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blisibimod

Phase 3

IgA Nephropathy | Small Molecules | Nephrology |Anthera Pharmaceuticals, Inc.|Trials Updated: Sep 18, 2017

blisibimod development status

Highest phase Phase 3 (NCT02052219)
Phase scored for ANTHPhase 2/3
Registered trials 7 across 1 sponsor since Jul 2011

blisibimod target and mechanism

Molecular targetTNFSF13B
Target classInhibitor
ModalitySmall Molecules
ChEMBLCHEMBL2107877

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials2
Total Enrollment499

FDA Designations

No designations recorded

blisibimod clinical trials

blisibimod · 2 trials · 2 indications

Phase 3 1Phase 2/3 1
NCT01395745CHABLIS-SC1: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus ErythematosusSystemic Lupus Erythematosus
COMPLETED442 Analytics
PHASE3COMPLETED
CHABLIS-SC1: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
NCT01395745442
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Study Endpoints

Primary Endpoints

Proportion of patients achieving an SLE Responder Index at week 52
Week 52
Proportion of subjects achieving reduction in proteinuria from baseline
24 weeks

Secondary Endpoints

Time to first severe SLE flare
Week 52
Proportion of subjects able to reduce oral steroid dose to ≤7.5 mg/day prednisone
Week 52
Change in the number of actively tender or swollen joints and in mucocutaneous disease activity
Week 52
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
blisibimod weekly doseEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
BlisibimodEXPERIMENTALBlisibimod administered subcutaneously

Interventions

NameTypeDescription
blisibimodDRUGblisibimod administered via subcutaneous injection every week for 52 weeks
PlaceboDRUGPlacebo will be administered weekly via subcutaneous injection for 52 weeks
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites90

Inclusion Criteria: * Fulfill at least 4 diagnostic criteria for SLE defined by American College of Rheumatology * Positive antinuclear antibodies (ANA) and/or anti-double stranded DNA (anti-dsDNA) * Active SLE disease as defined by SELENA-SLEDAI score ≥10 despite on-going stable corticosteroid the...

Countries:BelarusBrazilColombiaGeorgiaGuatemalaHong KongIndiaMalaysiaMexicoPhilippinesRussiaSingaporeSouth KoreaSri LankaTaiwanThailandCzechiaGermanyUnited Kingdom
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Competitive Landscape -IgA Nephropathy 42 trials

CompanyTickerTrialsLead PhaseDrugs
Novartis AG Sponsored ADRNVS12PHASE3Zigakibart, Atrasentan, Iptacopan
Vera Therapeutics, Inc. Class AVERA4PHASE3Atacicept
Vertex Pharmaceuticals IncorporatedVRTX4PHASE3Povetacicept, Sibeprenlimab
AstraZeneca PLCAZN2PHASE3Ravulizumab
Biogen Inc.BIIB2PHASE3Felzartamab
Biohaven Ltd.BHVN2PHASE3BHV-1400
Jade Biosciences, Inc.JBIO2PHASE3JADE101
Hoffmann-La RocheRHHBY1PHASE3Sefaxersen
Travere Therapeutics, Inc.TVTX1PHASE2Sparsentan
argenx SE Sponsored ADRARGX1PHASE2ARGX-121
ADARx Pharmaceuticals, Inc.ADRX2PHASE2ADX-038
Q32 Bio IncQTTB1PHASE2ADX-097
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Other drugs targeting TNFSF13B

Rozibafusp Alfa AMGN· PHASE2 Belimumab GSK· PHASE3 Belimumab Auto-Injector GSK· PHASE2 Tabalumab LLY· PHASE2 Atacicept MKGAF· PHASE3 Atacicept VERA· PHASE3 Tibulizumab ZURA· PHASE2

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