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

NCT03469934 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: ANB020-0042017-000647-40
• Study Type: interventional
• Target: 25
• Locations: 2 countries
• Sites: 7

Brief 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.

Conditions

Eosinophilic Asthma

Outcome Measures

Primary Outcomes (4)

• Change From Baseline in Peripheral Eosinophil Count at Day 22

  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.

  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).

  From first dose to Day 127

• Number of Participants With Positive Anti-drug Antibody

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

Secondary Outcomes (13)

• Change From Baseline in Peripheral Eosinophil Count at Day 127

  Baseline, Day 127

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

  Baseline, Day 127

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

  Baseline, Day 127

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

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

• Maximum Observed Concentration (Cmax) of Etokimab

  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

Study Arms (2)

Etokimab

EXPERIMENTAL

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.

Biological: Etokimab

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Etokimab BIOLOGICAL

Administered on Day 1 over 1 hour by IV infusion

Also known as: ANB020

Etokimab

Placebo DRUG

Administered on Day 1 over 1 hour by IV infusion

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AnaptysBio, Inc.: lead

Study Sites (7)

Midwest Allergy Sinus Asthma

Normal, Illinois, 61761, United States

Location

Pulmonary & Critical Care Specialists

Novi, Michigan, 48375, United States

Location

OK Clinical Research, LLC

Edmond, Oklahoma, 73034, United States

Location

Allergy & Asthma Center of Southern Oregon

Medford, Oregon, 97504, United States

Location

Medicines Evaluation Unit

Manchester, Greater Manchester, M239Q, United Kingdom

Location

Glenfield Hospital

Leicester, Leicestershire, LE3 9QP, United Kingdom

Location

Churchill Hospital

Oxford, Oxfordshire, OX3 7LE, United Kingdom

Location

Related Publications (1)

• Pavord ID, Marquette A, Kahm P, Pinkstaff J, Sacco N, Londei M. Single-dose Phase 2a trial of etokimab (anti-IL-33) in severe eosinophilic asthma. Paper presented at the European Academy of Allergy and Clinical Immunology (EEACI) Congress 2019; June 1-5, 2019; Lisbon, Portugal.

  RESULT

MeSH Terms

Conditions

Pulmonary Eosinophilia

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypereosinophilic Syndrome; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Clinical Project Leader
• Organization: AnaptysBio, Inc

info@anaptysbio.com

858-362-6295

Study Officials

• Bruce Randazzo, MD

  AnaptysBio, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2018
• First Posted: March 19, 2018
• Study Start: November 14, 2017
• Primary Completion: October 30, 2018
• Study Completion: October 30, 2018
• Last Updated: August 16, 2023
• Results First Posted: August 16, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3); US (4)