This study will assess the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of GSK4527363 in healthy participants (Part A), participants with active SLE (Part B), healthy participants of Chinese and Japanese descent (Part C), and participants with interstitial lung disease associated with connective tissue disease (Part D)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
142
GSK4527363 will be administered to participants.
Placebo matching GSK4527363 will be administered to participants.
Belimumab will be administered to participants.
Parts A and C: Number of Participants with Non-serious Adverse Events and Serious Adverse Events
Time frame: Up to Week 52
Parts B and D: Number of Participants with Non-serious Adverse Events and Serious Adverse Events
Time frame: Up to Week 68
Parts A and C: Number of Participants with Clinically Significant Changes in Physical Examination, Laboratory Parameters, Vital Signs, and 12 lead Electrocardiogram (ECG) Findings
Time frame: Up to Week 52
Parts B and D: Number of Participants with Clinically Significant Changes in Physical Examination, Laboratory Parameters, Vital Signs, and 12 lead Electrocardiogram (ECG) Findings
Time frame: Up to Week 68
Parts A and C: Number of Participants with Clinically Significant Changes in Columbia-Suicide Severity Rating Scale (C-SSRS)
The C-SSRS is an assessment tool that evaluates suicidal ideation and behavior. A suicidal ideation score will be calculated based on the maximum suicidal ideation category ranging from 1 to 5. Higher score indicates more suicidal ideation. A clinically important change in the C-SSRS is defined as a total score \>0.
Time frame: Up to Week 52
Parts B, and D: Number of Participants with Clinically Significant Changes in Columbia-Suicide Severity Rating Scale (C-SSRS)
The C-SSRS is an assessment tool that evaluates suicidal ideation and behavior. A suicidal ideation score will be calculated based on the maximum suicidal ideation category ranging from 1 to 5. Higher score indicates more suicidal ideation. A clinically important change in the C-SSRS is defined as a total score \>0.
Time frame: Up to Week 68
Parts A and C: Area Under the Concentration-time Curve to the Last Quantifiable Concentration (AUC[0-t]) of GSK4527363
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
GSK Investigational Site
Scottsdale, Arizona, United States
GSK Investigational Site
Aurora, Colorado, United States
RECRUITINGGSK Investigational Site
Las Vegas, Nevada, United States
RECRUITINGGSK Investigational Site
Columbus, Ohio, United States
RECRUITINGGSK Investigational Site
Oklahoma City, Oklahoma, United States
RECRUITINGGSK Investigational Site
Dallas, Texas, United States
WITHDRAWNGSK Investigational Site
Buenos Aires, Argentina
RECRUITINGGSK Investigational Site
Rosario, Argentina
RECRUITINGGSK Investigational Site
San Juan Bautista, Argentina
RECRUITINGGSK Investigational Site
San Miguel de Tucumán, Argentina
RECRUITING...and 17 more locations
Time frame: Up to Week 52
Parts A and C: Area Under the Concentration-time Curve to Infinity (AUC[0-inf]) of GSK4527363
Time frame: Up to Week 52
Parts A and C: Maximum Plasma Concentration (Cmax) of GSK4527363
Time frame: Up to Week 52
Parts A and C: Apparent Terminal Phase Half-life (t1/2) of GSK4527363
Time frame: Up to Week 52
Parts A and C: Number of Participants with Anti-drug Antibodies (ADAs) Against GSK4527363
Time frame: Up to Week 52
Parts B and D: Number of Participants with Anti-drug Antibodies (ADAs) Against GSK4527363
Time frame: Up to Week 68
Parts A, B and C: Titers of ADAs Against GSK4527363
Time frame: Up to Week 52
Parts A and C: Percentage change from Baseline in cytokine levels
Time frame: Baseline (Day 1) and up to Week 52
Parts B and D: Percentage change from Baseline in cytokine levels
Time frame: Baseline (Day 1) and up to Week 68
Part B and D: Area Under the Concentration-time Curve of GSK4527363
Time frame: Up to Week 12
Part B and D: Maximum Plasma Concentration of GSK4527363
Time frame: Up to Week 12
Part B and D: Concentration at the end of the First Dosing Interval of GSK4527363
Time frame: Up to Week 12