Proof of Concept Study to Investigate Etokimab (ANB020) Activity in Adult Participants With Severe Eosinophilic Asthma

AnaptysBio, Inc.25 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Eosinophilic Asthma

Interventions

EtokimabBIOLOGICAL

Administered on Day 1 over 1 hour by IV infusion

PlaceboDRUG

Administered on Day 1 over 1 hour by IV infusion

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participants with a confirmed clinical diagnosis of eosinophilic asthma * History of diagnosis of eosinophilic asthma * Severe asthma diagnosed according to the Global Initiative for Asthma (GINA) 2016 * Body mass index (BMI) of 18 to 38 kilograms per squared meters (kg/m\^2) (inclusive) and total body weight \> 50 kg (110 pounds) * Women of childbearing potential must have a negative serum pregnancy test at screening and be willing to use highly effective methods of contraception throughout the study * Male participants must be willing to use effective methods of contraception during the entire study period. * Participant must be on high dose inhaled corticosteroids (ICS) plus long-acting beta-2-agonists (LABA) * Willing and able to comply with the study protocol requirements * Have the ability to read and understand the study procedures and can communicate meaningfully with the Investigator and staff Exclusion Criteria: * Have concomitant medical condition(s) which may interfere with the Investigator's ability to evaluate the participant's response to the investigational product (IP) * Have experienced severe life threatening anaphylactic reactions * Have received any IP within a period of 3 months or 5 half lives of an IP * Have received high dose systemic corticosteroids * Have received treatment with biologics, such as mepolizumab or omalizumab, within 3 months or 5 half lives (whichever is longer) before screening * Abnormal electrocardiogram (ECG) assessment at screening * Uncontrolled hypertension, or acute ischemic cardiovascular diseases * If female, is pregnant or lactating, or intend to become pregnant during the study period * History (or suspected history) of alcohol or substance abuse within 2 years before screening * Any comorbidity that the Investigator believes is a contraindication to study participation * Have any other physical, mental, or medical conditions which, in the opinion of the Investigator, make study participation inadvisable or could confound study assessments * Planned surgery during the study or 30 days before screening * History of malignancy within 5 years, except non melanoma skin cancer which has been fully treated with no current active disease

Locations (7)

Midwest Allergy Sinus Asthma

Normal, Illinois, United States

Pulmonary & Critical Care Specialists

Novi, Michigan, United States

OK Clinical Research, LLC

Edmond, Oklahoma, United States

Allergy & Asthma Center of Southern Oregon

Medford, Oregon, United States

Outcomes

Primary Outcomes

Change From Baseline in Peripheral Eosinophil Count at Day 22

Time frame: Baseline, Day 22

Number of Participants With Treatment-Emergent Adverse Events

An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE was considered "serious" if there was any of the following outcomes: death, life-threatening, Inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of ability to conduct normal life functions, congenital anomaly/birth defect, other important medical events. Treatment-emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the date and time of the study drug infusion.

Time frame: From first dose to Day 127

Number of Asthma Exacerbations

Asthma exacerbation was defined as follows: 1. Use of systemic corticosteroids (or a temporary increase in a stable oral corticosteroid background dose) for at least 3 days; a single depo-injectable dose of corticosteroids was considered equivalent to a 3-day course of systemic corticosteroids. OR 2. An emergency room/urgent care visit (defined as evaluation and treatment for \<24 hours in an emergency department or urgent care center) due to asthma that required systemic corticosteroids (as per above). OR 3. An inpatient hospitalization (defined as admission to an inpatient facility and/or evaluation and treatment in a healthcare facility for ≥24 hours due to asthma).

Time frame: From first dose to Day 127

Number of Participants With Positive Anti-drug Antibody

Time frame: Day 1, Day 8, Day 36, Day 85, Day 106, end of study (up to Day 127)

Secondary Outcomes

Change From Baseline in Peripheral Eosinophil Count at Day 127

Data from ClinicalTrials.gov

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Medicines Evaluation Unit

Manchester, Greater Manchester, United Kingdom

Glenfield Hospital

Leicester, Leicestershire, United Kingdom

Churchill Hospital

Oxford, Oxfordshire, United Kingdom

Time frame: Baseline, Day 127

Change From Baseline in Prebronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Day 127

FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.

Time frame: Baseline, Day 127

Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) at Day 127

Measurement of FeNO was performed in accordance with the guidelines published by American Thoracic Society/European Respiratory Society (ATS/ERS).

Time frame: Baseline, Day 127

Change From Baseline in Whole Blood Ex-vivo Induced Interferon Gamma (IFN-γ)

Blood samples for ex vivo induced IFN-γ assessment were collected in a sodium heparin tube. The measurement of ex vivo induced IFN-γ was performed using validated assay method.

Time frame: Baseline, Day 8, Day 36, Day 85, Day 106, and End of Study (up to Day 127)

Maximum Observed Concentration (Cmax) of Etokimab

Cmax was obtained directly from the observed concentration versus time data.

Time frame: pre-dose, 0.50 hours post-start of infusion, end of infusion (EOI), EOI+3 hours, EOI+6 hours, and then 24, 168, 504, 840, 1512 hours post-start of infusion

Time to Maximum Observed Concentration (Tmax) of Etokimab

Tmax was obtained directly from the observed concentration versus time data.