Safety and Efficacy of a Lysophosphatidic Acid Receptor Antagonist in Idiopathic Pulmonary Fibrosis
|ClinicalTrials.gov Identifier: NCT01766817|
Recruitment Status : Completed
First Posted : January 11, 2013
Last Update Posted : March 24, 2017
|Condition or disease||Intervention/treatment||Phase|
|Idiopathic Pulmonary Fibrosis||Drug: BMS-986020 Drug: Placebo matching with BMS-986020||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Safety and Efficacy of a Lysophosphatidic Acid Receptor Antagonist in Idiopathic Pulmonary Fibrosis|
|Study Start Date :||January 2013|
|Primary Completion Date :||February 2016|
|Study Completion Date :||February 2016|
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
|Drug: Placebo matching with BMS-986020|
- Rate of change in forced vital capacity (FVC) [ Time Frame: 26 weeks ]Compare BMS-986020 600 mg once daily or BMS-986020 600 mg twice daily, vs. placebo.
- Safety [ Time Frame: 26 weeks ]Safety and tolerability will be measured based on AEs, vital signs, and standard clinical laboratory tests, including routine hematology, blood chemistry, and urinalysis.
- Quantitative Lung Fibrosis (QLF) score on HRCT [ Time Frame: 26 weeks ]Exploratory endpoint elevated to key secondary endpoint in Protocol Amendment 07 dated 06Feb2015; QLF shown in recent studies to be a sensitive clinical biomarker of progression of fibrosis and concordance observed between FVC change and QLF change.
- Change in 6 Minute Walk Test and Dyspnea [ Time Frame: 26 weeks ]To assess the effect of treatment with BMS-986020 on change in 6 minute walk distance and change in dyspnea in patients with IPF.
- Pharmacokinetic (PK) Endpoint [ Time Frame: 26 weeks ]Pharmacokinetic (PK) is a secondary endpoint and will be an estimate of the systemic exposure of BMS-986020 in subjects with IPF following single- and multiple-dose administration.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01766817
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|Study Director:||Bristol-Myers Squibb||Bristol-Myers Squibb|