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SAR448501

Phase 1

Systemic Lupus Erythematosus (SLE) | Small molecule | Immunology |Sanofi|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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment62
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06647069A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic DiseasesPHASE1 RECRUITING 62 — — Mar 27, 2025Jun 25, 2029May 22, 20267 Australia, Bosnia and Herzegovina +2
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Study Endpoints
Primary Endpoints
Incidence of treatment-emergent adverse events (TEAEs)
Baseline to Week 52 (End of Study (EOS))
Incidence of potentially clinically significant abnormalities (PCSAs)
Baseline to Week 52 (EOS)

PCSAs include laboratory parameters; vital signs; and ECG parameters including heart rate, PR, QRS, QT, QTcF.

Secondary Endpoints
Assessment of pharmacokinetic (PK) parameters: AUC0-t
Baseline to Week 20
Assessment of pharmacokinetic (PK) parameters: Cmax
Baseline to Week 20
Assessment of pharmacokinetic (PK) parameters: Ctrough
Baseline to Week 20
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
SAR448501 dose escalationEXPERIMENTALSAR448501 will be administered for up to 71 days. Different cohorts with up to 7 dose levels will be included.
Interventions
NameTypeDescription
SAR448501DRUGBispecific antibody
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Diagnosis of SLE and/or RA. American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria should be used. * Contraception during the study intervention period and for at least 140 days after the last administration of study intervent...

Countries:AustraliaBosnia and HerzegovinaNew ZealandSouth Africa
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Competitive Landscape -Systemic Lupus Erythematosus 94 trials
CompanyTickerTrialsLead PhaseDrugs
Biogen Inc.BIIB5PHASE3Litifilimab, BIIB059
Viatris, Inc.VTRS5PHASE3Cenerimod, cenerimod
Bristol-Myers Squibb CompanyBMY7PHASE3Deucravacitinib, Afimetoran, CC-97540, Fludarabine, Cyclophosphamide
Novartis AG Sponsored ADRNVS7PHASE3Ianalumab, ianalumab, VAY736 PFS, VAY736 AI, rapcabtagene autoleucel
AstraZeneca PLCAZN21PHASE3Medi-546, Anifrolumab, AZD0120, Cyclophosphamide, Fludarabine
AbbVie, Inc.ABBV2PHASE3Upadacitinib, ABBV-319
Johnson & JohnsonJNJ1PHASE3Nipocalimab
GSK plc Sponsored ADRGSK3PHASE2Belimumab, GSK4527363, GSK5926371
Sanofi SA Sponsored ADRSNY2PHASE2SAR441344, SAR448501
Alumis Inc.ALMS1PHASE2Envudeucitinib
Zenas BioPharma, Inc.ZBIO1PHASE2Obexelimab
Immunovant IncIMVT1PHASE2IMVT-1402
Amgen Inc.AMGN1PHASE2Inebilizumab, Blinatumomab
Fate Therapeutics, Inc.FATE2PHASE2FT819, Fludarabine, Cyclophosphamide, Bendamustine
Eli Lilly and CompanyLLY1PHASE1LY4298445
Gilead Sciences, Inc.GILD1PHASE1KITE-363, Fludarabine, Cyclophosphamide
Merck & Co., Inc.MRK1PHASE1MK-1045
Cartesian Therapeutics, Inc.RNAC2PHASE2Descartes-08
Artiva Biotherapeutics, Inc.ARTV2PHASE1AB-101, Cyclophosphamide, Fludarabine, Rituximab, Obinutuzumab
CRISPR Therapeutics AGCRSP1PHASE1CTX112
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06647069primaryCompletionDate: changed
LOWMay 24, 2026NCT06647069studyFirstPostDate: changed