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

Recruiting now · Phase 1 · Has a placebo group

Conditions studied: Systemic Lupus Erythematosus

In brief

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)

Key facts

Study ID

NCT06576271

Run by

GlaxoSmithKline

People needed

142

Starts

2024-09-02

Expected to finish

2028-01-11

Last updated by the study team

2026-06-22

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• GSK Investigational Site — Middlesex, United Kingdom (enrolling)
• GSK Investigational Site — Aurora, Colorado, United States (enrolling)
• GSK Investigational Site — Las Vegas, Nevada, United States (enrolling)
• GSK Investigational Site — Columbus, Ohio, United States (enrolling)
• GSK Investigational Site — Cambridge, United Kingdom (enrolling)
• GSK Investigational Site — Liverpool, United Kingdom (enrolling)
• GSK Investigational Site — London, United Kingdom (enrolling)
• GSK Investigational Site — Buenos Aires, Argentina (enrolling)
• GSK Investigational Site — Rosario, Argentina (enrolling)
• GSK Investigational Site — San Juan Bautista, Argentina (enrolling)
• GSK Investigational Site — San Miguel de Tucumán, Argentina (enrolling)
• GSK Investigational Site — Porto Alegre, Rio Grande do Sul, Brazil (enrolling)
• GSK Investigational Site — Juiz de Fora, Brazil (enrolling)
• GSK Investigational Site — Porto Alegre, Brazil (enrolling)
• GSK Investigational Site — Salvador, Brazil (enrolling)
• GSK Investigational Site — Bydgoszcz, Poland (enrolling)
• GSK Investigational Site — Krakow, Poland (enrolling)
• GSK Investigational Site — Poznan, Poland (enrolling)
• GSK Investigational Site — Warsaw, Poland (enrolling)
• GSK Investigational Site — Wroclaw, Poland (enrolling)
• GSK Investigational Site — Barcelona, Spain (enrolling)
• GSK Investigational Site — Bilbao, Spain (enrolling)
• GSK Investigational Site — Pamplona, Spain (enrolling)
• GSK Investigational Site — Sabadell Barcelona, Spain (enrolling)
• GSK Investigational Site — Valladolid, Spain (enrolling)

Full record on ClinicalTrials.gov

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