Trial · NCT03664960
An Extension Study of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Duodenitis
NCT03664960, Phase 2, Completed, Allakos Inc.; results first posted 2024-02-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. An Extension Study of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Duodenitis. Trials, record NCT03664960. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03664960
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Extension Study of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Duodenitis
- NCT number
- NCT03664960
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 58 participants, actual
- Lead sponsor
- Allakos Inc.
- Conditions
- Eosinophilic Gastritis, Eosinophilic Gastroenteritis, Eosinophilic Duodenitis
- Interventions
- AK002
- First posted
- 2018-09-11
- Last updated
- 2024-02-28
- Results first posted
- 2024-02-28
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 AK002 by Evaluating Adverse Events Assessed Using the CTCAE Version 4.03 | Through study completion, up to 28 months | Adverse events assessed using the CTCAE version 4.03 |
| Secondary | Percent Change in PRO Total Symptom Score (TSS) From AK002-003 Baseline | AK002-003 Baseline to End of Treatment (2 weeks post last dose, up to 26 months) | The PRO Total Symptom Score (TSS) is a patient-reported outcome (PRO) questionnaire comprises the following 8 symptoms: abdominal pain, nausea, vomiting, early satiety, loss of appetite, abdominal cramping, bloating, and diarrhea. Individual symptom scores ranged from 0 to 10. The daily total symptom score ranged from 0 to 80, with higher scores indicating greater severity. The End of treatment TSS score is defined as the average of the 14 daily scores on or after the day of the last dose of the extension study. |
| Secondary | Changes in the Number of Eosinophils in Gastric and/or Duodenal Mucosa From AK002-003 Baseline | AK002-003 Baseline to Day 547 | Percentage of Change in the Number of Eosinophils in Gastric and/or Duodenal Mucosa in each group from AK002-003 Baseline |
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 AK002 by Evaluating Adverse Events Assessed Using the CTCAE Version 4.03 | Through study completion, up to 28 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Percent Change in PRO Total Symptom Score (TSS) From AK002-003 Baseline | AK002-003 Baseline to End of Treatment (2 weeks post last dose, up to 26 months) | Percentage of change | MEAN | |
| SECONDARY | Changes in the Number of Eosinophils in Gastric and/or Duodenal Mucosa From AK002-003 Baseline | AK002-003 Baseline to Day 547 | Percentage of change | 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 AK002 by Evaluating Adverse Events Assessed Using the CTCAE Version 4.03 | Main Study Placebo to Extension Study 1 to 3.0 mg/kg of AK002 | Subjects with ≥1 adverse events | 21 | Participants | |
| The Safety and Tolerability of AK002 by Evaluating Adverse Events Assessed Using the CTCAE Version 4.03 | Main Study Active to Extension Study 1 to 3.0 mg/kg of AK002 | Subjects with ≥1 adverse events | 35 | Participants | |
| The Safety and Tolerability of AK002 by Evaluating Adverse Events Assessed Using the CTCAE Version 4.03 | Main Study Placebo to Extension Study 1 to 3.0 mg/kg of AK002 | Subjects with ≥1 treatment-related adverse events | 15 | Participants | |
| The Safety and Tolerability of AK002 by Evaluating Adverse Events Assessed Using the CTCAE Version 4.03 | Main Study Active to Extension Study 1 to 3.0 mg/kg of AK002 | Subjects with ≥1 treatment-related adverse events | 22 | Participants | |
| The Safety and Tolerability of AK002 by Evaluating Adverse Events Assessed Using the CTCAE Version 4.03 | Main Study Placebo to Extension Study 1 to 3.0 mg/kg of AK002 | Subjects with an adverse event leading to study discontinuation | 0 | Participants | |
| The Safety and Tolerability of AK002 by Evaluating Adverse Events Assessed Using the CTCAE Version 4.03 | Main Study Active to Extension Study 1 to 3.0 mg/kg of AK002 | Subjects with an adverse event leading to study discontinuation | 3 | Participants | |
| The Safety and Tolerability of AK002 by Evaluating Adverse Events Assessed Using the CTCAE Version 4.03 | Main Study Placebo to Extension Study 1 to 3.0 mg/kg of AK002 | Subjects with ≥1 serious adverse events | 2 | Participants | |
| The Safety and Tolerability of AK002 by Evaluating Adverse Events Assessed Using the CTCAE Version 4.03 | Main Study Active to Extension Study 1 to 3.0 mg/kg of AK002 | Subjects with ≥1 serious adverse events | 9 | Participants | |
| The Safety and Tolerability of AK002 by Evaluating Adverse Events Assessed Using the CTCAE Version 4.03 | Main Study Placebo to Extension Study 1 to 3.0 mg/kg of AK002 | Subjects with ≥1 treatment-related serious adverse events | 0 | Participants | |
| The Safety and Tolerability of AK002 by Evaluating Adverse Events Assessed Using the CTCAE Version 4.03 | Main Study Active to Extension Study 1 to 3.0 mg/kg of AK002 | Subjects with ≥1 treatment-related serious adverse events | 0 | 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 1 to 3.0 mg/kg of AK002 | 21 | |
| Overall Study | STARTED | Main Study Active to Extension Study 1 to 3.0 mg/kg of AK002 | 37 | |
| Overall Study | COMPLETED | Main Study Placebo to Extension Study 1 to 3.0 mg/kg of AK002 | 12 | |
| Overall Study | COMPLETED | Main Study Active to Extension Study 1 to 3.0 mg/kg of AK002 | 15 | |
| Overall Study | NOT COMPLETED | Main Study Placebo to Extension Study 1 to 3.0 mg/kg of AK002 | 9 | |
| Overall Study | NOT COMPLETED | Main Study Active to Extension Study 1 to 3.0 mg/kg of AK002 | 22 |
Source ClinicalTrials.gov
Adverse events102
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 | Anemia | Blood and lymphatic system disorders | Main Study Placebo to Extension Study 1 to 3.0 mg/kg of AK002 | 1 | 21 | |
| other | Anemia | Blood and lymphatic system disorders | Main Study Active to Extension Study 1 to 3.0 mg/kg of AK002 | 4 | 37 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Main Study Placebo to Extension Study 1 to 3.0 mg/kg of AK002 | 2 | 21 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Main Study Active to Extension Study 1 to 3.0 mg/kg of AK002 | 2 | 37 | |
| other | Neutrophilia | Blood and lymphatic system disorders | Main Study Placebo to Extension Study 1 to 3.0 mg/kg of AK002 | 3 | 21 | |
| other | Neutrophilia | Blood and lymphatic system disorders | Main Study Active to Extension Study 1 to 3.0 mg/kg of AK002 | 1 | 37 | |
| other | Abdominal pain | Gastrointestinal disorders | Main Study Placebo to Extension Study 1 to 3.0 mg/kg of AK002 | 3 | 21 | |
| other | Abdominal pain | Gastrointestinal disorders | Main Study Active to Extension Study 1 to 3.0 mg/kg of AK002 | 2 | 37 | |
| other | Constipation | Gastrointestinal disorders | Main Study Placebo to Extension Study 1 to 3.0 mg/kg of AK002 | 1 | 21 | |
| other | Constipation | Gastrointestinal disorders | Main Study Active to Extension Study 1 to 3.0 mg/kg of AK002 | 3 | 37 |
1 to 10 of 102Source ClinicalTrials.gov
See all 102 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 1 to 3.0 mg/kg of AK002 | 0 | 21 |
| Total, all-cause mortality | Main Study Active to Extension Study 1 to 3.0 mg/kg of AK002 | 0 | 37 |
| Total, other adverse events | Main Study Placebo to Extension Study 1 to 3.0 mg/kg of AK002 | 20 | 21 |
| Total, other adverse events | Main Study Active to Extension Study 1 to 3.0 mg/kg of AK002 | 32 | 37 |
| Total, serious adverse events | Main Study Placebo to Extension Study 1 to 3.0 mg/kg of AK002 | 2 | 21 |
| Total, serious adverse events | Main Study Active to Extension Study 1 to 3.0 mg/kg of AK002 | 9 | 37 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Main Study Active to Extension Study 1 to 3.0 mg/kg of AK002 vs Main Study Placebo to Extension Study 1 to 3.0 mg/kg of AK002: deaths from any cause | Trial comparisons |
| Main Study Active to Extension Study 1 to 3.0 mg/kg of AK002 vs Main Study Placebo to Extension Study 1 to 3.0 mg/kg of 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/NCT03664960
GET https://conductscience.org/api/trials/v1/NCT03664960/events?page=2