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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by Biogen Idec
Sponsor:
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01371305
First received: June 3, 2011
Last updated: January 15, 2015
Last verified: December 2014
  Purpose

The Primary objective of this study is to evaluate the safety and tolerability of subcutaneously (SC) administered multiple, escalating doses of STX-100 (BG00011) in patients with IPF. The Secondary objectives of the study are to estimate the pharmacokinetic (PK) parameters after the 1st dose and after the last dose of multiple, escalating doses of STX-100 in patients with IPF, to assess the immunogenicity of STX-100 in patients with IPF, and to assess the effect of STX-100 on biomarkers isolated from bronchoalveolar lavage (BAL) and peripheral blood in patients 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 Idec:

Primary Outcome Measures:
  • Number of participants that experience adverse events [ Time Frame: Weekly assessment over 20 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in peripheral blood biomarkers [ Time Frame: Up to 20 weeks ] [ Designated as safety issue: No ]
  • Change in biomarkers isolated from bronchoalveolar lavage (BAL) [ Time Frame: Up to 9 weeks ] [ Designated as safety issue: No ]
  • Incidence of antibodies to STX-100 [ Time Frame: Up to 16 weeks ] [ Designated as safety issue: No ]
  • Cmax: observed peak serum concentration [ Time Frame: Up to 20 weeks ] [ Designated as safety issue: No ]
  • Tmax: time to observed peak serum concentration of STX 100 [ Time Frame: Up to 20 weeks ] [ Designated as safety issue: No ]
  • AUC0-last: area under the serum STX-100 concentration-time curve from baseline to the last measurable concentration [ Time Frame: Up to 20 weeks ] [ Designated as safety issue: No ]
  • AUC0-∞: area under the serum STX-100 concentration-time curve from baseline extrapolated to infinity [ Time Frame: Up to 20 weeks ] [ Designated as safety issue: No ]
  • λz: terminal elimination rate constant of STX-100 [ Time Frame: Up to 20 weeks ] [ Designated as safety issue: No ]
  • T½ (elimination half-life) of STX-100 [ Time Frame: Up to 20 weeks ] [ Designated as safety issue: No ]
  • CL/F (clearance ) of STX-100 (unadjusted for bioavailability) [ Time Frame: Up to 20 weeks ] [ Designated as safety issue: No ]
  • Vz/F: volume of distribution of STX-100 (unadjusted for bioavailability) [ Time Frame: Up to 20 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: June 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: STX-100 (BG00011)
Participants will receive 8 consecutive weekly doses of STX-100
Drug: BG00011
STX-100 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 Idec.

  Eligibility

Ages Eligible for Study:   18 Years to 84 Years
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 ATS/ERS/JRS/ALAT consensus criteria for the diagnosis of IPF).
  2. FVC ≥ 50% of predicted value.
  3. DLco (corrected for hemoglobin) ≥ 30% predicted value.
  4. Oxygen saturation > 90% by pulse oximetry while breathing ambient air at rest or receiving ≤2 L/minute of supplemental oxygen.
  5. Residual volume ≤ 120% predicted value.
  6. Ratio of 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. HRCT image fulfills the criteria for 'UIP pattern'.
  9. Adequate bone marrow and liver function.
  10. 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 listed and/or anticipated to be listed for lung transplantation within the next 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 Idec clinicaltrials@biogenidec.com

Locations
United States, California
University of California-San Francisco Recruiting
San Francisco, California, United States, 94143
Stanford University Medical Center Active, not recruiting
Stanford, California, United States, 94305
United States, Florida
University of Florida Active, not recruiting
Gainesville, Florida, United States, 32610
University of Miami Recruiting
Miami, Florida, United States, 33136
United States, Georgia
Emory University School of Medicine Recruiting
Atlanta, Georgia, United States, 30322
United States, Illinois
University of Chicago Active, not recruiting
Chicago, Illinois, United States, 60637
United States, Kansas
University of Kansas Not yet recruiting
Kansas City, Kansas, United States, 66160
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center Active, not recruiting
Boston, Massachusetts, United States, 02215
United States, New Hampshire
Dartmouth-Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
United States, Texas
Baylor College of Medicine and The Methodist Hospital Active, not recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
Biogen Idec
Investigators
Study Director: Medical Director Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec
ClinicalTrials.gov Identifier: NCT01371305     History of Changes
Other Study ID Numbers: 203PF201, STX-003
Study First Received: June 3, 2011
Last Updated: January 15, 2015
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on March 03, 2015