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Monoclonal Antibodies

AK002 for Eosinophilic Duodenitis (EoDyssey Trial)

Phase 3
Waitlist Available
Research Sponsored by Allakos, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at weeks 23-24 and week 24, respectively
Awards & highlights
Pivotal Trial

Summary

This trial tests a medication called lirentelimab in adults with a specific type of small intestine inflammation. The medication works by lowering the number of cells that cause inflammation, aiming to reduce symptoms and improve health.

Eligible Conditions
  • Eosinophilic Gastroenteritis
  • Eosinophilic Duodenitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at weeks 23-24 and week 24, respectively
This trial's timeline: 3 weeks for screening, Varies for treatment, and at weeks 23-24 and week 24, respectively for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in PRO Total Symptom Score (TSS) From Baseline to Weeks 23-24
Proportion of Tissue Eosinophil Responders at Week 24
Secondary study objectives
Number of Treatment Responders
Percent Change in Tissue Eosinophils From Baseline to Week 24
Percent Change in Weekly TSS Over Time Using MMRM
+3 more

Side effects data

From 2023 Phase 3 trial • 94 Patients • NCT04856891
20%
Infusion related reaction
11%
Corona virus infection
9%
Sinusitis
7%
Abdominal pain
4%
Hiatus hernia
2%
Headache
2%
Diabetic ketoacidosis
2%
Diarrhea
2%
Depression
100%
80%
60%
40%
20%
0%
Study treatment Arm
3.0 mg/kg of Lirentelimab (AK002)
Placebo

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: 3.0 mg/kg of Lirentelimab (AK002)Experimental Treatment1 Intervention
Subjects in this arm will receive 6 monthly doses of lirentelimab (AK002) at 3 mg/kg.
Group II: PlaceboPlacebo Group1 Intervention
Subjects in this arm will receive 6 monthly doses of placebo at 3 mg/kg.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AK002
2016
Completed Phase 3
~340

Find a Location

Who is running the clinical trial?

Allakos, Inc.Lead Sponsor
14 Previous Clinical Trials
1,164 Total Patients Enrolled
4 Trials studying Eosinophilic Duodenitis
398 Patients Enrolled for Eosinophilic Duodenitis
Allakos Inc.Lead Sponsor
17 Previous Clinical Trials
1,499 Total Patients Enrolled
4 Trials studying Eosinophilic Duodenitis
398 Patients Enrolled for Eosinophilic Duodenitis
Craig Paterson, MDStudy DirectorAllakos Inc.
6 Previous Clinical Trials
774 Total Patients Enrolled
3 Trials studying Eosinophilic Duodenitis
239 Patients Enrolled for Eosinophilic Duodenitis
~21 spots leftby Nov 2025
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