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Idiopathic Pulmonary FibrosisPhase 2NCT01766817

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

A Phase 2 study testing BMS-986020 in people with Idiopathic Pulmonary Fibrosis, run by Bristol-Myers Squibb at 72 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 40 to 90 years
Conditions the study is for
Idiopathic Pulmonary Fibrosis
What is being tested?
BMS-986020
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
325 participants
Where
72 sitesin 6 countries
Study dates
31 Jan 2013to 29 Feb 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 19Show fewer
  • 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.

Who cannot join

  • 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.
Show all 45Show fewer
  • 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
  • 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
  • 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.
  • Has creatinine clearance less than 30 mL/minute, calculated using the Cockcroft-Gault formula.
  • 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
  • Is not a suitable candidate for enrollment or is unlikely to comply with the requirements of this study, in the opinion of the investigator.
  • Has smoked cigarettes within 4 weeks or screening or is unwilling to avoid tobacco products throughout the study.
  • 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.
  • Prisoners or subjects who are involuntarily incarcerated.
  • Subjects who are compulsorily detained for treatment either of a psychiatric or physical (e.g., infectious disease) illness.
  • Inability to comply with restrictions and prohibited activities/treatments as listed in Section 3.3 of the Protocol.

Trial locations and contacts

72 sites in 6 countries.

72 sites in 6 countries

United States48 sites

  • University of Michigan Health System

    Ann Arbor, Michigan, 48109-5360

  • Asheville Pulmonary and Critical Care Associates, P.A.

    Asheville, North Carolina, 28801

  • Johns Hopkins University

    Baltimore, Maryland, 21224

  • University of Alabama at Birmingham - Division of Pulmonary, Allergy & Criticial Care

    Birmingham, Alabama, 35294-0006

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02120

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • CardioPulmonary Research Center

    Chesterfield, Missouri, 63017

  • University of Chicago

    Chicago, Illinois, 60637

  • University of Cincinnati Pulmonary, Critical Care & Sleep Medicine

    Cincinnati, Ohio, 45267

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Vermont Lung Center

    Colchester, Vermont, 05444

  • The Ohio State University

    Columbus, Ohio, 43221

  • University of Texas Southwestern Medical Center - Dallas

    Dallas, Texas, 78212

  • Advanced Pulmonary & Sleep Research Institute of Florida

    Daytona Beach, Florida, 32117

  • National Jewish Health

    Denver, Colorado, 80206

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Inova Fairfax Medical Campus

    Falls Church, Virginia, 22042

  • ISA Clinical Research

    Forest Hills, New York, 11375

  • University of Florida

    Gainesville, Florida, 32610-0225

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • University of Kentucky- Center for Clinical and Translational Science

    Lexington, Kentucky, 40513

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • David Geffen School of Medicine at UCLA

    Los Angeles, California, 90095

  • University of Louisville

    Louisville, Kentucky, 40202

  • University of Wisconsin Hospital & Clinics

    Madison, Wisconsin, 53792

  • Metroplex Pulmonary and Sleep Center

    McKinney, Texas, 75069

  • ILD Research Center

    Miami, Florida, 33136

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Vanderbilt University

    Nashville, Tennessee, 37232

  • Yale University School of Medicine, Section of Pulmonary & Critical Care

    New Haven, Connecticut, 06511

  • Tulane University

    New Orleans, Louisiana, 70112

  • Weill Cornell Medical College

    New York, New York, 10065

  • Temple Lung Center

    Philadelphia, Pennsylvania, 19140

  • St. Joseph's Hospital and Medical Center - Heart Lung Institute/ Clinical Research

    Phoenix, Arizona, 85013

  • University of Pittsburgh Medical Center - Simmons Center for Interstitial Lung Disease

    Pittsburgh, Pennsylvania, 15213

  • The Oregon Clinic

    Portland, Oregon, 97220

  • Oregon Health Science University

    Portland, Oregon, 97239

  • Mayo Clinic, Pulmonary Clinical Research Unit

    Rochester, Minnesota, 55905

  • Highland Hospital

    Rochester, New York, 14620

  • University of Utah

    Salt Lake City, Utah, 84108

  • Alamo Clinical Research

    San Antonio, Texas, 78212

  • University of California at San Francisco

    San Francisco, California, 94143

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Stanford University Medical Center

    Stanford, California, 94305-5236

  • Pulmonary & Allergy Associates, PA

    Summit, New Jersey, 07901

  • University of Texas Health Science Center at Tyler

    Tyler, Texas, 75708

  • Cleveland Clinic Florida- Weston Hospital

    Weston, Florida, 33331

  • Via Christi Clinic

    Wichita, Kansas, 67028

Other trials in United States

Mexico6 sites

  • Local Institution

    Guadalajara, Jalisco, 44100

  • Local Institution

    Mexico City, Mexico City, 14050

  • Local Institution

    Mexico City, Mexico City, 14080

  • Local Institution

    Monterrey, Nuevo León, 64460

  • Local Institution

    Monterrey, Nuevo León, 64710

  • Local Institution

    Monterrey, Nuevo León, 66465

Other trials in Mexico

Australia5 sites

  • Local Institution

    Adelaide, South Australia, 5000

  • Local institution

    Frankston, Victoria, 3199

  • Local institution

    Greenslopes, Queensland, 4120

  • Local institution

    Nedlands, Western Australia, 6009

  • Local institution

    Westmead, New South Wales, 2145

Other trials in Australia

Peru5 sites

  • Local institution

    Lima, 01

  • Local Institution

    Lima, 1

  • Local institution

    Lima, 27

  • Local institution

    Lima, 33

  • Local institution

    Lima, 41

Other trials in Peru

Chile4 sites

  • Local institution

    Quillota

  • Local institution

    Santiago

  • Local Institution

    Talca, 3465584

  • Local institution

    Viña del Mar, Valparaiso

Other trials in Chile

Colombia4 sites

  • Fundacion Neumologica Colombiana

    Bogota, Cundinamarca

  • Hospital Universitario San Ignacio

    Bogota, Cundinamarca

  • Local Institution

    Bogota, Cundinamarca

  • Hospital Pablo Tobon Uribe

    Medellín, Antioquia

Other trials in Colombia

About this study

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).

Being tested
BMS-986020, Placebo matching with BMS-986020
Keywords
IPF
Medical subject headings
Idiopathic Pulmonary Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BMS-986020Drug

  • Placebo matching with BMS-986020Drug

Study groups in NCT01766817
Study groupRoleWhat they receive
Arm 1: BMS 986020, 600 mg. once dailyExperimentalBMS-986020, 600 mg tablets, by mouth, once daily, 26 weeks
Receives: Drug: BMS-986020
Arm 2: BMS-986020, 600 mg twice dailyExperimentalBMS-986020, 600 mg tablets, by mouth, twice daily, 26 weeks
Receives: Drug: BMS-986020
Arm 3: Placebo matching with BMS-986020Placebo comparatorPlacebo, 0 mg tablets, by mouth, twice daily, 26 weeks
Receives: Drug: Placebo matching with BMS-986020

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Forced Vital Capacity (FVC) Rate to Week 26

    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.

    Measured: Baseline, Week 26

Secondary outcomes (16)

  1. Geometric Mean Ratio (GMR) of Quantitative Lung Fibrosis (QLF) Score at Week 26 to Baseline

    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.

    Measured: Baseline, Week 26

  2. Mean Change From Baseline in Six-minute Walk Test (6MWT) Distance to Week 26

    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

    Measured: Baseline, Week 26

  3. 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

    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.

    Measured: Baseline, Week 26

  4. Mean Change From Baseline in Forced Vital Capacity (FVC) to Week 26

    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

    Measured: Baseline, Week 26

  5. 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

    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

    Measured: Baseline, Week 26

  6. Number of Participants With Death or Non-Elective Hospitalization

    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.

    Measured: Upto Day 210

  7. 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)

    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.

    Measured: Upto Day 210

  8. Mean Change From Baseline in Carbon Monoxide Diffusing Capacity (DLCO) to Week 26

    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.

    Measured: Baseline, Week 26

  9. Number of Participants With Definite or Probable Acute Exacerbation (AEx) of Idiopathic Pulmonary Fibrosis (IPF)

    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.

    Measured: Upto Day 210

  10. Maximum Observed Plasma Concentration (Cmax) BMS-986020

    Cmax is defined as the maximum observed plasma concentration.

    Measured: Day 1 and Day 7

  11. Time of Maximum Observed Plasma Concentration (Tmax) of BMS-986020

    Tmax is defined as the maximum observed plasma concentration.

    Measured: Day 1 and Day 7

  12. Accumulation Index (AI) of BMS-986020

    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.

    Measured: Day 7

  13. Area Under the Concentration Time Curve in One Dosing Interval of BMS -986020 in at Steady-state

    AUC(TAU) is the area under the concentration time curve in one dosing interval in at steady-state.

    Measured: Day 1 and Day 7

  14. Area Under the Plasma Concentration-time Curve Over 12 Hours Post-dose AUC(0-12) of BMS -986020

    AUC(0-12) is the area under the plasma concentration time curve over 12 hours post-dose.

    Measured: Day 1 and Day 7

  15. Apparent Oral Clearance (CLF/F) of BMS -986020

    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.

    Measured: Day 1 and Day 7

  16. Average Concentration of BMS -986020 at Steady State (Css[Avg])

    Css (avg) is the average concentration at steady state.

    Measured: Day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2013 (estimated)
  2. Study start31 Jan 2013
  3. Primary completion29 Feb 2016
  4. Study completion29 Feb 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
325 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01766817
Sponsor's protocol ID
IM136-003
Status last verified
Aug 2020
First submitted
10 Jan 2013
Last updated
11 Aug 2020
Data monitoring committee
Yes

Publications

  • Decato BE, Leeming DJ, Sand JMB, Fischer A, Du S, Palmer SM, Karsdal M, Luo Y, Minnich A. LPA1 antagonist BMS-986020 changes collagen dynamics and exerts antifibrotic effects in vitro and in patients with idiopathic pulmonary fibrosis. Respir Res. 2022 Mar 18;23(1):61. doi: 10.1186/s12931-022-01980-4.

    PubMed 35303880

  • Palmer SM, Snyder L, Todd JL, Soule B, Christian R, Anstrom K, Luo Y, Gagnon R, Rosen G. Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial of BMS-986020, a Lysophosphatidic Acid Receptor Antagonist for the Treatment of Idiopathic Pulmonary Fibrosis. Chest. 2018 Nov;154(5):1061-1069. doi: 10.1016/j.chest.2018.08.1058. Epub 2018 Sep 7.

    PubMed 30201408

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BMS-986020 in people with Idiopathic Pulmonary Fibrosis, run by Bristol-Myers Squibb at 72 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 45 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 72 sites in United States, Mexico, Australia, Peru, Chile and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Forced Vital Capacity (FVC) Rate to Week 26 (time frame: Baseline, Week 26). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01766817, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2020.

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