Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

June 3, 2011
January 15, 2015
June 2012
July 2015   (final data collection date for primary outcome measure)
Number of participants that experience adverse events [ Time Frame: Weekly assessment over 20 weeks ] [ Designated as safety issue: Yes ]
Incidence and severity of adverse events [ Time Frame: Weekly assessment over 24 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01371305 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Lab tests (hematology, serum chemistry, and urinalysis) [ Time Frame: Screening; Dosing days 1, 8, 15, 29, 43, and 50; Follow up days 3, 8, 29, 57, and 85 ] [ Designated as safety issue: Yes ]
  • Percent change in lung function: forced (expiratory) vital capacity (FVC), forced expiratory volume over one second (FEV1), total lung capacity (TLC), and carbon monoxide diffusion capacity (DLCO) [ Time Frame: Baseline, 4 weeks and 8 weeks ] [ Designated as safety issue: Yes ]
  • Change in radiographic evidence of IPF as measured by high resolution computed tomography (HRCT) [ Time Frame: Baseline, week 8 ] [ Designated as safety issue: Yes ]
  • Change in biomarkers isolated from bronchoalveolar lavage (BAL) [ Time Frame: Baseline, week 8 ] [ Designated as safety issue: Yes ]
  • Incidence of antibodies to STX-100 [ Time Frame: Baseline, follow up days 29 and 85 ] [ Designated as safety issue: Yes ]
  • Serum half-life of STX-100 [ Time Frame: Following the final dose of STX 100 at day 50 through day 85 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
STX-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Dose-Escalation Study of 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 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.

This study was previously posted by Stromedix, Inc. In April, 2014, sponsorship of the trial was transferred to Biogen Idec.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Idiopathic Pulmonary Fibrosis (IPF)
  • Drug: BG00011
    STX-100 will be administered at varying doses via subcutaneous (SC) injection
    Other Name: STX-100
  • Drug: Placebo
    Sterile normal saline (0.9% Sodium Chloride for Injection) via Subcutaneous (SC) injections.
  • Experimental: STX-100 (BG00011)
    Participants will receive 8 consecutive weekly doses of STX-100
    Intervention: Drug: BG00011
  • Placebo Comparator: Placebo
    Participants will receive 8 consecutive weekly doses of placebo.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
32
July 2015
July 2015   (final data collection date for primary outcome measure)

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.

Both
18 Years to 84 Years
No
Contact: Biogen Idec clinicaltrials@biogenidec.com
United States
 
NCT01371305
203PF201, STX-003
Yes
Biogen Idec
Biogen Idec
Not Provided
Study Director: Medical Director Biogen Idec
Biogen Idec
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP