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NCT06576271

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

StatusActive, Not Recruiting
PhasePhase 1
Primary completion (estimated)
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Record History

All 10 versions: 10 with changes below. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 67 words Show 5 more changesShow less
    • Enrollment closed, study ongoing
    • Trial sites reduced: 28 → 23 locations
    • Enrollment target: estimated 142 to confirmed 143
    • Primary and study completion dates: Jan 11, 2028 to Feb 1, 2028
    • Secondary endpoints: details revised at 1 of 12 entries
  2. Study sites: 27 to 28v9
  3. Primary endpoint(s) modified
    • Eligibility criteria shortened, about 786 words
    • Study sites: 26 to 27
    • Secondary endpoints: 10 to 12
    v8
  4. Eligibility criteria expanded, about 1,196 wordsv7 Show 5 more changesShow less
    • Primary endpoints revised (3)
    • Study sites: 21 to 26
    • Secondary endpoints revised (10)
    • Study arms: 9 to 10
    • Study title expanded, about 2 words
  5. Primary and study completion dates: Jun 1, 2027 to Jan 11, 2028
    • Enrollment target: 138 to 142
    • Study sites: 1 to 21
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. Primary and study completion dates: May 14, 2027 to Jun 1, 2027v5
  2. Eligibility criteria expanded, about 6 words
    • Enrollment target: 112 to 138
    v4
  3. Primary and study completion dates: Apr 29, 2027 to May 14, 2027v3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

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 (12)

Parts A and C: Area Under the Concentration-time Curve to the Last Quantifiable Concentration (AUC[0-t]) of GSK4527363
Parts A and C: Area Under the Concentration-time Curve to Infinity (AUC[0-inf]) of GSK4527363
Parts A and C: Maximum Plasma Concentration (Cmax) of GSK4527363
Parts A and C: Apparent Terminal Phase Half-life (t1/2) of GSK4527363
Parts A and C: Number of Participants with Anti-drug Antibodies (ADAs) Against GSK4527363
Show 7 moreShow less
Parts B and D: Number of Participants with Anti-drug Antibodies (ADAs) Against GSK4527363
Parts A, B and C: Titers of ADAs Against GSK4527363
Parts A and C: Percentage change from Baseline in cytokine levels
Parts B and D: Percentage change from Baseline in cytokine levels
Part B and D: Area Under the Concentration-time Curve of GSK4527363
Part B and D: Maximum Plasma Concentration of GSK4527363
Part B and D: Concentration at the end of the First Dosing Interval of GSK4527363

Arms and interventions

Part A: Healthy participants receiving GSK4527363Experimental
Part A: Healthy participants receiving placebo matching GSK4527363Placebo comparator
Part A: Healthy participants receiving belimumabExperimental
Part B: Participants with SLE receiving GSK4527363Experimental
Part B: Participants with SLE receiving belimumabExperimental
Part C: Healthy Japanese participants receiving GSK4527363Experimental
Part C: Healthy Japanese participants receiving placebo matching GSK4527363Placebo comparator
Part C: Healthy Chinese participants receiving GSK4527363Experimental
Part C: Healthy Chinese participants receiving placebo matching GSK4527363Placebo comparator
Part D: Participants with CTD-ILD receiving GSK4527363Experimental

Drugs: GSK4527363, Placebo matching GSK4527363, Belimumab

Sites

23 sites in 6 countries

Spain 5, Argentina 4, Brazil 4, Poland 4, United Kingdom 4, United States 2