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

NCT ID: NCT03573505

Last Updated: 2020-12-11

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-24

Study Completion Date

2019-11-14

Brief Summary

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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.

Detailed Description

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Conditions

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Idiopathic Pulmonary Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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BG00011

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

Group Type EXPERIMENTAL

BG00011

Intervention Type DRUG

Administered as specified in the treatment arm.

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered as specified in the treatment arm.

Interventions

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BG00011

Administered as specified in the treatment arm.

Intervention Type DRUG

Placebo

Administered as specified in the treatment arm.

Intervention Type DRUG

Eligibility Criteria

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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.

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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biogen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Biogen

Locations

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Research Site

Birmingham, Alabama, United States

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Phoenix, Arizona, United States

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Phoenix, Arizona, United States

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Los Angeles, California, United States

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New Haven, Connecticut, United States

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Miami, Florida, United States

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Atlanta, Georgia, United States

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Iowa City, Iowa, United States

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Boston, Massachusetts, United States

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Boston, Massachusetts, United States

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Minneapolis, Minnesota, United States

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Rochester, Minnesota, United States

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Chesterfield, Missouri, United States

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Kansas City, Missouri, United States

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Lebanon, New Hampshire, United States

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New York, New York, United States

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Cleveland, Ohio, United States

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Pittsburgh, Pennsylvania, United States

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Providence, Rhode Island, United States

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Charleston, South Carolina, United States

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Nashville, Tennessee, United States

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Houston, Texas, United States

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Falls Church, Virginia, United States

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Seattle, Washington, United States

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Tacoma, Washington, United States

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Madison, Wisconsin, United States

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Mar del Plata, Buenos Aires, Argentina

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San Miguel de Tucumán, Tucumán Province, Argentina

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Darlinghurst, New South Wales, Australia

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New Lambton Heights, New South Wales, Australia

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Newtown, New South Wales, Australia

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Chermside, Queensland, Australia

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Nundah, Queensland, Australia

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Woolloongabba, Queensland, Australia

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Frankston, Victoria, Australia

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Melbourne, Victoria, Australia

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Murdoch, Western Australia, Australia

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Heidelberg, , Australia

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Brussels, , Belgium

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Leuven, , Belgium

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Yvoir, , Belgium

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Talca, , Chile

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Olomouc, , Czechia

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Plzen Bory, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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Aarhus C, , Denmark

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Hellerup, , Denmark

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Montpellier, Herault, France

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Rennes, Ille Et Vilaine, France

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Paris, Paris, France

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Bron, Rhone, France

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Bobigny, Seine Saint Denis, France

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Heraklion, , Greece

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Larissa, , Greece

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Haifa, , Israel

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Jerusalem, , Israel

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Kfar Saba, , Israel

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Petah Tikva, , Israel

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Forlì, Cesena, Italy

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Catania, , Italy

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Milan, , Italy

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Roma, , Italy

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Siena, , Italy

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Amsterdam, , Netherlands

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Nieuwegein, , Netherlands

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Rotterdam, , Netherlands

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Gdansk, , Poland

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Warsaw, , Poland

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Kazan', , Russia

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Saint Petersburg, , Russia

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Yaroslavl, , Russia

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Yekaterinburg, , Russia

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Seongnam-si, Gyeonggi-do, South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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L'Hospitalet de Llobregat, Barcelona, Spain

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Barcelona, , Spain

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Barcelona, , Spain

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Madrid, , Spain

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Seville, , Spain

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Valencia, , Spain

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Cambridge, Cambridgeshire, United Kingdom

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Exeter, Devon, United Kingdom

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London, Greater London, United Kingdom

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London, Greater London, United Kingdom

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Edinburgh, Lothian Region, United Kingdom

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Liverpool, Merseyside, United Kingdom

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Newcastle, Tyne & Wear, United Kingdom

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Leeds, West Yorkshire, United Kingdom

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Countries

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United States Argentina Australia Belgium Chile Czechia Denmark France Greece Israel Italy Netherlands Poland Russia South Korea Spain United Kingdom

References

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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.

Reference Type DERIVED
PMID: 35771569 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33463535 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2017-003158-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

203PF203

Identifier Type: -

Identifier Source: org_study_id