Safety and Efficacy of a Lysophosphatidic Acid Receptor Antagonist in Idiopathic Pulmonary Fibrosis

Completed · Phase 2 · Has a placebo group

Conditions studied: Idiopathic Pulmonary Fibrosis

In brief

The purpose of this study is to determine if study drug (BMS-986020) dose of 600 mg once daily or 600 mg twice daily for 26 weeks compared with placebo will reduce the decline in forced vital capacity (FVC) and will be well tolerated in subjects with idiopathic pulmonary fibrosis (IPF).

Key facts

Study ID

NCT01766817

Run by

Bristol-Myers Squibb

People needed

325

Starts

2013-01-31

Expected to finish

2016-02-29

Last updated by the study team

2020-08-11

Who can join

Age: 40 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Are between the ages of 40 and 90 years, inclusive, at randomization.
• Have clinical symptoms consistent with IPF.
• Have first received a diagnosis of IPF less than 6 years before randomization. The date of diagnosis is defined as the date of the first available imaging or surgical lung biopsy consistent with IPF/UIP.
• Have a diagnosis of usual interstitial pulmonary fibrosis (UIP) or IPF by HRCT or surgical lung biopsy (SLB).
• Extent of fibrotic changes (honeycombing, reticular changes) greater than the extent of emphysema on HRCT scan.
• Have no features supporting an alternative diagnosis on transbronchial biopsy, BAL, or SLB, if performed.
• Have percent predicted post-bronchodilator FVC between 45% and 90%, inclusive, at screening.
• Have a change in post-bronchodilator FVC (measured in liters) between screening and day 1 that is less than a 10% relative difference, calculated as: the absolute value of 100% * (screening FVC (L) - day 1 FVC (L)) / screening FVC (L).
• Have carbon monoxide diffusing capacity (DLCO) between 30% and 80% (adjusted for hemoglobin and altitude), inclusive, at screening.
• Have no evidence of improvement in measures of IPF disease severity over the preceding year, in the investigator's opinion.
• Be able to walk 150 meters or more at screening.
• Demonstrate an exertional decrease in oxygen saturation of 2 percentage points or greater at screening (may be performed with supplemental oxygen titrating to keep oxygen saturation levels >88%).
• Are able to understand and sign a written informed consent form.
• Are able to understand the importance of adherence to study treatment and the study protocol and are willing to comply with all study requirements, including the concomitant medication restrictions, throughout the study.
• Women of childbearing potential (WOCBP) and men who are sexually active with WOCBP must use acceptable method(s) of contraception. The individual methods of contraception and duration should be determined in consultation with the investigator. WOCBP must follow instructions for birth control when the half-life of the investigational drug is less than 24 hours, contraception should be continued for a period of 30 days after the last dose of investigational product.
• Women must have a negative urine pregnancy test within 24 hours prior to the start of investigational product.
• Women must not be breastfeeding.
• Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. Men that are sexually active with WOCBP must follow instructions for birth control when the half-life of the investigational drug is less than 24 hours, contraception should be continued for a period of 90 days after the last dose of investigational product.
• Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) and azoospermic men do not require contraception.

You may not qualify if…

• Target Disease Exclusions
• Has significant clinical worsening of IPF between screening and day 1 (during the screening process), in the opinion of the investigator.
• Has forced expiratory volume in 1 second (FEV1)/FVC ratio less than 0.8 after administration of bronchodilator at screening.
• Has bronchodilator response, defined by an absolute increase of 12% or greater and an increase of 200 mL in FEV1 or FVC or both after bronchodilator use compared with the values before bronchodilator use at screening.
• Medical History and Concurrent Diseases
• Has a history of clinically significant environmental exposure known to cause pulmonary fibrosis, including, but not limited to, drugs (such as amiodarone), asbestos, beryllium, radiation, and domestic birds.
• Has a known explanation for interstitial lung disease, including, but not limited to, radiation, drug toxicity, sarcoidosis, hypersensitivity, pneumonitis, bronchiolitis, obliterans, organizing pneumonia, human immunodeficiency virus (HIV), viral hepatitis, and cancer.
• Has a clinical diagnosis of any connective tissue disease, including, but not limited to, scleroderma, polymyositis/dermatomyositis, systemic lupus erythematosus, rheumatoid arthritis, and undifferentiated connective tissue disease.
• Currently has clinically significant asthma or chronic obstructive pulmonary disease.
• Has clinical evidence of active infection, including, but not limited to, bronchitis, pneumonia, sinusitis, urinary tract infection, and cellulitis.
• Has any history of malignancy likely to result in significant disability or likely to require significant medical or surgical intervention within the next 2 years. This does not include minor surgical procedures for localized cancer (e.g., basal cell carcinoma).
• Has any condition other than IPF that, in the opinion of the investigator, is likely to result in the death of the subject within the next 2 years.
• Has a history of end-stage liver disease.
• Has a history of end-stage renal disease requiring dialysis.
• Has a history of unstable or deteriorating cardiac or pulmonary disease (other than IPF) within the previous 6 months, including, but not limited to, the following: i. Unstable angina pectoris or myocardial infarction ii. Congestive heart failure requiring hospitalization iii. Uncontrolled clinically significant arrhythmias
• Has any condition that, in the opinion of the investigator, might be significantly exacerbated by the known side effects associated with the administration of BMS-986020.
• Has a history of alcohol or substance abuse in the past 2 years.
• Has a family or personal history of long QT syndrome and/or Torsades de Pointes (polymorphic ventricular tachycardia).
• Has used any of the excluded medications per Appendix 1 of the Protocol, which includes, but is not limited to:
• current treatment with pirfenidone or nintedanib
• use of over-the-counter medications and herbal preparations, within 4 weeks before study drug administration except those medications cleared by the BMS medical monitor
• For subjects taking statins, there are restrictions on the maximum allowable doses for statins listed below. If subjects are currently taking statins and their doses are higher than those mentioned below, please reduce the dose to the maximum allowable dose.
• Additionally, if subjects are on statins and ready to start dosing, these subjects should limit statin doses by maximal allowable dose or lower for at least 5 days prior to the first BMS-986020 dosing. Shorter durations may be considered in select cases after discussion with the medical monitor.
• Maximum allowable dose for statins:
• Simvastatin 20 mg QD

Where it is running

• St. Joseph's Hospital and Medical Center - Heart Lung Institute/ Clinical Research — Phoenix, Arizona, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• David Geffen School of Medicine at UCLA — Los Angeles, California, United States
• University of California at San Francisco — San Francisco, California, United States
• Stanford University Medical Center — Stanford, California, United States
• National Jewish Health — Denver, Colorado, United States
• Yale University School of Medicine, Section of Pulmonary & Critical Care — New Haven, Connecticut, United States
• Advanced Pulmonary & Sleep Research Institute of Florida — Daytona Beach, Florida, United States
• University of Florida — Gainesville, Florida, United States
• ILD Research Center — Miami, Florida, United States
• Cleveland Clinic Florida- Weston Hospital — Weston, Florida, United States
• University of Chicago — Chicago, Illinois, United States
• Via Christi Clinic — Wichita, Kansas, United States
• University of Kentucky- Center for Clinical and Translational Science — Lexington, Kentucky, United States
• University of Louisville — Louisville, Kentucky, United States
• Tulane University — New Orleans, Louisiana, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• University of Michigan Health System — Ann Arbor, Michigan, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Mayo Clinic, Pulmonary Clinical Research Unit — Rochester, Minnesota, United States
• CardioPulmonary Research Center — Chesterfield, Missouri, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• University of Alabama at Birmingham - Division of Pulmonary, Allergy & Criticial Care — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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