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BG00011

Phase 2

Idiopathic Pulmonary Fibrosis (IPF) | Small molecule | Respiratory |Biogen Inc.|Last Updated: Feb 28, 2020

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 Trials1
Total Enrollment41
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01371305STX-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)PHASE2 COMPLETED 41Jul 16, 2012Mar 31, 2017Feb 28, 202010 United States
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Study Endpoints
Primary Endpoints
Number of Participants With Adverse Events (AEs)
up to Week 19

An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that did not necessarily have a causal relationship with this treatment.

Secondary Endpoints
Time to Reach Maximum Observed Serum Concentration (Tmax) of BG00011
Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50
Maximum Observed Serum Concentration (Cmax) of BG00011
Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50
Area Under the Serum Concentration Time Curve From Time 0 to Last Quantifiable Observed Concentration AUC(0-t) of BG00011
Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
BG00011EXPERIMENTALParticipants will receive 8 consecutive weekly doses of BG00011
PlaceboPLACEBO_COMPARATORParticipants will receive 8 consecutive weekly doses of placebo.
Interventions
NameTypeDescription
BG00011DRUGBG00011 will be administered at varying doses via subcutaneous (SC) injection
PlaceboDRUGSterile normal saline (0.9% Sodium Chloride for Injection) via Subcutaneous (SC) injections.
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Eligibility Criteria
Age Range18 Years — 84 Years
SexALL
Healthy VolunteersNo
Study Sites10

Key Inclusion Criteria: 1. Clinical features consistent with IPF prior to screening (based on the American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Association (ALAT) consensus criteria for the diagnosis of IPF). 2. Forced ...

Countries:United States
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