STX-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Condition: Idiopathic Pulmonary Fibrosis (IPF)
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Intervention: BG00011; Placebo
Intervention description: BG00011 will be administered at varying doses via subcutaneous (SC) injection; Sterile normal saline (0.9% Sodium Chloride for Injection) via Subcutaneous (SC) injections.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Maximum age: 84 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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.