Proof of Concept Study to Investigate Etokimab (ANB020) Activity in Adult Participants With Severe Eosinophilic Asthma
Completed · Phase 2 · Has a placebo group
Conditions studied: Eosinophilic Asthma
In brief
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.
Key facts
- Study ID
- NCT03469934
- Run by
- AnaptysBio, Inc.
- People needed
- 25
- Starts
- 2017-11-14
- Expected to finish
- 2018-10-30
- Last updated by the study team
- 2023-08-16
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- 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
Full record on ClinicalTrials.gov
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