🏛️ Verified NIH Record • Updated 2026-06-18

A Study of GSK5926371 in Participants With B-cell Driven Autoimmune Rheumatic Diseases (ARD) (NCT07371468)

🟢 Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: GlaxoSmithKline

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (44 items).

Location: GSK Investigational Site — Buenos Aires

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • 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.
  • Have any other clinically significant abnormal laboratory value, that in the opinion of the investigator, is capable of significantly altering the absorption, metabolism, or elimination of the clinical study intervention; or constitutes a risk when taking the clinical study intervention or interferes with the interpretation of the clinical study data.
  • Participant has a diagnosis of primary or acquired immunodeficiency, except for selective IgA deficiency.
  • Have an acute or chronic infection including requiring management as follows:
  • An acute infection within 2 weeks of dosing on Day 1.
  • An active infection requiring current systemic antibiotic, antiviral or anti-fungal treatment with the exception of topical treatments for fungal nail infections. Prophylactic medications are permitted.
  • History of, or currently being treated for, a clinically significant recurrent or chronic infection (except for minor localized infections, for example tinea pedis).
  • Any opportunistic infections within past 3 years. Uncomplicated herpes zoster, localized herpes simplex virus, and oral candidiasis are not considered as opportunistic infections for this purpose.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (19 Sites)

  • GSK Investigational Site — Buenos Aires,
  • GSK Investigational Site — San Miguel de Tucumán,
  • GSK Investigational Site — Campinas, São Paulo
  • GSK Investigational Site — São Paulo, São Paulo
  • GSK Investigational Site — Bordeaux,
  • GSK Investigational Site — Toulouse,
  • GSK Investigational Site — Cona, Ferrara
  • GSK Investigational Site — Fukuoka,
  • GSK Investigational Site — Hiroshima,
  • GSK Investigational Site — Hokkaido,
  • GSK Investigational Site — Panama City,
  • GSK Investigational Site — Panama City,
  • GSK Investigational Site — Panama City,
  • GSK Investigational Site — Poznan,
  • GSK Investigational Site — Warsaw,
  • GSK Investigational Site — Barcelona,
  • GSK Investigational Site — Madrid,
  • GSK Investigational Site — Madrid,
  • GSK Investigational Site — Taipei,

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
🏛️ View Official NIH Record ↗