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



Status:Recruiting
Conditions:Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:40 - 90
Updated:4/21/2016
Start Date:January 2013
End Date:May 2016
Contact:Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email:
Email:Clinical.Trials@bms.com

Use our guide to learn which trials are right for you!

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).


Inclusion Criteria:

- 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.

1. Women must have a negative urine pregnancy test within 24 hours prior to the
start of investigational product.

2. Women must not be breastfeeding.

3. 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.

4. Women who are not of childbearing potential (i.e., who are postmenopausal or
surgically sterile) and azoospermic men do not require contraception.

Exclusion Criteria:

Target Disease Exclusions

1. Has significant clinical worsening of IPF between screening and day 1 (during the
screening process), in the opinion of the investigator.

2. Has forced expiratory volume in 1 second (FEV1)/FVC ratio less than 0.8 after
administration of bronchodilator at screening.

3. 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

1. 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.

2. 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.

3. 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.

4. Currently has clinically significant asthma or chronic obstructive pulmonary disease.

5. Has clinical evidence of active infection, including, but not limited to, bronchitis,
pneumonia, sinusitis, urinary tract infection, and cellulitis.

6. 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).

7. 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.

8. Has a history of end-stage liver disease.

9. Has a history of end-stage renal disease requiring dialysis.

10. 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

11. 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.

12. Has a history of alcohol or substance abuse in the past 2 years.

13. Has a family or personal history of long QT syndrome and/or Torsades de Pointes
(polymorphic ventricular tachycardia).

14. 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

- Pitavastatin 2 mg QD

- Atorvastatin 40 mg QD

- Pravastatin 40 mg QD

- Rosuvastatin 20 mg QD

- Lovastatin 40 mg QD

- Fluvastatin 40 mg QD

- Prednisone is allowed up to a maximum of 15 mg po daily

- Pirfenidone or nintedanib dosing for a maximum of 3 months in the prior 12 months is
permitted with a 4 week washout period prior to dosing with BMS-986020.

Physical and Laboratory Test Findings

1. Has any of the following liver-function test criteria above the specified limits:
total bilirubin >1.5 x ULN, excluding subjects with Gilbert's syndrome; aspartate or
alanine aminotransferase (AST/SGOT or ALT/SGPT) greater than 3 x ULN; alkaline
phosphatase greater than 2.5 x ULN.

2. Has creatinine clearance less than 30 mL/minute, calculated using the Cockcroft-Gault
formula.

3. Has ECG result with a QT interval by Fridericia's correction (QTcF) of 500 msec or
greater or an uncorrected QT of 500 msec or greater at screening. Note: For subjects
with a machine read QT interval of >500 msec, if their heart rate is > 100 bpm, the
machine read QT interval (either corrected or not) may not be accurate. If the
investigator is uncertain about the QT abnormality, it is recommended that ECGs be
over-read by a cardiologist. The manually read QT interval by a cardiologist should
be used for assessment of eligibility whenever possible.

Allergies and Adverse Drug Reaction Has had prior use of BMS-986020 or has known
hypersensitivity to any of the components of study treatment.

Other Exclusion Criteria

1. Is not a suitable candidate for enrollment or is unlikely to comply with the
requirements of this study, in the opinion of the investigator.

2. Has smoked cigarettes within 4 weeks or screening or is unwilling to avoid tobacco
products throughout the study.

3. Is expected to receive a lung transplant within 1 year from randomization or, for
subjects at sites in the United States, is on a lung-transplant waiting list at
screening.

4. Prisoners or subjects who are involuntarily incarcerated.

5. Subjects who are compulsorily detained for treatment either of a psychiatric or
physical (e.g., infectious disease) illness.

6. Inability to comply with restrictions and prohibited activities/treatments as listed
in Section 3.3 of the Protocol.
We found this trial at
53
sites
5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Phone: 773-834-4053
University of Chicago One of the world's premier academic and research institutions, the University of...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Phone: 410-550-2062
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Phone: 617-525-9331
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
?
mi
from
Boston, MA
Click here to add this to my saved trials
330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Phone: 617-667-4905
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
?
mi
from
Boston, MA
Click here to add this to my saved trials
9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Phone: 216-445-0574
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
5323 Harry Hines Blvd
Dallas, Texas 75235
(214) 648-3111
Phone: 214-645-6489
Univ of Texas, Southwestern Med Ctr of Dallas The story of UT Southwestern Medical Center...
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Gainesville, Florida 32610
(352) 392-3261
Phone: 352-273-8666
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
?
mi
from
Gainesville, FL
Click here to add this to my saved trials
8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Phone: 310-423-4765
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Minneapolis, Minnesota 55455
(612) 625-5000
Phone: 612-625-7719
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Phone: 503-494-9570
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
?
mi
from
Portland, OR
Click here to add this to my saved trials
201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
Phone: 801-581-5864
University of Utah Research is a major component in the life of the U benefiting...
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
Phone: 734-936-8301
University of Michigan Health System The University of Michigan is home to one of the...
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Asheville, North Carolina 28801
Phone: 828-225-5241
?
mi
from
Asheville, NC
Click here to add this to my saved trials
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Chesterfield, Missouri 63017
Phone: 314-439-5864
?
mi
from
Chesterfield, MO
Click here to add this to my saved trials
Cincinnati, Ohio 45219
Phone: 513-558-0027
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
?
mi
from
Clearwater, FL
Click here to add this to my saved trials
Colchester, Vermont 05446
Phone: 802-847-2193
?
mi
from
Colchester, VT
Click here to add this to my saved trials
281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Phone: 614-336-2361
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Daytona Beach, Florida 32117
Phone: 336-677-6672
?
mi
from
Daytona Beach, FL
Click here to add this to my saved trials
1400 Jackson St
Denver, Colorado 80206
(303) 388-4461
Phone: 303-398-1708
National Jewish Health National Jewish Health is known worldwide for treatment of patients with respiratory,...
?
mi
from
Denver, CO
Click here to add this to my saved trials
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Phone: 919-613-6246
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
?
mi
from
Durham, NC
Click here to add this to my saved trials
Falls Church, Virginia 22042
Phone: 703-776-6147
?
mi
from
Falls Church, VA
Click here to add this to my saved trials
Forest Hills, New York 11375
Phone: 888-795-5255
?
mi
from
Forest Hills, NY
Click here to add this to my saved trials
1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Phone: 603-650-4711
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
?
mi
from
Lebanon, NH
Click here to add this to my saved trials
Lexington, Kentucky 40536
Phone: 859-323-2737
?
mi
from
Lexington, KY
Click here to add this to my saved trials
10833 Le Conte Ave
Los Angeles, California 90095
(310) 825-4321
Phone: 310-794-2466
David Geffen School of Medicine, UCLA In 2002 Mr. David Geffen announced a $200 million...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
500 S Preston St
Louisville, Kentucky
(502) 852-5555
Phone: 502-852-1358
University of Louisville The University of Louisville is a state supported research university located in...
?
mi
from
Louisville, KY
Click here to add this to my saved trials
600 Highland Ave
Madison, Wisconsin 53792
(608) 263-6400
Phone: 608-262-3456
University of Wisconsin Hospital and Clinics UW Health strives to meet the health needs of...
?
mi
from
Madison, WI
Click here to add this to my saved trials
McKinney, Texas 75069
Phone: 972-838-1892
?
mi
from
McKinney, TX
Click here to add this to my saved trials
Miami, Florida 33136
Phone: 305-243-3728
?
mi
from
Miami, FL
Click here to add this to my saved trials
2201 West End Ave
Nashville, Tennessee 37232
(615) 322-7311
Phone: 615-343-7068
Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
?
mi
from
Nashville, TN
Click here to add this to my saved trials
New Haven, Connecticut 06511
Phone: 203-785-7324
?
mi
from
New Haven, CT
Click here to add this to my saved trials
New Orleans, Louisiana 70112
Phone: 504-988-4040
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
New York, New York 10021
Phone: 646-962-5568
?
mi
from
New York, NY
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19140
Phone: 215-707-9842
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Portland, Oregon 97210
Phone: 503-963-3182
?
mi
from
Portland, OR
Click here to add this to my saved trials
Rochester, Minnesota 55905
Phone: 507-293-0637
?
mi
from
Rochester, MN
Click here to add this to my saved trials
Rochester, New York 14620
Phone: 585-341-6774
?
mi
from
Rochester, NY
Click here to add this to my saved trials
San Antonio, Texas 78212
Phone: 210-223-3010
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Francisco, California 94143
Phone: 415-502-1958
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
St. Louis, Missouri 63108
Phone: 314-747-1217
?
mi
from
St. Louis, MO
Click here to add this to my saved trials
300 Pasteur Dr
Stanford, California 94305
(650) 723-4000
Phone: 650-725-8083
Stanford Univ Med Ctr The Medical Center is uniquely advantaged by its location on the...
?
mi
from
Stanford, CA
Click here to add this to my saved trials
Summit, New Jersey 07901
Phone: 908-934-0440
?
mi
from
Summit, NJ
Click here to add this to my saved trials
Tacoma, Washington 98405
?
mi
from
Tacoma, WA
Click here to add this to my saved trials
Tyler, Texas 75708
Phone: 903-877-5518
?
mi
from
Tyler, TX
Click here to add this to my saved trials
Westmead, New South Wales 2145
?
mi
from
Westmead,
Click here to add this to my saved trials
Weston, Florida 33331
Phone: 954-659-6247
?
mi
from
Weston, FL
Click here to add this to my saved trials
Wichita, Kansas 67028
Phone: 316-689-9542
?
mi
from
Wichita, KS
Click here to add this to my saved trials
Winter Park, Florida 32789
?
mi
from
Winter Park, FL
Click here to add this to my saved trials