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SAR445088

Phase 2

Immune Thrombocytopenia (ITP) | Small molecule | Hematology |Sanofi|Last Updated: Sep 10, 2025

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
UNCONTROLLED
Total Trials1
Total Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04669600A Phase 2a Study Evaluating BIVV020 in Adults With Persistent/Chronic Immune Thrombocytopenia (ITP)PHASE2 COMPLETED 12Feb 4, 2021Feb 7, 2023Sep 10, 20259 United States, Czechia +4
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Study Endpoints
Primary Endpoints
Percentage of Participants With a Durable Platelet Response
From Week 3 to Week 24

A naive participant was a participant who did not use sutimlimab prior to enrollment. A switcher was a participant who used sutimlimab prior to enrollment. A naive participant was a responder if the platelet count was \>=50 × 10\^9/liter (L) at \>=50 percent (%) of scheduled visits, or for participants with baseline platelet count \<15 × 10\^9/L, a \>=20 × 10\^9/L increase in platelet count from baseline at \>=50% of scheduled visits, without receiving rescue immune thrombocytopenia (ITP) therapy. A switcher was a responder if the maintenance platelet count was \>=30 × 10\^9/L at \>=50% of scheduled visits, without receiving rescue ITP therapy.

Secondary Endpoints
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious AEs (SAE)
From first study treatment administration (Day 1) up to Week 103
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematology
On Days 1, 15, 29, at Weeks 8, 12, 24, and then every 8 weeks until the end of study (EOS) (Week 103)
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Clinical Chemistry
On Days 1, 15, 29, Weeks 8, 12 and 24, then every 8 weeks until the EOS (Week 103)
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
SAR445088EXPERIMENTALParticipants received SAR445088 (BIVV020).
Interventions
NameTypeDescription
SAR445088 (BIVV020)DRUGPharmaceutical form:solution for injection
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion criteria : * Male and female participants ≥18 years of age at the time of signing the informed consent * Confirmed diagnosis of primary ITP; for participants who previously received sutimlimab in study TDR16218 (NCT03275454), a response to sutimlimab must have been obtained, as defined by...

Countries:United StatesCzechiaGermanyNetherlandsSpainUnited Kingdom
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