Trial · NCT04620811
An Extension Study of Lirentelimab in Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis)
NCT04620811, Phase 3, Completed, Allakos Inc.; results first posted 2024-04-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Extension Study of Lirentelimab in Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis). Trials, record NCT04620811. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04620811
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Extension Study of Lirentelimab in Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis)
- NCT number
- NCT04620811
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 159 participants, actual
- Lead sponsor
- Allakos Inc.
- Conditions
- Eosinophilic Gastritis, Eosinophilic Duodenitis
- Interventions
- lirentelimab
- First posted
- 2020-11-09
- Last updated
- 2024-04-22
- Results first posted
- 2024-04-18
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Safety and Tolerability of Lirentelimab by Evaluating Adverse Events Assessed Using the CTCAE Version 5.0 | Through study completion, up to 21 months | Adverse events assessed using the CTCAE version 5.0. |
| Other | Proportion of Tissue Eosinophil Responders | At Follow-up EGD (Esophago-Gastro-Duodenoscopy) (Day 505 or 28 days after last dose if ET) | A tissue eosinophil responder is defined as mean eosinophil count ≤4 cells/HPF in 5 gastric HPFs for EG only patients, ≤15 cells/HPF in 3 duodenal HPFs for EoD only patients, and ≤4 cells/HPF in 5 gastric HPFs and ≤15 cells/HPF in 3 duodenal HPFs for EG+EoD patients. |
| Other | Change in PRO Total System Score (TSS) From AK002-016/AK002-012 Baseline | Main Study Baseline to Extension Weeks 71-72 | 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
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Safety and Tolerability of Lirentelimab by Evaluating Adverse Events Assessed Using the CTCAE Version 5.0 | Through study completion, up to 21 months | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Proportion of Tissue Eosinophil Responders | At Follow-up EGD (Esophago-Gastro-Duodenoscopy) (Day 505 or 28 days after last dose if ET) | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Change in PRO Total System Score (TSS) From AK002-016/AK002-012 Baseline | Main Study Baseline to Extension Weeks 71-72 | Number of participants with available data within Safety Population | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Safety and Tolerability of Lirentelimab by Evaluating Adverse Events Assessed Using the CTCAE Version 5.0 | Main Study Placebo to Extension Study 3.0 mg/kg of Lirentelimab (AK002) | No. of Subjects with >=1 Adverse Events | 66 | Participants | |
| The Safety and Tolerability of Lirentelimab by Evaluating Adverse Events Assessed Using the CTCAE Version 5.0 | Main Study Active to Extension Study 3.0 mg/kg of Lirentelimab (AK002) | No. of Subjects with >=1 Adverse Events | 75 | Participants | |
| The Safety and Tolerability of Lirentelimab by Evaluating Adverse Events Assessed Using the CTCAE Version 5.0 | Main Study Placebo to Extension Study 3.0 mg/kg of Lirentelimab (AK002) | No. of Subjects with >=1 Treatment-Related Adverse Events | 33 | Participants | |
| The Safety and Tolerability of Lirentelimab by Evaluating Adverse Events Assessed Using the CTCAE Version 5.0 | Main Study Active to Extension Study 3.0 mg/kg of Lirentelimab (AK002) | No. of Subjects with >=1 Treatment-Related Adverse Events | 29 | Participants | |
| The Safety and Tolerability of Lirentelimab by Evaluating Adverse Events Assessed Using the CTCAE Version 5.0 | Main Study Placebo to Extension Study 3.0 mg/kg of Lirentelimab (AK002) | No. of Subjects with >=1 Serious Adverse Events | 6 | Participants | |
| The Safety and Tolerability of Lirentelimab by Evaluating Adverse Events Assessed Using the CTCAE Version 5.0 | Main Study Active to Extension Study 3.0 mg/kg of Lirentelimab (AK002) | No. of Subjects with >=1 Serious Adverse Events | 14 | Participants | |
| The Safety and Tolerability of Lirentelimab by Evaluating Adverse Events Assessed Using the CTCAE Version 5.0 | Main Study Placebo to Extension Study 3.0 mg/kg of Lirentelimab (AK002) | No. of Subjects with an Adverse Event Leading to Study Drug Discontinuation | 6 | Participants | |
| The Safety and Tolerability of Lirentelimab by Evaluating Adverse Events Assessed Using the CTCAE Version 5.0 | Main Study Active to Extension Study 3.0 mg/kg of Lirentelimab (AK002) | No. of Subjects with an Adverse Event Leading to Study Drug Discontinuation | 10 | Participants | |
| The Safety and Tolerability of Lirentelimab by Evaluating Adverse Events Assessed Using the CTCAE Version 5.0 | Main Study Placebo to Extension Study 3.0 mg/kg of Lirentelimab (AK002) | No. of Subjects with >=1 Treatment-Related Serious Adverse Events | 1 | Participants | |
| The Safety and Tolerability of Lirentelimab by Evaluating Adverse Events Assessed Using the CTCAE Version 5.0 | Main Study Active to Extension Study 3.0 mg/kg of Lirentelimab (AK002) | No. of Subjects with >=1 Treatment-Related Serious Adverse Events | 1 | Participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Main Study Placebo to Extension Study 3.0 mg/kg of Lirentelimab (AK002) | 75 | |
| Overall Study | STARTED | Main Study Active to Extension Study 3.0 mg/kg of Lirentelimab (AK002) | 84 | |
| Overall Study | COMPLETED | Main Study Placebo to Extension Study 3.0 mg/kg of Lirentelimab (AK002) | 42 | |
| Overall Study | COMPLETED | Main Study Active to Extension Study 3.0 mg/kg of Lirentelimab (AK002) | 40 | |
| Overall Study | NOT COMPLETED | Main Study Placebo to Extension Study 3.0 mg/kg of Lirentelimab (AK002) | 33 | |
| Overall Study | NOT COMPLETED | Main Study Active to Extension Study 3.0 mg/kg of Lirentelimab (AK002) | 44 |
Source ClinicalTrials.gov
Adverse events82
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 | Anaemia | Blood and lymphatic system disorders | Main Study Placebo to Extension Study 3.0 mg/kg of Lirentelimab (AK002) | 2 | 75 | |
| other | Anaemia | Blood and lymphatic system disorders | Main Study Active to Extension Study 3.0 mg/kg of Lirentelimab (AK002) | 6 | 84 | |
| other | Abdominal pain | Gastrointestinal disorders | Main Study Placebo to Extension Study 3.0 mg/kg of Lirentelimab (AK002) | 7 | 75 | |
| other | Abdominal pain | Gastrointestinal disorders | Main Study Active to Extension Study 3.0 mg/kg of Lirentelimab (AK002) | 9 | 84 | |
| other | Diarrhoea | Gastrointestinal disorders | Main Study Placebo to Extension Study 3.0 mg/kg of Lirentelimab (AK002) | 11 | 75 | |
| other | Diarrhoea | Gastrointestinal disorders | Main Study Active to Extension Study 3.0 mg/kg of Lirentelimab (AK002) | 8 | 84 | |
| other | Gastroenteritis eosinophilic | Gastrointestinal disorders | Main Study Placebo to Extension Study 3.0 mg/kg of Lirentelimab (AK002) | 4 | 75 | |
| other | Gastroenteritis eosinophilic | Gastrointestinal disorders | Main Study Active to Extension Study 3.0 mg/kg of Lirentelimab (AK002) | 3 | 84 | |
| other | Nausea | Gastrointestinal disorders | Main Study Placebo to Extension Study 3.0 mg/kg of Lirentelimab (AK002) | 11 | 75 | |
| other | Nausea | Gastrointestinal disorders | Main Study Active to Extension Study 3.0 mg/kg of Lirentelimab (AK002) | 5 | 84 |
1 to 10 of 82Source ClinicalTrials.gov
See all 82 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Main Study Placebo to Extension Study 3.0 mg/kg of Lirentelimab (AK002) | 0 | 75 |
| Total, all-cause mortality | Main Study Active to Extension Study 3.0 mg/kg of Lirentelimab (AK002) | 1 | 84 |
| Total, other adverse events | Main Study Placebo to Extension Study 3.0 mg/kg of Lirentelimab (AK002) | 52 | 75 |
| Total, other adverse events | Main Study Active to Extension Study 3.0 mg/kg of Lirentelimab (AK002) | 57 | 84 |
| Total, serious adverse events | Main Study Placebo to Extension Study 3.0 mg/kg of Lirentelimab (AK002) | 6 | 75 |
| Total, serious adverse events | Main Study Active to Extension Study 3.0 mg/kg of Lirentelimab (AK002) | 14 | 84 |
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| 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): Proportion of Tissue Eosinophil Responders | Trial comparisons |
| 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): deaths from any cause | Trial comparisons |
| 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 |
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/NCT04620811
GET https://conductscience.org/api/trials/v1/NCT04620811/events?page=2