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Vonsetamig

Phase 1

Chronic Kidney Disease (CKD) | Small molecule | Nephrology |Regeneron Pharmaceuticals, Inc.|Last Updated: Jul 9, 2026

Success Probability
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Market & Valuation
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Trial Design
UNCONTROLLED
Total Trials1
Total Enrollment43
FDA Designations
No designations recorded
Clinical trial landscape

Vonsetamig · 2 trials · 2 indications

Phase 1 2
NCT06975787Dose Escalation Study With Bispecific Antibodies in Adult Participants With Lupus NephritisLupus Nephritis (LN)
RECRUITING90 Analytics
NCT05092347A Study to Learn How Safe and Tolerable Vonsetamig is in Adult Patients With Chronic Kidney Disease (CKD) Who Need Kidney Transplantation and Are Highly Sensitized to Human Leukocyte Antigen (HLA)Chronic Kidney Disease (CKD)
ACTIVE NOT_RECRUITING43 Analytics
PHASE1RECRUITING
Dose Escalation Study With Bispecific Antibodies in Adult Participants With Lupus Nephritis
Lupus Nephritis (LN)Unlock trial analytics
PHASE1ACTIVE NOT_RECRUITING
A Study to Learn How Safe and Tolerable Vonsetamig is in Adult Patients With Chronic Kidney Disease (CKD) Who Need Kidney Transplantation and Are Highly Sensitized to Human Leukocyte Antigen (HLA)
Chronic Kidney Disease (CKD)Unlock trial analytics
Study Endpoints
Primary Endpoints
Occurrence of Dose Limiting Toxicities (DLT)
Up to 56 days
Occurrence of Treatment Emergent Adverse Events (TEAEs)
Through week 76
Severity of TEAEs
Through week 76
Incidence of adverse event(s) of interest (AEI) from the first dose through end of the safety observation period
Up to approximately 6 weeks
Incidence and severity of treatment-emergent adverse events (TEAE)s from the first study drug dose up to the end of the study
Up to 78 weeks

TEAEs include adverse events of special interest (AESI) and serious adverse events (SAEs)

Secondary Endpoints
Proportion of participants no longer receiving a corticosteroid
At 6 months
Cumulative total exposure to corticosteroids
At 76 weeks
Absolute values of urine Protein-Creatinine Ratio (uPCR)
Through week 76
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Experimental Arm 1: VonsetamigEXPERIMENTAL -
Experimental Arm 2: OdronextamabEXPERIMENTAL -
VonsetamigEXPERIMENTAL -
Interventions
NameTypeDescription
VonsetamigDRUGAdministered as per the protocol
OdronextamabDRUGAdministered as per the protocol
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Eligibility Criteria
Age Range18 Years to 60 Years
SexALL
Healthy VolunteersNo
Study Sites18

Key General Inclusion Criteria: 1. Diagnosis of Systemic Lupus Erythematosus (SLE) and LN, as described in the protocol 2. Participant must have refractory or relapsed disease, as described in the protocol Key General Exclusion Criteria: 1. History of or active severe or unstable lupus-associated...

Countries:United StatesFranceGermanySouth KoreaSpainTaiwan
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Recent Changes (Last 90 Days)
LOWJul 9, 2026NCT06975787lastUpdatePostDate: changed
LOWJul 9, 2026NCT06975787lastUpdatePostDate: changed
LOWJun 18, 2026NCT06975787lastUpdatePostDate: changed
LOWJun 18, 2026NCT06975787lastUpdatePostDate: changed
LOWJun 18, 2026NCT06975787lastUpdatePostDate: changed
LOWJun 18, 2026NCT06975787lastUpdatePostDate: changed
MEDIUMJun 8, 2026NCT06975787primaryCompletionDate: changed
MEDIUMJun 8, 2026NCT06975787primaryCompletionDate: changed
MEDIUMJun 8, 2026NCT06975787primaryCompletionDate: changed
HIGHJun 2, 2026NCT05092347Status: RECRUITING → ACTIVE_NOT_RECRUITING
HIGHJun 2, 2026NCT05092347Status: RECRUITING → ACTIVE_NOT_RECRUITING
HIGHJun 2, 2026NCT05092347Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMMay 26, 2026NCT05092347primaryCompletionDate: changed
LOWMay 26, 2026NCT06975787primaryCompletionDate: changed
LOWMay 24, 2026NCT05092347studyFirstPostDate: changed
LOWMay 24, 2026NCT06975787studyFirstPostDate: changed