Trial · NCT03496571

A Study of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Gastroenteritis

NCT03496571, Phase 2, Completed, Allakos Inc.; results first posted 2024-01-17

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Gastroenteritis. Trials, record NCT03496571. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03496571

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Gastroenteritis
NCT number: NCT03496571
Status: Completed
Phases: Phase 2
Enrollment: 65 participants, actual
Lead sponsor: Allakos Inc.
Conditions: Eosinophilic Gastritis, Eosinophilic Gastroenteritis
Interventions: AK002, Placebo
First posted: 2018-04-12
Last updated: 2024-01-19
Results first posted: 2024-01-17

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percent Change in the Number of Eosinophils Per High Power Field in Gastric or Duodenal Mucosa From Baseline	Baseline to Day 99	Tissue eosinophil count obtained in biopsy specimens from the stomach and/or duodenum using esophago-gastro- duodenoscopy (EGD)
Secondary	Number of Treatment Responders	On Days 85-99 and Day 99, respectively	Treatment Responders defined by \>30% improvement in TSS and a reduction of \>75% in eosinophils in gastric and/or duodenal mucosa. The eosinophil count is obtained on Day 99 and the TSS score is the average of the daily scores from Days 85-99.
Secondary	Percent Change in PRO Total Symptom Score (TSS) From Baseline	Baseline to Days 85-99	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. TSS score at the End of Study is the average of the daily scores from Days 85-99.

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	Percent Change in the Number of Eosinophils Per High Power Field in Gastric or Duodenal Mucosa From Baseline	Baseline to Day 99	Intention-to-treat	Percentage of Change	MEAN
SECONDARY	Number of Treatment Responders	On Days 85-99 and Day 99, respectively	Intention-to-treat	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Percent Change in PRO Total Symptom Score (TSS) From Baseline	Baseline to Days 85-99	Intention-to-treat	Percentage of Change	MEAN

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Percent Change in the Number of Eosinophils Per High Power Field in Gastric or Duodenal Mucosa From Baseline	1 mg/kg of AK002	-79	95% Confidence Interval -95 to -59	Percentage of Change
Percent Change in the Number of Eosinophils Per High Power Field in Gastric or Duodenal Mucosa From Baseline	3 mg/kg of AK002	-92	95% Confidence Interval -100 to -81	Percentage of Change
Percent Change in the Number of Eosinophils Per High Power Field in Gastric or Duodenal Mucosa From Baseline	Combined AK002	-86	95% Confidence Interval -94 to -71	Percentage of Change
Percent Change in the Number of Eosinophils Per High Power Field in Gastric or Duodenal Mucosa From Baseline	Placebo	9	95% Confidence Interval -15 to 31	Percentage of Change
Number of Treatment Responders	1 mg/kg of AK002	13		Participants
Number of Treatment Responders	3 mg/kg of AK002	14		Participants
Number of Treatment Responders	Combined AK002	27		Participants
Number of Treatment Responders	Placebo	1		Participants
Percent Change in PRO Total Symptom Score (TSS) From Baseline	1 mg/kg of AK002	-42	95% Confidence Interval -56 to -28	Percentage of Change
Percent Change in PRO Total Symptom Score (TSS) From Baseline	3 mg/kg of AK002	-55	95% Confidence Interval -70 to -40	Percentage of Change

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	1 mg/kg of AK002	22
Overall Study	STARTED	3 mg/kg of AK002	21
Overall Study	STARTED	Placebo	22
Overall Study	COMPLETED	1 mg/kg of AK002	20
Overall Study	COMPLETED	3 mg/kg of AK002	19
Overall Study	COMPLETED	Placebo	20
Overall Study	NOT COMPLETED	1 mg/kg of AK002	2
Overall Study	NOT COMPLETED	3 mg/kg of AK002	2
Overall Study	NOT COMPLETED	Placebo	2

Source ClinicalTrials.gov

Adverse events84

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
other	Infusion related reaction	Injury, poisoning and procedural complications	1 mg/kg of AK002	16	22
other	Infusion related reaction	Injury, poisoning and procedural complications	3 mg/kg of AK002	10	21
other	Infusion related reaction	Injury, poisoning and procedural complications	Placebo	5	22
other	Headache	Nervous system disorders	1 mg/kg of AK002	3	22
other	Headache	Nervous system disorders	3 mg/kg of AK002	1	21
other	Headache	Nervous system disorders	Placebo	2	22
other	Upper respiratory tract infection	Infections and infestations	1 mg/kg of AK002	2	22
other	Upper respiratory tract infection	Infections and infestations	3 mg/kg of AK002	2	21
other	Upper respiratory tract infection	Infections and infestations	Placebo	2	22
other	Urinary tract infection	Infections and infestations	1 mg/kg of AK002	2	22

1 to 10 of 84Source ClinicalTrials.gov

See all 84 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	1 mg/kg of AK002	0	22
Total, all-cause mortality	3 mg/kg of AK002	0	21
Total, all-cause mortality	Placebo	0	22
Total, other adverse events	1 mg/kg of AK002	20	22
Total, other adverse events	3 mg/kg of AK002	15	21
Total, other adverse events	Placebo	17	22
Total, serious adverse events	1 mg/kg of AK002	2	22
Total, serious adverse events	3 mg/kg of AK002	2	21
Total, serious adverse events	Placebo	3	22

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
33085861	DERIVED	PubMed
34089846	DERIVED	PubMed
38423296	DERIVED	PubMed

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT03496571

GET https://conductscience.org/api/trials/v1/NCT03496571/events?page=2

API reference For AI assistants