A Study of GSK4527363 in Healthy Participants and Those with Systemic Lupus Erythematosus or Connective Tissue Disease-related Lung Disease
This study is testing a drug called GSK4527363, a placebo (an inactive substance that looks like the drug), and Belimumab. Researchers want to understand how safe these treatments are and how your body handles them. The study includes healthy volunteers, people with active Systemic Lupus Erythematosus (SLE), healthy people of Chinese and Japanese descent, and people with interstitial lung disease (lung scarring) linked to connective tissue disease. The main goal is to track any side effects, both serious and non-serious, and to see if there are any significant changes in your physical exams, lab results, vital signs, or heart readings. You may be able to join if you are between 18 and 65 years old. The current recruitment status is unclear.
- Study design
- This interventional study plans to enroll 142 participants. It involves giving participants either GSK4527363, a matching placebo, or Belimumab.
- What's involved
- Participants in Parts A and C will be followed for up to 52 weeks. Participants in Parts B and D will be followed for up to 68 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants in Parts A and C will be followed for up to 52 weeks. Participants in Parts B and D will be followed for up to 68 weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06576271
A Study of GSK4527363 in Healthy Participants, Systemic Lupus Erythematosus (SLE) Participants, Healthy Chinese, and Japanese Participants and CTD-ILD Participants
Recruiting
PHASE1Ages 18–65InterventionalTreatmentGlaxoSmithKline
~142 participants
Updated 2026-06-22 on ClinicalTrials.gov
What's tested:GSK4527363Placebo matching GSK4527363Belimumab
At a glance
Recruiting sites
25 of 28 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Parts A and C: Number of Participants with Non-serious Adverse Events and Serious Adverse Events
Measured over Up to Week 52
+5 more outcomes measured
Conditions
Where it's being run
28 sites across 12 statesPoland5
Spain5
Argentina4
United Kingdom4
Brazil3
Arizona1
Colorado1
Nevada1
Study leadership
- GSK Clinical Trials · STUDY_DIRECTOR · GlaxoSmithKline
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent form
Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring (vital signs and 12-lead ECG)
Part C only: Be of Japanese (Cohort C1) or Chinese (Cohort C2) ancestry i. Born in Japan (Cohort C1) or China mainland, Hong Kong or Taiwan (Cohort C2); and ii. Descendent of 2 ethnic Japanese (Cohort C1) or Chinese (Cohort C2) parents and 4 ethnic grandparents; and iii. Have lived outside Japan (Cohort C1) or China mainland, Hong Kong or Taiwan (Cohort C2) for less than 10 years at the time of screening
Body weight greater than or equals to (\>=) 45 kilograms (kg)
Body mass index (BMI) within the range 18-32 kilograms per square meter (kg/m\^2) (inclusive)
Male or female of non-childbearing potential
18 to 65 years of age inclusive, at the time of signing the informed consent form
Documented clinical diagnosis of SLE according to the (European alliance of associations of rheumatology \[EULAR\]/ American College of Rheumatology \[ACR\] SLE classification criteria)
Body weight \>= 45 kg
BMI within the range 18-32 kg/m\^2 (inclusive)
Male or female
Capable of giving signed informed consent For Part D (CTD-ILD Participants)
Participants must be 18 to 65 years of age, at the time of signing the informed consent form
Documented clinical diagnosis of specific Connective Tissue Diseases in accordance with internationally recognised classification criteria
Documented clinical diagnosis of interstitial lung disease (ILD) as determined by historical High-resolution computed tomography (HRCT)
Participants must be on a stable dose of therapy to manage ILD and/or underlying connective tissue disease (CTD)
Body weight \>= 45 kg
BMI within the range 18-32 kg/m\^2 (inclusive)
Male or female
Capable of giving signed informed consent
Exclusion
History or presence or cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurological disorders
A history of recurrent infections, or treatment of a chronic infection within 3 months prior to the first dose of study drug
Any acute infection (including upper respiratory tract infections and urinary tract infections) which has not fully resolved within four weeks before dosing
Symptomatic herpes zoster within 3 months prior to screening
Have a history of malignancy, or a strong family history of malignancies related to immunosuppression
Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions
Abnormal blood pressure
Evidence of active or latent Tuberculosis (TB)
Alanine transaminase (ALT) \>=1.1\* Upper limit of normal (ULN)
Total bilirubin \>1.0\*ULN; Participants with Gilbert's syndrome can be included with total bilirubin \>=1.5\*ULN as long as direct bilirubin is less than or equal to (\<=)1.5\*ULN
Presence of Hepatitis B surface antigen (HBsAg) and Hepatitis B core antibody (HBcAb) at screening or within 3 months prior to first dose of study intervention
Positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention
Positive Hepatitis C Ribonucleic acid (RNA) test result at screening or within 3 months prior to first dose of study intervention
Positive Human immunodeficiency virus (HIV) antibody test at screening
Prior medical history of anaphylaxis
QT interval corrected for heart rate according to Fridericia's formula (QTcF) \>450 milliseconds (msec)
Live vaccine(s) within 30 days before the dosing day or plans to receive such vaccines during the study
Any acute, severe lupus related flare during the Screening Period that needs immediate treatment
Have clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to SLE which, in the opinion of the principal investigator (PI), could confound the results of the clinical study or put the participant at undue risk
Have an acute or chronic infection requiring management as follows:
Evidence of active or latent TB
Confirmed Progressive Multifocal Leukoencephalopathy (PML) or unexplained new-onset or deteriorating neurologic signs and symptoms
ALT \>2\*ULN
Total bilirubin \>1.5\*ULN; Participants with Gilbert's syndrome can be included with total bilirubin \>1.5\*ULN as long as direct bilirubin is \>1.5\*ULN
Presence of HBsAg and/or HBcAb at screening or within 3 months prior to first dose of study intervention
Positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention
Positive hepatitis C RNA test result at screening or within 3 months prior to first dose of study intervention
History or positive test at Screening for HIV
QTcF \>450 msec
Solid or hematological malignancy or a history of malignancy (in the past 5 years) of except for basal cell or squamous cell in situ skin carcinomas, Cervical intraepithelial neoplasia (CIN) or carcinoma in situ of the cervix that have been resected with no evidence of metastatic disease for 3 years
Live or live-attenuated vaccine(s) within 30 days prior to Screening
A diagnosis of: ILD other than CTD-ILD and/or SLE
FVC \<= 45% predicted at Screening Pulmonary arterial hypertension, as determined by the Investigator, prior to Day 1
Major surgery (including joint surgery) within 3 months prior to Screening or planned during the duration of the study
Previous or planned major organ transplant (e.g. heart, lung, kidney, liver) or bone marrow transplant (e.g. autologous stem cell transplant)
Have clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to CTD-ILD (i.e., cardiovascular, metabolic, hematologic, GI, hepatic, renal, neurological, psychiatric, malignancy, or infectious diseases) which, in the opinion of the PI, could confound the results of the clinical study or put the participant at undue risk
Have an acute or chronic infection including requiring management
Evidence of active or latent TB
Confirmed PML or unexplained new-onset or deteriorating neurologic signs and symptoms
ALT \>2\*ULN
Total bilirubin \>1.5\*ULN; Participants with Gilbert's syndrome can be included with total bilirubin \>1.5\*ULN as long as direct bilirubin is \>1.5\*ULN
Presence of HBsAg and/or HBcAb at screening or within 3 months prior to first dose of study intervention
Positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention
Positive hepatitis C RNA test result at screening or within 3 months prior to first dose of study intervention
History or positive test at Screening for HIV
Solid or hematological malignancy or a history of malignancy (in the past 5 years) of except for basal cell or squamous cell in situ skin carcinomas, CIN or carcinoma in situ of the cervix that have been resected with no evidence of metastatic disease for 3 years
Live or live-attenuated vaccine(s) within 30 days prior to Screening or plans to receive such vaccines during the Screening period or during the clinical study
What this trial measures
- Parts A and C: Number of Participants with Non-serious Adverse Events and Serious Adverse EventsUp to Week 52
- Parts B and D: Number of Participants with Non-serious Adverse Events and Serious Adverse EventsUp 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) FindingsUp 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) FindingsUp to Week 68
- Parts A and C: Number of Participants with Clinically Significant Changes in Columbia-Suicide Severity Rating Scale (C-SSRS)Up to Week 52
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.
- Parts B, and D: Number of Participants with Clinically Significant Changes in Columbia-Suicide Severity Rating Scale (C-SSRS)Up to Week 68
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.