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

April 24, 2026 updated by: GlaxoSmithKline

A Phase 1, First-time-in-human, Four-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)

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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

142

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1280AEB
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Damian Duartes Noe
      • Rosario, Argentina, S2002
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marina Carcamo Diaz
      • San Juan Bautista, Argentina, B1888AAE
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Julia Papagno
      • San Miguel de Tucumán, Argentina, T4000IHE
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Francisco Colombres
  • Brazil
      • Juiz de Fora, Brazil, 36010-570
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Viviane Souza
      • Porto Alegre, Brazil, 90480000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mauro Keiserman
      • Salvador, Brazil, 40050-410
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Adriane da Paz
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Odirlei Andre Monticielo
  • Poland
      • Bydgoszcz, Poland, 85-065
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Katarzyna Kolossa
        • Contact:
        • Contact:
      • Krakow, Poland, 30-688
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Mariusz Korkosz
        • Contact:
        • Contact:
      • Poznan, Poland, 61-848
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Wlodzimierz Samborski
      • Warsaw, Poland, 02-665
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Anna Zubrzycka Sienkiewicz
      • Wroclaw, Poland, 50-556
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Piotr Wiland
  • Spain
      • Barcelona, Spain, 08916
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Ivette Casafont Sole
        • Contact:
        • Contact:
      • Bilbao, Spain, 48013
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Esther RUIZ LUCEA
      • Pamplona, Spain, 31008
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Patricia Fanlo
      • Sabadell Barcelona, Spain, 08208
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Joan Calvet Fontova
      • Valladolid, Spain, 47012
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Maria Julia Barbado Ajo
        • Contact:
        • Contact:
  • United Kingdom
      • Cambridge, United Kingdom, CB2 0GG
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michalis Kostapanos
      • Liverpool, United Kingdom, L7 8YE
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Richard FitzGerald
        • Contact:
        • Contact:
      • Middlesex, United Kingdom, HA1 3UJ
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rajni Vekaria
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85260
        • Withdrawn
        • GSK Investigational Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Christopher Striebich
        • Contact:
        • Contact:
    • Nevada
      • Las Vegas, Nevada, United States, 89154
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Walter Chatham
    • Ohio
      • Columbus, Ohio, United States, 44109
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Judith Lin
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Cristina Arriens
        • Contact:
        • Contact:
    • Texas
      • Dallas, Texas, United States, 75390
        • Withdrawn
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part A: Healthy participants receiving GSK4527363
Drug: GSK4527363
GSK4527363 will be administered to participants.
Placebo Comparator: Part A: Healthy participants receiving placebo matching GSK4527363
Drug: Placebo matching GSK4527363
Placebo matching GSK4527363 will be administered to participants.
Experimental: Part A: Healthy participants receiving belimumab
Drug: Belimumab
Belimumab will be administered to participants.
Experimental: Part B: Participants with SLE receiving GSK4527363
Drug: GSK4527363
GSK4527363 will be administered to participants.
Experimental: Part B: Participants with SLE receiving belimumab
Drug: Belimumab
Belimumab will be administered to participants.
Experimental: Part C: Healthy Japanese participants receiving GSK4527363
Drug: GSK4527363
GSK4527363 will be administered to participants.
Placebo Comparator: Part C: Healthy Japanese participants receiving placebo matching GSK4527363
Drug: Placebo matching GSK4527363
Placebo matching GSK4527363 will be administered to participants.
Experimental: Part C: Healthy Chinese participants receiving GSK4527363
Drug: GSK4527363
GSK4527363 will be administered to participants.
Placebo Comparator: Part C: Healthy Chinese participants receiving placebo matching GSK4527363
Drug: Placebo matching GSK4527363
Placebo matching GSK4527363 will be administered to participants.
Experimental: Part D: Participants with CTD-ILD receiving GSK4527363
Drug: GSK4527363
GSK4527363 will be administered to participants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parts A and C: Number of Participants with Non-serious Adverse Events and Serious Adverse Events
Time Frame: Up to Week 52
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
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
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
Up to Week 68
Parts A and C: Number of Participants with Clinically Significant Changes in Columbia-Suicide Severity Rating Scale (C-SSRS)
Time Frame: 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.
Up to Week 52
Parts B, and D: Number of Participants with Clinically Significant Changes in Columbia-Suicide Severity Rating Scale (C-SSRS)
Time Frame: 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.
Up to Week 68

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
Up to Week 52
Parts A and C: Maximum Plasma Concentration (Cmax) of GSK4527363
Time Frame: Up to Week 52
Up to Week 52
Parts A and C: Apparent Terminal Phase Half-life (t1/2) of GSK4527363
Time Frame: Up to Week 52
Up to Week 52
Parts A, B and C: Titers of ADAs Against GSK4527363
Time Frame: Up to Week 52
Up to Week 52
Parts A and C: Number of Participants with Anti-drug Antibodies (ADAs) Against GSK4527363
Time Frame: Up to Week 52
Up to Week 52
Parts B and D: Number of Participants with Anti-drug Antibodies (ADAs) Against GSK4527363
Time Frame: Up to Week 68
Up to Week 68
Parts A and C: Percentage change from Baseline in cytokine levels
Time Frame: Baseline (Day 1) and up to Week 52
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
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
Up to Week 12
Part B and D: Maximum Plasma Concentration of GSK4527363
Time Frame: Up to Week 12
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
Up to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 2, 2024

Primary Completion (Estimated)

January 11, 2028

Study Completion (Estimated)

January 11, 2028

Study Registration Dates

First Submitted

August 26, 2024

First Submitted That Met QC Criteria

August 26, 2024

First Posted (Actual)

August 28, 2024

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 24, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 221458
  • 2024-514186-18-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.

IPD Sharing Access Criteria

Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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