Last updated: 04/24/2026 07:50:18

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

GSK study ID
221458
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Trial status
Recruiting
Recruiting
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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)
Trial description: 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)
Primary purpose:
Treatment
Trial design:
Parallel
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Parts A and C: Number of Participants with Non-serious Adverse Events and Serious Adverse Events

Timeframe: Up to Week 52

Parts B and D: Number of Participants with Non-serious Adverse Events and Serious Adverse Events

Timeframe: Up to Week 68

Parts A and C: Number of Participants with Clinically Significant Changes in Physical Examination, Laboratory Parameters, Vital Signs, and 12 lead Electrocardiogram (ECG) Findings

Timeframe: Up to Week 52

Parts B and D: Number of Participants with Clinically Significant Changes in Physical Examination, Laboratory Parameters, Vital Signs, and 12 lead Electrocardiogram (ECG) Findings

Timeframe: Up to Week 68

Parts A and C: Number of Participants with Clinically Significant Changes in Columbia-Suicide Severity Rating Scale (C-SSRS)

Timeframe: Up to Week 52

Parts B, and D: Number of Participants with Clinically Significant Changes in Columbia-Suicide Severity Rating Scale (C-SSRS)

Timeframe: Up to Week 68

Secondary outcomes:

Parts A and C: Area Under the Concentration-time Curve to the Last Quantifiable Concentration (AUC[0-t]) of GSK4527363

Timeframe: Up to Week 52

Parts A and C: Area Under the Concentration-time Curve to Infinity (AUC[0-inf]) of GSK4527363

Timeframe: Up to Week 52

Parts A and C: Maximum Plasma Concentration (Cmax) of GSK4527363

Timeframe: Up to Week 52

Parts A and C: Apparent Terminal Phase Half-life (t1/2) of GSK4527363

Timeframe: Up to Week 52

Parts A and C: Number of Participants with Anti-drug Antibodies (ADAs) Against GSK4527363

Timeframe: Up to Week 52

Parts B and D: Number of Participants with Anti-drug Antibodies (ADAs) Against GSK4527363

Timeframe: Up to Week 68

Parts A, B and C: Titers of ADAs Against GSK4527363

Timeframe: Up to Week 52

Parts A and C: Percentage change from Baseline in cytokine levels

Timeframe: Baseline (Day 1) and up to Week 52

Parts B and D: Percentage change from Baseline in cytokine levels

Timeframe: Baseline (Day 1) and up to Week 68

Part B and D: Area Under the Concentration-time Curve of GSK4527363

Timeframe: Up to Week 12

Part B and D: Maximum Plasma Concentration of GSK4527363

Timeframe: Up to Week 12

Part B and D: Concentration at the end of the First Dosing Interval of GSK4527363

Timeframe: Up to Week 12

Interventions:
Drug: GSK4527363
Drug: Placebo matching GSK4527363
Drug: Belimumab
Enrollment:
142
Observational study model:
Not applicable
Primary completion date:
2028-11-01
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Systemic Lupus Erythematosus
Product
Not applicable
Collaborators
Not applicable
Study date(s)
September 2024 to January 2028
Type
Interventional
Phase
1

Participation criteria

Sex
Female & Male
Age
18 - 65 Years
Accepts healthy volunteers
Yes
  • 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
  • For Part A and Part C (Healthy Participants):
  • History or presence or cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurological disorders

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
CAMBRIDGE, Unmapped, CB2 0GG
Status
Recruiting
Location
GSK Investigational Site
Barcelona, Spain, 08916
Status
Recruiting
Location
GSK Investigational Site
Valladolid, Spain, 47012
Status
Recruiting
Location
GSK Investigational Site
Rosario, Argentina, S2002
Status
Recruiting
Location
GSK Investigational Site
Middlesex, Unmapped, HA1 3UJ
Status
Recruiting
Location
GSK Investigational Site
San Miguel de TucumAn, Argentina, T4000IHE
Status
Recruiting
Location
GSK Investigational Site
Pamplona, Spain, 31008
Status
Recruiting
Location
GSK Investigational Site
Sabadell Barcelona, Spain, 08208
Status
Recruiting
Location
GSK Investigational Site
Bydgoszcz, Poland, 85-065
Status
Recruiting
Location
GSK Investigational Site
Las Vegas, NV, Unmapped, 89154
Status
Recruiting
Location
GSK Investigational Site
Wroclaw, Poland, 50-556
Status
Recruiting
Location
GSK Investigational Site
Columbus, OH, Unmapped, 44109
Status
Recruiting
Location
GSK Investigational Site
Scottsdale, AZ, Unmapped, 85260
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Bilbao, Spain, 48013
Status
Recruiting
Location
GSK Investigational Site
Liverpool, Unmapped, L7 8YE
Status
Recruiting
Location
GSK Investigational Site
Warszawa, Poland, 02-665
Status
Recruiting
Location
GSK Investigational Site
Juiz de Fora, Brazil, 36010-570
Status
Recruiting
Location
GSK Investigational Site
Porto Alegre, Brazil, 90480000
Status
Recruiting
Location
GSK Investigational Site
Poznan, Poland, 61-848
Status
Recruiting
Location
GSK Investigational Site
Buenos Aires, Argentina, C1280AEB
Status
Recruiting
Location
GSK Investigational Site
Salvador, Brazil, 40050-410
Status
Recruiting
Location
GSK Investigational Site
Aurora, CO, Unmapped, 80045
Status
Recruiting
Location
GSK Investigational Site
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
Status
Recruiting
Location
GSK Investigational Site
Oklahoma City, OK, Unmapped, 73104
Status
Recruiting
Location
GSK Investigational Site
Dallas, TX, Unmapped, 75390
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Florencio Varela, Argentina, B1888AAE
Status
Recruiting
Location
GSK Investigational Site
Krakow, Poland, 30-688
Status
Recruiting

Study documents

No study documents available.

Results overview

Study Results yet to be posted

Recruitment status
Recruiting
Actual primary completion date
Not applicable
Actual study completion date
Not applicable

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

Additional information
Not applicable
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