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

Study Purpose

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.

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Study Type
Interventional
Eligible Ages 40 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT03573505

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
Phase 2

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Biogen

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
Medical Director
Principal Investigator Affiliation Biogen

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Industry
Overall Status Recruiting
Countries Argentina, Australia, Belgium, Chile, Czechia, Denmark, France, Greece, Israel, Italy, Korea, Republic of, Netherlands, Poland, Russian Federation, Spain, United Kingdom, United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Idiopathic Pulmonary Fibrosis

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Research Site, Madison, Wisconsin

Status

Recruiting

Address

Research Site

Madison, Wisconsin, 53792

Research Site, Tacoma, Washington

Status

Active, not recruiting

Address

Research Site

Tacoma, Washington, 98405

Research Site, Seattle, Washington

Status

Recruiting

Address

Research Site

Seattle, Washington, 98195

Research Site, Falls Church, Virginia

Status

Recruiting

Address

Research Site

Falls Church, Virginia, 22042

Reserach Site, Houston, Texas

Status

Recruiting

Address

Reserach Site

Houston, Texas, 77030

Research Site, Nashville, Tennessee

Status

Recruiting

Address

Research Site

Nashville, Tennessee, 37232

Research Site, Charleston, South Carolina

Status

Recruiting

Address

Research Site

Charleston, South Carolina, 29425

Research Site, Providence, Rhode Island

Status

Recruiting

Address

Research Site

Providence, Rhode Island, 02903

Research Site, Pittsburgh, Pennsylvania

Status

Recruiting

Address

Research Site

Pittsburgh, Pennsylvania, 15213

Research Site, Cleveland, Ohio

Status

Recruiting

Address

Research Site

Cleveland, Ohio, 44195

Research Site, New York, New York

Status

Recruiting

Address

Research Site

New York, New York, 10029

Research Site, Lebanon, New Hampshire

Status

Recruiting

Address

Research Site

Lebanon, New Hampshire, 03756

Research Site, Kansas City, Missouri

Status

Recruiting

Address

Research Site

Kansas City, Missouri, 66160

Research Site, Chesterfield, Missouri

Status

Recruiting

Address

Research Site

Chesterfield, Missouri, 63017

Research Site, Rochester, Minnesota

Status

Recruiting

Address

Research Site

Rochester, Minnesota, 55905

Research Site, Minneapolis, Minnesota

Status

Recruiting

Address

Research Site

Minneapolis, Minnesota, 55407

Research Site, Boston, Massachusetts

Status

Recruiting

Address

Research Site

Boston, Massachusetts, 02115

Research Site, Boston, Massachusetts

Status

Recruiting

Address

Research Site

Boston, Massachusetts, 02114

Research Site, Atlanta, Georgia

Status

Recruiting

Address

Research Site

Atlanta, Georgia, 30322

Research Site, Miami, Florida

Status

Recruiting

Address

Research Site

Miami, Florida, 33125

Research Site, New Haven, Connecticut

Status

Recruiting

Address

Research Site

New Haven, Connecticut, 06510-3221

Research Site, Los Angeles, California

Status

Recruiting

Address

Research Site

Los Angeles, California, 90048

Research Site, Phoenix, Arizona

Status

Recruiting

Address

Research Site

Phoenix, Arizona, 85013

Research Site, Phoenix, Arizona

Status

Recruiting

Address

Research Site

Phoenix, Arizona, 85006

Research Site, Birmingham, Alabama

Status

Recruiting

Address

Research Site

Birmingham, Alabama, 35294

International Sites

Research Site, Leeds, West Yorkshire, United Kingdom

Status

Recruiting

Address

Research Site

Leeds, West Yorkshire, LS9 7TF

Research Site, Newcastle, Tyne & Wear, United Kingdom

Status

Recruiting

Address

Research Site

Newcastle, Tyne & Wear, NE1 4LP

Research Site, Liverpool, Merseyside, United Kingdom

Status

Recruiting

Address

Research Site

Liverpool, Merseyside, L9 7AL

Research Site, London, Greater London, United Kingdom

Status

Recruiting

Address

Research Site

London, Greater London, SW3 6NP

Research Site, Exeter, Devon, United Kingdom

Status

Recruiting

Address

Research Site

Exeter, Devon, EX2 5DW

Research Site, Cambridge, Cambridgeshire, United Kingdom

Status

Recruiting

Address

Research Site

Cambridge, Cambridgeshire, CB2 0AY

Research Site, Valencia, Spain

Status

Recruiting

Address

Research Site

Valencia, , 46014

Research Site, Madrid, Spain

Status

Recruiting

Address

Research Site

Madrid, , 28006

Research Site, Barcelona, Spain

Status

Recruiting

Address

Research Site

Barcelona, , 08025

Research Site, Barcelona, Spain

Status

Recruiting

Address

Research Site

Barcelona, , 08006

Research Site, L'Hospitalet de Llobregat, Barcelona, Spain

Status

Recruiting

Address

Research Site

L'Hospitalet de Llobregat, Barcelona, 08907

Research Site, Yaroslavl, Russian Federation

Status

Recruiting

Address

Research Site

Yaroslavl, , 150003

Research Site, Saint-Petersburg, Russian Federation

Status

Recruiting

Address

Research Site

Saint-Petersburg, , 197022

Research Site, Gdansk, Poland

Status

Recruiting

Address

Research Site

Gdansk, , 80-952

Research Site, Rotterdam, Netherlands

Status

Recruiting

Address

Research Site

Rotterdam, , 3015 CE

Research Site, Nieuwegein, Netherlands

Status

Recruiting

Address

Research Site

Nieuwegein, , 3435 CM

Research Site, Amsterdam, Netherlands

Status

Recruiting

Address

Research Site

Amsterdam, , 1091 AC

Research Site, Seoul, Korea, Republic of

Status

Recruiting

Address

Research Site

Seoul, , 3080

Research Site, Seoul, Korea, Republic of

Status

Recruiting

Address

Research Site

Seoul, , 05505

Research Site, Seongnam-si, Gyeonggi-do, Korea, Republic of

Status

Recruiting

Address

Research Site

Seongnam-si, Gyeonggi-do, 13620

Research Site, Roma, Italy

Status

Recruiting

Address

Research Site

Roma, , 00168

Research Site, Milano, Italy

Status

Recruiting

Address

Research Site

Milano, , 20123

Research Site, Catania, Italy

Status

Recruiting

Address

Research Site

Catania, , 95123

Research Site, Forli, Cesena, Italy

Status

Recruiting

Address

Research Site

Forli, Cesena, 47100

Research Site, Kfar-Saba, Israel

Status

Recruiting

Address

Research Site

Kfar-Saba, , 4428164

Research Site, Jerusalem, Israel

Status

Recruiting

Address

Research Site

Jerusalem, , 91120

Research Site, Haifa, Israel

Status

Recruiting

Address

Research Site

Haifa, , 34362

Research Site, Larissa, Greece

Status

Recruiting

Address

Research Site

Larissa, , 41110

Research Site, Heraklion, Greece

Status

Recruiting

Address

Research Site

Heraklion, , 71110

Research Site, Paris Cedex 18, Paris, France

Status

Recruiting

Address

Research Site

Paris Cedex 18, Paris, 75877

Research Site, Montpellier cedex 5, Herault, France

Status

Recruiting

Address

Research Site

Montpellier cedex 5, Herault, 34295

Research Site, Hellerup, Denmark

Status

Recruiting

Address

Research Site

Hellerup, , 2900

Research Site, Aarhus C, Denmark

Status

Recruiting

Address

Research Site

Aarhus C, , 8000

Research Site, Praha 8, Czechia

Status

Recruiting

Address

Research Site

Praha 8, , 180 01

Research Site, Praha 4, Czechia

Status

Recruiting

Address

Research Site

Praha 4, , 140 59

Research Site, Plzen Bory, Czechia

Status

Recruiting

Address

Research Site

Plzen Bory, , 305 99

Research Site, Olomouc, Czechia

Status

Recruiting

Address

Research Site

Olomouc, , 775 20

Research Site, Talca, Chile

Status

Recruiting

Address

Research Site

Talca, , 3465586

Research Site, Yvoir, Belgium

Status

Recruiting

Address

Research Site

Yvoir, , 5530

Research Site, Leuven, Belgium

Status

Recruiting

Address

Research Site

Leuven, , 3000

Research Site, Bruxelles, Belgium

Status

Recruiting

Address

Research Site

Bruxelles, , 1070

Research Site, Heidelberg, Australia

Status

Recruiting

Address

Research Site

Heidelberg, , 3084

Research Site, Murdoch, Western Australia, Australia

Status

Recruiting

Address

Research Site

Murdoch, Western Australia, 6150

Research Site, Melbourne, Victoria, Australia

Status

Recruiting

Address

Research Site

Melbourne, Victoria, 3004

Research Site, Frankston, Victoria, Australia

Status

Recruiting

Address

Research Site

Frankston, Victoria, 3939

Research Site, Woolloongabba, Queensland, Australia

Status

Recruiting

Address

Research Site

Woolloongabba, Queensland, 4102

Research Site, Nundah, Queensland, Australia

Status

Recruiting

Address

Research Site

Nundah, Queensland, 4012

Research Site, Chermside, Queensland, Australia

Status

Recruiting

Address

Research Site

Chermside, Queensland, 4032

Research Site, Newtown, New South Wales, Australia

Status

Recruiting

Address

Research Site

Newtown, New South Wales, 2042

Research Site, New Lambton Heights, New South Wales, Australia

Status

Recruiting

Address

Research Site

New Lambton Heights, New South Wales, 2305

Research Site, Darlinghurst, New South Wales, Australia

Status

Recruiting

Address

Research Site

Darlinghurst, New South Wales, 2010

Research Site, San Miguel de Tucuman, Tucuman, Argentina

Status

Recruiting

Address

Research Site

San Miguel de Tucuman, Tucuman, 4000

Research Site, Mar del Plata, Buenos Aires, Argentina

Status

Recruiting

Address

Research Site

Mar del Plata, Buenos Aires, B7600FZ

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