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

ConditionSystemic Lupus Erythematosus
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorGlaxoSmithKline

About this trial

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)

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent form

Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring (vital signs and 12-lead ECG)

Part C only: Be of Japanese (Cohort C1) or Chinese (Cohort C2) ancestry i. Born in Japan (Cohort C1) or China mainland, Hong Kong or Taiwan (Cohort C2); and ii. Descendent of 2 ethnic Japanese (Cohort C1) or Chinese (Cohort C2) parents and 4 ethnic grandparents; and iii. Have lived outside Japan (Cohort C1) or China mainland, Hong Kong or Taiwan (Cohort C2) for less than 10 years at the time of screening

Body weight greater than or equals to (>=) 45 kilograms (kg)

Disqualifiers

History or presence or cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurological disorders

A history of recurrent infections, or treatment of a chronic infection within 3 months prior to the first dose of study drug

Any acute infection (including upper respiratory tract infections and urinary tract infections) which has not fully resolved within four weeks before dosing

Symptomatic herpes zoster within 3 months prior to screening

Trial design

Design model

Parallel

Treatments tested in this trial

  • GSK4527363

    Drug

    GSK4527363 will be administered to participants.

  • Placebo matching GSK4527363

    Drug

    Placebo matching GSK4527363 will be administered to participants.

  • Belimumab

    Drug

    Belimumab will be administered to participants.

Treatment groups

142 Participants
are divided into 10 treatment groups

10

Treatment groups

See each treatment group below.

Group A: Part A: Healthy participants receiving GSK4527363Experimental treatment 1 intervention
Group B: Part A: Healthy participants receiving placebo matching GSK4527363Placebo comparator 1 intervention
Group C: Part A: Healthy participants receiving belimumabExperimental treatment 1 intervention
Group D: Part B: Participants with SLE receiving GSK4527363Experimental treatment 1 intervention
Group E: Part B: Participants with SLE receiving belimumabExperimental treatment 1 intervention
Group F: Part C: Healthy Japanese participants receiving GSK4527363Experimental treatment 1 intervention
Group G: Part C: Healthy Japanese participants receiving placebo matching GSK4527363Placebo comparator 1 intervention
Group H: Part C: Healthy Chinese participants receiving GSK4527363Experimental treatment 1 intervention
Group I: Part C: Healthy Chinese participants receiving placebo matching GSK4527363Placebo comparator 1 intervention
Group J: Part D: Participants with CTD-ILD receiving GSK4527363Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Up to Week 52
2

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

Time frame
Up to Week 68
3

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

Time frame
Up to Week 52
4

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

Time frame
Up to Week 68

Secondary outcomes

1

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

Time frame
Up to Week 52
2

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

Time frame
Up to Week 52
3

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

Time frame
Up to Week 52
4

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

Time frame
Up to Week 52

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

GlaxoSmithKline

Lead sponsor

Source ClinicalTrials.gov
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