Idiopathic Pulmonary FibrosisPhase 2SPIRITNCT03573505
An Efficacy and Safety Study of BG00011 in Participants With Idiopathic Pulmonary Fibrosis
A Phase 2 study testing BG00011 in people with Idiopathic Pulmonary Fibrosis, run by Biogen at 90 sites in 17 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- BG00011
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 109 participants
- Where
- 90 sitesin 17 countries
- Study dates
- 24 Sep 2018to 14 Nov 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
90 sites in 17 countries.
90 sites in 17 countries
United States26 sites
Research Site
Atlanta, Georgia, 30322
Research Site
Birmingham, Alabama, 35294
Research Site
Boston, Massachusetts, 02114
Research Site
Boston, Massachusetts, 02115
Research Site
Charleston, South Carolina, 29425
Research Site
Chesterfield, Missouri, 63017
Research Site
Cleveland, Ohio, 44195
Research Site
Falls Church, Virginia, 22042
Reserach Site
Houston, Texas, 77030
Research Site
Iowa City, Iowa, 52242
Research Site
Kansas City, Missouri, 66160
Research Site
Lebanon, New Hampshire, 03756
Research Site
Los Angeles, California, 90048
Research Site
Madison, Wisconsin, 53792
Research Site
Miami, Florida, 33125
Research Site
Minneapolis, Minnesota, 55407
Research Site
Nashville, Tennessee, 37232
Research Site
New Haven, Connecticut, 06510-3221
Research Site
New York, New York, 10029
Research Site
Phoenix, Arizona, 85006
Research Site
Phoenix, Arizona, 85013
Research Site
Pittsburgh, Pennsylvania, 15213
Research Site
Providence, Rhode Island, 02903
Research Site
Rochester, Minnesota, 55905
Research Site
Seattle, Washington, 98195
Research Site
Tacoma, Washington, 98405
Australia10 sites
Research Site
Chermside, Queensland, 4032
Research Site
Darlinghurst, New South Wales, 2010
Research Site
Frankston, Victoria, 3939
Research Site
Heidelberg, 3084
Research Site
Melbourne, Victoria, 3004
Research Site
Murdoch, Western Australia, 6150
Research Site
New Lambton Heights, New South Wales, 2305
Research Site
Newtown, New South Wales, 2042
Research Site
Nundah, Queensland, 4012
Research Site
Woolloongabba, Queensland, 4102
United Kingdom8 sites
Research Site
Cambridge, Cambridgeshire, CB2 0AY
Research Site
Edinburgh, Lothian Region, EH4 2XU
Research Site
Exeter, Devon, EX2 5DW
Research Site
Leeds, West Yorkshire, LS9 7TF
Research Site
Liverpool, Merseyside, L9 7AL
Research Site
London, Greater London, SW3 6NP
Research Site
London, Greater London, W12 0HS
Research Site
Newcastle, Tyne & Wear, NE1 4LP
Spain6 sites
Research Site
Barcelona, 08006
Research Site
Barcelona, 08025
Research Site
L'Hospitalet de Llobregat, Barcelona, 08907
Research Site
Madrid, 28006
Research Site
Seville, 41013
Research Site
Valencia, 46014
France5 sites
Research Site
Bobigny, Seine Saint Denis, 93009
Research Site
Bron, Rhone, 69677
Research Site
Montpellier, Herault, 34295
Research Site
Paris, Paris, 75877
Research Site
Rennes, Ille Et Vilaine, 35033
Italy5 sites
Research Site
Catania, 95123
Research Site
Forlì, Cesena, 47100
Research Site
Milan, 20123
Research Site
Roma, 00168
Research Site
Siena, 53100
Czechia4 sites
Research Site
Olomouc, 775 20
Research Site
Plzen Bory, 305 99
Research Site
Prague, 140 59
Research Site
Prague, 180 01
Israel4 sites
Research Site
Haifa, 34362
Research Site
Jerusalem, 91120
Research Site
Kfar Saba, 4428164
Research Site
Petah Tikva, 49100
Russia4 sites
Research Site
Kazan', 420103
Research Site
Saint Petersburg, 197022
Research Site
Yaroslavl, 150003
Research Site
Yekaterinburg, 620039
Belgium3 sites
Research Site
Brussels, 1070
Research Site
Leuven, 3000
Research Site
Yvoir, 5530
Netherlands3 sites
Research Site
Amsterdam, 1091 AC
Research Site
Nieuwegein, 3435 CM
Research Site
Rotterdam, 3015 CE
South Korea3 sites
Research Site
Seongnam-si, Gyeonggi-do, 13620
Research Site
Seoul, 05505
Research Site
Seoul, 3080
Argentina2 sites
Research Site
Mar del Plata, Buenos Aires, B7600FZ
Research Site
San Miguel de Tucumán, Tucumán Province, 4000
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis
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.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- BG00011, Placebo
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BG00011Drug
Administered as specified in the treatment arm.
PlaceboDrug
Administered as specified in the treatment arm.
| Study group | Role | What they receive |
|---|---|---|
| BG00011 | Experimental | Participants will receive BG00011 56 mg once weekly by subcutaneous (SC) injection for 52 weeks. Receives: Drug: BG00011 |
| Placebo | Placebo comparator | Participants will receive placebo once weekly by (SC) injection for 52 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Forced (Expiratory) Vital Capacity (FVC) at Week 52
FVC is the total amount of air exhaled during the forced expiratory volume test that is measured during spirometry and is the most important measurement of lung function. This test requires participant to breath into a tube connected to a machine that measures the amount of air that can be moved in and out of the lungs. Change from baseline is defined as post-baseline value minus baseline value. A negative change from baseline indicates decline.
Measured: Baseline, Week 52
Secondary outcomes (19)
Change From Baseline in FVC, Expressed in Percent Predicted at Week 52
FVC is the total amount of air exhaled during the forced expiratory volume test that is measured during spirometry and is the most important measurement of lung function. This test requires participant to breath into a tube connected to a machine that measures the amount of air that can be moved in and out of the lungs after taking an inhaled bronchodilator medicine which is used to dilate participant's bronchial (breathing) tubes. Percent predicted FVC (in %, here FVC was measured in litres) = [(observed FVC)/(predicted FVC)]*100. Change from baseline is defined as post-baseline value minus baseline value. A negative change from baseline indicates decline.
Measured: Baseline, Week 52
Time to Progression
Time to progression is 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. The earliest time to meet at least 1 composite criterion was calculated.
Measured: Up to Week 60 (End of Study)
Time to First Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation
Time to first acute IPF exacerbation is defined as time from randomization to the first occurrence of acute IPF exacerbation. Acute IPF exacerbation is defined as a clinically significant deterioration of unidentifiable cause in a participant with underlying IPF. The diagnostic criteria for IPF used in this study were derived from evidence-based guidelines developed by the American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association (ATS/ERS/JRS/ALAT) joint task force for the diagnosis and management of IPF. Participants were assessed according to the modified 2007 diagnostic criteria for acute IPF exacerbation.
Measured: Up to Early Termination Visit (Up to Week 52)
Number of Participants With at Least One Acute IPF Exacerbation
Acute IPF exacerbation is defined as a clinically significant deterioration of unidentifiable cause in a participant with underlying IPF. The diagnostic criteria for IPF used in this study were derived from evidence-based guidelines developed by the American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association (ATS/ERS/JRS/ALAT) joint task force for the diagnosis and management of IPF. Participants were assessed according to the modified 2007 diagnostic criteria for acute IPF exacerbation.
Measured: Up to Early Termination Visit (Up to Week 52)
Number of IPF Exacerbations
The IPF exacerbation is defined as a clinically significant deterioration of unidentifiable cause in a participant with underlying IPF. The diagnostic criteria for IPF used in this study were derived from evidence-based guidelines developed by the American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association (ATS/ERS/JRS/ALAT) joint task force for the diagnosis and management of IPF. Participants were assessed according to the modified 2007 diagnostic criteria for acute IPF exacerbation.
Measured: Up to Early Termination Visit (Up to Week 52)
Number of Participants With Absolute Decline of 10% Predicted in FVC
FVC is the is the total amount of air exhaled during the forced expiratory volume test that is measured during spirometry and is the most important measurement of lung function. This test requires participant to breath into a tube connected to a machine that measures the amount of air that can be moved in and out of the lungs after taking an inhaled bronchodilator medicine which is used to dilate participant's bronchial (breathing) tubes. Absolute Decline of 10% = FVC percent predicted (baseline) - FVC percent predicted (progression) ≥10%.
Measured: Up to Early Termination Visit (Up to Week 52)
Time to Death or Lung Transplantation
Time to Death or Lung Transplantation is defined as the time from randomization to the first occurrence of any one of the event (death or lung transplantation).
Measured: Up to Week 60 (End of Study)
Time to All Non-elective Hospitalizations
Time to all non-elective hospitalizations is defined as the time from randomization to the first occurrence of hospitalization which was not elected by the participant.
Measured: Up to Week 60 (End of Study)
Time to All Non-Elective Respiratory Hospitalizations
Time to all non-elective respiratory hospitalizations is defined as the time from randomization to the first occurrence of hospitalization due to respiratory problems, which was not elected by the participant.
Measured: Up to Week 60 (End of Study)
Change From Baseline in Absolute FVC
FVC is the total amount of air exhaled during the forced expiratory volume test that is measured during spirometry and is the most important measurement of lung function. This test requires participant to breath into a tube connected to a machine that measures the amount of air that can be moved in and out of the lungs after taking an inhaled bronchodilator medicine which is used to dilate participant's bronchial (breathing) tubes. Change from baseline is defined as post-baseline value minus baseline value. A negative change from baseline indicates decline.
Measured: Up to Week 44
Change From Baseline in Percent Predicted FVC
FVC is the total amount of air exhaled during the forced expiratory volume test that is measured during spirometry and is the most important measurement of lung function. This test requires participant to breath into a tube connected to a machine that measures the amount of air that can be moved in and out of the lungs after taking an inhaled bronchodilator medicine which is used to dilate participant's bronchial (breathing) tubes. Percent predicted FVC (in %) = [(observed FVC)/(predicted FVC)]*100. Change from baseline is defined as post-baseline value minus baseline value. A negative change from baseline indicates decline.
Measured: Up to Week 44
Change From Baseline in Absolute Carbon Monoxide Diffusion Capacity (DLco)
DLCO is a measurement of the ability of the lungs to transfer gases from the air to the blood. Evaluation of DLco was be performed by single-breath carbon monoxide diffusing capacity. DLCO was assessed in milliliters per minute per millimeter of mercury (mL/min/mmHg). Change from baseline is defined as post-baseline value minus baseline value. A negative change from baseline indicates decline.
Measured: Up to Early Termination Visit (Up to Week 52)
Change From Baseline in Percent Predicted Carbon Monoxide Diffusion Capacity (DLco)
DLCO is a measurement of the ability of the lungs to transfer gases from the air to the blood. Evaluation of DLco was be performed by single-breath carbon monoxide diffusing capacity. Percent of predicted DLco (in %) = [(observed DLco)/(predicted DLco)]*100. Change from baseline is defined as post-baseline value minus baseline value. A negative change from baseline indicates decline.
Measured: Up to Early Termination Visit (Up to Week 52)
Change From Baseline in Absolute Total Lung Capacity (TLC)
Total lung capacity is the measure of lung volume was measured by full-body plethysmography. Change from baseline is defined as post-baseline value minus baseline value. A negative change from baseline indicates decline.
Measured: Up to Early Termination Visit (Up to Week 52)
Change From Baseline in Percent Predicted TLC
Total lung capacity is the measure of lung volume was measured by full-body plethysmography. Percent predicted TLC (in %) = [(observed TLC)/(predicted TLC)]*100. Change from baseline is defined as post-baseline value minus baseline value. A negative change from baseline indicates decline.
Measured: Up to Early Termination Visit (Up to Week 52)
Change From Baseline in 6 Minute Walk Test (6MWT) Parameters
The 6MWT measures the distance (in meters), a participant is able to walk in 6 minutes. This test measures the distance a person can walk quickly on a flat, hard surface in 6 minutes and reflects an individual's ability to perform daily physical activities.
Measured: Baseline, Week 26 and Week 52
Number 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.
Measured: Up to Week 60 (End of Study)
Number of Participants With Anti-BG00011 Antibodies in the Serum
Measured: Up to Week 60 (End of Study)
Concentration of BG00011 in the Serum
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2018
- Study start24 Sep 2018
- Primary completion14 Nov 2019
- Study completion14 Nov 2019
Why it stopped: Study was stopped because of safety concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03573505
- Sponsor's protocol ID
- 203PF203
- Other IDs
- 2017-003158-18, 2017
- Acronym
- SPIRIT
- Status last verified
- Dec 2020
- First submitted
- 19 Jun 2018
- Last updated
- 11 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Raghu G, Mouded M, Chambers DC, Martinez FJ, Richeldi L, Lancaster LH, Hamblin MJ, Gibson KF, Rosas IO, Prasse A, Zhao G, Serenko M, Novikov N, McCurley A, Bansal P, Stebbins C, Arefayene M, Ibebunjo S, Violette SM, Gallagher D, Behr J. A Phase IIb Randomized Clinical Study of an Anti-alphavbeta6 Monoclonal Antibody in Idiopathic Pulmonary Fibrosis. Am J Respir Crit Care Med. 2022 Nov 1;206(9):1128-1139. doi: 10.1164/rccm.202112-2824OC.
PubMed 35771569Shenderov K, Collins SL, Powell JD, Horton MR. Immune dysregulation as a driver of idiopathic pulmonary fibrosis. J Clin Invest. 2021 Jan 19;131(2):e143226. doi: 10.1172/JCI143226.
PubMed 33463535
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT03573505
- Acronym / sponsor ID
- SPIRIT / 203PF203
- Conditions
- Idiopathic Pulmonary Fibrosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was stopped because of safety concerns.
- Enrolment
- 109 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 24 Sep 2018 (actual)
- Primary completion
- 14 Nov 2019 (actual)
- Study completion
- 14 Nov 2019 (actual)
- First posted
- 29 Jun 2018 (actual)
- Results
- Posted 20 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BG00011 | Experimental | Drug: BG00011Participants will receive BG00011 56 mg once weekly by subcutaneous (SC) injection for 52 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo once weekly by (SC) injection for 52 weeks. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BG00011Administered as specified in the treatment arm. | Drug | BG00011 |
| PlaceboAdministered as specified in the treatment arm. | Drug | Placebo |
Primary outcome
Change From Baseline in Forced (Expiratory) Vital Capacity (FVC) at Week 52
Time frame: Baseline, Week 52
FVC is the total amount of air exhaled during the forced expiratory volume test that is measured during spirometry and is the most important measurement of lung function. This test requires participant to breath into a tube connected to a machine that measures the amount of air that can be moved in and out of the lungs. Change from baseline is defined as post-baseline value minus baseline value. A negative change from baseline indicates decline.
19 secondary outcomes
Change From Baseline in FVC, Expressed in Percent Predicted at Week 52
Time frame: Baseline, Week 52
Time to Progression
Time frame: Up to Week 60 (End of Study)
Time to First Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation
Time frame: Up to Early Termination Visit (Up to Week 52)
Number of Participants With at Least One Acute IPF Exacerbation
Time frame: Up to Early Termination Visit (Up to Week 52)
Number of IPF Exacerbations
Time frame: Up to Early Termination Visit (Up to Week 52)
Number of Participants With Absolute Decline of 10% Predicted in FVC
Time frame: Up to Early Termination Visit (Up to Week 52)
Time to Death or Lung Transplantation
Time frame: Up to Week 60 (End of Study)
Time to All Non-elective Hospitalizations
Time frame: Up to Week 60 (End of Study)
Time to All Non-Elective Respiratory Hospitalizations
Time frame: Up to Week 60 (End of Study)
Change From Baseline in Absolute FVC
Time frame: Up to Week 44
Change From Baseline in Percent Predicted FVC
Time frame: Up to Week 44
Change From Baseline in Absolute Carbon Monoxide Diffusion Capacity (DLco)
Time frame: Up to Early Termination Visit (Up to Week 52)
Change From Baseline in Percent Predicted Carbon Monoxide Diffusion Capacity (DLco)
Time frame: Up to Early Termination Visit (Up to Week 52)
Change From Baseline in Absolute Total Lung Capacity (TLC)
Time frame: Up to Early Termination Visit (Up to Week 52)
Change From Baseline in Percent Predicted TLC
Time frame: Up to Early Termination Visit (Up to Week 52)
Change From Baseline in 6 Minute Walk Test (6MWT) Parameters
Time frame: Baseline, Week 26 and Week 52
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to Week 60 (End of Study)
Number of Participants With Anti-BG00011 Antibodies in the Serum
Time frame: Up to Week 60 (End of Study)
Concentration of BG00011 in the Serum
Time frame: 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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35771569Raghu G, Mouded M, Chambers DC, Martinez FJ, Richeldi L, Lancaster LH, Hamblin MJ, Gibson KF, Rosas IO, Prasse A, Zhao G, Serenko M, Novikov N, McCurley A, Bansal P, Stebbins C, Arefayene M, Ibebunjo S, Violette SM, Gallagher D, Behr J. A Phase IIb Randomized Clinical Study of an Anti-alphavbeta6 Monoclonal Antibody in Idiopathic Pulmonary Fibrosis. Am J Respir Crit Care Med. 2022 Nov 1;206(9):1128-1139. doi: 10.1164/rccm.202112-2824OC.
- Derived from this study: PubMed 33463535Shenderov K, Collins SL, Powell JD, Horton MR. Immune dysregulation as a driver of idiopathic pulmonary fibrosis. J Clin Invest. 2021 Jan 19;131(2):e143226. doi: 10.1172/JCI143226.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Biogen
90 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BG00011 in people with Idiopathic Pulmonary Fibrosis, run by Biogen at 90 sites in 17 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 90 sites in United States, Australia, United Kingdom, Spain, France and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Forced (Expiratory) Vital Capacity (FVC) at Week 52 (time frame: Baseline, Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03573505, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2020.