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STX-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2017 by Biogen
Information provided by (Responsible Party):
Biogen Identifier:
First received: June 3, 2011
Last updated: February 28, 2017
Last verified: February 2017
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.

Condition Intervention Phase
Idiopathic Pulmonary Fibrosis (IPF)
Drug: BG00011
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Dose-Escalation Study of STX-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Resource links provided by NLM:

Further study details as provided by Biogen:

Primary Outcome Measures:
  • Number of participants that experience adverse events [ Time Frame: Up to 16 weeks ]

Secondary Outcome Measures:
  • Change in peripheral blood biomarkers [ Time Frame: Up to 16 weeks ]
    Multiple-dose (MD) and Follow-up (FU) Periods only

  • Change in biomarkers isolated from bronchoalveolar lavage (BAL) [ Time Frame: Up to 9 weeks ]
    MD and FU Periods only

  • Incidence of antibodies to BG00011 [ Time Frame: Up to 16 weeks ]
  • Cmax: observed peak serum concentration [ Time Frame: Up to 16 weeks ]
    MD and FU Periods only

  • Tmax: time to observed peak serum concentration of BG00011 [ Time Frame: Up to 16 weeks ]
    MD and FU Periods only

  • AUC0-last: area under the serum BG00011 concentration-time curve from baseline to the last measurable concentration [ Time Frame: Up to 16 weeks ]
    MD and FU Periods only

  • AUC0-∞: area under the serum BG00011 concentration-time curve from baseline extrapolated to infinity [ Time Frame: Up to 16 weeks ]
    MD and FU Periods only

  • λz: terminal elimination rate constant of BG00011 [ Time Frame: Up to 16 weeks ]
    MD and FU Periods only

  • T½ (elimination half-life) of BG00011 [ Time Frame: Up to 16 weeks ]
    MD and FU Periods only

  • CL/F (clearance ) of BG00011 (unadjusted for bioavailability) [ Time Frame: Up to 16 weeks ]
    MD and FU Periods only

  • Vz/F: volume of distribution of BG00011 (unadjusted for bioavailability) [ Time Frame: Up to 16 weeks ]
    MD and FU Periods only

Estimated Enrollment: 40
Study Start Date: July 2012
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BG00011
Participants will receive 8 consecutive weekly doses of BG00011
Drug: BG00011
BG00011 will be administered at varying doses via subcutaneous (SC) injection
Other Name: STX-100
Placebo Comparator: Placebo
Participants will receive 8 consecutive weekly doses of placebo.
Drug: Placebo
Sterile normal saline (0.9% Sodium Chloride for Injection) via Subcutaneous (SC) injections.

Detailed Description:
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.

Ages Eligible for Study:   18 Years to 84 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01371305

Contact: Biogen

United States, California
Research Site Recruiting
San Francisco, California, United States, 94143
Research Site Completed
Stanford, California, United States, 94305
United States, Florida
Research Site Recruiting
Kissimmee, Florida, United States, 34741
Research Site Recruiting
Miami, Florida, United States, 33136
United States, Georgia
Research Site Recruiting
Atlanta, Georgia, United States, 30322
United States, Kansas
Research Site Recruiting
Kansas City, Kansas, United States, 66160
Research Site Completed
Overland Park, Kansas, United States, 66211
United States, Massachusetts
Research Site Recruiting
Boston, Massachusetts, United States, 02114
Research Site Recruiting
Boston, Massachusetts, United States, 02115
United States, New Hampshire
Research Site Recruiting
Lebanon, New Hampshire, United States, 03756
United States, North Carolina
Research Site Completed
Charlotte, North Carolina, United States, 28207
United States, Ohio
Research Site Recruiting
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Research Site Recruiting
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Research Site Recruiting
Nashville, Tennessee, United States, 37232
United States, Texas
Research Site Completed
Houston, Texas, United States, 77030
Sponsors and Collaborators
Study Director: Medical Director Biogen
  More Information

Responsible Party: Biogen Identifier: NCT01371305     History of Changes
Other Study ID Numbers: 203PF201
STX-003 ( Other Identifier: Stromedix, Inc. )
Study First Received: June 3, 2011
Last Updated: February 28, 2017

Additional relevant MeSH terms:
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Pulmonary Fibrosis
Pathologic Processes
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases processed this record on March 24, 2017