CompletedNCT04620811Updated Apr 22, 2024Results posted

An Extension Study of Lirentelimab in Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis)

A Phase 3 interventional study of lirentelimab in Eosinophilic Gastritis and Eosinophilic Duodenitis, sponsored by Allakos Inc.. Completed at 38 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-04-22.

Sponsored by Allakos Inc. · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 159
Allocation: Not applicable
Ages: 18 Years to 80 Years
Sex: All

Study summary

This is a Phase 3, open-label, extension study to assess the long term efficacy and safety of lirentelimab given monthly.

Conditions studied

Eosinophilic Gastritis
Eosinophilic Duodenitis

In context

Lead sponsor

Allakos Inc. is the lead sponsor of 18 studies on the registry; none are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 9 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

Key Inclusion Criteria:

Provide written informed consent.
Completed Study AK002-016, defined as having received 6 infusions of study drug and followed through Day 176 (±3) or completed Study AK002-012, defined as having received the cohort-appropriate amount of doses and followed for 5 months after last dose of study drug.
If patient is on pre-existing dietary restrictions, willingness to maintain those restrictions, throughout the study.
Able and willing to comply with all study procedures.
Female patients must be either post-menopausal for at least 1 year or surgically sterile (tubal ligation, hysterectomy, or bilateral oophorectomy) for at least 3 months, or if of childbearing potential, have a negative pregnancy test and agree to use dual methods of contraception, or abstain from sexual activity until the end of the study, or for 120 days following the last dose of study drug, whichever is longer.
Male patients with female partners of childbearing potential must agree to use a highly effective method of contraception until the end of the study or for 120 days following the last dose of study drug, whichever is longer. All fertile men with female partners of childbearing potential should be instructed to contact the Investigator immediately if they suspect their partner might be pregnant at any time during study participation.

Key Exclusion Criteria:

Known hypersensitivity to any constituent of the study drug.
Any disease, condition (medical or surgical), or cardiac abnormality, which, in the opinion of the Investigator, would place the patient at increased risk.
Planned or expected vaccination with live attenuated vaccines during the Treatment Period, or vaccination expected within 5 half-lives (4 months) of AK002 administration.
Women who are pregnant, breastfeeding, or planning to become pregnant while participating in the study.
Any other reason that, in the opinion of the Investigator or Medical Monitor, makes the patient unsuitable for enrollment.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 159 participants (actual)

Study arms

Experimental
3.0 mg/kg of Lirentelimab (AK002)
Subjects in this arm will receive up to 18 monthly doses (3mg/kg) of lirentelimab (AK002)
Drug: lirentelimab

Interventions

Druglirentelimab
Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8
Also known as: AK002

What researchers measure

Primary outcomes

The Safety and Tolerability of Lirentelimab by Evaluating Adverse Events Assessed Using the CTCAE Version 5.0
Adverse events assessed using the CTCAE version 5.0.
Time frame: Through study completion, up to 21 months

Other outcomes

Proportion of Tissue Eosinophil Responders
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.
Time frame: At Follow-up EGD (Esophago-Gastro-Duodenoscopy) (Day 505 or 28 days after last dose if ET)
Change in PRO Total System Score (TSS) From AK002-016/AK002-012 Baseline
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.
Time frame: Main Study Baseline to Extension Weeks 71-72

Results

Posted Apr 18, 2024

Participant flow

The participants who were enrolled in and completed the studies AK002-016 (NCT04322604) or AK002-012 had the option to participate in this open-label extension study.

Participant flow — Overall Study
Milestone	Main Study Placebo to Extension Study 3.0 mg/kg of Lirentelimab (AK002)	Main Study Active to Extension Study 3.0 mg/kg of Lirentelimab (AK002)
Started	75	84
Completed	42	40
Not completed	33	44
Withdrew: Withdrawal by subject	18	15
Withdrew: Adverse event	6	11
Withdrew: Lost to follow-up	4	8
Withdrew: Physician decision	1	4
Withdrew: Sponsor decision	0	1
Withdrew: Elevation of alt or ast	1	0
Withdrew: Other	3	5

Outcome measures

PrimaryThe Safety and Tolerability of Lirentelimab by Evaluating Adverse Events Assessed Using the CTCAE Version 5.0

Adverse events assessed using the CTCAE version 5.0.

Time frame:: Through study completion, up to 21 months
Reported as:: Count of participants · Participants

The Safety and Tolerability of Lirentelimab by Evaluating Adverse Events Assessed Using the CTCAE Version 5.0
Participants	Main Study Placebo to Extension Study 3.0 mg/kg of Lirentelimab (AK002)	Main Study Active to Extension Study 3.0 mg/kg of Lirentelimab (AK002)
No. of Subjects with >=1 Adverse Events	66	75
No. of Subjects with >=1 Treatment-Related Adverse Events	33	29
No. of Subjects with >=1 Serious Adverse Events	6	14
No. of Subjects with an Adverse Event Leading to Study Drug Discontinuation	6	10
No. of Subjects with >=1 Treatment-Related Serious Adverse Events	1	1

Other pre-specifiedProportion of Tissue Eosinophil Responders

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.

Time frame:: At Follow-up EGD (Esophago-Gastro-Duodenoscopy) (Day 505 or 28 days after last dose if ET)
Reported as:: Count of participants · Participants

Proportion of Tissue Eosinophil Responders
Participants	Main Study Placebo to Extension Study 3.0 mg/kg of Lirentelimab (AK002)	Main Study Active to Extension Study 3.0 mg/kg of Lirentelimab (AK002)
Proportion of Tissue Eosinophil Responders	52	48

Other pre-specifiedChange in PRO Total System Score (TSS) From AK002-016/AK002-012 Baseline

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.

Time frame:: Main Study Baseline to Extension Weeks 71-72
Reported as:: Mean · score on a scale

Change in PRO Total System Score (TSS) From AK002-016/AK002-012 Baseline
score on a scale	Main Study Placebo to Extension Study 3.0 mg/kg of Lirentelimab (AK002)	Main Study Active to Extension Study 3.0 mg/kg of Lirentelimab (AK002)
Change in PRO Total System Score (TSS) From AK002-016/AK002-012 Baseline	-14.4 ± 11.0	-17.0 ± 12.1

Adverse events

Collected over Through study completion, up to 21 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Main Study Placebo to Extension Study 3.0 mg/kg of Lirentelimab (AK002)	0/75 (0%)	6/75 (8%)	52/75 (69.3%)
Main Study Active to Extension Study 3.0 mg/kg of Lirentelimab (AK002)	1/84 (1.2%)	14/84 (16.7%)	57/84 (67.9%)

Most frequent serious events

Showing 10 of 23

Most frequent serious events
Event	Main Study Placebo to Extension Study 3.0 mg/kg of Lirentelimab (AK002)	Main Study Active to Extension Study 3.0 mg/kg of Lirentelimab (AK002)
CellulitisInfections and infestations	2/75	0/84
AppendicitisInfections and infestations	0/75	2/84
Gastrointestinal haemorrhageGastrointestinal disorders	1/75	0/84
Hiatus herniaGastrointestinal disorders	1/75	0/84
Pelvic abscessInfections and infestations	1/75	0/84
Diabetic ketoacidosisMetabolism and nutrition disorders	1/75	0/84
AsthmaRespiratory, thoracic and mediastinal disorders	1/75	1/84
AnaemiaBlood and lymphatic system disorders	0/75	1/84
LeukopeniaBlood and lymphatic system disorders	0/75	1/84
Abdominal painGastrointestinal disorders	0/75	1/84

Most frequent other events

Showing 10 of 18

Most frequent other events
Event	Main Study Placebo to Extension Study 3.0 mg/kg of Lirentelimab (AK002)	Main Study Active to Extension Study 3.0 mg/kg of Lirentelimab (AK002)
Infusion related reactionInjury, poisoning and procedural complications	27/75	19/84
Corona virus infectionInfections and infestations	15/75	21/84
DiarrhoeaGastrointestinal disorders	11/75	8/84
NauseaGastrointestinal disorders	11/75	5/84
VomitingGastrointestinal disorders	3/75	10/84
Abdominal painGastrointestinal disorders	7/75	9/84
Urinary tract infectionInfections and infestations	8/75	5/84
ArthralgiaMusculoskeletal and connective tissue disorders	4/75	8/84
HeadacheNervous system disorders	6/75	7/84
NasopharyngitisInfections and infestations	6/75	4/84

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Main Study Placebo to Extension Study 3.0 mg/kg of Lirentelimab (AK002)	Main Study Active to Extension Study 3.0 mg/kg of Lirentelimab (AK002)	Total
Median	42 (18 to 79)	42 (18 to 77)	42 (18 to 79)

Sex: Female, Male
Sex: Female, Male(Participants)	Main Study Placebo to Extension Study 3.0 mg/kg of Lirentelimab (AK002)	Main Study Active to Extension Study 3.0 mg/kg of Lirentelimab (AK002)	Total
Female	50	53	103
Male	25	31	56

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Main Study Placebo to Extension Study 3.0 mg/kg of Lirentelimab (AK002)	Main Study Active to Extension Study 3.0 mg/kg of Lirentelimab (AK002)	Total
Hispanic or Latino	10	13	23
Not Hispanic or Latino	65	71	136
Unknown or Not Reported	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Main Study Placebo to Extension Study 3.0 mg/kg of Lirentelimab (AK002)	Main Study Active to Extension Study 3.0 mg/kg of Lirentelimab (AK002)	Total
American Indian or Alaska Native	0	2	2
Asian	3	2	5
Native Hawaiian or Other Pacific Islander	1	2	3
Black or African American	5	7	12
White	66	68	134
More than one race	0	2	2
Unknown or Not Reported	0	1	1

Region of Enrollment
Region of Enrollment(Participants)	Main Study Placebo to Extension Study 3.0 mg/kg of Lirentelimab (AK002)	Main Study Active to Extension Study 3.0 mg/kg of Lirentelimab (AK002)	Total
United States	75	84	159

Study locations

38 sites

Allakos Investigational Site 216-068
Birmingham, Alabama 35209, United States
Allakos Investigational Site 216-002
Huntsville, Alabama 35802, United States
Allakos Investigational Site 216-035
Phoenix, Arizona 85018, United States
Allakos Investigational Site 216-032
Chula Vista, California 91910, United States
Allakos Investigational Site 216-014
Santa Monica, California 90404, United States
Allakos Investigational Site 216-038
Tustin, California 92780, United States
Allakos Investigational Site 216-049
Walnut Creek, California 94598, United States
Allakos Investigational Site 216-034
Aurora, Colorado 80045, United States
Allakos Investigational Site 216-063
Brandon, Florida 33511, United States
Allakos Investigational Site 216-027
Edgewater, Florida 32132, United States
Allakos Investigational Site 216-056
Jacksonville, Florida 32256, United States
Allakos Investigational Site 216-013
Miami, Florida 33176, United States
Allakos Investigational Site 216-053
New Port Richey, Florida 34653, United States
Allakos Investigational Site 216-007
Chicago, Illinois 60611, United States
Allakos Investigational Site 216-001
Crowley, Louisiana 70526, United States
Allakos Investigational Site 216-026
Boston, Massachusetts 02111, United States
Allakos Investigational Site 216-052
Boston, Massachusetts 02115, United States
Allakos Investigational Site 216-051
Boston, Massachusetts 02215, United States
Allakos Investigational Site 216-005
Rochester, Minnesota 55905, United States
Allakos Investigational Site 216-042
Kansas City, Missouri 64108, United States
Allakos Investigational Site 216-045
Reno, Nevada 89511, United States
Allakos Investigational Site 216-025
New York, New York 10029, United States
Allakos Investigational Site 216-020
Chapel Hill, North Carolina 27599, United States
Allakos Investigational Site 216-048
Durham, North Carolina 27710, United States
Allakos Investigational Site 216-050
Winston-Salem, North Carolina 27157, United States
Allakos Investigational Site 216-031
Cincinnati, Ohio 45229, United States
Allakos Investigational Site 216-028
Cincinnati, Ohio 45236, United States
Allakos Investigational Site 216-044
Mentor, Ohio 44060, United States
Allakos Investigational Site 216-021
Philadelphia, Pennsylvania 19104, United States
Allakos Investigational Site 216-006
Chattanooga, Tennessee 37343, United States
Allakos Investigational Site 216-003
Chattanooga, Tennessee 37404, United States
Allakos Investigational Site 216-011
Chattanooga, Tennessee 37421, United States
Allakos Investigational Site 216-062
Kingsport, Tennessee 37663, United States
Allakos Investigational Site 216-022
Austin, Texas 78742, United States
Allakos Investigational Site 216-039
Ogden, Utah 84405, United States
Allakos Investigational Site 216-030
Salt Lake City, Utah 84132, United States
Allakos Investigational Site 216-055
Sandy City, Utah 84092, United States
Allakos Investigational Site 216-064
Spokane, Washington 99202, United States

References and documents

Study documents

Protocol and statistical analysis plan · Apr 8, 2022

Documents are hosted by the registry — open the source record to download them.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2020 to primary completion in May 2023, 29 months.

Results were first posted in Apr 2024, 11 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered: Nov 3, 2020
First posted: Nov 9, 2020
StartActual: Dec 3, 2020
Primary completionActual: May 15, 2023
CompletionActual: Jul 7, 2023
Results first posted: Apr 18, 2024
Last update: Apr 22, 2024

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Apr 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04620811
Lead sponsor: Allakos Inc.
Responsible party: Sponsor
First posted: Nov 9, 2020
Start date: Dec 3, 2020
Primary completion: May 15, 2023
Completion: Jul 7, 2023
Results posted: Apr 18, 2024
Last update: Apr 22, 2024

Study contacts

Craig Patterson, MD

study director · Allakos Inc.

Oversight

FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: AK002

Other studies in this condition

Eosinophilic enteropathy

Other studies from this sponsor

Allakos Inc.

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