Health Trials

A Study of GSK5926371 in Participants With B-cell Driven Autoimmune Rheumatic Diseases (ARD)

ConditionSystemic Lupus Erythematosus
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorGlaxoSmithKline

About this trial

This is a 2-part study of GSK5926371 in participants with autoimmune rheumatic diseases (ARD). In part 1, participants will receive different doses of GSK5926371 to find a suitable priming dose. In part 2, participants will receive GSK5926371 at doses based on data from part 1. The study is aimed at testing if GSK5926371 is safe, well-tolerated, how the body processes the study drug, how it works in the body, and whether it triggers any immune responses.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Part 1 will enroll adult participants with systemic lupus erythematosus (SLE) or rheumatoid arthritis (RA).

Part 2 will enroll adult participants with SLE, RA, idiopathic inflammatory myopathies (IIM) or Sjogren's disease (SjD).

Participants must be 18 to 70 years of age inclusive at the time of signing the informed consent form.

Body mass index (BMI) between 18-35 kilograms per square meter (kg/m²) inclusive with a body weight of greater than or equal to (>=) 45 kilograms (kg).

Disqualifiers

Any acute, severe autoimmune disease-related flare before, or during the Screening Period (up to and including Day 1) that needs immediate treatment or is expected to require escalation of treatment to prohibited medications for the duration of the study.

Significant allergies to humanized monoclonal antibodies or significant sensitivity to any constituents of the study drug (including excipients).

Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A (IgA) dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis).

Have clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to the autoimmune condition under study (i.e., cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, or infectious diseases) and/or a planned surgical procedure, which, in the opinion of the investigator, could confound the results of the clinical study or put the participant at undue risk.

Trial design

Design model

Sequential

Treatments tested in this trial

  • GSK5926371

    Biological/Vaccine

    GSK5926371 will be administered.

Treatment groups

44 Participants
are divided into 2 treatment groups
Group A: Part 1: Dose Escalation of GSK5926371Experimental treatment 1 intervention
Group B: Part 2: Dose Division of GSK5926371Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Part 1 and Part 2: Number of Participants with Adverse Events (AEs) and Serious AEs (SAEs)

Time frame
Up to 196 days

Secondary outcomes

1

Part 1: Maximum Observed Plasma Concentration (Cmax) After GSK5926371 Dosing

Time frame
Up to 43 days
2

Part 2: Cmax After GSK5926371 Dosing

Time frame
Up to 113 days
3

Part 1 and Part 2: Number of Participants with Anti-drug Antibodies (ADAs) Against GSK5926371

Time frame
Up to 196 days
4

Part 1 and Part 2: Titers of ADAs Against GSK5926371

Time frame
Up to 196 days

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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