Safety and Efficacy of a Lysophosphatidic Acid Receptor Antagonist in Idiopathic Pulmonary Fibrosis
Study type: Interventional What is this?
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase: II What is this?
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
- Rochester, Minnesota: 12-009967
NCT ID: NCT01766817
Sponsor Protocol Number: IM136003
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).
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.
See eligibility 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 50% 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 during the 6 minute walk test (6MWT) at screening.
- Demonstrate a decrease in oxygen saturation of 2 percentage points or greater during the 6MWT 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.
- 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.
- Has a known explanation for interstitial lung disease.
- Has a clinical diagnosis of any connective tissue disease.
- Currently has clinically significant asthma or chronic obstructive pulmonary disease.
- Has clinical evidence of active infection.
- 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.
- 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).
- Unable to discontinue certain CYP2C8, CYP2C9, and OATP1B1 substrates/inhibitors/inducers within 7 days of screening.
- Additional Protocol Requirement
Throughout the study, participants prescribed certain statin medications cannot exceed maximum dosage limitations set per the protocol.
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.
|Mayo Clinic Location
Mayo Clinic principal investigator
Jay Ryu, M.D.
Open for enrollment
Jay Ryu M.D.