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Felzartamab

Phase 3

Antibody-mediated Rejection | Small molecule | Other |Biogen Inc.|Last Updated: Jun 5, 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_CONTROLLEDDMCBiomarker
Total Trials3
Total Enrollment274
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07444489A Study to Learn More About the Long-Term Safety and Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Antibody-Mediated Rejection (AMR)PHASE3 ENROLLING BY_INVITATION 120 — — Apr 16, 2026May 28, 2031Apr 27, 20262 United States
NCT06685757A Study to Learn More About the Effects and Safety of Felzartamab Infusions in Adults With Kidney Transplants Who Have Antibody-Mediated Rejection (AMR)PHASE3 ACTIVE NOT_RECRUITING 132 — — Dec 3, 2024Jun 1, 2027Jun 5, 202656 United States, Argentina +10
NCT05021484Felzartamab in Late Antibody-Mediated RejectionPHASE2 COMPLETED 22 — — Oct 6, 2021Mar 7, 2024Apr 18, 20242 Austria, Germany
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Study Endpoints
Primary Endpoints
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESI)
From first dose of study drug up to end of study follow-up (Up to Week 204)
Number of Participants who Discontinue Treatment due to an AE
From first dose of study drug up to end of study follow-up (Up to Week 204)
Number of Participants with Clinically Significant Laboratory, Vital Signs and Electrocardiograms (ECGs) Abnormalities
From first dose of study drug up to end of trial visit (up to Week 200)
Part A: Percentage of Participants Who Achieve Biopsy-proven Histologic Resolution (BPHR)
Week 24
Incidence of treatment-emergent adverse events
12 months

(Serious) adverse events will be classified using the Medical Dictionary for Regulatory Activities (MedDRA). Documentation of an AE will include the assessment of its relationship with the study drug (unrelated, related) and the severity of AE will be graded on a three-point scale (mild, moderate, severe).

Secondary Endpoints
Percentage of Participants Achieving Biopsy-proven Histologic Resolution (BPHR)
Up to Week 200
Microvascular Inflammation (MVI) Score
Up to Week 200
Percentage of Participants Achieving an MVI Score of 0
Up to Week 200
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Long-Term Extension: FelzartamabEXPERIMENTALParticipants will receive felzartamab, intravenously (IV), once every 8 weeks for up to 200 weeks in the LTE period.
FelzartamabEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
FelzartamabDRUGAdministered IV
PlaceboDRUGParticipants will receive 0.9% saline solution by intravenous infusion.
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites2

Key Inclusion Criteria: * Have completed the parent study Week 52 visit or will be completing all Week 52 visit procedures (for participants who sign consent before reaching the Week 52 visit). * Have received at least one dose of felzartamab in the parent study. Participants who discontinued study...

Countries:United StatesArgentinaAustraliaAustriaBrazilCanadaCzechiaFranceGermanyNew ZealandSpainSwitzerland
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Recent Changes (Last 90 Days)
MEDIUMJun 5, 2026NCT06685757Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMJun 5, 2026NCT06685757Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMJun 5, 2026NCT06685757Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMJun 5, 2026NCT06685757Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWMay 26, 2026NCT06685757primaryCompletionDate: changed
LOWMay 26, 2026NCT07444489Status: NOT_YET_RECRUITING → ENROLLING_BY_INVITATION
LOWMay 24, 2026NCT06685757studyFirstPostDate: changed
LOWMay 24, 2026NCT07444489studyFirstPostDate: changed