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GLPG3667

Phase 2

Systemic Lupus Erythematosus | Small molecule | Immunology |Galapagos NV|Last Updated: May 14, 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
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment186
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05856448A Study Evaluating the Effects of GLPG3667 Administered as Oral Treatment in Adult Participants With Active Systemic Lupus ErythematosusPHASE2 COMPLETED 186Jun 28, 2023Feb 27, 2026May 14, 202684 United States, Argentina +10
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Study Endpoints
Primary Endpoints
Percentage of Participants who Achieved the SLE Responder Index (SRI)-4 Response at Week 32
Week 32
Secondary Endpoints
Percentage of Participants who Achieved the SRI-4 Response at Week 48
Week 48
Percentage of Participants who Achieved the British Isles Lupus Assessment Group (BILAG)-Based Composite Lupus Assessment (BICLA) Response at Week 32 and Week 48
Week 32, Week 48
Percentage of Participants with >=50% Reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) score at Week 32 and Week 48
Week 32, Week 48
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
GLPG3667 - Treatment AEXPERIMENTALParticipant will receive a dose A of GLPG3667 capsules orally once daily (q.d.) for 48 weeks.
GLPG3667 - Treatment BEXPERIMENTALParticipant will receive a dose B of GLPG3667 capsules orally (q.d.) for 48 weeks.
PlaceboPLACEBO_COMPARATORParticipant will receive placebo matched to GLPG3667 capsules orally q.d for 48 weeks.
Interventions
NameTypeDescription
GLPG3667DRUGCapsule
PlaceboDRUGCapsule
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites84

Key Inclusion Criteria: 1. Participant with documented diagnosis of SLE as defined by the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria with a disease diagnosed ≥24 weeks before the screening visit. 2. Participant has a total Systemic...

Countries:United StatesArgentinaBulgariaChileFranceGeorgiaGermanyHungaryPeruPolandPuerto RicoSpain
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Recent Changes (Last 90 Days)
HIGHMay 26, 2026NCT05856448Status: ACTIVE_NOT_RECRUITING → COMPLETED
LOWMay 24, 2026NCT05856448studyFirstPostDate: changed