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
This study is trying to find the right dose of a long-lasting medicine called GSK5784283 for people with asthma that remains uncontrolled even though they are using regular asthma treatments. GSK5784283 blocks the action of an inflammatory protein called TSLP that may be contributing to your asthma. The study will be conducted in two parts - Part A (dose finding phase) and Part B (extended dosing phase). Part A will assess the lung function, asthma control, participant safety and certain markers of asthma inflammation in the air you breath out and in your blood. Part B will assess the safety and long-term effects of the repeated or single doses of GSK5784283.
∙ Participants are eligible to be included in the study only if all of the following criteria apply:
• Informed Consent: Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and this protocol. The participant must be willing and able to comply with trial and follow-up procedures.
• 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.
• An asthma exacerbation defined as a worsening of asthma symptoms.
• 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.
• Weight \>=40 kg.
• Male or eligible Female.
• 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. The investigator should evaluate potential for contraceptive method failure (e.g. non-compliance, recently initiated) in relationship to the first dose of study intervention.
⁃ A WOCBP must have a negative serum pregnancy test at screening and a highly sensitive pregnancy test (\[urine or serum\] as required by local regulations) within 24 hours before each dose of study intervention.
⁃ If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
⁃ The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
⁃ Contraceptive use by women should be consistent with location regulations regarding the methods of highly effective contraception for those participating in clinical trials.