Moderate to Severe Asthma
Overview:
A Multicentre, Randomized, Double-Blind, Placebo Controlled, Dose Finding, Parallel Group, Phase 2 Study of an Anti-TSLP Antibody (GSK5784283) in Adults Aged 18 to 75 Years of Age with Uncontrolled Asthma
Inclusion Criteria:
Age: Participants must be 18 to 75 years of age inclusive, at the time of signing the informed consent.
Documented physician-diagnosed asthma for >= 2 years that meets the National Heart, Lung, and Blood Institute guidelines
Evidence of variable airflow obstruction consistent with asthma
Documented history of asthma exacerbation within 12 months prior to Visit 1.
A well- documented requirement for regular treatment with medium or high-dose ICS for at least 6 months prior to screening.
At least one additional maintenance asthma controller medication is required according to standard practice of care (e.g., long-acting beta 2 agonist (LABA), leukotriene receptors antagonists (LTRA), theophylline, long-acting muscarinic antagonist (LAMA), chromones, etc.). Use of additional asthma controller medications must be documented for at least 3 months prior to Visit 1.
Female participants: A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
Not a woman of childbearing potential (WONCBP) OR
Is a WOCBP and using a contraceptive method that is highly effective, with a failure rate of <1%, 28 days prior to the 1st dose of the study drug and during the study intervention period and follow-up period.
Contraceptive use by women should be consistent with location regulations regarding the methods of highly effective contraception for those participating in clinical trials.
Exclusion Criteria:
• Any concomitant respiratory disease that in the opinion of the investigator and/or medical monitor will interfere with the evaluation of the investigational product or interpretation of subject safety or study result
Active or latent tuberculosis
Malignancy: A current malignancy or previous history of cancer in remission for less than 5 years prior to screening (Participants that had localized carcinoma of the skin which was resected for cure will not be excluded).
A known immunodeficiency (e.g. human immunodeficiency virus - HIV), other than that explained by the use of corticosteroids taken as therapy for asthma.
Receipt of any marketed or investigational biologic agent within 4 months or 5 half-lives prior to Visit 1, whichever is longer and up until the end of study.
Use of immunosuppressive medication (e.g., methotrexate, troleandomycin, oral gold, cyclosporine, azathioprine, intramuscular long-acting depot corticosteroid, systemic (oral) corticosteroids) within 3 months prior to Visit 1 and up until the end of study.
Systemic corticosteroid burst including taper within 15 days prior to Visit 1 or during the screening/run-in period.
Current smokers (tobacco and marijuana) or former smokers with a smoking history >=10 pack years and subjects using vaping products, including electronic cigarettes.
History of chronic alcohol or drug abuse within 2 years.
There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.