Phase 3 study of Bardoxolone Methyl in patients with CTD-PAH
Research type
Research Study
Full title
A study of the efficacy and safety of bardoxolone methyl in patients with connective tissue disease-associated pulmonary arterial hypertension
IRAS ID
205593
Contact name
John Gerard Coghlan
Contact email
Sponsor organisation
Reata Pharmaceuticals, Inc.
Eudract number
2016-000196-24
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 4 months, 26 days
Research summary
Research Summary
Pulmonary Arterial Hypertension (PAH) is abnormal high blood pressure in the pulmonary artery. This disease is severely debilitating and life-threatening. Despite available therapies, the prognosis for PAH remains poor, especially for patients with connective tissue disease (CTD).Patients with CTD-PAH are generally less responsive to existing therapies and have a worse prognosis than patients with other forms of PAH. The primary CTDs underlying connective tissue diseases associated with pulmonary arterial hypertension (CTD-PAH) include scleroderma, lupus, and mixed CTDs. CTD-PAH patients make up approximately 30% of the overall PAH population.
This study is sponsored by Reata Pharmaceuticals, Inc., and will investigate the safety, tolerability and effectiveness of bardoxolone methyl in patients with World Health Organisation (WHO) Group 1 CTD-PAH. It is a double-blind, placebo controlled study.
Bardoxolone methyl directly targets the bioenergetic and inflammatory components of Pulmonary Hypertension (PH). Bardoxolone methyl has the potential to improve metabolism and mitochondrial function while also inhibiting inflammatory and proliferative signaling. It is thought that by addressing a novel pathway in PH, bardoxolone methyl may provide additional benefits beyond current PAH therapies.
Preliminary efficacy data from a Phase 2 study in WHO Group 1 PAH patients with bardoxolone methyl showed that bardoxolone methyl improves six-minute-walk distance (6MWD) on top of optimal vasodilation background therapies in CTD-PAH patients. The available safety data from this study suggests that bardoxolone methyl is well-tolerated in PAH patients when administered on top of current standard-of-care therapies. Approximately 1900 individuals have been exposed to bardoxolone methyl, including healthy volunteers, cancer patients, kidney disease patients, and PAH patients.
The study plans to enroll approximately 130 participants aged between 18 and 75 years old (inclusively), from approximately 100 different study centres worldwide. The length of the time a participant would be involved in study procedures is approximately 32 to 40 weeks.
Summary of Results
We have not yet submitted results for the CATALYST trial to clinicaltrials.gov as the results are not required until the earlier of either April 28, 2023 or 30 days from an FDA approval of BARD.REC name
London - Westminster Research Ethics Committee
REC reference
16/LO/1423
Date of REC Opinion
18 Oct 2016
REC opinion
Further Information Favourable Opinion