Actively Recruiting
A Study of GSK4527363 in Healthy Participants, Systemic Lupus Erythematosus (SLE) Participants, Healthy Chinese, and Japanese Participants and CTD-ILD Participants
Led by GlaxoSmithKline · Updated on 2026-04-29
142
Participants Needed
27
Research Sites
175 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
A Study of GSK4527363 in Healthy Participants, Systemic Lupus Erythematosus (SLE) Participants, Healthy Chinese, and Japanese Participants and CTD-ILD Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- For Parts A and C: Age 18 to 55 years at consent
- For Part B and D: Age 18 to 65 years at consent
- Healthy participants must be overtly healthy by medical evaluation
- Part C: Participants of Japanese or Chinese ancestry with specific birth and ancestry requirements
- Body weight at least 45 kilograms
- Body mass index (BMI) between 18 and 32 kg/m² inclusive
- Male or female of non-childbearing potential (Parts A and C); male or female (Parts B and D)
- For Part B: Documented clinical diagnosis of Systemic Lupus Erythematosus
- For Part D: Documented diagnosis of specific connective tissue diseases and interstitial lung disease with stable therapy
- Capable of giving signed informed consent (Parts B and D)
You will not qualify if you...
- For Parts A and C: History or presence of significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurological disorders
- Recent or recurrent infections or acute infections not resolved within 4 weeks
- Symptomatic herpes zoster within 3 months prior to screening
- History of malignancy or strong family history related to immunosuppression
- Severe drug allergies or intolerance to topical corticosteroids
- Abnormal blood pressure
- Evidence of active or latent tuberculosis
- Elevated liver enzymes above specified limits
- Positive hepatitis B, hepatitis C, or HIV tests
- History of anaphylaxis
- QTcF interval >450 msec
- Receipt of live vaccines within 30 days before dosing or plans to receive during the study
- For Part B: Acute severe lupus flare needing immediate treatment
- Unstable or uncontrolled diseases not due to SLE or CTD-ILD
- Serious infections requiring recent antibiotic treatment or hospitalization
- Confirmed progressive multifocal leukoencephalopathy or unexplained neurological symptoms
- Malignancy within 5 years except some skin or cervical conditions
- Major surgery or planned organ transplants (Part D)
- Pulmonary arterial hypertension or low lung function (Part D)
- Plans to receive live vaccines during the study (Part D)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 27 locations
1
GSK Investigational Site
Scottsdale, Arizona, United States, 85260
Withdrawn
2
GSK Investigational Site
Aurora, Colorado, United States, 80045
Actively Recruiting
3
GSK Investigational Site
Las Vegas, Nevada, United States, 89154
Actively Recruiting
4
GSK Investigational Site
Columbus, Ohio, United States, 44109
Actively Recruiting
5
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
6
GSK Investigational Site
Dallas, Texas, United States, 75390
Withdrawn
7
GSK Investigational Site
Buenos Aires, Argentina, C1280AEB
Actively Recruiting
8
GSK Investigational Site
Rosario, Argentina, S2002
Actively Recruiting
9
GSK Investigational Site
San Juan Bautista, Argentina, B1888AAE
Actively Recruiting
10
GSK Investigational Site
San Miguel de Tucumán, Argentina, T4000IHE
Actively Recruiting
11
GSK Investigational Site
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
Actively Recruiting
12
GSK Investigational Site
Juiz de Fora, Brazil, 36010-570
Actively Recruiting
13
GSK Investigational Site
Porto Alegre, Brazil, 90480000
Actively Recruiting
14
GSK Investigational Site
Salvador, Brazil, 40050-410
Actively Recruiting
15
GSK Investigational Site
Bydgoszcz, Poland, 85-065
Actively Recruiting
16
GSK Investigational Site
Krakow, Poland, 30-688
Actively Recruiting
17
GSK Investigational Site
Poznan, Poland, 61-848
Actively Recruiting
18
GSK Investigational Site
Warsaw, Poland, 02-665
Actively Recruiting
19
GSK Investigational Site
Wroclaw, Poland, 50-556
Actively Recruiting
20
GSK Investigational Site
Barcelona, Spain, 08916
Actively Recruiting
21
GSK Investigational Site
Bilbao, Spain, 48013
Actively Recruiting
22
GSK Investigational Site
Pamplona, Spain, 31008
Actively Recruiting
23
GSK Investigational Site
Sabadell Barcelona, Spain, 08208
Actively Recruiting
24
GSK Investigational Site
Valladolid, Spain, 47012
Actively Recruiting
25
GSK Investigational Site
Cambridge, United Kingdom, CB2 0GG
Actively Recruiting
26
GSK Investigational Site
Liverpool, United Kingdom, L7 8YE
Actively Recruiting
27
GSK Investigational Site
Middlesex, United Kingdom, HA1 3UJ
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
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
10
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