A Phase 1 interventional study of GSK4527363 and Placebo matching GSK4527363 in Systemic Lupus Erythematosus, sponsored by GlaxoSmithKline. Recruiting at 28 sites in 6 countries. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-22.
Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Treatment
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)
1,202 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.
This study's planned enrollment of 142 is above the median of 50 across 867 interventional studies indexed under Lupus Erythematosus, Systemic.
Browse Lupus Erythematosus, Systemic studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
For Part A and Part C (Healthy Participants):
For Part B (SLE participants):
Exclusion criteria:
For Part A and Part C (Healthy Participants):
For Part B (SLE participants):
Have an acute or chronic infection requiring management as follows:
i. Currently on any suppressive therapy for a chronic infection such as pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster, or atypical mycobacteria ii. A serious infection requiring treatment with antibiotics and/or hospitalization if the last dose of antibiotics or the hospital discharge date was within 60 days of the first day of dosing (Day 1). Prophylactic anti-infective treatment is allowed
For Part D Participants:
Drug: GSK4527363
Drug: Placebo matching GSK4527363
Drug: Belimumab
Drug: GSK4527363
Drug: Belimumab
Drug: GSK4527363
Drug: Placebo matching GSK4527363
Drug: GSK4527363
Drug: Placebo matching GSK4527363
Drug: GSK4527363
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
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
Plan to share: Yes — Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf
Supporting information: Study protocol, Sap, Icf, Csr
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Lupus Erythematosus, Systemic→
GlaxoSmithKline