Proof of Concept Study to Investigate Etokimab (ANB020) Activity in Adult Participants With Severe Eosinophilic Asthma
Condition: Eosinophilic Asthma
MeSH terms: Asthma; Pulmonary Eosinophilia
Intervention: Etokimab; Placebo
Intervention description: Administered on Day 1 over 1 hour by IV infusion; Administered on Day 1 over 1 hour by IV infusion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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