Status:
COMPLETED
Proof of Concept Study to Investigate Etokimab (ANB020) Activity in Adult Participants With Severe Eosinophilic Asthma
Lead Sponsor:
AnaptysBio, Inc.
Conditions:
Eosinophilic Asthma
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 14 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2018
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03469934
Start Date
November 14 2017
End Date
October 30 2018
Last Update
August 16 2023
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Midwest Allergy Sinus Asthma
Normal, Illinois, United States, 61761
2
Pulmonary & Critical Care Specialists
Novi, Michigan, United States, 48375
3
OK Clinical Research, LLC
Edmond, Oklahoma, United States, 73034
4
Allergy & Asthma Center of Southern Oregon
Medford, Oregon, United States, 97504