Phase
Condition
N/ATreatment
Biological: Solrikitug high dose
Biological: Solrikitug low dose
Placebo
Clinical Study ID
Ages 40-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
At least 40 years of age and no older than 75 years.
Documented diagnosis of COPD for at least 12 months prior to Screening, defined bythe GOLD Guidelines (2023), and elevated blood eosinophils at screening.
At Screening FEV1/FVC ratio must be <0.70, and Post-bronchodilator FEV1 must be ≥40%to <80% predicted normal value calculated using Global Lung Function Initiative (GLI) reference equations (Cooper et al 2017).
Symptomatic (COPD Assessment Test [CAT] Score ≥10) at Screening Visit 1.
Participants must be on 2 or more inhaled maintenance medications for management oftheir COPD, for at least 3 months prior to screening.
Exclusion
Exclusion Criteria:
Female participant who is pregnant or breastfeeding.
Participant has a known hypersensitivity to any component of the formulation ofsolrikitug, including any of the excipients, or a history of anaphylactic reactionto any therapeutic monoclonal antibody.
Participant has history or evidence of any clinically significant cardiovascular,hematologic, hepatic, immunologic, metabolic, urologic, neurologic, dermatologic,psychiatric, renal and/or other major disease or malignancy, or any other conditionthat in the opinion of the Investigator or Medical Monitor might obfuscate the studydata.
Any other pulmonary disease than COPD that in the opinion of the Investigator, theseverity of the disorder would impact the conduct of the study.
Undergone major lung surgery, within 1 year of Screening Visit 1.
Participant has a lower respiratory tract infection that required antibiotics within 6 weeks prior to Screening.
Study Design
Study Description
Connect with a study center
Research Site 031
Lancaster, California 93534
United StatesActive - Recruiting
Research Site 018
Newport Beach, California 92663
United StatesActive - Recruiting
Research Site 020
Englewood, Colorado 80110
United StatesActive - Recruiting
Research Site 002
Clearwater, Florida 33765
United StatesActive - Recruiting
Research Site 035
Cutler Bay, Florida 33189
United StatesActive - Recruiting
Research Site 004
Miami, Florida 33186
United StatesActive - Recruiting
Research Site 013
Orlando, Florida 32825
United StatesActive - Recruiting
Research Site 007
Sarasota, Florida 34239
United StatesActive - Recruiting
Research Site 001
Tampa, Florida 33606
United StatesActive - Recruiting
Research Site 003
Rincon, Georgia 31326
United StatesActive - Recruiting
Research Site 021
Meridian, Idaho 83642
United StatesActive - Recruiting
Research Site 022
Merrillville, Indiana 46410
United StatesActive - Recruiting
Research Site 017
South Dartmouth, Massachusetts 02747
United StatesActive - Recruiting
Research Site 009
Saint Charles, Missouri 63301
United StatesSite Not Available
Research Site 015
Henderson, Nevada 89052
United StatesActive - Recruiting
Research Site 005
Gastonia, North Carolina 28054
United StatesActive - Recruiting
Research Site 008
High Point, North Carolina 27260
United StatesActive - Recruiting
Research Site 006
Wilmington, North Carolina 28401
United StatesActive - Recruiting
Research Site 014
Winston-Salem, North Carolina 27103
United StatesSite Not Available
Research Site 011
Medford, Oregon 97504
United StatesActive - Recruiting
Research Site 023
Anderson, South Carolina 29621
United StatesActive - Recruiting
Research Site 028
Columbia, South Carolina 29204
United StatesActive - Recruiting
Research Site 027
Greenville, South Carolina 29615
United StatesActive - Recruiting
Research Site 010
Rock Hill, South Carolina 29732
United StatesActive - Recruiting
Research Site 024
Spartanburg, South Carolina 29303
United StatesActive - Recruiting
Research Site 029
Union, South Carolina 29379
United StatesActive - Recruiting
Research Site 016
Boerne, Texas 78006
United StatesSite Not Available
Research Site 025
Houston, Texas 77070
United StatesActive - Recruiting
Research Site 012
McKinney, Texas 75071
United StatesActive - Recruiting
Research Site 019
Hampton, Virginia 23666
United StatesActive - Recruiting
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