of Treatment Responders | At Weeks 23-24 and Week 24, Respectively | Treatment responders defined by \>30% improvement in TSS and eosinophil count ≤15 cells per hpf in 3 duodenal hpf |
| Secondary | Subjects Who Achive ≥50% Reduction in TSS From Baseline to Weeks 23-24 | At Weeks 23-24 | 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. |
| Secondary | Subjects Who Achieve ≥70% Reduction in TSS From Baseline to Weeks 23-24 | At Weeks 23-24 | 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. |
| Secondary | Percent Change in Weekly TSS Over Time Using MMRM | Baseline to Week 24 | 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. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Tissue Eosinophil Responders at Week 24 | At Week 24 | Modified Intention-to-treat | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Change in PRO Total Symptom Score (TSS) 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 Tissue Eosinophils From Baseline to Week 24 | Baseline to Week 24 | Modified Intention-to-treat | Percentage of Change | MEAN |
| SECONDARY | Subjects Achieving Eosinophils Count ≤1 Cell/Hpf in 3 Highest Duodenal 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 Achive ≥50% Reduction in TSS From Baseline to Weeks 23-24 | At Weeks 23-24 | Modified Intention-to-treat | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Subjects Who Achieve ≥70% Reduction in TSS From Baseline to Weeks 23-24 | At Weeks 23-24 | Modified Intention-to-treat | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percent Change in Weekly TSS Over Time Using MMRM | Baseline to Week 24 | Modified Intention-to-treat | Percentage of Change | MEAN |
Source ClinicalTrials.gov
Results by group38
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Tissue Eosinophil Responders at Week 24 | 3.0 mg/kg of Lirentelimab (AK002) | 38 | Participants | ||
| Proportion of Tissue Eosinophil Responders at Week 24 | Placebo | 2 | Participants | ||
| Change in PRO Total Symptom Score (TSS) From Baseline to Weeks 23-24 | 3.0 mg/kg of Lirentelimab (AK002) | -12.7 | Standard Error 1.7 | Score on a scale | |
| Change in PRO Total Symptom Score (TSS) From Baseline to Weeks 23-24 | Placebo | -13.0 | Standard Error 1.7 | Score on a scale | |
| Percent Change in Tissue Eosinophils From Baseline to Week 24 | 3.0 mg/kg of Lirentelimab (AK002) | -99.9 | Standard Deviation 0.4 | Percentage of Change | |
| Percent Change in Tissue Eosinophils From Baseline to Week 24 | Placebo | -24.1 | Standard Deviation 30.5 | Percentage of Change | |
| Subjects Achieving Eosinophils Count ≤1 Cell/Hpf in 3 Highest Duodenal Hpf at Week 24 | 3.0 mg/kg of Lirentelimab (AK002) | 37 | Participants | ||
| Subjects Achieving Eosinophils Count ≤1 Cell/Hpf in 3 Highest Duodenal Hpf at Week 24 | Placebo | 0 | Participants | ||
| Number of Treatment Responders | 3.0 mg/kg of Lirentelimab (AK002) | 21 | Participants | ||
| Number of Treatment Responders | Placebo | 1 | Participants |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 3.0 mg/kg of Lirentelimab (AK002) | 46 | |
| Overall Study | STARTED | Placebo | 47 | |
| Overall Study | COMPLETED | 3.0 mg/kg of Lirentelimab (AK002) | 38 | |
| Overall Study | COMPLETED | Placebo | 44 | |
| Overall Study | NOT COMPLETED | 3.0 mg/kg of Lirentelimab (AK002) | 8 | |
| Overall Study | NOT COMPLETED | Placebo | 3 |
Source ClinicalTrials.gov
Adverse events20
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 | Abdominal pain | Gastrointestinal disorders | 3.0 mg/kg of Lirentelimab (AK002) | 3 | 46 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 0 | 47 | |
| other | Diarrhea | Gastrointestinal disorders | 3.0 mg/kg of Lirentelimab (AK002) | 1 | 46 | |
| other | Diarrhea | Gastrointestinal disorders | Placebo | 3 | 47 | |
| other | Hiatus hernia | Gastrointestinal disorders | 3.0 mg/kg of Lirentelimab (AK002) | 2 | 46 | |
| other | Hiatus hernia | Gastrointestinal disorders | Placebo | 4 | 47 | |
| other | Corona virus infection | Infections and infestations | 3.0 mg/kg of Lirentelimab (AK002) | 5 | 46 | |
| other | Corona virus infection | Infections and infestations | Placebo | 4 | 47 | |
| other | Sinusitis | Infections and infestations | 3.0 mg/kg of Lirentelimab (AK002) | 4 | 46 | |
| other | Sinusitis | Infections and infestations | Placebo | 1 | 47 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 3.0 mg/kg of Lirentelimab (AK002) | 0 | 46 |
| Total, all-cause mortality | Placebo | 0 | 47 |
| Total, other adverse events | 3.0 mg/kg of Lirentelimab (AK002) | 18 | 46 |
| Total, other adverse events | Placebo | 19 | 47 |
| Total, serious adverse events | 3.0 mg/kg of Lirentelimab (AK002) | 2 | 46 |
| Total, serious adverse events | Placebo | 1 | 47 |
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 comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| 3.0 mg/kg of Lirentelimab (AK002) vs Placebo: Subjects Who Achive ≥50% Reduction in TSS From Baseline to Weeks 23-24 | Trial comparisons |
| 3.0 mg/kg of Lirentelimab (AK002) vs Placebo: Proportion of Tissue Eosinophil Responders at Week 24 | Trial comparisons |
| 3.0 mg/kg of Lirentelimab (AK002) vs Placebo: Subjects Achieving Eosinophils Count ≤1 Cell/Hpf in 3 Highest Duodenal Hpf at Week 24 | Trial comparisons |
| 3.0 mg/kg of Lirentelimab (AK002) vs Placebo: Subjects Who Achieve ≥70% Reduction in TSS From Baseline to Weeks 23-24 | Trial comparisons |
| 3.0 mg/kg of Lirentelimab (AK002) vs Placebo: Number of Treatment Responders | Trial comparisons |
| 3.0 mg/kg of Lirentelimab (AK002) vs Placebo: deaths from any cause | Trial comparisons |
| 3.0 mg/kg of Lirentelimab (AK002) vs Placebo: serious adverse events | Trial comparisons |
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/NCT04856891
GET https://conductscience.org/api/trials/v1/NCT04856891/results?page=2