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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2015 by Biogen
Sponsor:
Information provided by (Responsible Party):
Biogen
ClinicalTrials.gov Identifier:
NCT01371305
First received: June 3, 2011
Last updated: October 23, 2015
Last verified: October 2015
  Purpose
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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in peripheral blood biomarkers [ Time Frame: Up to 16 weeks ] [ Designated as safety issue: No ]
    Multiple-dose (MD) and Follow-up (FU) Periods only

  • Change in biomarkers isolated from bronchoalveolar lavage (BAL) [ Time Frame: Up to 9 weeks ] [ Designated as safety issue: No ]
    MD and FU Periods only

  • Incidence of antibodies to BG00011 [ Time Frame: Up to 16 weeks ] [ Designated as safety issue: No ]
  • Cmax: observed peak serum concentration [ Time Frame: Up to 16 weeks ] [ Designated as safety issue: No ]
    MD and FU Periods only

  • Tmax: time to observed peak serum concentration of BG00011 [ Time Frame: Up to 16 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    MD and FU Periods only

  • λz: terminal elimination rate constant of BG00011 [ Time Frame: Up to 16 weeks ] [ Designated as safety issue: No ]
    MD and FU Periods only

  • T½ (elimination half-life) of BG00011 [ Time Frame: Up to 16 weeks ] [ Designated as safety issue: No ]
    MD and FU Periods only

  • CL/F (clearance ) of BG00011 (unadjusted for bioavailability) [ Time Frame: Up to 16 weeks ] [ Designated as safety issue: No ]
    MD and FU Periods only

  • Vz/F: volume of distribution of BG00011 (unadjusted for bioavailability) [ Time Frame: Up to 16 weeks ] [ Designated as safety issue: No ]
    MD and FU Periods only


Estimated Enrollment: 40
Study Start Date: June 2012
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: December 2016 (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.
  Eligibility

Ages Eligible for Study:   18 Years to 84 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  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 ClinicalTrials.gov identifier: NCT01371305

Contacts
Contact: Biogen clinicaltrials@biogen.com

Locations
United States, California
Research Site Recruiting
San Francisco, California, United States, 94143
Research Site Active, not recruiting
Stanford, California, United States, 94305
United States, Florida
Research Site Not yet 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 Not yet recruiting
Kansas City, Kansas, United States, 66160
Research Site Active, not recruiting
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 Not yet recruiting
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 Active, not recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
Biogen
Investigators
Study Director: Medical Director Biogen
  More Information

Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT01371305     History of Changes
Other Study ID Numbers: 203PF201  STX-003 
Study First Received: June 3, 2011
Last Updated: October 23, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial

ClinicalTrials.gov processed this record on July 28, 2016