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BG00011

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment41

FDA Designations

No designations recorded

Clinical trial landscape

BG00011 · 1 trial · 1 indication

Phase 2 1
NCT01371305STX-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary Fibrosis (IPF)
COMPLETED41 Analytics
PHASE2COMPLETED
STX-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Idiopathic Pulmonary Fibrosis (IPF)Unlock trial analytics

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 to 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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Frequently asked questions about BG00011

What is BG00011 used for?

BG00011 is an investigational small molecule being developed for the treatment of Idiopathic Pulmonary Fibrosis (IPF), a chronic and progressive lung disease. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

What does BG00011 target?

The specific molecular target of BG00011 is not disclosed in the available information. The drug is being studied for its potential effects in patients with Idiopathic Pulmonary Fibrosis, but its precise mechanism of action has not been publicly detailed.

Who makes BG00011?

BG00011 is being developed by Biogen Inc., a biotechnology company traded on the NASDAQ under the ticker symbol BIIB. The company is conducting clinical research to evaluate the drug's safety and efficacy in patients with Idiopathic Pulmonary Fibrosis.

What phase is BG00011 in?

BG00011 is in Phase 2 clinical development. It is an investigational drug, meaning it has not yet received approval from regulatory agencies. The drug is being studied for the treatment of Idiopathic Pulmonary Fibrosis, and its clinical program is ongoing.

What clinical trials is BG00011 in?

BG00011 has been studied in one completed Phase 2 clinical trial with the identifier NCT01371305. This trial, titled 'STX-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)', enrolled 41 participants in the United States. The study was randomized, double-blind, and placebo-controlled.

Is BG00011 the same as STX-100?

Yes, BG00011 is also known as STX-100. The clinical trial NCT01371305, which evaluated the drug in patients with Idiopathic Pulmonary Fibrosis, used the name STX-100 in its title. Both names refer to the same investigational compound being developed by Biogen.