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Completed

NCT Number: NCT03469934

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

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.

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Key information

Conditions

Eosinophilic Asthma Eosinophilia Hematologic Diseases Hemic and Lymphatic Diseases Hypereosinophilic Syndrome Leukocyte Disorders Lung Diseases Pulmonary Eosinophilia Respiratory Tract Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Medicines Evaluation Unit, Manchester, Greater Manchester, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Etokimab

Biological

Administered on Day 1 over 1 hour by IV infusion

Other names: ANB020

Placebo

Drug

Administered on Day 1 over 1 hour by IV infusion

Primary outcomes

  1. Change From Baseline in Peripheral Eosinophil Count at Day 22

    Time frame: Baseline, Day 22

  2. Number of Participants With Treatment-Emergent Adverse Events

    Time frame: From first dose to Day 127

    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.

  3. Number of Asthma Exacerbations

    Time frame: From first dose to Day 127

    Asthma exacerbation was defined as follows:

    • 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

    • 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

    • 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).

  4. 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

  1. Change From Baseline in Peripheral Eosinophil Count at Day 127

    Time frame: Baseline, Day 127

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

    Time frame: Baseline, Day 127

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

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

    Time frame: Baseline, Day 127

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

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

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

    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.

  5. Maximum Observed Concentration (Cmax) of Etokimab

    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

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

  6. Time to Maximum Observed Concentration (Tmax) of Etokimab

    Time frame: 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

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

  7. Area Under the Concentration-time Curve in Serum From Time Zero (Predose) Extrapolated to Infinite Time (AUC0-inf) of Etokimab

    Time frame: 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

    AUC0-inf was calculated by linear up/log down trapezoidal summation and extrapolated to infinity by addition of the last quantifiable concentration divided by the apparent terminal rate constant.

  8. Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of Etokimab

    Time frame: 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

    AUC0-last was calculated by linear up/log down trapezoidal summation.

  9. Apparent Total Body Clearance (CL) of Etokimab

    Time frame: 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

    CL was calculated as dose/ AUC0-inf.

  10. Apparent Terminal Rate Constant (λz) of Etokimab

    Time frame: 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

    λz was determined by linear regression of the terminal points of the log-linear concentration-time curve.

  11. Apparent Terminal Half-life (t1/2) of Etokimab

    Time frame: 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

    Apparent terminal half-life was determined as (natural logarithm of 2 [ln2] divided by λz).

  12. Volume of Distribution During Terminal Phase (Vz) of Etokimab

    Time frame: 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

    Vz was estimated by dividing the systemic clearance by λz.

  13. Volume of Distribution at Steady State Following Intravenous Dosing (Vss) of Etokimab

    Time frame: 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

    Volume of distribution at steady state following intravenous dosing was calculated as [([AUMClast + ([tlast*Clast]/λz) + Clast/λz^2]/ AUC(0-inf)) - TI/ 2]*CL, Clast is last observed (quantifiable) plasma concentration, where AUMClast is the area under the moment curve from the time of dosing to Clast, tlast is the time of Clast, and TI is infusion duration.

Sponsors and collaborators

Lead sponsor

AnaptysBio, Inc.

Industry

Registry information

Official study title

Placebo-Controlled Proof of Concept Study to Investigate ANB020 Activity in Adult Patients With Severe Eosinophilic Asthma

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 19, 2018
Registry last updated
Aug 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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