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

NCT03573505 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: 203PF2032017-003158-18
• Study Type: interventional
• Target: 109
• Locations: 17 countries
• Sites: 90

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.

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, Week 52

Secondary Outcomes (19)

• Change From Baseline in FVC, Expressed in Percent Predicted at Week 52

  Baseline, Week 52

• Time to Progression

  Up to Week 60 (End of Study)

• Time to First Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation

  Up to Early Termination Visit (Up to Week 52)

• Number of Participants With at Least One Acute IPF Exacerbation

  Up to Early Termination Visit (Up to Week 52)

• Number of IPF Exacerbations

  Up to Early Termination Visit (Up to Week 52)

Study Arms (2)

BG00011

EXPERIMENTAL

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

Drug: BG00011

Placebo

PLACEBO COMPARATOR

Participants will receive placebo once weekly by (SC) injection for 52 weeks.

Drug: Placebo

Interventions

BG00011 DRUG

Administered as specified in the treatment arm.

BG00011

Placebo DRUG

Administered as specified in the treatment arm.

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead

Study Sites (90)

Research Site

Birmingham, Alabama, 35294, United States

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Phoenix, Arizona, 85006, United States

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Phoenix, Arizona, 85013, United States

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Los Angeles, California, 90048, United States

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New Haven, Connecticut, 06510-3221, United States

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Miami, Florida, 33125, United States

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Atlanta, Georgia, 30322, United States

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Iowa City, Iowa, 52242, United States

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Boston, Massachusetts, 02114, United States

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Boston, Massachusetts, 02115, United States

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Minneapolis, Minnesota, 55407, United States

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Rochester, Minnesota, 55905, United States

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Chesterfield, Missouri, 63017, United States

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Kansas City, Missouri, 66160, United States

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Lebanon, New Hampshire, 03756, United States

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New York, New York, 10029, United States

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Cleveland, Ohio, 44195, United States

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Pittsburgh, Pennsylvania, 15213, United States

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Providence, Rhode Island, 02903, United States

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Charleston, South Carolina, 29425, United States

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Nashville, Tennessee, 37232, United States

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Houston, Texas, 77030, United States

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Falls Church, Virginia, 22042, United States

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Seattle, Washington, 98195, United States

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Tacoma, Washington, 98405, United States

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Madison, Wisconsin, 53792, United States

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Mar del Plata, Buenos Aires, B7600FZ, Argentina

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San Miguel de Tucumán, Tucumán Province, 4000, Argentina

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Darlinghurst, New South Wales, 2010, Australia

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New Lambton Heights, New South Wales, 2305, Australia

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Newtown, New South Wales, 2042, Australia

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Chermside, Queensland, 4032, Australia

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Nundah, Queensland, 4012, Australia

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Woolloongabba, Queensland, 4102, Australia

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Frankston, Victoria, 3939, Australia

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Melbourne, Victoria, 3004, Australia

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Murdoch, Western Australia, 6150, Australia

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Heidelberg, 3084, Australia

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Brussels, 1070, Belgium

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Leuven, 3000, Belgium

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Yvoir, 5530, Belgium

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Talca, 3465586, Chile

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Olomouc, 775 20, Czechia

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Plzen Bory, 305 99, Czechia

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Prague, 140 59, Czechia

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Prague, 180 01, Czechia

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Aarhus C, 8000, Denmark

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Hellerup, 2900, Denmark

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Montpellier, Herault, 34295, France

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Rennes, Ille Et Vilaine, 35033, France

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Paris, Paris, 75877, France

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Bron, Rhone, 69677, France

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Bobigny, Seine Saint Denis, 93009, France

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Heraklion, 71110, Greece

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Larissa, 41110, Greece

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Haifa, 34362, Israel

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Jerusalem, 91120, Israel

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Kfar Saba, 4428164, Israel

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Petah Tikva, 49100, Israel

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Forlì, Cesena, 47100, Italy

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Catania, 95123, Italy

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Milan, 20123, Italy

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Roma, 00168, Italy

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Siena, 53100, Italy

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Amsterdam, 1091 AC, Netherlands

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Nieuwegein, 3435 CM, Netherlands

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Rotterdam, 3015 CE, Netherlands

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Gdansk, 80-952, Poland

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Warsaw, 01-138, Poland

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Kazan', 420103, Russia

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Saint Petersburg, 197022, Russia

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Yaroslavl, 150003, Russia

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Yekaterinburg, 620039, Russia

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Seongnam-si, Gyeonggi-do, 13620, South Korea

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Seoul, 05505, South Korea

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Seoul, 3080, South Korea

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L'Hospitalet de Llobregat, Barcelona, 08907, Spain

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Barcelona, 08006, Spain

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Barcelona, 08025, Spain

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Madrid, 28006, Spain

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Seville, 41013, Spain

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Valencia, 46014, Spain

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Cambridge, Cambridgeshire, CB2 0AY, United Kingdom

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Exeter, Devon, EX2 5DW, United Kingdom

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London, Greater London, SW3 6NP, United Kingdom

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London, Greater London, W12 0HS, United Kingdom

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Edinburgh, Lothian Region, EH4 2XU, United Kingdom

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Liverpool, Merseyside, L9 7AL, United Kingdom

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Newcastle, Tyne & Wear, NE1 4LP, United Kingdom

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Leeds, West Yorkshire, LS9 7TF, United Kingdom

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Related Publications (2)

• 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.

  PMID: 35771569 DERIVED

• Shenderov 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.

  PMID: 33463535 DERIVED

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

The study was terminated early due to safety findings.

Results Point of Contact

• Title: US Biogen Clinical Trial Center
• Organization: Biogen

clinicaltrials@biogen.com

866-633-4636

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2018
• First Posted: June 29, 2018
• Study Start: September 24, 2018
• Primary Completion: November 14, 2019
• Study Completion: November 14, 2019
• Last Updated: December 11, 2020
• Results First Posted: November 20, 2020

Record last verified: 2020-12

Locations

US (26); IL (4); BE (3); AR (2); DK (2); IT (5); NL (3); CZ (4); PL (2); CL (1); FR (5); GR (2); AU (10); RU (4); KR (3); ES (6); GB (8)