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

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ClinicalTrials.gov Identifier: NCT01371305
Recruitment Status : Completed
First Posted : June 10, 2011
Results First Posted : February 28, 2020
Last Update Posted : February 28, 2020
Sponsor:
Information provided by (Responsible Party):
Biogen

Tracking Information
First Submitted Date  ICMJE June 3, 2011
First Posted Date  ICMJE June 10, 2011
Results First Submitted Date  ICMJE February 12, 2020
Results First Posted Date  ICMJE February 28, 2020
Last Update Posted Date February 28, 2020
Actual Study Start Date  ICMJE July 16, 2012
Actual Primary Completion Date March 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 12, 2020)
Number of Participants With Adverse Events (AEs) [ Time Frame: up to Week 19 ]
An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that did not necessarily have a causal relationship with this treatment.
Original Primary Outcome Measures  ICMJE
 (submitted: June 9, 2011)
Incidence and severity of adverse events [ Time Frame: Weekly assessment over 24 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2020)
  • Time to Reach Maximum Observed Serum Concentration (Tmax) of BG00011 [ Time Frame: Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50 ]
  • Maximum Observed Serum Concentration (Cmax) of BG00011 [ Time Frame: Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50 ]
  • Area Under the Serum Concentration Time Curve From Time 0 to Last Quantifiable Observed Concentration AUC(0-t) of BG00011 [ Time Frame: Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50 ]
  • Area Under the Serum Concentration-Time Curve From Time 0 to 168 Hours AUC(0-168) of BG00011 [ Time Frame: Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50 ]
  • Apparent Terminal Elimination Half Life (T1/2) of BG00011 [ Time Frame: Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50 ]
  • Apparent Terminal Rate Constant [λz] [ Time Frame: Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50 ]
  • Area Under the Concentration Versus Time Curve From Time Zero to Infinity AUC(0-inf) of BG00011 [ Time Frame: Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50 ]
  • Apparent Clearance (CL/F) of BG00011 [ Time Frame: Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50 ]
  • Apparent Volume of Distribution (Vd/F) of BG00011 [ Time Frame: Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50 ]
  • Percentage Change (PC) From Baseline in Biomarkers Isolated From Bronchoalveolar Lavage (BAL) [ Time Frame: Baseline, Day 8 (Follow up) ]
    The expression level of 7 genes; Arachidonate 5-lipoxygenase (ALOX5), fibronectin 1 (FN1), Oxidized low density lipoprotein receptor 1 (OLR1), Plasminogen activator inhibitor-1 (PAI-1; aka SERPINE 1), Transglutaminase 2 (TGM2), Triggering receptor expressed on myeloid cells 1 (TREM1), and v-ets erythroblastosis virus E26 oncogene homolog 1 (ETS1) were assessed via BAL as well as a ratio of pSMAD2 to tSMAD2 levels.
  • Number of Participants With Treatment Emergent Antibodies to BG00011 [ Time Frame: Up to Week 19 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 9, 2011)
  • 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 ]
  • 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 ]
  • Change in radiographic evidence of IPF as measured by high resolution computed tomography (HRCT) [ Time Frame: Baseline, week 8 ]
  • Change in biomarkers isolated from bronchoalveolar lavage (BAL) [ Time Frame: Baseline, week 8 ]
  • Incidence of antibodies to STX-100 [ Time Frame: Baseline, follow up days 29 and 85 ]
  • Serum half-life of STX-100 [ Time Frame: Following the final dose of STX 100 at day 50 through day 85 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE STX-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Official Title  ICMJE Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Dose-Escalation Study of STX-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Brief Summary 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Idiopathic Pulmonary Fibrosis (IPF)
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 23, 2018)
41
Original Estimated Enrollment  ICMJE
 (submitted: June 9, 2011)
32
Actual Study Completion Date  ICMJE March 31, 2017
Actual Primary Completion Date March 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 84 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01371305
Other Study ID Numbers  ICMJE 203PF201
STX-003 ( Other Identifier: Stromedix, Inc. )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Biogen
Study Sponsor  ICMJE Biogen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Biogen
PRS Account Biogen
Verification Date February 2020

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