Last updated: 12/04/2025 12:00:41

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

GSK study ID
221458
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
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, Three-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), and Healthy Participants of Chinese and Japanese Descent (Part C)
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), and healthy participants of Chinese and Japanese descent (Part C)
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Parts A, B and C: Number of participants with non-serious adverse events and serious adverse events

Timeframe: Up to Week 52

Parts A, B 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 A, B and C: Number of participants with clinically significant changes in Columbia-Suicide Severity Rating Scale (C-SSRS)

Timeframe: Up to Week 52

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, B and C: Number of participants with anti-drug antibodies (ADAs) against GSK4527363

Timeframe: Up to Week 52

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

Timeframe: Up to Week 52

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

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

Part B: Area under the concentration-time curve to the end of the dosing period (AUC[0-tau]) of GSK4527363

Timeframe: Up to Week 52

Part B: Maximum plasma concentration (Cmax) of GSK4527363

Timeframe: Up to Week 52

Part B: Concentration at the end of the dosing interval (Ctrough) of GSK4527363

Timeframe: Up to Week 52

Interventions:
  • Drug: GSK4527363
  • Drug: Placebo matching GSK4527363
  • Drug: Belimumab
  • Enrollment:
    142
    Primary completion date:
    2028-11-01
    Observational study model:
    Not applicable
    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, United Kingdom, 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, United Kingdom, 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, United States, 89154
    Status
    Recruiting
    Location
    GSK Investigational Site
    Wroclaw, Poland, 50-556
    Status
    Recruiting
    Location
    GSK Investigational Site
    Columbus, OH, United States, 44109
    Status
    Recruiting
    Location
    GSK Investigational Site
    Scottsdale, AZ, United States, 85260
    Status
    Terminated/Withdrawn
    Location
    GSK Investigational Site
    Bilbao, Spain, 48013
    Status
    Recruiting
    Location
    GSK Investigational Site
    Liverpool, United Kingdom, 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, 40.150-410
    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
    Participate in clinical trial
    Access to clinical trial data by researchers
    Visit website