Bardoxolone Methyl in Patients With Connective Tissue Disease-associated Pulmonary Arterial Hypertension - CATALYST

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Connective Tissue Disease-Associated Pulmonary Arterial Hypertension

In brief

This study assesses the safety and efficacy of bardoxolone methyl relative to placebo in patients with connective tissue disease-associated pulmonary arterial hypertension to determine the recommended dose range and evaluate the change from baseline in 6-minute walk distance (6MWD) following 24 weeks of study participation.

Key facts

Study ID

NCT02657356

Run by

Biogen

People needed

202

Starts

2016-10-04

Expected to finish

2020-05-07

Last updated by the study team

2025-06-04

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• BMI > 18.5 kg/m2;
• Symptomatic pulmonary hypertension WHO/NYHA FC class II and III;
• WHO Group I PAH associated with connective tissue disease;
• Had a diagnostic right heart catheterization performed and documented within 36 months prior to Day 1 that confirmed a diagnosis of PAH according to all the following criteria:
• Mean pulmonary artery pressure ≥ 25 mm Hg (at rest);
• Pulmonary capillary wedge pressure (PCWP) ≤ 15 mm Hg;
• Pulmonary vascular resistance > 240 dyn.sec/cm5 or > 3 mm Hg/liter (L)/minute;
• Has BNP level ≤ 400 pg/mL;
• Had an average 6MWD ≥ 150 meters on two consecutive tests performed on different days prior to randomization, with both tests measuring within 15% of one another;
• Has been receiving no more than two (2) approved disease-specific PAH therapies. PAH therapy must have been at a stable dose for at least 90 days prior to Day 1. No additions or changes should be made to PAH therapies and doses should remain stable for the duration of the study;
• Has maintained a stable dose for 30 days prior to Day 1 if receiving any of the following therapies that may affect PAH: vasodilators (including calcium channel blockers), digoxin, L-arginine supplementation, or oxygen supplementation. No additions or changes should be made to therapies and doses should remain stable for the duration of the study;
• If receiving treatment for CTD with prednisone or any other drugs, doses must remain stable for at least 30 days prior to Day 1 and for the duration of the study Had pulmonary function tests (PFTs) within 90 days prior to Day 1 with total lung capacity ≥ 65% (predicted);
• Had a ventilation-perfusion (V/Q) lung scan, spiral/helical/electron beam computed tomography (CT), or pulmonary angiogram prior to Day 1 that shows no evidence of thromboembolic disease (i.e., should note normal or low probability for pulmonary embolism). If V/Q scan was abnormal (i.e., results other than normal or low probability), then a confirmatory CT or selective pulmonary angiography must exclude chronic thromboembolic pulmonary hypertension;
• Has adequate kidney function defined as an estimated glomerular filtration rate (eGFR) ≥ 45 mL/min/1.73 m2 as measured by the central lab;
• Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures;
• Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study prior to initiation of any patient-mandated procedures

You may not qualify if…

• Participation in other investigational clinical studies involving interventional products being tested or used in a way different from the approved form or when used for an unapproved indication within 30 days prior to Day 1;
• Initiation of an exercise program for cardio-pulmonary rehabilitation within 90 days prior to Day 1 or planned initiation during the study;
• Stopped receiving any PAH chronic therapy within 60 days prior to Day 1;
• Received a dose of prednisone > 20 mg/day (or equivalent dose if other corticosteroid) within 30 days prior to Day 1;
• Received intravenous (iv) or subcutaneous (sc) prostacyclin/prostacyclin analogues within 90 days prior to Day 1;
• Received intravenous inotropes within 30 days prior to Day 1;
• Has uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure (BP) > 160 mm Hg or sitting diastolic BP > 100 mm Hg during Screening after a period of rest;
• Has systolic BP < 90 mm Hg during Screening after a period of rest;
• Has a history of clinically significant left-sided heart disease and/or clinically significant cardiac disease, including but not limited to any of the following:
• Congenital or acquired valvular disease if clinically significant apart from tricuspid valvular insufficiency due to pulmonary hypertension;
• Pericardial constriction;
• Restrictive or congestive cardiomyopathy;
• Left ventricular ejection fraction < 40% per echocardiogram (ECHO) within 90 days of Day 1;
• Symptomatic coronary artery disease within the last 3 years;
• Acutely decompensated heart failure within 30 days prior to Day 1, per investigator assessment;
• Has more than two of the following clinical risk factors for left ventricular diastolic dysfunction:
• Age > 65 years;
• BMI ≥ 30 kg/m2;
• History of systemic hypertension;
• History of type 2 diabetes;
• History of atrial fibrillation;
• History of atrial septostomy within 180 days prior to Day 1;
• History of uncontrolled obstructive sleep apnea;
• Has a history of portal hypertension or chronic liver disease, including hepatitis B and/or hepatitis C (with evidence of recent infection and/or active virus replication) defined as mild to severe hepatic impairment (Child-Pugh Class A-C);
• Serum aminotransferase (ALT or AST) levels > 1.5X the upper limit of normal (ULN) at Screening;

Where it is running

• Arizona Pulmonary Specialists — Phoenix, Arizona, United States
• Cedars Sinai Medical Center — Beverly Hills, California, United States
• Regents of The University of California — Fresno, California, United States
• University of California San Diego — La Jolla, California, United States
• David Geffen School of Medicine UCLA — Los Angeles, California, United States
• Pacific Pulmonary Research, Inc. — San Diego, California, United States
• Santa Barbara Pulmonary Associates — Santa Barbara, California, United States
• Harbor - UCLA Medical Center — Torrance, California, United States
• Georgetown University Medical Center - Department of Rheumatology — Washington D.C., District of Columbia, United States
• University of Miami Miller School of Medicine — Miami, Florida, United States
• Cleveland Clinic Florida — Weston, Florida, United States
• Augusta University — Augusta, Georgia, United States
• Piedmont-Georgia Lung — Austell, Georgia, United States
• University of Illinois at Chicago — Chicago, Illinois, United States
• Kentuckiana Pulmonary Associates — Louisville, Kentucky, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Boston University School of Medicine — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• University of New Mexico — Albuquerque, New Mexico, United States
• NYU Langone Health — New York, New York, United States
• University of Rochester - University of Rochester Medical Center — Rochester, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Banner University Medical Center, Phoenix Advanced Lung Disease Institute — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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