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An Efficacy and Safety Study of BG00011 in Participants With Idiopathic Pulmonary Fibrosis (SPIRIT)

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ClinicalTrials.gov Identifier: NCT03573505
Recruitment Status : Recruiting
First Posted : June 29, 2018
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Biogen

Brief Summary:
The primary objective of this study is to evaluate the efficacy of BG00011 compared with placebo in participants with Idiopathic Pulmonary Fibrosis (IPF). The secondary objectives of this study are: to evaluate the efficacy of BG00011 compared with placebo in participants with IPF as determined by change in percent predicted forced (expiratory) vital capacity (FVC); to assess progression-free survival in participants who receive BG00011 compared with placebo; to assess the occurrence of IPF exacerbation in participants who receive BG00011 compared with placebo; to assess the incidence of absolute decline in FVC ≥10% in participants who receive BG00011 compared with placebo; to assess the time to death or lung transplantation in participants who receive BG00011 compared with placebo, and the transplant-free survival rate at Week 26 and Week 52; to assess the time to non-elective hospitalizations in participants who receive BG00011 compared with placebo; to assess additional pulmonary function test (PFT) findings in participants who receive BG00011 compared with placebo; To assess performance on the 6 minute walk test (6MWT) in participants who receive BG00011 compared with placebo; to evaluate the safety and tolerability of BG00011; and to evaluate the serum concentration of BG00011.

Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis Drug: BG00011 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 290 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis
Actual Study Start Date : September 24, 2018
Estimated Primary Completion Date : November 17, 2021
Estimated Study Completion Date : November 17, 2021


Arm Intervention/treatment
Experimental: BG00011
Participants will receive BG00011 56 mg once weekly by subcutaneous (SC) injection for 52 weeks.
Drug: BG00011
Administered as specified in the treatment arm.

Placebo Comparator: Placebo
Participants will receive placebo once weekly by (SC) injection for 52 weeks.
Drug: Placebo
Administered as specified in the treatment arm.




Primary Outcome Measures :
  1. Yearly Rate of Change in Forced (Expiratory) Vital Capacity (FVC) [ Time Frame: Up to Week 52 ]
    The FVC is the volume of air, measured in milliliters (mL), which can be forcibly exhaled from the lungs after taking the deepest breath possible.


Secondary Outcome Measures :
  1. Percent Predicted Yearly Rate of Change in FVC [ Time Frame: Up to Week 52 ]
    The FVC is the volume of air, measured in milliliters (mL), which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC can be expressed as a % predicted of normal.

  2. Time to Progression [ Time Frame: Up to Week 52 ]

    Defined by a composite endpoint, including any of the following events: Absolute decline of 10% predicted in FVC (FVC percent predicted (baseline) - FVC percent predicted (progression) ≥10%); Non-elective hospitalization for respiratory events; Lung transplantation or death.

    Measured in Days.


  3. Time to First Acute Exacerbation [ Time Frame: Up to Week 52 ]

    Specific criteria for acute exacerbation of Idiopathic Pulmonary Fibrosis (IPF) will be determined by the Investigator.

    Measured in Days.


  4. Percentage of Participants with at least 1 Acute Exacerbation [ Time Frame: Up to Week 52 ]
    Specific criteria for acute exacerbation of Idiopathic Pulmonary Fibrosis (IPF) will be determined by the Investigator, using a modified definition of IPF exacerbation derived from the IPF Clinical Research Network (IPFnet) definition of acute exacerbations of IPF in 2007.

  5. Number of Exacerbations [ Time Frame: Up to Week 52 ]
    Specific criteria for acute exacerbation of Idiopathic Pulmonary Fibrosis (IPF) will be determined by the Investigator, using a modified definition of IPF exacerbation derived from the IPF Clinical Research Network (IPFnet) definition of acute exacerbations of IPF in 2007.

  6. Number of Participants with Absolute Decline of 10% Predicted in FVC [ Time Frame: Up to Week 52 ]

    The FVC is the volume of air, measured in milliliters (mL), which can be forcibly exhaled from the lungs after taking the deepest breath possible.

    Absolute Decline of 10% = FVC percent predicted (baseline) - FVC percent predicted (progression) ≥10%


  7. Time to Death or Lung Transplantation [ Time Frame: Up to Week 52 ]
    Measured in Days.

  8. Time to All Non-Elective Hospitalizations [ Time Frame: Up to Week 52 ]
    Measured in Days.

  9. Time to All Non-Elective Respiratory Hospitalizations [ Time Frame: Up to Week 52 ]
    Measured in Days.

  10. Change from Baseline in Absolute Predicted FVC [ Time Frame: Baseline and at Multiple Time Points Up to Week 52 ]
    The FVC is the volume of air, measured in milliliters (mL), which can be forcibly exhaled from the lungs after taking the deepest breath possible.

  11. Change from Baseline in Percent Predicted FVC [ Time Frame: Baseline and at Multiple Time Points Up to Week 52 ]
    The FVC is the volume of air, measured in milliliters (mL), which can be forcibly exhaled from the lungs after taking the deepest breath possible.

  12. Change from Baseline in Absolute Predicted Carbon Monoxide Diffusion Capacity (DLco) [ Time Frame: Baseline and at Multiple Time Points Up to Week 52 ]
    Evaluation of DLco will be performed by single-breath carbon monoxide diffusing capacity.

  13. Change from Baseline in Percent Predicted Carbon Monoxide Diffusion Capacity (DLco) [ Time Frame: Baseline and at Multiple Time Points Up to Week 52 ]
    Evaluation of DLco will be performed by single-breath carbon monoxide diffusing capacity.

  14. Change from Baseline in Absolute Predicted Total Lung Capacity [ Time Frame: Baseline, and Weeks 26 and 52 ]
    Lung volumes, measured in milliliters (mL), including total lung capacity and residual volume, will be measured by full-body plethysmography.

  15. Change from Baseline in Percent Predicted Total Lung Capacity [ Time Frame: Baseline and Weeks 26 and 52 ]
    Lung volumes, measured in milliliters (mL), including total lung capacity and residual volume, will be measured by full-body plethysmography.

  16. Change from Baseline in 6 Minute Walk Test (6MWT) Parameters [ Time Frame: Baseline, and Weeks 26 and 52 ]
    This test assesses the distance in meters that a subject can walk in 6 minutes.

  17. Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to Week 52 ]
    An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An SAE is any untoward medical occurrence that at any dose results in death, requires inpatient hospitalization, results in persistent or significant disability and/or results in a congenital anomaly.

  18. Percentage of Participants With Anti-BG00011 Antibodies in the Serum [ Time Frame: Baseline and at Multiple Time Points Up to Week 52 ]
  19. Concentration of BG00011 in the Serum [ Time Frame: Baseline and at Multiple Time Points Up to Week 60 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Female subjects must be surgically sterile, postmenopausal (minimum 1 year without menses), or agree to use 1 or more forms of highly effective contraception from the time of signing of the informed consent form (ICF) until 3 months after the last injection of study medication. Male subjects must also agree to use 1 or more forms of highly effective contraception for either themselves or their partners from signing of ICF until 4 months after last injection of study medication.
  • IPF diagnosed based on modified ATS/ERS/JRS/ALAT IPF guideline for diagnosis and management, within 3 years of Screening.
  • Combination of high-resolution computed tomography (HRCT) pattern and, if one has been obtained, surgical lung biopsy pattern, consistent with diagnosis of IPF.
  • Carbon monoxide diffusion capacity (DLco) (corrected for hemoglobin): 30% to 79% predicted of normal at Screening, with no clinically significant deterioration between the Screening Visit and randomization, as determined by the Investigator.
  • Forced (expiratory) vital capacity (FVC) ≥50% predicted of normal at Screening, with no clinically significant deterioration between the Screening Visit and randomization, as determined by the Investigator.
  • If a subject is taking nintedanib or pirfenidone, they must be on a stable dose for at least 8 weeks prior to randomization.

Key Exclusion Criteria:

  • Unable to perform pulmonary functional tests (PFTs) or undergo HRCT procedure.
  • Peripheral capillary oxygen saturation (SpO2) <90% at rest (if on oxygen supplementation, must be ≤2 L/min at rest).
  • Airway obstruction (i.e., prebronchodilator FEV1/FVC <0.7) or evidence of a bronchodilator response as defined by an absolute increase of ≥12% and an increase of ≥200 milliliters (mL) in FEV1 or FVC, or both, after bronchodilator use, compared with the values before bronchodilator use at Screening.
  • End-stage fibrotic disease likely requiring organ transplantation within 12 months, or if the subject has initiated active evaluation for organ transplantation.
  • The extent of emphysema in the lungs exceeds fibrosis, based on central review of HRCT scans.
  • Body weight <60 kg at Screening.
  • History of or ongoing malignant disease, including solid tumors and hematologic malignancies, with the exception of basal cell carcinomas, squamous cell carcinomas, and carcinoma in situ of the cervix that have been completely excised and considered cured >2 years prior to Screening.
  • Significant cardiac disease (e.g., New York Heart Association Class 3 or 4; myocardial infarction within the past 6 months; unstable angina; coronary angioplasty or coronary artery bypass graft within the past 6 months; uncontrolled atrial or ventricular cardiac arrhythmias; or pulmonary hypertension requiring pharmacologic treatment).
  • Clinical diagnosis of any connective tissue disease (including but not limited to scleroderma, polymyositis/dermatomyositis, systemic lupus erythematosus, and rheumatoid arthritis) or a diagnosis of interstitial pneumonia with autoimmune features as determined by the Investigator.
  • Other disease that may interfere with testing procedures or, in the judgment of the Investigator, may interfere with study participation or may put the patient at risk when participating in this study.
  • Other unspecified reasons that, in the opinion of the Investigator or Biogen, make the subject unsuitable for enrollment.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03573505


Contacts
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Contact: US Biogen Clinical Trial Center 866-633-4636 clinicaltrials@biogen.com
Contact: Global Biogen Clinical Trial Center clinicaltrials@biogen.com

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Sponsors and Collaborators
Biogen
Investigators
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Study Director: Medical Director Biogen

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Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT03573505     History of Changes
Other Study ID Numbers: 203PF203
2017-003158-18 ( EudraCT Number )
First Posted: June 29, 2018    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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