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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 by Biogen
Sponsor:
Information provided by (Responsible Party):
Biogen
ClinicalTrials.gov Identifier:
NCT01371305
First received: June 3, 2011
Last updated: November 23, 2016
Last verified: November 2016

June 3, 2011
November 23, 2016
June 2012
July 2017   (final data collection date for primary outcome measure)
Number of participants that experience adverse events [ Time Frame: Up to 16 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 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
  • 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 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.
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.
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
    BG00011 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: BG00011
    Participants will receive 8 consecutive weekly doses of BG00011
    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
40
August 2017
July 2017   (final data collection date for primary outcome measure)

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.

Both
18 Years to 84 Years   (Adult, Senior)
No
Contact: Biogen clinicaltrials@biogen.com
United States
 
NCT01371305
203PF201, STX-003
Yes
Not Provided
Not Provided
Biogen
Biogen
Not Provided
Study Director: Medical Director Biogen
Biogen
November 2016

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