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

AnaptysBio

Status and phase: Completed; Phase 2

Conditions: Eosinophilic Asthma

Treatments: Drug: Placebo; Biological: Etokimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03469934

ANB020-004

2017-000647-40 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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25 participants in 2 patient groups, including a placebo group

Etokimab

Experimental group

Description:

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.

Treatment:

Biological: Etokimab

Placebo

Placebo Comparator group

Description:

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:

Drug: Placebo