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REGN9933

Phase 2

Venous Thromboembolism | Small molecule | Cardiovascular |Regeneron Pharmaceuticals, Inc.|Last Updated: Apr 13, 2026

Success Probability
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Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials2
Total Enrollment568
FDA Designations
No designations recorded
Clinical trial landscape

REGN9933 · 4 trials · 2 indications

Phase 2 2Phase 1 2
NCT06299111A Trial to Learn How Well REGN9933 and REGN7508 Work for Preventing Blood Clots, and How Safe They Are, in Adults Who Have a Peripherally Inserted Central Catheter (PICC)Venous Thromboembolism
COMPLETED195 Analytics
NCT05618808A Trial to Learn How Well REGN9933 Works for Preventing Blood Clots After Knee Replacement Surgery in Adult ParticipantsVenous Thromboembolism
COMPLETED373 Analytics
PHASE2COMPLETED
A Trial to Learn How Well REGN9933 and REGN7508 Work for Preventing Blood Clots, and How Safe They Are, in Adults Who Have a Peripherally Inserted Central Catheter (PICC)
Venous Thromboembolism
NCT06299111195
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PHASE2COMPLETED
A Trial to Learn How Well REGN9933 Works for Preventing Blood Clots After Knee Replacement Surgery in Adult Participants
Venous Thromboembolism
NCT05618808373
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Study Endpoints
Primary Endpoints
Incidence of confirmed VTE per central reading center (CRC) review
Through Day 14
Incidence of treatment-emergent adverse event (TEAEs)
Up to Day 100
Severity of TEAEs
Up to Day 100
Percentage of Participants With Confirmed, Adjudicated Venous Thromboembolism (VTE) (REGN9933 vs Enoxaparin)
Through Day 12

Composite endpoint that includes: asymptomatic deep DVT (deep venous thrombosis) detected by unilateral venography of the operated leg; confirmed symptomatic DVT of either leg; confirmed fatal or nonfatal pulmonary embolism (PE) including unexplained death for which PE cannot be ruled out

Change in fecal hemoglobin content (FHC)
Baseline and up to day 22
Incidence and severity of treatment emergent adverse events (TEAE)
Until resolution of pharmacodynamic (PD) effects; approximately 36 days
Secondary Endpoints
Incidence of confirmed PICC associated venous thrombosis per CRC review
Through Day 14
Incidence of major bleeding
Through Day 14
Incidence of clinically relevant non-major (CRNM) bleeding
Through Day 14
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
REGN9933EXPERIMENTALRandomized 1:1:1
REGN7508EXPERIMENTALRandomized 1:1:1
PlaceboPLACEBO_COMPARATORRandomized 1:1:1
EnoxaparinACTIVE_COMPARATOREnoxaparin will be administered by subcutaneous (SC) administration
ApixabanACTIVE_COMPARATORApixaban will be administered orally twice a day
Arm 1: AspirinACTIVE_COMPARATORRandomized 1:1:1:1
Arm 2: Aspirin + REGN9933EXPERIMENTALRandomized 1:1:1:1
Arm 3: Aspirin + REGN7508EXPERIMENTALRandomized 1:1:1:1
Arm 4: Aspirin + RivaroxabanACTIVE_COMPARATORRandomized 1:1:1:1
Intravenous CohortsEXPERIMENTALRandomized 6:2 to REGN9933 or placebo
Subcutaneous CohortsEXPERIMENTALRandomized 6:2 to REGN9933 or placebo
Interventions
NameTypeDescription
REGN9933DRUGIntravenous (IV) single dose administered
REGN7508DRUGIV single dose administered
PlaceboDRUGIV single dose administered
EnoxaparinDRUGParticipants will receive enoxaparin by SC administration daily through the time of venography (or day 12, whichever is earlier)
ApixibanDRUGParticipants will receive apixaban orally twice a day through the time of venography (or day 12, whichever is earlier)
AspirinDRUGOral administration
RivaroxabanDRUGOral administration
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites23

Key Inclusion Criteria: 1. PICC is clinically indicated for at least 14 days and is anticipated to remain in place for at least 14 days 2. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2 or equivalent functional status as described in the protocol 3. Body weight ≥45 kg and ≤130 kg d...

Countries:United StatesBulgariaCanadaIsraelRomaniaUnited KingdomBelgiumHungaryLatviaLithuaniaPoland
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT06299111TRIAL_REMOVED: changed
LOWMay 24, 2026NCT06299111studyFirstPostDate: changed