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.

Contact us to confirm eligibility