A Study of GSK4527363 in Healthy Participants, Systemic Lupus Erythematosus (SLE) Participants and Healthy Chinese and Japanese Participants
NCT ID: NCT06576271
Last Updated: 2025-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1
142 participants
INTERVENTIONAL
2024-09-02
2028-01-11
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
GSK1550188 A 52 Week Study of Belimumab Versus Placebo in the Treatment of Subjects With Systemic Lupus Erythematosus (SLE) Located in Northeast Asia
NCT01345253
Efficacy and Immunological Evaluation of Belimumab Plus Low Dose IL-2 in the Treatment of Systemic Lupus Erythematosus
NCT05262686
Belimumab Phase I Study in Chinese Subjects With Systemic Lupus Erythematosus
NCT02880852
Efficacy and Safety of Belimumab in Black Race Patients With Systemic Lupus Erythematosus (SLE)
NCT01632241
Japanese phase1 Study of Belimumab (IV vs SC)
NCT01516450
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Part A: Healthy participants receiving GSK4527363
GSK4527363
GSK4527363 will be administered to participants.
Part A: Healthy participants receiving placebo matching GSK4527363
Placebo matching GSK4527363
Placebo matching GSK4527363 will be administered to participants.
Part A: Healthy participants receiving belimumab
Belimumab
Belimumab will be administered to participants.
Part B: Participants with SLE receiving GSK4527363
GSK4527363
GSK4527363 will be administered to participants.
Part B: Participants with SLE receiving belimumab
Belimumab
Belimumab will be administered to participants.
Part C: Healthy Japanese participants receiving GSK4527363
GSK4527363
GSK4527363 will be administered to participants.
Part C: Healthy Japanese participants receiving placebo matching GSK4527363
Placebo matching GSK4527363
Placebo matching GSK4527363 will be administered to participants.
Part C: Healthy Chinese participants receiving GSK4527363
GSK4527363
GSK4527363 will be administered to participants.
Part C: Healthy Chinese participants receiving placebo matching GSK4527363
Placebo matching GSK4527363
Placebo matching GSK4527363 will be administered to participants.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
GSK4527363
GSK4527363 will be administered to participants.
Placebo matching GSK4527363
Placebo matching GSK4527363 will be administered to participants.
Belimumab
Belimumab will be administered to participants.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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 \<=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
18 Years
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
GlaxoSmithKline
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
GSK Investigational Site
Scottsdale, Arizona, United States
GSK Investigational Site
Las Vegas, Nevada, United States
GSK Investigational Site
Columbus, Ohio, United States
GSK Investigational Site
Buenos Aires, , Argentina
GSK Investigational Site
Rosario, , Argentina
GSK Investigational Site
San Miguel de Tucumán, , Argentina
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
GSK Investigational Site
Pamplona, , Spain
GSK Investigational Site
Sabadell Barcelona, , Spain
GSK Investigational Site
Valladolid, , Spain
GSK Investigational Site
Cambridge, , United Kingdom
GSK Investigational Site
Liverpool, , United Kingdom
GSK Investigational Site
Middlesex, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
221458
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.