Proof of Concept Study to Investigate Etokimab (ANB020) Activity in Adult Participants With Severe Eosinophilic Asthma
NCT ID: NCT03469934
Last Updated: 2023-08-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
25 participants
INTERVENTIONAL
2017-11-14
2018-10-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Etokimab
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.
Etokimab
Administered on Day 1 over 1 hour by IV infusion
Placebo
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.
Placebo
Administered on Day 1 over 1 hour by IV infusion
Interventions
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Etokimab
Administered on Day 1 over 1 hour by IV infusion
Placebo
Administered on Day 1 over 1 hour by IV infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
65 Years
ALL
No
Sponsors
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AnaptysBio, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Bruce Randazzo, MD
Role: STUDY_DIRECTOR
AnaptysBio, Inc.
Locations
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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
Medicines Evaluation Unit
Manchester, Greater Manchester, United Kingdom
Glenfield Hospital
Leicester, Leicestershire, United Kingdom
Churchill Hospital
Oxford, Oxfordshire, United Kingdom
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2017-000647-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ANB020-004
Identifier Type: -
Identifier Source: org_study_id
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