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RecruitingNCT06576271Updated Jun 22, 2026

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

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

From the registry’s dates

  • Started Sep 2024; still recruiting 2 years 1 month later.
Phase
Phase 1
Study type
Interventional
Enrollment
142
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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)

02

Conditions studied

  • Systemic Lupus Erythematosus

Keywords

  • Belimumab
  • First time in human study
  • GSK4527363
  • Healthy participants
  • Immunogenicity
  • Pharmacokinetics
  • Systemic lupus erythematosus
  • Interstitial lung disease
  • Connective tissue disease
03

In context

Lupus Erythematosus, Systemic

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
142 participants (estimated)

Study arms

  • Experimental
    Part A: Healthy participants receiving GSK4527363

    Drug: GSK4527363

  • Placebo comparator
    Part A: Healthy participants receiving placebo matching GSK4527363

    Drug: Placebo matching GSK4527363

  • Experimental
    Part A: Healthy participants receiving belimumab

    Drug: Belimumab

  • Experimental
    Part B: Participants with SLE receiving GSK4527363

    Drug: GSK4527363

  • Experimental
    Part B: Participants with SLE receiving belimumab

    Drug: Belimumab

  • Experimental
    Part C: Healthy Japanese participants receiving GSK4527363

    Drug: GSK4527363

  • Placebo comparator
    Part C: Healthy Japanese participants receiving placebo matching GSK4527363

    Drug: Placebo matching GSK4527363

  • Experimental
    Part C: Healthy Chinese participants receiving GSK4527363

    Drug: GSK4527363

  • Placebo comparator
    Part C: Healthy Chinese participants receiving placebo matching GSK4527363

    Drug: Placebo matching GSK4527363

  • Experimental
    Part D: Participants with CTD-ILD receiving GSK4527363

    Drug: GSK4527363

Interventions

  • DrugGSK4527363

    GSK4527363 will be administered to participants.

  • DrugPlacebo matching GSK4527363

    Placebo matching GSK4527363 will be administered to participants.

  • DrugBelimumab

    Belimumab will be administered to participants.

06

What researchers measure

Primary outcomes

  1. Parts A and C: Number of Participants with Non-serious Adverse Events and Serious Adverse Events

    Time frame: Up to Week 52

  2. Parts B and D: Number of Participants with Non-serious Adverse Events and Serious Adverse Events

    Time frame: Up to Week 68

  3. 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

  4. 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

  5. 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

  6. 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

Secondary outcomes

  1. 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

  2. Parts A and C: Area Under the Concentration-time Curve to Infinity (AUC[0-inf]) of GSK4527363

    Time frame: Up to Week 52

  3. Parts A and C: Maximum Plasma Concentration (Cmax) of GSK4527363

    Time frame: Up to Week 52

  4. Parts A and C: Apparent Terminal Phase Half-life (t1/2) of GSK4527363

    Time frame: Up to Week 52

  5. Parts A and C: Number of Participants with Anti-drug Antibodies (ADAs) Against GSK4527363

    Time frame: Up to Week 52

  6. Parts B and D: Number of Participants with Anti-drug Antibodies (ADAs) Against GSK4527363

    Time frame: Up to Week 68

  7. Parts A, B and C: Titers of ADAs Against GSK4527363

    Time frame: Up to Week 52

  8. Parts A and C: Percentage change from Baseline in cytokine levels

    Time frame: Baseline (Day 1) and up to Week 52

  9. Parts B and D: Percentage change from Baseline in cytokine levels

    Time frame: Baseline (Day 1) and up to Week 68

  10. Part B and D: Area Under the Concentration-time Curve of GSK4527363

    Time frame: Up to Week 12

  11. Part B and D: Maximum Plasma Concentration of GSK4527363

    Time frame: Up to Week 12

  12. Part B and D: Concentration at the end of the First Dosing Interval of GSK4527363

    Time frame: Up to Week 12

07

Study locations

25 of 28 sites recruiting
  • GSK Investigational Site
    Scottsdale, Arizona 85260, United States
    Withdrawn
  • GSK Investigational Site
    Aurora, Colorado 80045, United States
    Recruiting
  • GSK Investigational Site
    Las Vegas, Nevada 89154, United States
    Recruiting
  • GSK Investigational Site
    Columbus, Ohio 44109, United States
    Recruiting
  • GSK Investigational Site
    Oklahoma City, Oklahoma 73104, United States
    Withdrawn
  • GSK Investigational Site
    Dallas, Texas 75390, United States
    Withdrawn
  • GSK Investigational Site
    Buenos Aires, C1280AEB, Argentina
    Recruiting
  • GSK Investigational Site
    Rosario, S2002, Argentina
    Recruiting
  • GSK Investigational Site
    San Juan Bautista, B1888AAE, Argentina
    Recruiting
  • GSK Investigational Site
    San Miguel de Tucumán, T4000IHE, Argentina
    Recruiting
  • GSK Investigational Site
    Porto Alegre, Rio Grande do Sul 90035-903, Brazil
    Recruiting
  • GSK Investigational Site
    Juiz de Fora, 36010-570, Brazil
    Recruiting
  • GSK Investigational Site
    Porto Alegre, 90480000, Brazil
    Recruiting
  • GSK Investigational Site
    Salvador, 40050-410, Brazil
    Recruiting
  • GSK Investigational Site
    Bydgoszcz, 85-065, Poland
    Recruiting
  • GSK Investigational Site
    Krakow, 30-688, Poland
    Recruiting
  • GSK Investigational Site
    Poznan, 61-848, Poland
    Recruiting
  • GSK Investigational Site
    Warsaw, 02-665, Poland
    Recruiting
  • GSK Investigational Site
    Wroclaw, 50-556, Poland
    Recruiting
  • GSK Investigational Site
    Barcelona, 08916, Spain
    Recruiting
  • GSK Investigational Site
    Bilbao, 48013, Spain
    Recruiting
  • GSK Investigational Site
    Pamplona, 31008, Spain
    Recruiting
  • GSK Investigational Site
    Sabadell Barcelona, 08208, Spain
    Recruiting
  • GSK Investigational Site
    Valladolid, 47012, Spain
    Recruiting
  • GSK Investigational Site
    Cambridge, CB2 0GG, United Kingdom
    Recruiting
  • GSK Investigational Site
    Liverpool, L7 8YE, United Kingdom
    Recruiting
  • GSK Investigational Site
    London, SW3 6HP, United Kingdom
    Recruiting
  • GSK Investigational Site
    Middlesex, HA1 3UJ, United Kingdom
    Recruiting
08

References and documents

Individual participant data

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.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06576271
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Aug 28, 2024
Start date
Sep 2, 2024
Primary completion
Jan 11, 2028 (estimated)
Completion
Jan 11, 2028 (estimated)
Last update
Jun 22, 2026

Study contacts

US GSK Clinical Trials Call Center
Contact
GSKClinicalSupportHD@gsk.com
877-379-3718
EU GSK Clinical Trials Call Center
Contact
GSKClinicalSupportHD@gsk.com
+44 (0) 20 89904466
GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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