Testing Depemokimab for asthma

Exclusion

• −Participants with allergy/intolerance to a mAb or biologic or any of the excipients of depemokimab
• −A known immunodeficiency (e.g. human immunodeficiency virus HIV), other than that explained by the use of corticosteroids (CSs) taken as therapy for asthma
• −Presence of a known pre-existing, clinically important lung condition other than asthma. This includes (but is not limited to) current infection, bronchiectasis, pulmonary fibrosis, bronchopulmonary aspergillosis, or a history of lung cancer. Participants with current diagnoses of emphysema or chronic bronchitis (Chronic obstructive pulmonary disease \[COPD\] other than asthma) are excluded
• −Participants with other conditions that could lead to elevated eosinophils such as hyper eosinophilic syndromes including (but not limited to) Eosinophilic Granulomatosis with Polyangiitis (EGPA, formerly known as Churg-Strauss Syndrome) or eosinophilic esophagitis
• −Participants who developed an exacerbation within 4 weeks before screeningScreeningThe checks done before joining, to see whether a study fits.Read more →
• −Participants with a known, pre-existing parasitic infestation within 6 months prior to screening unless treated and evidenced to have been resolved
• −A current malignancy or previous history of cancer in remission for less than 12 months prior to screening
• −Participants who have known, pre-existing, clinically significant cardiac, endocrine, autoimmune, metabolic, neurological, psychiatric, renal, gastrointestinal, hepatic, hematologic abnormalities or any other system abnormalities that are uncontrolled with standard treatmentStandard of careThe treatment normally given for a condition outside a study.Read more →
• −Participants with current diagnosis of vasculitis
• −Participants who have a previous documented failure with anti-IL-5/5R therapy
• −Participants who have received monoclonal antibody (mAb) therapy targeting IL 5/5R, IL 4R/IL 13, IL 33, IgE, or Thymic Stromal Lymphpoietin (TSLP) within 12 months or 5 terminal phase half-lives of the drug, whichever is longer prior to the screening. Authorized treatments for Coronavirus disease-2019 (COVID-19) are permitted
• −Participants who have received treatment with an investigational drug within the past 30 days or 5 terminal phase half-lives of the drug whichever is longer, prior to the first dose of study intervention (this also includes investigational formulations of marketed products)
• −Previously participated in any clinical study with biologic treatments for asthma (for example, omalizumab, mepolizumab, dupilumab, reslizumab, benralizumab, other mAbs (including Tezepelumab) or depemokimab and received study intervention (including placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more →) within 12 months prior to the first dose of study intervention
• −A history (or suspected history) of alcohol misuse or substance abuse within 2 years prior to the first dose of study intervention
• −Participants who have known evidence of lack of adherence to controller medications and/or ability to follow physician's recommendations
• −Presence of metal objects that may interfere with chest CT quantification including presence of a cardiac pacemaker, defibrillator, metal prosthetic heart valve, metal projectile or metal weapon fragment (bullet, shrapnel, shotgun shot) or metal shoulder prosthesis
• −Evidence of clinically significant abnormality in the hematological, biochemical or urinalysis screen at screening (Visit 0), as judged by the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →
• −Participants who are pregnant or breastfeeding
• −Participants who have occupational ionizing-radiation exposure exceeding 10 Millisievert (mSV) over 3 years as documented with a dosimeter; have been exposed to elevated ionizing radiation from research imaging studies, for example, Participation in a research study with a single positron emission tomography scan in the past 3 years, and Participation in a research study with 2 or more computed tomography (CT) scans in the past 3 years in the following anatomical regions: chest, abdomen, cardiac, or spine
• −Current smokers or former smokers with a smoking history \>=20 pack years (number of pack years = \[number of cigarettes per day/20\] x number of years smoked) and vapers