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Monoclonal Antibodies

Etokimab for Asthma

Phase 2
Waitlist Available
Research Sponsored by AnaptysBio, 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 pre-dose, 0.50 hours post-start of infusion, eoi, eoi+3 hours, eoi+6 hours, and then 24, 168, 504, 840, 1512 hours post-start of infusion
Awards & highlights

Study Summary

This is a proof of concept study designed to assess the effects of a single intravenous dose of etokimab compared to placebo in adult participants with severe eosinophilic asthma. This study will also assess the safety and tolerability of etokimab in adult participants with severe eosinophilic asthma.

Eligible Conditions
  • Asthma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose, 0.50 hours post-start of infusion, eoi, eoi+3 hours, eoi+6 hours, and then 24, 168, 504, 840, 1512 hours post-start of infusion
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose, 0.50 hours post-start of infusion, eoi, eoi+3 hours, eoi+6 hours, and then 24, 168, 504, 840, 1512 hours post-start of infusion 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 From Baseline in Peripheral Eosinophil Count at Day 22
Number of Asthma Exacerbations
Number of Participants With Positive Anti-drug Antibody
+1 more
Secondary outcome measures
Apparent Terminal Half-life (t1/2) of Etokimab
Apparent Terminal Rate Constant (λz) of Etokimab
Apparent Total Body Clearance (CL) of Etokimab
+10 more

Side effects data

From 2018 Phase 2 trial • 25 Patients • NCT03469934
17%
Pharyngitis streptococcal
8%
Ear pain
8%
Panic attack
8%
Sinusitis
8%
Contusion
8%
Upper respiratory tract infection
8%
Asthma
8%
Arthralgia
8%
Pharyngitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Etokimab
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: EtokimabExperimental Treatment1 Intervention
Participants received a single dose of 300 milligrams (mg) etokimab administered on Day 1 by intravenous (IV) infusion over 1 hour. After completing the Day 1 assessments, all participants were followed up for 18 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Participants received a single dose of placebo (0.9% sodium chloride) administered on Day 1 by IV infusion over 1 hour. After completing the Day 1 assessments, all participants were followed up for 18 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Etokimab
2017
Completed Phase 2
~460

Find a Location

Who is running the clinical trial?

AnaptysBio, Inc.Lead Sponsor
16 Previous Clinical Trials
1,623 Total Patients Enrolled
1 Trials studying Asthma
4 Patients Enrolled for Asthma
Bruce Randazzo, MDStudy DirectorAnaptysBio, Inc.
10 Previous Clinical Trials
794 Total Patients Enrolled
Marco Londei, M.D.Study DirectorAnaptysBio, Inc.
1 Previous Clinical Trials
302 Total Patients Enrolled
~3 spots leftby Jun 2025
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