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Looking for participantsPhase1

A Study of GSK4527363 in Healthy Participants, Systemic Lupus Erythematosus (SLE) Participants, Healthy Chinese, and Japanese Participants and CTD-ILD Participants

Sponsor: GlaxoSmithKline

NCT ID: NCT06576271

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
GSK4527363 (drug), Placebo matching GSK4527363 (drug), Belimumab (drug)
How long the study runs
Study runs about 40 months (dates as stated)
About the drug or intervention
GSK4527363 — drug: GSK4527363 will be administered to participants. · Placebo matching GSK4527363 — drug: Placebo matching GSK4527363 will be administered to participants. · Belimumab — drug: Belimumab will be administered to participants.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years to 65 Years
Who
All
Number of participants
142
Started
2024-09-02
Last checked
2026-06

Plain English Summary

What is this study?

  • • Testing a new treatment for systemic lupus erythematosus
  • • Phase1 - 142 participants
  • • 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)

Who can take part?

  • • Ages 18 Years to 65 Years
  • • Diagnosed with systemic lupus erythematosus

Where?

  • • Cambridge - GSK Investigational Site
  • • Liverpool - GSK Investigational Site
  • • London - GSK Investigational Site
  • • Middlesex - GSK Investigational Site

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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)

Systemic Lupus Erythematosus

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 65 Years
  • Who can join: All genders

Biomarkers mentioned

History or positive

What the study is looking for

  • ✓For Part A and Part C (Healthy Participants):
  • ✓Participant must be 18 to 55 years of age inclusive, at the time of signing the agreement to take part form
  • ✓Participants who are overtly healthy as determined by medical evaluation including medical history, physical...
  • ✓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)

Who cannot take part

  • ✗For Part A and Part C (Healthy Participants):
  • ✗History or presence or cardiovascular, respiratory, liver, kidney, gastrointestinal, endocrine, blood, or...
  • ✗A history of recurrent infections, or treatment of a chronic infection within 3 months prior to the first dose of...
  • ✗Any acute infection (including upper respiratory tract infections and urinary tract infections) which has not fully...
  • ✗causing symptoms herpes zoster within 3 months prior to screening
See the full criteria
Inclusion criteria: For Part A and Part C (Healthy Participants): * 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 For Part B (SLE participants): * 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 criteria: For Part A and Part C (Healthy Participants): * 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 For Part B (SLE participants): * 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: 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 * 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 For Part D Participants: * 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

Where Is This Study? (4 UK sites)

GSK Investigational Site

Cambridge CB2 0GG, United Kingdom

Recruiting
Site contact (verified)
Michalis KostapanosPrincipal Investigator
US GSK Clinical Trials Call Center877-379-3718GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

GSK Investigational Site

Liverpool L7 8YE, United Kingdom

Recruiting
Site contact (verified)
Richard FitzgeraldPrincipal Investigator
US GSK Clinical Trials Call Center877-379-3718GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

GSK Investigational Site

London SW3 6HP, United Kingdom

Recruiting
Site contact (verified)
Philip MolyneauxPrincipal Investigator
US GSK Clinical Trials Call Center877-379-3718GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

GSK Investigational Site

Middlesex HA1 3UJ, United Kingdom

Recruiting
Site contact (verified)
Rajni VekariaPrincipal Investigator
US GSK Clinical Trials Call Center877-379-3718GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

How to Get in Touch

US GSK Clinical Trials Call Center

Sponsor contact

CONTACT

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

Sponsor contact

CONTACT

+44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-06