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GSK5926371

Phase 1

Systemic Lupus Erythematosus | Monoclonal antibody | Immunology |GSK plc|Last Updated: Mar 17, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment54
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07371468A Study of GSK5926371 in Participants With B-cell Driven Autoimmune Rheumatic Diseases (ARD)PHASE1 RECRUITING 54Feb 10, 2026Mar 15, 2028Mar 17, 20263 Japan
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Study Endpoints
Primary Endpoints
Part 1 and Part 2: Number of Participants with Adverse Events (AEs) and Serious AEs (SAEs)
Up to 196 days
Secondary Endpoints
Part 1: Maximum Observed Plasma Concentration (Cmax) After GSK5926371 Dosing
Up to 43 days
Part 2: Cmax After GSK5926371 Dosing
Up to 113 days
Part 1 and Part 2: Number of Participants with Anti-drug Antibodies (ADAs) Against GSK5926371
Up to 196 days
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part 1: Dose Escalation of GSK5926371EXPERIMENTAL -
Part 2: Dose Division of GSK5926371EXPERIMENTAL -
Interventions
NameTypeDescription
GSK5926371BIOLOGICALGSK5926371 will be administered.
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * 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 i...

Countries:Japan
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07371468primaryCompletionDate: changed
LOWMay 24, 2026NCT07371468studyFirstPostDate: changed