NCT04856891: EoDyssey

A Study of Lirentelimab (AK002) in Patients With Active Eosinophilic Duodenitis

Completed Phase 3 Results posted Last updated 2 January 2024

What this trial tests

Phase 3 trial testing AK002 in Eosinophilic Duodenitis in 94 participants. Completed in 9 January 2023.

Timeline

20 May 2021

Primary endpoint
14 June 2022

9 January 2023

Quick facts

Lead sponsor	Allakos Inc.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	94
Start date	20 May 2021
Primary completion	14 June 2022
Estimated completion	9 January 2023
Sites	39 locations across United States

Drugs / interventions tested

• AK002 — full drug profile →
• Placebo

Conditions studied

• Eosinophilic Duodenitis — all drugs for Eosinophilic Duodenitis →
• Eosinophilic Gastroenteritis — all drugs for Eosinophilic Gastroenteritis →

Sponsor

Allakos Inc. — full company profile →

Who can join

Adults 18 to 80, any sex, with Eosinophilic Duodenitis or Eosinophilic Gastroenteritis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Proportion of Tissue Eosinophil Responders at Week 24 Primary · At Week 24

A tissue eosinophil responder is defined as mean eosinophil count \<=15 cells/HPF in 3 duodenal HPFs

Group	Value	95% CI
3.0 mg/kg of Lirentelimab (AK002)	38
Placebo	2

Change in PRO Total Symptom Score (TSS) From Baseline to Weeks 23-24 Primary · 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.

Group	Value	95% CI
3.0 mg/kg of Lirentelimab (AK002)	-12.7	± 1.7
Placebo	-13.0	± 1.7

Percent Change in Tissue Eosinophils From Baseline to Week 24 Secondary · Baseline to Week 24

Tissue eosinophil count obtained in biopsy specimens from the duodenum using esophago-gastro-duodenoscopy (EGD)

Group	Value	95% CI
3.0 mg/kg of Lirentelimab (AK002)	-99.9	± 0.4
Placebo	-24.1	± 30.5

Subjects Achieving Eosinophils Count ≤1 Cell/Hpf in 3 Highest Duodenal Hpf at Week 24 Secondary · At Week 24

Tissue eosinophil count obtained in biopsy specimens from the duodenum using esophago-gastro-duodenoscopy (EGD)

Group	Value	95% CI
3.0 mg/kg of Lirentelimab (AK002)	37
Placebo	0

Number of Treatment Responders Secondary · 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

Group	Value	95% CI
3.0 mg/kg of Lirentelimab (AK002)	21
Placebo	1

Subjects Who Achive ≥50% Reduction in TSS From Baseline to Weeks 23-24 Secondary · 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.

Group	Value	95% CI
3.0 mg/kg of Lirentelimab (AK002)	13
Placebo	14

Subjects Who Achieve ≥70% Reduction in TSS From Baseline to Weeks 23-24 Secondary · 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.

Group	Value	95% CI
3.0 mg/kg of Lirentelimab (AK002)	11
Placebo	8

Percent Change in Weekly TSS Over Time Using MMRM Secondary · 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.

Week 2

Group	Value	95% CI
3.0 mg/kg of Lirentelimab (AK002)	-16.5	± 41.8
Placebo	-13.3	± 37.6

Week 4

Group	Value	95% CI
3.0 mg/kg of Lirentelimab (AK002)	-22.6	± 34.6
Placebo	-19.7	± 29.1

Week 6

Group	Value	95% CI
3.0 mg/kg of Lirentelimab (AK002)	-30.4	± 35.4
Placebo	-31.2	± 31.2

Week 8

Group	Value	95% CI
3.0 mg/kg of Lirentelimab (AK002)	-31.4	± 37.5
Placebo	-32.6	± 33.0

Week 10

Group	Value	95% CI
3.0 mg/kg of Lirentelimab (AK002)	-38.0	± 33.1
Placebo	-35.4	± 31.8

Week 12

Group	Value	95% CI
3.0 mg/kg of Lirentelimab (AK002)	-40.4	± 33.0
Placebo	-38.1	± 37.0

Week 14

Group	Value	95% CI
3.0 mg/kg of Lirentelimab (AK002)	-45.0	± 35.6
Placebo	-43.7	± 30.9

Week 16

Group	Value	95% CI
3.0 mg/kg of Lirentelimab (AK002)	-47.0	± 35.7
Placebo	-49.6	± 31.8

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline up to Day 225. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

3.0 mg/kg of Lirentelimab (AK002)

Serious: 2/46 (4%)

Deaths: 0/46

Placebo

Serious: 1/47 (2%)

Deaths: 0/47

Serious adverse events (3 terms)

Reaction	System	3.0 mg/kg of Lirentelimab …	Placebo
Diabetic ketoacidosis	Metabolism and nutrition disorders	—	—
Ovarian neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Depression	Psychiatric disorders	—	—

Other adverse events (7 terms — click to expand)

Reaction	System	3.0 mg/kg of Lirentelimab …	Placebo
Infusion related reaction	Injury, poisoning and procedural complications	—	—
Corona virus infection	Infections and infestations	—	—
Hiatus hernia	Gastrointestinal disorders	—	—
Sinusitis	Infections and infestations	—	—
Abdominal pain	Gastrointestinal disorders	—	—
Diarrhea	Gastrointestinal disorders	—	—
Headache	Nervous system disorders	—	—

Most-reported serious reactions: Diabetic ketoacidosis, Ovarian neoplasm, Depression.

Data from ClinicalTrials.gov NCT04856891 adverse events section.

Sponsor's own description

This is a Phase 3, multi-center, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of lirentelimab (AK002) given monthly for 6 doses in adult patients with active eosinophilic duodenitis. Subjects who complete the randomized, double-blind, placebo-controlled treatment may have the option to receive 6 doses of open-label lirentelimab (AK002) through the OLE Period of the study.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. New insights into the pathophysiology and therapeutic targets of asthma and comorbid chronic rhinosinusitis with or without nasal polyposis.
   Striz I, Golebski K, Strizova Z, Loukides S, et al · · 2023 · cited 37× · PMID 37199256 · DOI 10.1042/cs20190281
2. Human Lung Mast Cells: Therapeutic Implications in Asthma.
   Poto R, Criscuolo G, Marone G, Brightling CE, et al · · 2022 · cited 26× · PMID 36430941 · DOI 10.3390/ijms232214466
3. The role of biologics in pediatric food allergy and eosinophilic gastrointestinal disorders.
   Sindher SB, Barshow S, Tirumalasetty J, Arasi S, et al · · 2023 · cited 24× · PMID 36872039 · DOI 10.1016/j.jaci.2023.01.007
4. Current and Novel Therapies for Eosinophilic Gastrointestinal Diseases.
   Marasco G, Visaggi P, Vassallo M, Fiocca M, et al · · 2023 · cited 23× · PMID 37894846 · DOI 10.3390/ijms242015165
5. Eosinophilic gastroenteritis: Pathogenesis, diagnosis, and treatment.
   Li K, Ruan G, Liu S, Xu T, et al · · 2023 · cited 23× · PMID 37022943 · DOI 10.1097/cm9.0000000000002511
6. Primary eosinophilic gastrointestinal disorders and allergy: Clinical and therapeutic implications.
   Rossi CM, Lenti MV, Merli S, Licari A, et al · · 2022 · cited 20× · PMID 35620572 · DOI 10.1002/clt2.12146
7. Siglecs in allergy and asthma.
   Bochner BS, O'Sullivan JA, Chang AT, Youngblood BA. · · 2023 · cited 18× · PMID 35835621 · DOI 10.1016/j.mam.2022.101104
8. Advances in Biologic Therapies for Allergic Diseases: Current Trends, Emerging Agents, and Future Perspectives.
   Alska E, Łaszczych D, Napiórkowska-Baran K, Szymczak B, et al · · 2025 · cited 13× · PMID 40004611 · DOI 10.3390/jcm14041079