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Monoclonal Antibodies

3 mg/kg of lirentelimab (AK002) for Eosinophilic Esophagitis (KRYPTOS Trial)

Phase 2 & 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at weeks 23-24 and week 24, respectively
Awards & highlights

KRYPTOS Trial Summary

This trial will test if the drug lirentelimab is effective in treating patients with active eosinophilic esophagitis, a chronic inflammatory disease of the esophagus. The trial will last for 6 months, and patients will be randomly assigned to receive either the drug or a placebo.

Eligible Conditions
  • Eosinophilic Esophagitis

KRYPTOS Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Dysphagia Symptom Questionnaire (DSQ) Score From Baseline to Weeks 23-24.
Proportion of Subjects Who Achieve a Peak Esophageal Intraepithelial Count of ≤6 Eosinophils/Hpf at Week 24
Secondary outcome measures
Change in Biweekly Mean DSQ Over Time Using MMRM
Change in EoE Reference Score for Endoscopic Abnormalities (EREFS) From Baseline to Week 24
Number of Treatment Responders
+5 more

Side effects data

From 2022 Phase 3 trial • 181 Patients • NCT04322604
34%
Infusion related reaction
5%
Abdominal pain
5%
Fatigue
4%
Corona virus infection
3%
Vomiting
3%
Coronavirus test positive
3%
Urinary tract infection
2%
Nausea
1%
Cholecystitis acute
1%
Seizure
1%
Hypokalaemia
1%
Lumbar radiculopathy
1%
Osteomyelitis
1%
Diabetic ketoacidosis
1%
Pharyngeal haemorrhage
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
3 mg/kg of Lirentelimab (AK002)

KRYPTOS Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: 3 mg/kg of lirentelimab (AK002)Experimental Treatment1 Intervention
Subjects in this arm will receive 6 monthly doses of lirentelimab (AK002): A first dose of 1 mg/kg, followed by 5 monthly doses of 3 mg/kg.
Group II: 1 mg/kg of lirentelimab (AK002)Experimental Treatment1 Intervention
Subjects in this arm will receive 6 monthly doses of lirentelimab (AK002) (1mg/kg).
Group III: PlaceboPlacebo Group1 Intervention
Subjects in this arm will receive 6 monthly doses of placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lirentelimab
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Allakos, Inc.Lead Sponsor
14 Previous Clinical Trials
980 Total Patients Enrolled
6 Trials studying Eosinophilic Esophagitis
557 Patients Enrolled for Eosinophilic Esophagitis
Allakos Inc.Lead Sponsor
16 Previous Clinical Trials
1,247 Total Patients Enrolled
6 Trials studying Eosinophilic Esophagitis
557 Patients Enrolled for Eosinophilic Esophagitis
Craig Paterson, MDStudy DirectorAllakos Inc.
6 Previous Clinical Trials
590 Total Patients Enrolled
4 Trials studying Eosinophilic Esophagitis
333 Patients Enrolled for Eosinophilic Esophagitis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study of Lirentelimab (AK002) in Patients With Active Eosinophilic Esophagitis
2020. "A Study of Lirentelimab (AK002) in Patients With Active Eosinophilic Esophagitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04322708.
~58 spots leftby Apr 2025
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