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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

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

A Phase 1, First-time-in-human, Three-part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of GSK4527363 in Healthy Participants (Part A), Participants With Active Systemic Lupus Erythematosus (Part B), Healthy Participants of Chinese and Japanese Descent (Part C) and Participants With Interstitial Lung Disease Associated With Connective Tissue Disease (Part D)

A Study of GSK4527363 in Healthy Participants, Systemic Lupus Erythematosus (SLE) Participants, Healthy Chinese, and Japanese Participants and CTD-ILD Participants (NCT06576271) is a Phase 1 interventional studying Systemic Lupus Erythematosus, sponsored by GlaxoSmithKline. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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)

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Systemic Lupus Erythematosus, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 142 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Systemic Lupus Erythematosus subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: For Part A and Part C (Healthy Participants): - Participant must be 18 to 55 years of age inclusive, at the time of signing the willing to sign a consent form 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 willing to sign a consent form 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 willing to sign a consent form For Part D (CTD-ILD Participants) - Participants must be 18 to 65 years of age, at the time of signing the willing to sign a consent form form. - Documented clinical diagnosis of Rheumatoid arthritis (RA), Systemic sclerosis (SSc), Idiopathic inflammatory myopathy (IIM); including polymyositis, dermatomyositis, antisynthetase syndrome, Primary Sjogren's syndrome (pSS) or mixed connective tissue disease (MCTD) in accordance with internationally recognised classification criteria ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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 Rheumatoid arthritis (RA), Systemic sclerosis (SSc), Idiopathic inflammatory myopathy (IIM); including polymyositis, dermatomyositis, antisynthetase syndrome, Primary Sjogren's syndrome (pSS) or mixed connective tissue disease (MCTD) 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) * Participant has an area of skin that, in the opinion of the Investigator, would allow Subcutaneous (SC) administration of study intervention according to the protocol * Participants must be current for all vaccinations in accordance with local guidelines, within a year of, and at least 30 days before, first dose. If local guidelines recommend seasonal influenza vaccine, this need only be administered during Flu season (October to April) * Body weight \>= 45 kg * BMI within the range 18-32 kg/m\^2 (inclusive) * Male or female 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 Systemic lupus erythematosus (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. * Alanine transaminase (ALT) \>2\*Upper limit of normal (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 * History of primary immunodeficiency, or hypogammaglobulinemia (Immunoglobulin G \[IgG\] less than \[\<\]600 milligrams per decilitres \[mg/dL\]) or Immunoglobulin A \[IgA\] deficiency (IgA \<10 mg/dL) at screening * Have a Grade 2 or greater neutropenia, defined as absolute neutrophil count \<1,500 /cubic millimeters (mm\^3) (\<1.5×10\^9/liters \[L\]) based on the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 at screening * Have a Grade 2 or greater lymphopenia, defined as absolute lymphocyte count \< 800 /mm3 (\< 0.8 x 10\^9/L) based on CTCAE v5.0 at screening * Participants with rapidly progressive disease (absolute drop of \>=10 percent (%) in Forced vital capacity (FVC) between screening and Day 1 and/or recent pulmonary hospitalisation) * FVC \<= 45% predicted at Screening * DLCO (corrected for haemaglobin) \<= 50% of predicted based on historical assessment within 6 months of Screening * History or presence of diffuse alveolar haemorrhage (DAH) or other confounding pulmonary disease, signs or symptoms. * Pulmonary arterial hypertension, as determined by the Investigator, prior to Day 1. * For participants with underlying SSc only: renal crisis within 6 months prior to Day 1. * Dependence on continuous oxygen supplementation. * Obstructive pulmonary disease (pre-bronchodilator Forced expiratory volume in 1 second (FEV1)/FVC \< 0.7). * 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 any other clinically significant abnormal laboratory value, that in the opinion of the investigator, is capable of significantly altering the absorption, metabolism, or elimination of the clinical study intervention; or constitutes a risk when taking the clinical study intervention or interferes with the interpretation of the clinical study data. * 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 as documented by medical history and examination (including chest X-rays, if available), and TB testing: either a positive Tuberculin skin test (TST) or a positive (not indeterminate) TB test such as QuantiFERON-TB Gold Plus test * Confirmed Progressive Multifocal Leukoencephalopathy (PML) or unexplained new-onset or deteriorating neurologic signs and symptoms. * Risk of suicide, as judged by the investigator, based upon available source information, including the C-SSRS, indicating current suicidal ideation or a history of active suicidal ideation or suicide attempts. * Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). * ALT greater than (\>)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. * A positive confirmation of Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection or signs and symptoms suggestive of SARS-CoV-2 at screening or pre-dose. * Estimated glomerular filtration rate (eGFR) \<=45 milliliters per minute (mL/min) at screening * QTcF \>450 milliseconds (msec) or \>480 msec for patients with bundle branch block and/or hypokalemia, and/or family history of long QT syndrome. * Known to have titers of human anti-mouse antibody or history of hypersensitivity reactions when treated with diagnostic or therapeutic monoclonal antibodies. * 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. Prior/concomitant therapy (Part D) * 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. * Current or prior treatment of any of the following: * Belimumab, at any time. * B-cell depleting agents, including anti-CD20 (e.g. Rituximab, Obinutuzumab, Ocrelizumab), anti-CD19 (e.g. Blinatumomab) and anti-CD38 (e.g. Daratumumab, TAK079, MOR202, isatuximab) within 12 months of Day 1. * Cell therapies, including CAR-T, TCE and others at any time. * Immune-Modulating Biologic agents, including anti- Tumour necrosis factor (TNF) therapy (e.g., adalimumab, etanercept, infliximab), abatacept, and interleukin1 receptor antagonist (anakinra) within 3 months or 5 half-lives (whichever is longer) of screening. * Small molecule inhibitors, including inhibitors of Janus kinases (JAKis, baricitinib, tofacitinib, upadacitinib, filgotinib); or Bruton tyrosine kinase inhibitors (ibrutinib, fenebrutinib), within 4 weeks of screening. * Cyclophosphamide (oral or intravenous \[IV\]) within 6 months of Day 1. * Cytotoxic agents such as chlorambucil, nitrogen mustard or other alkylating agents within 6 months of Day 1. * Intravenous immunoglobulin, within 12 weeks of Day 1. * Plasmapheresis or extracorporeal photophoresis, or use of plasma filtering devices within 12 weeks of screening. * Intra-articular, IM, or IV corticosteroids within 6 weeks of Day 1. Other exclusion criteria (Part D): * Sensitivity to the clinical study interventions, or components thereof, or drug or other allergy that, in the opinion of the investigator, contraindicates participation in the clinical study. * Current drug or alcohol dependence, or a history of drug or alcohol abuse or dependence within 364 days prior to Day 1. * Current enrolment or past participation in any other clinical study involving an investigational study treatment (including investigational vaccines) within 3 months or 5 half-lives of the investigational drug (whichever is longer) before allocation. * Use of any medicinal products intended to treat medical conditions that are not approved by the governing health authority in the participant's country or region. * Participants who are expected to be non-compliant with restrictions on medications and vaccinations prior to the study, during the study.

Treatments Being Tested

DRUG

GSK4527363

GSK4527363 will be administered to participants.

DRUG

Placebo matching GSK4527363

Placebo matching GSK4527363 will be administered to participants.

DRUG

Belimumab

Belimumab will be administered to participants.

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

GSK Investigational Site
Scottsdale, Arizona, United States
GSK Investigational Site
Aurora, Colorado, United States
GSK Investigational Site
Las Vegas, Nevada, United States
GSK Investigational Site
Columbus, Ohio, United States
GSK Investigational Site
Oklahoma City, Oklahoma, United States
GSK Investigational Site
Dallas, Texas, United States
GSK Investigational Site
Buenos Aires, Argentina
GSK Investigational Site
Rosario, Argentina
GSK Investigational Site
San Juan Bautista, Argentina
GSK Investigational Site
San Miguel de Tucumán, Argentina
GSK Investigational Site
Porto Alegre, Rio Grande do Sul, Brazil
GSK Investigational Site
Juiz de Fora, Brazil
GSK Investigational Site
Porto Alegre, Brazil
GSK Investigational Site
Salvador, Brazil
GSK Investigational Site
Bydgoszcz, Poland
GSK Investigational Site
Poznan, Poland
GSK Investigational Site
Warsaw, Poland
GSK Investigational Site
Wroclaw, Poland
GSK Investigational Site
Barcelona, Spain
GSK Investigational Site
Bilbao, Spain

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06576271), the sponsor (GlaxoSmithKline), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06576271 clinical trial studying?

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) The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06576271?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06576271?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06576271. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06576271. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.