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

Conditions

Asthma

Brief summary

FeNO (ppb) over 26 Weeks.

Detailed description

Part A Dose Finding: Blood eosinophil counts over 26 Weeks., Part A Dose Finding: Lung function as measured by pre-and postbronchodilator forced expiratory volume (FEV1) and forced vital capacity (FVC) over 26 Weeks., Part A Dose Finding: Asthma Control Questionnaire (ACQ-5) over 26 Weeks., Part A Dose Finding: Maximum change from baseline in FeNO, blood eosinophil count, FEV1 and ACQ-5 over 26 Weeks, Part A Dose Finding: PK parameters of GSK5784283: maximum value (Cmax), time of Cmax (tmax), and area under the curve over the dosing interval (AUC0-tau) at Week 26, Part B Extension: Change from baseline in FeNO and blood eosinophil counts at Week 52 and other prespecified timepoints according to SoA, Part B Extension: Change from baseline in lung function as measured by pre- and post-bronchodilator FEV1 and FVC at Week 52 and other pre-specified timepoints according to SoA, Part B Extension: Change from baseline in ACQ-5 at Week 52 and other pre-specified timepoints according to the SoA, Part B Extension: Ratio to baseline in FeNO and blood eosinophil counts at Week 52 and other pre-specified timepoints according to SoA

Related papers

No related papers found yet.

Interventions

DRUGPlacebo for GSK5784283.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
FeNO (ppb) over 26 Weeks.	—

Secondary

Measure	Time frame
Part A Dose Finding: Blood eosinophil counts over 26 Weeks., Part A Dose Finding: Lung function as measured by pre-and postbronchodilator forced expiratory volume (FEV1) and forced vital capacity (FVC) over 26 Weeks., Part A Dose Finding: Asthma Control Questionnaire (ACQ-5) over 26 Weeks., Part A Dose Finding: Maximum change from baseline in FeNO, blood eosinophil count, FEV1 and ACQ-5 over 26 Weeks, Part A Dose Finding: PK parameters of GSK5784283: maximum value (Cmax), time of Cmax (tmax), and area under the curve over the dosing interval (AUC0-tau) at Week 26, Part B Extension: Change from baseline in FeNO and blood eosinophil counts at Week 52 and other prespecified timepoints according to SoA, Part B Extension: Change from baseline in lung function as measured by pre- and post-bronchodilator FEV1 and FVC at Week 52 and other pre-specified timepoints according to SoA, Part B Extension: Change from baseline in ACQ-5 at Week 52 and other pre-specified timepoints according to the SoA	—

Measure

Time frame

Part A Dose Finding: Blood eosinophil counts over 26 Weeks., Part A Dose Finding: Lung function as measured by pre-and postbronchodilator forced expiratory volume (FEV1) and forced vital capacity (FVC) over 26 Weeks., Part A Dose Finding: Asthma Control Questionnaire (ACQ-5) over 26 Weeks., Part A Dose Finding: Maximum change from baseline in FeNO, blood eosinophil count, FEV1 and ACQ-5 over 26 Weeks, Part A Dose Finding: PK parameters of GSK5784283: maximum value (Cmax), time of Cmax (tmax), and area under the curve over the dosing interval (AUC0-tau) at Week 26, Part B Extension: Change from baseline in FeNO and blood eosinophil counts at Week 52 and other prespecified timepoints according to SoA, Part B Extension: Change from baseline in lung function as measured by pre- and post-bronchodilator FEV1 and FVC at Week 52 and other pre-specified timepoints according to SoA, Part B Extension: Change from baseline in ACQ-5 at Week 52 and other pre-specified timepoints according to the SoA

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Countries

Bulgaria, Czechia, Germany, Romania, Spain

Outcome results

None listed