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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03573505
Ethics application status
Date submitted
19/06/2018
Date registered
29/06/2018
Date last updated
11/12/2020

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
Change From Baseline in Forced (Expiratory) Vital Capacity (FVC) at Week 52
Timepoint [1] 0 0
Baseline, Week 52
Secondary outcome [1] 0 0
Change From Baseline in FVC, Expressed in Percent Predicted at Week 52
Timepoint [1] 0 0
Baseline, Week 52
Secondary outcome [2] 0 0
Time to Progression
Timepoint [2] 0 0
Up to Week 60 (End of Study)
Secondary outcome [3] 0 0
Time to First Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation
Timepoint [3] 0 0
Up to Early Termination Visit (Up to Week 52)
Secondary outcome [4] 0 0
Number of Participants With at Least One Acute IPF Exacerbation
Timepoint [4] 0 0
Up to Early Termination Visit (Up to Week 52)
Secondary outcome [5] 0 0
Number of IPF Exacerbations
Timepoint [5] 0 0
Up to Early Termination Visit (Up to Week 52)
Secondary outcome [6] 0 0
Number of Participants With Absolute Decline of 10% Predicted in FVC
Timepoint [6] 0 0
Up to Early Termination Visit (Up to Week 52)
Secondary outcome [7] 0 0
Time to Death or Lung Transplantation
Timepoint [7] 0 0
Up to Week 60 (End of Study)
Secondary outcome [8] 0 0
Time to All Non-elective Hospitalizations
Timepoint [8] 0 0
Up to Week 60 (End of Study)
Secondary outcome [9] 0 0
Time to All Non-Elective Respiratory Hospitalizations
Timepoint [9] 0 0
Up to Week 60 (End of Study)
Secondary outcome [10] 0 0
Change From Baseline in Absolute FVC
Timepoint [10] 0 0
Up to Week 44
Secondary outcome [11] 0 0
Change From Baseline in Percent Predicted FVC
Timepoint [11] 0 0
Up to Week 44
Secondary outcome [12] 0 0
Change From Baseline in Absolute Carbon Monoxide Diffusion Capacity (DLco)
Timepoint [12] 0 0
Up to Early Termination Visit (Up to Week 52)
Secondary outcome [13] 0 0
Change From Baseline in Percent Predicted Carbon Monoxide Diffusion Capacity (DLco)
Timepoint [13] 0 0
Up to Early Termination Visit (Up to Week 52)
Secondary outcome [14] 0 0
Change From Baseline in Absolute Total Lung Capacity (TLC)
Timepoint [14] 0 0
Up to Early Termination Visit (Up to Week 52)
Secondary outcome [15] 0 0
Change From Baseline in Percent Predicted TLC
Timepoint [15] 0 0
Up to Early Termination Visit (Up to Week 52)
Secondary outcome [16] 0 0
Change From Baseline in 6 Minute Walk Test (6MWT) Parameters
Timepoint [16] 0 0
Baseline, Week 26 and Week 52
Secondary outcome [17] 0 0
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [17] 0 0
Up to Week 60 (End of Study)
Secondary outcome [18] 0 0
Number of Participants With Anti-BG00011 Antibodies in the Serum
Timepoint [18] 0 0
Up to Week 60 (End of Study)
Secondary outcome [19] 0 0
Concentration of BG00011 in the Serum
Timepoint [19] 0 0
Predose on Day 0, Day 5, Week 4, Week 8, Week 12, Week 26, Week 38, Week 52, and Safety Follow-up Visit (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
Sex
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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/09/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/11/2019
Sample size
Target
Accrual to date
Final
109
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
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
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
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Minnesota
Country [10] 0 0
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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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South Carolina
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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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Praha 8
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Denmark
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Aarhus C
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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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Paris
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Heraklion
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Jerusalem
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Kfar-Saba
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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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Gyeonggi-do
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Rotterdam
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Gdansk
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Kazan
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Devon
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Merseyside
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Tyne & Wear
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United Kingdom
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West Yorkshire

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT03573505