Bardoxolone Methyl Evaluation in Patients With Pulmonary Hypertension (PH) - LARIAT

Pulmonary Hypertension Clinical Trial

Official title: A Dose-Ranging Study of the Efficacy and Safety of Bardoxolone Methyl in Patients With Pulmonary Hypertension

Status Completed

Clinical Trial Summary

This study assesses the safety and efficacy of bardoxolone methyl relative to placebo in patients with pulmonary hypertension to determine the recommended dose range, evaluate the change from baseline in 6-minute walk distance (6MWD) and determine the effect of Bardoxolone methyl in pulmonary hypertension associated with connective tissue disease, interstitial lung disease, and idiopathic etiologies, including subsets of patients with WHO Group III or WHO Group V PH following 16 weeks of study participation.

Clinical Trial Description

The molecular and pharmacological effects of bardoxolone methyl are broad through its induction of Nrf2 and suppression of NF-κB. Bardoxolone methyl may therefore address multiple facets of the pathophysiology of PH because it suppresses activation of proinflammatory mediators, enhances endothelial NO bioavailability, improves metabolic dysfunction, suppresses vascular proliferation, and prevents maladaptive remodeling. Furthermore, while existing therapies primarily target only smooth muscle cells, bardoxolone methyl targets multiple cell types relevant to PH, including endothelial cells, smooth muscle cells, and macrophages.

This is a two-part study.

Part 1: Part 1 of the study will include a dose-ranging phase and a dose-titration phase.

Part 2 (extension period): All patients from Part 1 who complete the 16-week treatment period as planned will be eligible to continue directly into the extension period to evaluate the intermediate and long-term safety and efficacy of bardoxolone methyl.

Study Sponsor, originally Reata Pharmaceuticals, Inc., is now Reata Pharmaceuticals, Inc., a wholly owned subsidiary of Biogen. ;

Related Conditions & MeSH terms

• Acute Interstitial Pneumonitis
• Bronchiolitis
• Cryptogenic Organizing Pneumonia
• Desquamative Interstitial Pneumonia
• Fibrosis
• Hypertension
• Hypertension, Pulmonary
• Idiopathic Interstitial Pneumonia
• Idiopathic Interstitial Pneumonias
• Idiopathic Lymphoid Interstitial Pneumonia
• Idiopathic Pleuroparenchymal Fibroelastosis
• Idiopathic Pulmonary Fibrosis
• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial
• Organizing Pneumonia
• Pneumonia
• Pulmonary Arterial Hypertension
• Pulmonary Fibrosis
• Pulmonary Hypertension
• Respiratory Bronchiolitis Associated Interstitial Lung Disease
• Sarcoidosis

• NCT number: NCT02036970
• Study type: Interventional
• Source: Biogen
• Status: Completed
• Phase: Phase 2
• Start date: May 31, 2014
• Completion date: May 16, 2018