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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03573505




Registration number
NCT03573505
Ethics application status
Date submitted
19/06/2018
Date registered
29/06/2018
Date last updated
27/01/2020

Titles & IDs
Public title
An Efficacy and Safety Study of BG00011 in Participants With Idiopathic Pulmonary Fibrosis
Scientific title
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis
Secondary ID [1] 0 0
2017-003158-18
Secondary ID [2] 0 0
203PF203
Universal Trial Number (UTN)
Trial acronym
SPIRIT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idiopathic Pulmonary Fibrosis 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BG00011
Treatment: Drugs - Placebo

Experimental: BG00011 - Participants will receive BG00011 56 mg once weekly by subcutaneous (SC) injection for 52 weeks.

Placebo Comparator: Placebo - Participants will receive placebo once weekly by (SC) injection for 52 weeks.


Treatment: Drugs: BG00011
Administered as specified in the treatment arm.

Treatment: Drugs: Placebo
Administered as specified in the treatment arm.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Yearly Rate of Change in Forced (Expiratory) Vital Capacity (FVC) - 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.
Timepoint [1] 0 0
Up to Week 52
Secondary outcome [1] 0 0
Percent Predicted Yearly Rate of Change in FVC - 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.
Timepoint [1] 0 0
Up to Week 52
Secondary outcome [2] 0 0
Time to Progression - 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.
Timepoint [2] 0 0
Up to Week 52
Secondary outcome [3] 0 0
Time to First Acute Exacerbation - Specific criteria for acute exacerbation of Idiopathic Pulmonary Fibrosis (IPF) will be determined by the Investigator.
Measured in Days.
Timepoint [3] 0 0
Up to Week 52
Secondary outcome [4] 0 0
Percentage of Participants with at least 1 Acute Exacerbation - 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.
Timepoint [4] 0 0
Up to Week 52
Secondary outcome [5] 0 0
Number of Exacerbations - 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.
Timepoint [5] 0 0
Up to Week 52
Secondary outcome [6] 0 0
Number of Participants with Absolute Decline of 10% Predicted in FVC - 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%
Timepoint [6] 0 0
Up to Week 52
Secondary outcome [7] 0 0
Time to Death or Lung Transplantation - Measured in Days.
Timepoint [7] 0 0
Up to Week 52
Secondary outcome [8] 0 0
Time to All Non-Elective Hospitalizations - Measured in Days.
Timepoint [8] 0 0
Up to Week 52
Secondary outcome [9] 0 0
Time to All Non-Elective Respiratory Hospitalizations - Measured in Days.
Timepoint [9] 0 0
Up to Week 52
Secondary outcome [10] 0 0
Change from Baseline in Absolute Predicted FVC - 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.
Timepoint [10] 0 0
Baseline and at Multiple Time Points Up to Week 52
Secondary outcome [11] 0 0
Change from Baseline in Percent Predicted FVC - 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.
Timepoint [11] 0 0
Baseline and at Multiple Time Points Up to Week 52
Secondary outcome [12] 0 0
Change from Baseline in Absolute Predicted Carbon Monoxide Diffusion Capacity (DLco) - Evaluation of DLco will be performed by single-breath carbon monoxide diffusing capacity.
Timepoint [12] 0 0
Baseline and at Multiple Time Points Up to Week 52
Secondary outcome [13] 0 0
Change from Baseline in Percent Predicted Carbon Monoxide Diffusion Capacity (DLco) - Evaluation of DLco will be performed by single-breath carbon monoxide diffusing capacity.
Timepoint [13] 0 0
Baseline and at Multiple Time Points Up to Week 52
Secondary outcome [14] 0 0
Change from Baseline in Absolute Predicted Total Lung Capacity - Lung volumes, measured in milliliters (mL), including total lung capacity and residual volume, will be measured by full-body plethysmography.
Timepoint [14] 0 0
Baseline, and Weeks 26 and 52
Secondary outcome [15] 0 0
Change from Baseline in Percent Predicted Total Lung Capacity - Lung volumes, measured in milliliters (mL), including total lung capacity and residual volume, will be measured by full-body plethysmography.
Timepoint [15] 0 0
Baseline and Weeks 26 and 52
Secondary outcome [16] 0 0
Change from Baseline in 6 Minute Walk Test (6MWT) Parameters - This test assesses the distance in meters that a subject can walk in 6 minutes.
Timepoint [16] 0 0
Baseline, and Weeks 26 and 52
Secondary outcome [17] 0 0
Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) - 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.
Timepoint [17] 0 0
Up to Week 52
Secondary outcome [18] 0 0
Percentage of Participants With Anti-BG00011 Antibodies in the Serum
Timepoint [18] 0 0
Baseline and at Multiple Time Points Up to Week 52
Secondary outcome [19] 0 0
Concentration of BG00011 in the Serum
Timepoint [19] 0 0
Baseline and at Multiple Time Points Up to Week 60

Eligibility
Key inclusion criteria
Key

- 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
Minimum age
40 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Research Site - Darlinghurst
Recruitment hospital [2] 0 0
Research Site - New Lambton Heights
Recruitment hospital [3] 0 0
Research Site - Newtown
Recruitment hospital [4] 0 0
Research Site - Chermside
Recruitment hospital [5] 0 0
Research Site - Nundah
Recruitment hospital [6] 0 0
Research Site - Woolloongabba
Recruitment hospital [7] 0 0
Research Site - Frankston
Recruitment hospital [8] 0 0
Research Site - Melbourne
Recruitment hospital [9] 0 0
Research Site - Murdoch
Recruitment hospital [10] 0 0
Research Site - Heidelberg
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [3] 0 0
2042 - Newtown
Recruitment postcode(s) [4] 0 0
4032 - Chermside
Recruitment postcode(s) [5] 0 0
4012 - Nundah
Recruitment postcode(s) [6] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [7] 0 0
3939 - Frankston
Recruitment postcode(s) [8] 0 0
3004 - Melbourne
Recruitment postcode(s) [9] 0 0
6150 - Murdoch
Recruitment postcode(s) [10] 0 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
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California
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United States of America
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Connecticut
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United States of America
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Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Iowa
Country [8] 0 0
United States of America
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Massachusetts
Country [9] 0 0
United States of America
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Minnesota
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Missouri
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New Hampshire
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New York
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Ohio
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Pennsylvania
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Rhode Island
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United States of America
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South Carolina
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United States of America
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Tennessee
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Texas
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Virginia
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Washington
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United States of America
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Wisconsin
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Argentina
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Buenos Aires
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Argentina
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Tucuman
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Belgium
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Bruxelles
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Belgium
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Leuven
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Belgium
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Yvoir
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Chile
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Talca
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Czechia
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Olomouc
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Czechia
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Plzen Bory
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Czechia
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Praha 4
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Czechia
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Praha 8
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Denmark
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Aarhus C
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Denmark
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Hellerup
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France
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Herault
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France
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Ille Et Vilaine
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France
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Paris
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France
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Rhone
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France
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Seine Saint Denis
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Greece
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Heraklion
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Greece
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Larissa
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Kfar-Saba
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Israel
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Petach Tikva
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Italy
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Cesena
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Italy
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Catania
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Italy
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Milano
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Italy
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Roma
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Italy
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Siena
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Seoul
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Netherlands
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Amsterdam
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Netherlands
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Nieuwegein
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Netherlands
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Rotterdam
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Poland
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Gdansk
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Poland
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Warszawa
Country [57] 0 0
Russian Federation
State/province [57] 0 0
Ekaterinburg
Country [58] 0 0
Russian Federation
State/province [58] 0 0
Kazan
Country [59] 0 0
Russian Federation
State/province [59] 0 0
Saint-Petersburg
Country [60] 0 0
Russian Federation
State/province [60] 0 0
Yaroslavl
Country [61] 0 0
Spain
State/province [61] 0 0
Barcelona
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Spain
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Madrid
Country [63] 0 0
Spain
State/province [63] 0 0
Sevilla
Country [64] 0 0
Spain
State/province [64] 0 0
Valencia
Country [65] 0 0
United Kingdom
State/province [65] 0 0
Cambridgeshire
Country [66] 0 0
United Kingdom
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Devon
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United Kingdom
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Greater London
Country [68] 0 0
United Kingdom
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Lothian Region
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United Kingdom
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Merseyside
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United Kingdom
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Tyne & Wear
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United Kingdom
State/province [71] 0 0
West Yorkshire

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Biogen
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT03573505
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Biogen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03573505