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History of Changes for Study: NCT03573505
An Efficacy and Safety Study of BG00011 in Participants With Idiopathic Pulmonary Fibrosis (SPIRIT)
Latest version (submitted December 10, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 19, 2018 None (earliest Version on record)
2 September 17, 2018 Recruitment Status, Study Status, Contacts/Locations and Eligibility
3 September 20, 2018 Contacts/Locations and Study Status
4 October 8, 2018 Study Status and Contacts/Locations
5 November 9, 2018 Study Status, Contacts/Locations and Study Identification
6 January 8, 2019 Contacts/Locations and Study Status
7 February 20, 2019 Contacts/Locations and Study Status
8 March 1, 2019 Contacts/Locations and Study Status
9 March 6, 2019 Contacts/Locations and Study Status
10 March 19, 2019 Contacts/Locations and Study Status
11 March 26, 2019 Contacts/Locations and Study Status
12 April 3, 2019 Study Status
13 April 16, 2019 Contacts/Locations and Study Status
14 April 22, 2019 Contacts/Locations and Study Status
15 April 30, 2019 Contacts/Locations and Study Status
16 May 8, 2019 Study Status and Contacts/Locations
17 May 15, 2019 Contacts/Locations, Study Status and Study Identification
18 May 23, 2019 Contacts/Locations and Study Status
19 June 10, 2019 Study Status and Contacts/Locations
20 June 20, 2019 Contacts/Locations and Study Status
21 July 9, 2019 Contacts/Locations and Study Status
22 August 7, 2019 Study Status
23 August 12, 2019 Contacts/Locations and Study Status
24 September 13, 2019 Recruitment Status, Study Status, Contacts/Locations, Study Design and Study Description
25 November 18, 2019 Study Status and Study Description
26 January 24, 2020 Recruitment Status, Study Status and Study Description
27 July 24, 2020 Study Status
28 September 30, 2020 Study Status
29 October 29, 2020 Outcome Measures, Study Status, Document Section and Results
30 December 10, 2020 Study Status
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Changes (Merged) for Study: NCT03573505
August 12, 2019 (v23) -- September 13, 2019 (v24)

Changes in: Study Status, Study Description, Study Design and Contacts/Locations

Open or close this module Study Identification
Unique Protocol ID: 203PF203
Brief Title: An Efficacy and Safety Study of BG00011 in Participants With Idiopathic Pulmonary Fibrosis (SPIRIT)
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis
Secondary IDs: 2017-003158-18 [EudraCT Number]
Open or close this module Study Status
Record Verification: August 2019 September 2019
Overall Status: Recruiting Active, not recruiting
Study Start: September 24, 2018
Primary Completion: November 17 29, 2021 2019 [Anticipated]
Study Completion: November 17 29, 2021 2019 [Anticipated]
First Submitted: June 19, 2018
First Submitted that
Met QC Criteria:
June 19, 2018
First Posted: June 29, 2018 [Actual]
Last Update Submitted that
Met QC Criteria:
August 12, 2019 September 13, 2019
Last Update Posted: August 13 September 16, 2019 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Biogen
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
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.

Study was stopped because of safety concerns. End-of-study and safety follow-up visits are in progress.

Detailed Description:
Open or close this module Conditions
Conditions: Idiopathic Pulmonary Fibrosis
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 290 [Anticipated] 109 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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.
Open or close this module Outcome Measures
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 ]

Open or close this module Eligibility
Minimum Age: 40 Years
Maximum Age:
Sex: All
Gender Based:
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.

Open or close this module Contacts/Locations
Central Contact Person: US Biogen Clinical Trial Center
Telephone: 866-633-4636
Email: clinicaltrials@biogen.com
Central Contact Backup: Global Biogen Clinical Trial Center
Email: clinicaltrials@biogen.com
Study Officials: Medical Director
Study Director
Biogen
Locations: United States, Alabama
Research Site
[Recruiting]
Birmingham, Alabama, United States, 35294
United States, Arizona
Research Site
[Recruiting]
Phoenix, Arizona, United States, 85006
Research Site
[Recruiting]
Phoenix, Arizona, United States, 85013
United States, California
Research Site
[Recruiting]
Los Angeles, California, United States, 90048
United States, Connecticut
Research Site
[Recruiting]
New Haven, Connecticut, United States, 06510-3221
United States, Florida
Research Site
[Recruiting]
Miami, Florida, United States, 33125
United States, Georgia
Research Site
[Recruiting]
Atlanta, Georgia, United States, 30322
United States, Iowa
Research Site
[Recruiting]
Iowa City, Iowa, United States, 52242
United States, Massachusetts
Research Site
[Recruiting]
Boston, Massachusetts, United States, 02114
Research Site
[Recruiting]
Boston, Massachusetts, United States, 02115
United States, Minnesota
Research Site
[Recruiting]
Minneapolis, Minnesota, United States, 55407
Research Site
[Recruiting]
Rochester, Minnesota, United States, 55905
United States, Missouri
Research Site
[Recruiting]
Chesterfield, Missouri, United States, 63017
Research Site
[Recruiting]
Kansas City, Missouri, United States, 66160
United States, New Hampshire
Research Site
[Recruiting]
Lebanon, New Hampshire, United States, 03756
United States, New York
Research Site
[Recruiting]
New York, New York, United States, 10029
United States, Ohio
Research Site
[Recruiting]
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Research Site
[Recruiting]
Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
Research Site
[Recruiting]
Providence, Rhode Island, United States, 02903
United States, South Carolina
Research Site
[Recruiting]
Charleston, South Carolina, United States, 29425
United States, Tennessee
Research Site
[Recruiting]
Nashville, Tennessee, United States, 37232
United States, Texas
Reserach Site
[Recruiting]
Houston, Texas, United States, 77030
United States, Virginia
Research Site
[Recruiting]
Falls Church, Virginia, United States, 22042
United States, Washington
Research Site
[Recruiting]
Seattle, Washington, United States, 98195
Research Site
[Active, not recruiting]
Tacoma, Washington, United States, 98405
United States, Wisconsin
Research Site
[Recruiting]
Madison, Wisconsin, United States, 53792
Argentina, Buenos Aires
Research Site
[Recruiting]
Mar del Plata, Buenos Aires, Argentina, B7600FZ
Argentina, Tucuman
Research Site
[Recruiting]
San Miguel de Tucuman, Tucuman, Argentina, 4000
Australia
Research Site
[Recruiting]
Heidelberg, Australia, 3084
Australia, New South Wales
Research Site
[Recruiting]
Darlinghurst, New South Wales, Australia, 2010
Research Site
[Recruiting]
New Lambton Heights, New South Wales, Australia, 2305
Research Site
[Recruiting]
Newtown, New South Wales, Australia, 2042
Australia, Queensland
Research Site
[Recruiting]
Chermside, Queensland, Australia, 4032
Research Site
[Recruiting]
Nundah, Queensland, Australia, 4012
Research Site
[Recruiting]
Woolloongabba, Queensland, Australia, 4102
Australia, Victoria
Research Site
[Recruiting]
Frankston, Victoria, Australia, 3939
Research Site
[Recruiting]
Melbourne, Victoria, Australia, 3004
Australia, Western Australia
Research Site
[Recruiting]
Murdoch, Western Australia, Australia, 6150
Belgium
Research Site
[Recruiting]
Bruxelles, Belgium, 1070
Research Site
[Recruiting]
Leuven, Belgium, 3000
Research Site
[Recruiting]
Yvoir, Belgium, 5530
Chile
Research Site
[Recruiting]
Talca, Chile, 3465586
Czechia
Research Site
[Recruiting]
Olomouc, Czechia, 775 20
Research Site
[Recruiting]
Plzen Bory, Czechia, 305 99
Research Site
[Recruiting]
Praha 4, Czechia, 140 59
Research Site
[Recruiting]
Praha 8, Czechia, 180 01
Denmark
Research Site
[Recruiting]
Aarhus C, Denmark, 8000
Research Site
[Recruiting]
Hellerup, Denmark, 2900
France, Herault
Research Site
[Recruiting]
Montpellier cedex 5, Herault, France, 34295
France, Ille Et Vilaine
Research Site
[Recruiting]
Rennes Cedex 09, Ille Et Vilaine, France, 35033
France, Paris
Research Site
[Recruiting]
Paris Cedex 18, Paris, France, 75877
France, Rhone
Research Site
[Recruiting]
Bron cedex, Rhone, France, 69677
France, Seine Saint Denis
Research Site
[Recruiting]
Bobigny Cedex, Seine Saint Denis, France, 93009
Greece
Research Site
[Recruiting]
Heraklion, Greece, 71110
Research Site
[Recruiting]
Larissa, Greece, 41110
Israel
Research Site
[Recruiting]
Haifa, Israel, 34362
Research Site
[Recruiting]
Jerusalem, Israel, 91120
Research Site
[Recruiting]
Kfar-Saba, Israel, 4428164
Research Site
[Recruiting]
Petach Tikva, Israel, 49100
Italy
Research Site
[Recruiting]
Catania, Italy, 95123
Research Site
[Recruiting]
Milano, Italy, 20123
Research Site
[Recruiting]
Roma, Italy, 00168
Research Site
[Recruiting]
Siena, Italy, 53100
Italy, Cesena
Research Site
[Recruiting]
Forli, Cesena, Italy, 47100
Korea, Republic of
Research Site
[Recruiting]
Seoul, Korea, Republic of, 05505
Research Site
[Recruiting]
Seoul, Korea, Republic of, 3080
Korea, Republic of, Gyeonggi-do
Research Site
[Recruiting]
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
Netherlands
Research Site
[Recruiting]
Amsterdam, Netherlands, 1091 AC
Research Site
[Recruiting]
Nieuwegein, Netherlands, 3435 CM
Research Site
[Recruiting]
Rotterdam, Netherlands, 3015 CE
Poland
Research Site
[Recruiting]
Gdansk, Poland, 80-952
Research Site
[Recruiting]
Warszawa, Poland, 01-138
Russian Federation
Research Site
[Recruiting]
Ekaterinburg, Russian Federation, 620039
Research Site
[Recruiting]
Kazan, Russian Federation, 420103
Research Site
[Recruiting]
Saint-Petersburg, Russian Federation, 197022
Research Site
[Recruiting]
Yaroslavl, Russian Federation, 150003
Spain
Research Site
[Recruiting]
Barcelona, Spain, 08006
Research Site
[Recruiting]
Barcelona, Spain, 08025
Research Site
[Recruiting]
Madrid, Spain, 28006
Research Site
[Recruiting]
Sevilla, Spain, 41013
Research Site
[Recruiting]
Valencia, Spain, 46014
Spain, Barcelona
Research Site
[Recruiting]
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
United Kingdom, Cambridgeshire
Research Site
[Recruiting]
Cambridge, Cambridgeshire, United Kingdom, CB2 0AY
United Kingdom, Devon
Research Site
[Recruiting]
Exeter, Devon, United Kingdom, EX2 5DW
United Kingdom, Greater London
Research Site
[Recruiting]
London, Greater London, United Kingdom, SW3 6NP
Research Site
[Recruiting]
London, Greater London, United Kingdom, W12 0HS
United Kingdom, Lothian Region
Research Site
[Recruiting]
Edinburgh, Lothian Region, United Kingdom, EH4 2XU
United Kingdom, Merseyside
Research Site
[Recruiting]
Liverpool, Merseyside, United Kingdom, L9 7AL
United Kingdom, Tyne & Wear
Research Site
[Recruiting]
Newcastle, Tyne & Wear, United Kingdom, NE1 4LP
United Kingdom, West Yorkshire
Research Site
[Recruiting]
Leeds, West Yorkshire, United Kingdom, LS9 7TF
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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