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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
EoDyssey Trial Summary
This study is evaluating whether a drug may help treat a digestive disorder.
Eligible Conditions
- Eosinophilic Gastroenteritis
- Eosinophilic Duodenitis
EoDyssey Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at weeks 23-24 and week 24, respectively
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at weeks 23-24 and week 24, respectively
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in PRO Total Symptom Score (TSS) From Baseline to Weeks 23-24
Proportion of Tissue Eosinophil Responders at Week 24
Secondary outcome measures
Number of Treatment Responders
Percent Change in Tissue Eosinophils From Baseline to Week 24
Percent Change in Weekly TSS Over Time Using MMRM
+3 moreSide effects data
From 2023 Phase 3 trial • 94 Patients • NCT0485689120%
Infusion related reaction
11%
Corona virus infection
9%
Sinusitis
7%
Abdominal pain
4%
Hiatus hernia
2%
Diabetic ketoacidosis
2%
Diarrhea
2%
Depression
2%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
3.0 mg/kg of Lirentelimab (AK002)
Placebo
EoDyssey 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
1,163 Total Patients Enrolled
4 Trials studying Eosinophilic Duodenitis
398 Patients Enrolled for Eosinophilic Duodenitis
Allakos Inc.Lead Sponsor
16 Previous Clinical Trials
1,430 Total Patients Enrolled
4 Trials studying Eosinophilic Duodenitis
398 Patients Enrolled for Eosinophilic Duodenitis
Craig Paterson, MDStudy DirectorAllakos Inc.
6 Previous Clinical Trials
773 Total Patients Enrolled
3 Trials studying Eosinophilic Duodenitis
239 Patients Enrolled for Eosinophilic Duodenitis
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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