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IONIS-FB-LRx

Phase 2

Primary IgA Nephropathy | Small molecule | Nephrology |Ionis Pharmaceuticals, Inc.|Last Updated: Jan 23, 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment23
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04014335A Study to Evaluate the Effectiveness and Safety of IONIS-FB-LRx, an Antisense Inhibitor of Complement Factor B, in Adult Participants With Primary IgA NephropathyPHASE2 COMPLETED 23 — — Dec 4, 2019Apr 11, 2024Jan 23, 20257 Australia, Canada +2
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Study Endpoints
Primary Endpoints
Percent Reduction in 24-hour Urine Protein Excretion
Baseline to Week 29 (If participant discontinues Study Drug prior to Week 25, Baseline and 4 weeks after the last dose of Study Drug will be measured)
Secondary Endpoints
Absolute Reduction in 24-hour Urine Protein Excretion
Baseline to Week 29 (If participant discontinues Study Drug prior to Week 25, Baseline and 4 weeks after the last dose of Study Drug will be measured)
Absolute Reduction in Albuminuria (UACr Ratio)
Baseline to Week 29
Absolute Reduction in Proteinuria (UPCr Ratio)
Baseline to Week 29
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
IONIS-FB-LRxEXPERIMENTAL -
Interventions
NameTypeDescription
IONIS-FB-LRxDRUGParticipants will receive IONIS-FB-LRx, by subcutaneous injection (SC) at Week 1 and every 4 weeks through Week 25. Optional 48-week Extension, with drug dosing continuing every 4 weeks.
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria * Females must be non-pregnant and non-lactating, and either surgically sterile or post-menopausal OR use a highly effective method of birth control * Biopsy-proven primary immunoglobulin A (IgA) nephropathy * Hematuria * Proteinuria Exclusion Criteria * Clinically significant ...

Countries:AustraliaCanadaNew ZealandSingapore
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