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LY3871801

Phase 2

Rheumatoid Arthritis | Small molecule | Immunology |Eli Lilly and Company|Last Updated: May 22, 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_CONTROLLEDDMC
Total Trials1
Total Enrollment164
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05848258An Adaptive Phase 2a/2b Study of LY3871801 in Adult Participants With Rheumatoid ArthritisPHASE2 COMPLETED 164 — — May 23, 2023Apr 22, 2026May 22, 202654 United States, Argentina +8
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Study Endpoints
Primary Endpoints
Phase 2a: Change from Baseline in Disease Activity Score - high-sensitivity C-reactive protein (DAS28-hsCRP)
Baseline, Week 12
Phase 2b: Percentage of Participants Achieving American College of Rheumatology (ACR)50
Baseline to Week 12
Secondary Endpoints
Phase 2a: Percentage of Participants Achieving ACR20/50/70
Baseline to Week 12
Phase 2b: Change from Baseline in DAS28-hsCRP
Baseline, Week 12
Phase 2b: Percentage of Participants Achieving ACR20/70
Week 12
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
LY3871801 Phase 2aEXPERIMENTALParticipants will receive LY3871801 administered orally.
Placebo Phase 2aPLACEBO_COMPARATORParticipants will receive placebo.
LY3871801 Dose 1 Phase 2bEXPERIMENTALParticipants will receive LY3871801 administered orally.
LY3871801 Dose 2 Phase 2bEXPERIMENTALParticipants will receive LY3871801 administered orally.
LY3871801 Dose 3 Phase 2bEXPERIMENTALParticipants will receive LY3871801 administered orally.
Placebo Phase 2bPLACEBO_COMPARATORParticipants will receive placebo.
Interventions
NameTypeDescription
LY3871801DRUGAdministered orally
PlaceboDRUGAdministered orally
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites54

Inclusion Criteria: * Have a diagnosis of adult-onset RA for at least 3 months prior to screening as defined by the 2010 ACR/European League Against Rheumatism (EULAR) classification criteria. * Have moderately-to-severely active RA at screening and baseline, defined by the presence of * ≥6 swol...

Countries:United StatesArgentinaCzechiaFranceGermanyHungaryIndiaMexicoPolandUnited Kingdom
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Competitive Landscape -Rheumatoid Arthritis 97 trials
CompanyTickerTrialsLead PhaseDrugs
AbbVie, Inc.ABBV6PHASE3Upadacitinib, Adalimumab, Tocilizumab, Lutikizumab, Ravagalimab
Eli Lilly and CompanyLLY5PHASE3Baricitinib, Tocilizumab, LY3541860, LY4213663, LY4298445
Bristol-Myers Squibb CompanyBMY6PHASE3Abatacept, Adalimumab, Methotrexate, BMS-986528, CC-97540
Johnson & JohnsonJNJ2PHASE3Ustekinumab, Guselkumab
AstraZeneca PLCAZN4PHASE2AZD1163, AZD0120, AZD5492, Surovatamig
Novartis AG Sponsored ADRNVS4PHASE2VAY736 PFS, VAY736 AI, PIT565, Secukinumab
Merck & Co., Inc.MRK2PHASE2Tulisokibart, Methotrexate, MK-1045
Sanofi SA Sponsored ADRSNY3PHASE2Sarilumab SAR153191, SAR448501, Leflunomide
AnaptysBio, Inc.ANAB1PHASE2Rosnilimab
Spyre Therapeutics, IncSYRE1PHASE2SPY002-072
Immunovant IncIMVT1PHASE2IMVT-1402
XBiotech, Inc.XBIT1PHASE2Natrunix, Methotrexate
Amgen Inc.AMGN1PHASE2Inebilizumab, Blinatumomab
Artiva Biotherapeutics, Inc.ARTV2PHASE2Allogeneic NK Cells, AB-101, Rituximab, Cyclophosphamide, Fludarabine
Gilead Sciences, Inc.GILD1PHASE1GS-0151
Zenas BioPharma, Inc.ZBIO1PHASE1ZB002
Stryker CorporationSYK5NAUndisclosed
Sonoma Pharmaceuticals, Inc.SNOA2PHASE1SBT777101
Zimmer Biomet Holdings, Inc.ZBH29NAUndisclosed
Adicet Bio IncACET1PHASE1ADI-001, Fludarabine, Cyclophosphamide
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Recent Changes (Last 90 Days)
HIGHMay 26, 2026NCT05848258Status: RECRUITING → COMPLETED
LOWMay 24, 2026NCT05848258studyFirstPostDate: changed