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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01766817
First received: January 10, 2013
Last updated: October 6, 2014
Last verified: October 2014
  Purpose

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).


Condition Intervention Phase
Idiopathic Pulmonary Fibrosis
Drug: BMS-986020
Drug: Placebo matching with BMS-986020
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of a Lysophosphatidic Acid Receptor Antagonist in Idiopathic Pulmonary Fibrosis

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Rate of change in forced vital capacity (FVC) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    Compare BMS-986020 600 mg once daily or BMS-986020 600 mg twice daily, vs. placebo.


Secondary Outcome Measures:
  • Safety [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]
    Safety will be measured based on AEs, vital signs, and clinical laboratory tests.


Estimated Enrollment: 300
Study Start Date: January 2013
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1: BMS 986020, 600 mg. once daily
BMS-986020, 600 mg tablets, by mouth, once daily, 26 weeks
Drug: BMS-986020
Experimental: Arm 2: BMS-986020, 600 mg twice daily
BMS-986020, 600 mg tablets, by mouth, twice daily, 26 weeks
Drug: BMS-986020
Placebo Comparator: Arm 3: Placebo matching with BMS-986020
Placebo, 0 mg tablets, by mouth, twice daily, 26 weeks
Drug: Placebo matching with BMS-986020

  Eligibility

Ages Eligible for Study:   40 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 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.

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.
    2. Has a known explanation for interstitial lung disease.
    3. Has a clinical diagnosis of any connective tissue disease.
    4. Currently has clinically significant asthma or chronic obstructive pulmonary disease.
    5. Has clinical evidence of active infection.
    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.
    11. Has a history of alcohol or substance abuse in the past 2 years.
    12. Has a family or personal history of long QT syndrome and/or Torsades de Pointes (polymorphic ventricular tachycardia).
    13. 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01766817

Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.

  Show 73 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01766817     History of Changes
Other Study ID Numbers: IM136-003
Study First Received: January 10, 2013
Last Updated: October 6, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
IPF

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial

ClinicalTrials.gov processed this record on October 19, 2014