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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
307
GSK5784283 will be administered.
Placebo will be administered.
GSK Investigational Site
Little Rock, Arkansas, United States
GSK Investigational Site
Long Beach, California, United States
GSK Investigational Site
Los Angeles, California, United States
GSK Investigational Site
Redding, California, United States
GSK Investigational Site
Riverside, California, United States
Part A: Change from baseline in the fraction of exhaled nitric oxide (FeNo)
Time frame: Baseline (Day 1) and at 2, 4, 8,12, 20 and 26 weeks
Part A: Change from baseline in blood eosinophil counts
Time frame: Baseline (Day 1) and at 2, 4, 8,12, 20 and 26 weeks
Part A: Change from baseline in the forced expiratory volume (FEV1) [pre-and post-bronchodilator
Time frame: Baseline (Day 1) and at 2, 4, 8,12, 20 and 26 weeks
Part A: Change from baseline in the forced vital capacity (FVC) [pre-and post-bronchodilator
Time frame: Baseline (Day 1) and at 2, 4, 8,12, 20 and 26 weeks
Part A: Change from baseline in the 5-item Asthma Control Questionnaire (ACQ-5)
The ACQ-5 is a five-item questionnaire, which has been developed as a measure of participants' asthma control. The five questions enquire about the frequency and/or severity of symptoms (nocturnal awakening on waking in the morning, activity limitation, and shortness of breath, wheeze) over the previous week. The response options for all these questions consist of a zero (no impairment/limitation) to six (total impairment/ limitation) scale.
Time frame: Baseline (Day 1) and at 2, 4, 8,12, 20 and 26 weeks
Part A: Maximum Observed Plasma Concentration (Cmax) of GSK5784283
Time frame: Up to 26 weeks
Part A: Time to Reach Cmax (Tmax) of GSK5784283
Time frame: Up to 26 weeks
Part A: Area under the curve over the dosing interval (AUC0-tau) of GSK5784283
Time frame: Up to 26 weeks
Part A & B: Number of participants with treatment emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events of special interest (AESIs)
Time frame: Up to 52 weeks
Part A & B: Number of participants with clinically significant changes in hematology, clinical chemistry and urinalysis
Time frame: Up to 52 weeks
Part A & B: Number of participants with clinically significant changes in vital signs, including blood pressure, body temperature, and pulse rate
Time frame: Up to 52 weeks
Part A & B: Number of participants with clinically significant changes in Electrocardiogram (ECG)
Time frame: Up to 52 weeks
Part A & Part B: Number of participants with treatment-emergent Anti-drug antibodies (ADA) to GSK5784283
Time frame: Up to 52 weeks
Part A & Part B: Titers of ADA to GSK5784283
Time frame: Up to 52 weeks
Part A: Number of participants with Neutralizing Antibody (NAb) to GSK5784283
Time frame: Baseline (Day 1) and at 2, 4, 8,12, 20 and 26 weeks
Part B: Change from baseline in the fraction of exhaled nitric oxide (FeNo)
Time frame: Baseline (Day 1) and at 2, 4, 8,12, 20, 26, 28, 30, 34, 38, 46, and 52 weeks
Part B: Change from baseline in blood eosinophil counts
Time frame: Baseline (Day 1) and at 2, 4, 8,12, 20, 26, 28, 30, 34, 38, 46, and 52 weeks
Part B: Ratio to change from baseline in FeNO and blood eosinophil counts
Time frame: Baseline (Day 1) and 52 weeks
Part B: Change from baseline in the forced expiratory volume (FEV1) [pre-and post-bronchodilator
Time frame: Baseline (Day 1) and at 2, 4, 8,12, 20, 26, 28, 30, 34, 38, 46, and 52 weeks
Part B: Change from baseline in the forced vital capacity (FVC) [pre-and post-bronchodilator
Time frame: Baseline (Day 1) and at 2, 4, 8,12, 20, 26, 28, 30, 34, 38, 46, and 52 weeks
Part B: Change from baseline in the 5-item Asthma Control Questionnaire (ACQ-5)
The ACQ-5 is a five-item questionnaire, which has been developed as a measure of participants' asthma control. The five questions enquire about the frequency and/or severity of symptoms (nocturnal awakening on waking in the morning, activity limitation, and shortness of breath, wheeze) over the previous week. The response options for all these questions consist of a zero (no impairment/limitation) to six (total impairment/ limitation) scale.
Time frame: Baseline (Day 1) and at 2, 4, 8,12, 20, 26, 34, 46, and 52
Part B: Number of participants with Neutralizing Antibody (NAb) to GSK5784283
Time frame: Baseline (Day 1) and at 2, 4, 8,12, 20, 26, 28, 30, 34, 38, 46, and 52 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
GSK Investigational Site
Sacramento, California, United States
GSK Investigational Site
San Jose, California, United States
GSK Investigational Site
Colorado Springs, Colorado, United States
GSK Investigational Site
Lakewood, Colorado, United States
GSK Investigational Site
Wheat Ridge, Colorado, United States
...and 124 more locations