Testing GSK4527363 in healthy individuals and those with systemic lupus erythematosus
Official title: 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)
Run by GlaxoSmithKline · NCT06576271 · Data updated 2026-11-12
This study is testing a new drug called GSK4527363 in healthy people and those with systemic lupus erythematosus to see how safe it is and how it works in the body.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 142 (estimated) |
| Sponsor | GlaxoSmithKline Industry-sponsored |
| Locations | 28 sites (Scottsdale, Arizona and 27 other locations) |
| Status | Recruiting |
| Started | September 2, 2024 |
| Main results expected | January 11, 2028 |
| Study ends | January 11, 2028 |
| Registry record updated | June 22, 2026 |
| Trial ID | NCT06576271 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include healthy adults aged 18 to 55 and those with active systemic lupus erythematosus.
✕Probably not a fit
Patients who are not of Japanese or Chinese descent may not benefit from the specific focus of this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of GSK4527363 in three groups: healthy participants, participants with active systemic lupus erythematosus (SLE), and healthy individuals of Chinese and Japanese descent. The trial is divided into three parts, with the first part focusing on healthy participants, the second on those with SLE, and the third specifically on healthy participants from Asian backgrounds. Participants will receive either GSK4527363 or a placebo, and their responses will be closely monitored to gather data on the drug's effects.
Why it matters
Potential benefit: If successful, this study could lead to new treatment options for patients with systemic lupus erythematosus.
How similar studies have gone: Other studies have shown promise with similar approaches, particularly in evaluating new treatments for systemic lupus erythematosus.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
GSK Investigational Site
Aurora, Colorado, United States Recruiting -
GSK Investigational Site
Las Vegas, Nevada, United States Recruiting -
GSK Investigational Site
Columbus, Ohio, United States Recruiting -
GSK Investigational Site
Buenos Aires, Argentina Recruiting -
GSK Investigational Site
Rosario, Argentina Recruiting -
GSK Investigational Site
San Juan Bautista, Argentina Recruiting
Show 22 more locations
-
GSK Investigational Site
San Miguel de Tucumán, Argentina Recruiting -
GSK Investigational Site
Porto Alegre, Rio Grande do Sul, Brazil Recruiting -
GSK Investigational Site
Juiz de Fora, Brazil Recruiting -
GSK Investigational Site
Porto Alegre, Brazil Recruiting -
GSK Investigational Site
Salvador, Brazil Recruiting -
GSK Investigational Site
Bydgoszcz, Poland Recruiting -
GSK Investigational Site
Krakow, Poland Recruiting -
GSK Investigational Site
Poznan, Poland Recruiting -
GSK Investigational Site
Warsaw, Poland Recruiting -
GSK Investigational Site
Wroclaw, Poland Recruiting -
GSK Investigational Site
Barcelona, Spain Recruiting -
GSK Investigational Site
Bilbao, Spain Recruiting -
GSK Investigational Site
Pamplona, Spain Recruiting -
GSK Investigational Site
Sabadell Barcelona, Spain Recruiting -
GSK Investigational Site
Valladolid, Spain Recruiting -
GSK Investigational Site
Cambridge, United Kingdom Recruiting -
GSK Investigational Site
Liverpool, United Kingdom Recruiting -
GSK Investigational Site
London, United Kingdom Recruiting -
GSK Investigational Site
Middlesex, United Kingdom Recruiting -
GSK Investigational Site
Scottsdale, Arizona, United States Withdrawn -
GSK Investigational Site
Oklahoma City, Oklahoma, United States Withdrawn -
GSK Investigational Site
Dallas, Texas, United States Withdrawn
Study contacts
- Study coordinator: US GSK Clinical Trials Call Center
- Email: GSKClinicalSupportHD@gsk.com
- Phone: 877-379-3718
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Effects of anifrolumab on arterial inflammation in SLE patients
This study tests whether anifrolumab can reduce blood vessel inflammation in people with active systemic lupus erythematosus.
-
Home urine testing for people with lupus
Participants with lupus will try weekly home urine tests in addition to usual care to see if this helps monitor kidney health over a year.
-
CR-402 treatment for refractory autoimmune disease
This study tests CRT-402, a CD19-targeted CAR-T therapy, in adults with active, treatment-resistant autoimmune diseases like SLE, systemic sclerosis, and inflammatory myopathy to see if it is safe and capable of helping control disease.
-
ATG-201 in adults with autoimmune diseases
This early, open-label study tests ATG-201 in adults with autoimmune diseases to see if it is safe and tolerable, and to get initial clues about how the body handles the drug and its effects.
-
Biomarker tests in adults with lupus to see how kidney disease changes over time
Researchers will follow adults with lupus to see if blood and urine biomarkers can predict kidney involvement, flares, and treatment responses during routine care.
-
Sirolimus added to standard therapy for adults with SLE-associated immune thrombocytopenia
This trial tests whether adding sirolimus to usual treatment helps adults with SLE-related immune thrombocytopenia see their platelet counts improve.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.