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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01766817
Registration number
NCT01766817
Ethics application status
Date submitted
10/01/2013
Date registered
11/01/2013
Date last updated
11/08/2020
Titles & IDs
Public title
Safety and Efficacy of a Lysophosphatidic Acid Receptor Antagonist in Idiopathic Pulmonary Fibrosis
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Scientific title
Safety and Efficacy of a Lysophosphatidic Acid Receptor Antagonist in Idiopathic Pulmonary Fibrosis
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Secondary ID [1]
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IM136-003
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Idiopathic Pulmonary Fibrosis
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Condition category
Condition code
Respiratory
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Other respiratory disorders / diseases
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Inflammatory and Immune System
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Connective tissue diseases
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - BMS-986020
Treatment: Drugs - Placebo matching with BMS-986020
Experimental: Arm 1: BMS 986020, 600 mg. once daily - BMS-986020, 600 mg tablets, by mouth, once daily, 26 weeks
Experimental: Arm 2: BMS-986020, 600 mg twice daily - BMS-986020, 600 mg tablets, by mouth, twice daily, 26 weeks
Placebo Comparator: Arm 3: Placebo matching with BMS-986020 - Placebo, 0 mg tablets, by mouth, twice daily, 26 weeks
Treatment: Drugs: BMS-986020
Treatment: Drugs: Placebo matching with BMS-986020
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline in Forced Vital Capacity (FVC) Rate to Week 26
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Assessment method [1]
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FVC is the 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 after taking an inhaled bronchodilator medicine which is used to dilate participant's bronchial (breathing) tubes.
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Timepoint [1]
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Baseline, Week 26
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Secondary outcome [1]
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Geometric Mean Ratio (GMR) of Quantitative Lung Fibrosis (QLF) Score at Week 26 to Baseline
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Assessment method [1]
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The QLF score itself ranges from 0 to 100%, where greater values represent a greater amount of lung fibrosis and are considered a worse health status. Hence smaller geometric mean ratios to baseline were considered favorable. Baseline included all testing done on Day -1 as well as predose on Day 1.
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Timepoint [1]
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Baseline, Week 26
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Secondary outcome [2]
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Mean Change From Baseline in Six-minute Walk Test (6MWT) Distance to Week 26
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Assessment method [2]
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The 6MWT measures the distance (in meters), a participant is able to walk in 6 minutes. This test measures the distance a person can walk quickly on a flat, hard surface in 6 minutes and reflects an individual's ability to perform daily physical activities. Baseline included all testing done on Day -1 as well as predose on Day 1
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Timepoint [2]
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Baseline, Week 26
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Secondary outcome [3]
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Mean Change From Baseline in the University of California at San Diego Shortness of Breath Questionnaire (UCSD SOBQ) Total Score as a Measure of Dyspnea to Week 26
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Assessment method [3]
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The UCSD SOBQ is a 24-item questionnaire developed to measure breathlessness on a scale between zero and five where 0 is not at all breathless and 5 is maximally breathless or too breathless to do the activity. Baseline included all testing done on Day -1 as well as predose on Day 1. The total score ranges from 0 to 120, with higher scores indicating worse dyspnea.
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Timepoint [3]
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Baseline, Week 26
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Secondary outcome [4]
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Mean Change From Baseline in Forced Vital Capacity (FVC) to Week 26
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Assessment method [4]
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FVC is 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 lungs after taking an inhaled bronchodilator medicine which is used to dilate bronchial (breathing) tubes. Baseline included all testing done on Day -1 as well as predose on Day 1
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Timepoint [4]
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Baseline, Week 26
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Secondary outcome [5]
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Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Study (MOS) 36-Item Short-Form Health Survey (SF-36) to Week 26
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Assessment method [5]
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The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the Aggregate Physical score of the SF-36. Items 5-8 primarily contribute to the Aggregate mental score of the SF-36. Scores on each item are summed and averaged. Range for Aggregate Physical Score : 0=worst to 100=best; and for Aggregate Mental Score: 0=worst to 100=best. Increases from baseline indicate improvement. Baseline included all testing done on Day -1 as well as predose on Day 1
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Timepoint [5]
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Baseline, Week 26
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Secondary outcome [6]
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Number of Participants With Death or Non-Elective Hospitalization
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Assessment method [6]
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Time to death or non-elective hospitalization was defined as the elapsed time (days) from randomization to the date of death or the first non-elective hospitalization.
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Timepoint [6]
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Upto Day 210
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Secondary outcome [7]
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Number of Participants With Death or Respiratory Hospitalization or 10 Percent (%) Decline in Absolute Volume of FVC or 25-Meter Loss in 6-Minute Walk Distance (6MWD)
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Assessment method [7]
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Number of participants with death or respiratory hospitalization or 10% decline in absolute volume of FVC or 25 meter loss in 6MWD over time were reported.
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Timepoint [7]
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Upto Day 210
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Secondary outcome [8]
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Mean Change From Baseline in Carbon Monoxide Diffusing Capacity (DLCO) to Week 26
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Assessment method [8]
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DLCO is a measurement of the ability of the lungs to transfer gases from the air to the blood. Participant breathe in (inhale) air containing a very small, harmless amount of a tracer gas, such as carbon monoxide. Participant hold the breath for 10 seconds, then rapidly blow it out (exhale). The exhaled gas was tested to determine how much of the tracer gas was absorbed during the breath. DLCO, both uncorrected and corrected for hemoglobin in milliliter per minute per millimeter of mercury (mL/min/mmHg) was assessed.
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Timepoint [8]
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Baseline, Week 26
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Secondary outcome [9]
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Number of Participants With Definite or Probable Acute Exacerbation (AEx) of Idiopathic Pulmonary Fibrosis (IPF)
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Assessment method [9]
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Acute IPF exacerbations is defined as a clinically significant deterioration of unidentifiable cause in a participant with underlying IPF. Exacerbations of IPF were adjudicated as definite (>=1 AEx) and Probable. Investigators were asked to make the diagnosis of acute exacerbation of IPF on the basis of subjective worsening over 30 days or less, new bilateral radiographic opacities, and the absence of infection or another identifiable etiology. The final diagnosis, however, was confirmed by the study medical monitor.
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Timepoint [9]
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Upto Day 210
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Secondary outcome [10]
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Maximum Observed Plasma Concentration (Cmax) BMS-986020
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Assessment method [10]
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Cmax is defined as the maximum observed plasma concentration.
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Timepoint [10]
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Day 1 and Day 7
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Secondary outcome [11]
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Time of Maximum Observed Plasma Concentration (Tmax) of BMS-986020
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Assessment method [11]
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Tmax is defined as the maximum observed plasma concentration.
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Timepoint [11]
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Day 1 and Day 7
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Secondary outcome [12]
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Accumulation Index (AI) of BMS-986020
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Assessment method [12]
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AI is the ratio of area under the concentration time curve in one dosing interval in (AUC[TAU]) at steady-state to AUC(TAU) after the first dose.
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Timepoint [12]
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Day 7
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Secondary outcome [13]
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Area Under the Concentration Time Curve in One Dosing Interval of BMS -986020 in at Steady-state
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Assessment method [13]
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AUC(TAU) is the area under the concentration time curve in one dosing interval in at steady-state.
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Timepoint [13]
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Day 1 and Day 7
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Secondary outcome [14]
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Area Under the Plasma Concentration-time Curve Over 12 Hours Post-dose AUC(0-12) of BMS -986020
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Assessment method [14]
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AUC(0-12) is the area under the plasma concentration time curve over 12 hours post-dose.
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Timepoint [14]
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Day 1 and Day 7
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Secondary outcome [15]
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Apparent Oral Clearance (CLF/F) of BMS -986020
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Assessment method [15]
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Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
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Timepoint [15]
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Day 1 and Day 7
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Secondary outcome [16]
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Average Concentration of BMS -986020 at Steady State (Css[Avg])
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Assessment method [16]
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Css (avg) is the average concentration at steady state.
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Timepoint [16]
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Day 7
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Eligibility
Key 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.
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Minimum age
40
Years
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Maximum age
90
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
31/01/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
29/02/2016
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Sample size
Target
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Accrual to date
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Final
325
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
0
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Local institution - Westmead
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Recruitment hospital [2]
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Local institution - Greenslopes
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Recruitment hospital [3]
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Local Institution - Adelaide
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Recruitment hospital [4]
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Local institution - Frankston
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Recruitment hospital [5]
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Local institution - Nedlands
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Recruitment postcode(s) [1]
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2145 - Westmead
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Recruitment postcode(s) [2]
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4120 - Greenslopes
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Recruitment postcode(s) [3]
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5000 - Adelaide
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Recruitment postcode(s) [4]
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3199 - Frankston
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Recruitment postcode(s) [5]
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6009 - Nedlands
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Recruitment outside Australia
Country [1]
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United States of America
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Alabama
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Texas
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Santiago
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Talca
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Colombia
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Antioquia
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Colombia
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Cundinamarca
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Mexico
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Distrito Federal
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Mexico
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Jalisco
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Mexico
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Nuevo Leon
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Peru
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Lima
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bristol-Myers Squibb
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01766817
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Trial related presentations / publications
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Public notes
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Contacts
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Bristol-Myers Squibb
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Bristol-Myers Squibb
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01766817
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