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Abetimus

Phase 3

Immunologic Diseases | Small molecule | Immunology |Innoviva, Inc.|Last Updated: Sep 25, 2006

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-BlindUNCONTROLLED
Total Trials1
Total Enrollment330
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00035308Safety and Efficacy Study of LJP 394 (Abetimus Sodium) to Treat Lupus Kidney DiseasePHASE3 COMPLETED 330 -Dec 1, 2002Sep 25, 200682 United States, Austria +8
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
Abetimus sodium (LJP 394)DRUG -
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Eligibility Criteria
Age Range12 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites82

Inclusion Criteria * Diagnosed with SLE * Historical evidence of SLE renal disease * Elevated levels of dsDNA antibodies * Weight of 40 kg or greater Exclusion Criteria * Active SLE renal disease * Use of certain anti-inflammatory or cytotoxic therapies or therapeutic interventions during the mon...

Countries:United StatesAustriaCanadaFranceGermanyItalyMexicoSpainSwedenUnited Kingdom
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