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Monoclonal Antibodies
Proof of Concept Study to Investigate Etokimab (ANB020) Activity in Adult Participants With Severe Eosinophilic 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
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 weeks3 visits
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
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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Asthma Exacerbations
Number of Participants With Treatment-Emergent Adverse Events
Secondary study objectives
Apparent Terminal Half-life (t1/2) of Etokimab
Apparent Terminal Rate Constant (λz) of Etokimab
Apparent Total Body Clearance (CL) of Etokimab
+9 moreSide effects data
From 2018 Phase 2 trial • 25 Patients • NCT0346993417%
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
Placebo
Etokimab
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