Actively Recruiting
A Study of GSK5926371 in Participants With B-cell Driven Autoimmune Rheumatic Diseases (ARD)
Led by GlaxoSmithKline · Updated on 2026-03-17
54
Participants Needed
3
Research Sites
109 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a 2-part study of GSK5926371 in participants with autoimmune rheumatic diseases (ARD). In part 1, participants will receive different doses of GSK5926371 to find a suitable priming dose. In part 2, participants will receive GSK5926371 at doses based on data from part 1. The study is aimed at testing if GSK5926371 is safe, well-tolerated, how the body processes the study drug, how it works in the body, and whether it triggers any immune responses.
CONDITIONS
Official Title
A Study of GSK5926371 in Participants With B-cell Driven Autoimmune Rheumatic Diseases (ARD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult participants aged 18 to 70 years inclusive
- Diagnosis of systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), idiopathic inflammatory myopathies (IIM), or Sjogren's disease (SjD) depending on study part
- Body mass index (BMI) between 18 and 35 kg/m² inclusive and body weight of at least 45 kilograms
- Female participants must not be pregnant or breastfeeding
- Female participants of childbearing potential must use a highly effective contraceptive method with less than 1% failure rate starting 28 days before and continuing through 28 weeks after the first dose
- Negative sensitive pregnancy test within 24 hours before the first dose for females of childbearing potential
- Signed informed consent form agreeing to comply with study visits and hospitalization requirements
You will not qualify if you...
- Acute, severe autoimmune flare needing immediate or escalated treatment before or during screening
- Severe allergies or sensitivity to humanized monoclonal antibodies or study drug components
- Significant unstable or uncontrolled acute or chronic diseases unrelated to autoimmune condition
- Clinically significant abnormal lab values affecting drug absorption or safety
- Diagnosis of primary or acquired immunodeficiency except selective IgA deficiency
- Recent or active infections including serious, opportunistic, or herpes zoster within 3 months
- Positive or history of tuberculosis, HIV, or progressive multifocal leukoencephalopathy (PML)
- History of significant neurological or psychiatric disorders affecting study participation
- History or recent malignancy except certain treated skin and cervical cancers
- Recent treatment with prohibited medications including corticosteroids, other T-cell engagers, CAR-T therapy, B-cell depleting agents, certain biologics, small molecule inhibitors, IV immunoglobulin, or plasmapheresis within specified timeframes
- Participation in another investigational study within 3 months or relevant drug half-lives
- Contraindications to prophylactic or rescue medications for cytokine release syndrome
- Recent drug or alcohol dependence or abuse within 12 months
- Elevated liver enzymes or bilirubin above specified limits, except Gilbert's syndrome cases
- Current or chronic liver or biliary disease except specified exceptions
- Positive hepatitis B or C tests at screening
- Corrected QT interval above specified limits on ECG at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
GSK Investigational Site
Fukuoka, Japan, 812-8582
Actively Recruiting
2
GSK Investigational Site
Hiroshima, Japan, 734-8551
Actively Recruiting
3
GSK Investigational Site
Hokkaido, Japan, 060-8648
Actively Recruiting
Research Team
U
US GSK Clinical Trials Call Center
CONTACT
E
EU GSK Clinical Trials Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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