STX-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
STX-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
The primary objective of this study is to evaluate the safety and tolerability of
 subcutaneously (SC) administered multiple, escalating doses of BG00011 (a humanized
 monoclonal antibody directed against the alpha v beta 6 (αvβ6) integrin, formerly known as
 STX-100) in participants with IPF. The Secondary objectives are to estimate the
 pharmacokinetic (PK) parameters after the 1st dose and after the last dose of multiple,
 escalating doses of BG00011 in participants with IPF, to assess the immunogenicity of BG00011
 in participants with IPF, and to assess the effect of BG00011 on biomarkers isolated from
 bronchoalveolar lavage (BAL) and peripheral blood in participants with IPF.
This study was previously posted by Stromedix, Inc. In April, 2014, sponsorship of the trial
 was transferred to Biogen. The study drug name was changed from STX-100 to BG00011 and the
 study number was changed from STX-003 to 203PF201, to align with sponsor conventions.
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 (expiratory) Vital Capacity (FVC) ≥ 50% of predicted value.

 3. DLco (corrected for hemoglobin) ≥ 30% predicted value.

 4. Oxygen saturation > 90% at rest by pulse oximetry while breathing ambient air or
 receiving ≤2 L/minute of supplemental oxygen.

 5. Residual volume ≤ 120% predicted value.

 6. Ratio of Forced Expiratory Volume over 1 second (FEV1) to FVC ≥ 0.65 after the use of
 a bronchodilator.

 7. Other known causes of interstitial lung disease have been excluded (e.g., drug
 toxicities, environmental exposures, connective tissue diseases).

 8. High Resolution Computed Tomography (HRCT) image fulfills the criteria for 'Usual
 Interstitial Pneumonia (UIP) pattern'.

 9. If the HRCT image does not fulfill the criteria for 'UIP pattern' a surgical lung
 biopsy is necessary for the diagnosis of IPF (lung biopsy performed prior to screening
 is acceptable). If a lung biopsy has been performed, it must fulfill the
 histopathological criteria for either 'UIP pattern' or 'probable UIP pattern' with the
 appropriate HRCT correlate.

 10. Adequate bone marrow and liver function.

 11. Patient has a life expectancy of at least 12 months.

 Key Exclusion Criteria:

 1. Findings that are diagnostic of a condition other than UIP on surgical lung biopsy
 (performed either before or after screening), HRCT imaging, transbronchial lung
 biopsy, or bronchoalveolar lavage (BAL).

 2. Serious local infection or systemic infection within 3 months prior to screening.

 3. Treatment with another investigational drug, investigational device, or approved
 therapy for investigational use within 4 weeks of initial screening.

 4. Currently receiving high dose corticosteroid, cytotoxic therapy (e.g., chlorambucil,
 azathioprine, cyclophosphamide, methotrexate), nintedanib (Ofev®), vasodilator therapy
 for pulmonary hypertension (e.g., bosentan), unapproved and/or investigational therapy
 for IPF or administration of such therapeutics within 5 half-lives of the agent prior
 to initial screening in this study.

 5. End-stage fibrotic disease requiring organ transplantation within 6 months

 NOTE: Other protocol defined Inclusion/Exclusion Criteria may apply.