Pulmonary Arterial HypertensionPhase 2NCT02036970
Bardoxolone Methyl Evaluation in Patients With Pulmonary Hypertension (PH) - LARIAT
A Phase 2 study testing Bardoxolone methyl in people with Pulmonary Arterial Hypertension and Pulmonary Hypertension, run by Biogen at 32 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pulmonary Arterial Hypertension, Pulmonary Hypertension, Interstitial Lung Disease
- What is being tested?
- Bardoxolone methyl
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 166 participants
- Where
- 32 sitesin 2 countries
- Study dates
- 31 May 2014to 16 May 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male and female patients ≥ 18 to ≤ 75 years of age upon study consent;
- BMI > 18.5 kg/m²
- Symptomatic pulmonary hypertension WHO class II and III;
- WHO Group I, III, or V PH according to the following criteria:
- If diagnosed with WHO Group I PAH, then on of the following subtypes:
- Idiopathic or heritable PAH;
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- PAH associated with connective tissue disease;
- PAH associated with simple, congenital systemic-to-pulmonary shunts at least 1 year following shunt repair;
- PAH associated with anorexigen or drug-induced toxicity;
- PAH associated with human immunodeficiency virus (HIV); or
- If WHO Group III PH then primary diagnosis must be one of the following subtypes:
- Connective tissue disease associated ILD (CTD-ILD);
- Idiopathic pulmonary fibrosis (IPF);
- Nonspecific interstitial pneumonia (NSIP); or
- If WHO Group V PH then patient must be diagnosed with sarcoidosis;
- Had a diagnostic right heart catheterization performed and documented within 36 months prior to Day 1 that confirmed a diagnosis of PH
- If WHO Group I, has been receiving no more than three (3) FDA-approved disease-specific PAH therapies except for intravenous (iv) prostacyclin/prostacyclin analogues. PAH therapy must be at a stable dose for at least 90 days prior to Day 1;
- Has adequate kidney function defined as an estimated glomerular filtration rate (eGFR) ≥ 45 mL/min/1.73 m2 using the Modification of Diet in Renal Disease (MDRD) 4-variable formula;
Who cannot join
- Participation in other interventional clinical studies involving pharmaceutical 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 3 months (90 days) prior to Day 1 or planned initiation during Part 1 of the study;
- Stopped receiving any PH chronic therapy within 60 days prior to Day 1;
- Requirement for receipt of 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 blood pressure > 100 mm Hg during Screening after a period of rest;
- Has systolic BP < 90 mm Hg during Screening after a period of rest;
Show all 24Show fewer
- WHO Group III or V patients who at rest require supplemental oxygen at a rate of >4 L/min and have peripheral capillary oxygen saturation levels <92%;
- 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 60 days of Day 1;
- Any current or prior history of symptomatic coronary disease (prior myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft surgery, or anginal chest pain);
- Acutely decompensated heart failure within 30 days prior to Day 1, as per Investigator assessment;
- History of atrial septostomy within 180 days prior to Day 1;
- History of obstructive sleep apnea that is untreated;
- 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 > the upper limit of normal (ULN) at Screening;
- For patients with HIV-associated PAH, any of the following:
- Concomitant active opportunistic infections within 180 days prior to Screening;
- Detectable viral load within 90 days prior to Screening;
- Cluster designation (CD+) T-cell count < 200 mm3 within 90 days prior to Screening;
- Changes in antiretroviral regimen within 90 days prior to Screening;
- Using inhaled pentamidine
Trial locations and contacts
32 sites in 2 countries.
32 sites in 2 countries
United States30 sites
University of Colorado Denver - Division of Pulmonary Sciences
Aurora, Colorado, 80045
Cedars Sinai Medical Center
Beverly Hills, California, 90211
Tufts Medical Center
Boston, Massachusetts, 02111
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Boston University School of Medicine
Boston, Massachusetts, 02118
University of Chicago
Chicago, Illinois, 60637
The Lindner Clinical Trial Center
Cincinnati, Ohio, 45219
University of Cincinnati - Department of Internal Medicine Pulmonary, Critical Care & Sleep Medicine
Cincinnati, Ohio, 45267
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
BreatheAmerica El Paso, Inc.
El Paso, Texas, 79912
Houston Methodist Research Institute
Houston, Texas, 77030
The University of Texas - Health Science Center & Medical School at Houston
Houston, Texas, 77030
University of Texas Houston - Division of Rheumatology and Clinical Immunogenetics
Houston, Texas, 77030
South Denver Cardiology Associates, P.C
Littleton, Colorado, 80120
VA Healthcare System of Greater Los Angeles
Los Angeles, California, 90073
Winthrop University Hospital
Mineola, New York, 11501
Mount Sinai, Beth Israel Medical Center
New York, New York, 10003
Weill Cornell Medical Center
New York, New York, 10021
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, 73120
Banner University Medical Center, Phoenix Advanced Lung Disease Institute
Phoenix, Arizona, 85004
Arizona Pulmonary Specialists
Phoenix, Arizona, 85012
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Maine Medical Center - Division of Pulmonary and Critical Care Medicine
Portland, Maine, 04102
University of Rochester - University of Rochester Medical Center
Rochester, New York, 14642
University of California Davis Medical Center - Division of Pulmonary and Critical Care
Sacramento, California, 95817
University of Utah
Salt Lake City, Utah, 84132
Harbor - UCLA Medical Center
Torrance, California, 90502
Georgetown University Medical Center - Department of Rheumatology
Washington D.C., District of Columbia, 20007
Cleveland Clinic of Florida
Weston, Florida, 33331
Germany2 sites
University Clinic Carl Gustav Carus
Dresden, 01304
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, 20246
About this study
Official title: A Dose-Ranging Study of the Efficacy and Safety of Bardoxolone Methyl in Patients With Pulmonary Hypertension
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.
Read the detailed 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.
- Conditions
- Pulmonary Arterial Hypertension, Pulmonary Hypertension, Interstitial Lung Disease, Idiopathic Interstitial Pneumonia, Idiopathic Pulmonary Fibrosis, Sarcoidosis
- Being tested
- Bardoxolone methyl, Placebo
- Keywords
- Pulmonary Arterial Hypertension, PAH, Bardoxolone methyl, 6-minute walk distance, CDDO-me, RTA 402, Pulmonary Hypertension, Interstitial Lung Disease, Idiopathic Interstitial Pneumonia, Idiopathic Pulmonary Fibrosis, Sarcoidosis, Respiratory Bronchiolitis Associated ILD, Desquamative Interstitial Pneumonia, Cryptogenic Organizing Pneumonia, Acute Interstitial Pneumonitis, Idiopathic Lymphoid Interstitial Pneumonia, Idiopathic Pleuroparenchymal Fibroelastosis
- Medical subject headings
- Pulmonary Arterial Hypertension, Hypertension, Pulmonary, Lung Diseases, Interstitial, Idiopathic Interstitial Pneumonias, Idiopathic Pulmonary Fibrosis, Sarcoidosis, Interstitial Pneumonitis, Desquamative, Familial, Cryptogenic Organizing Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bardoxolone methylDrug
Also called RTA 402 capsules
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Part 1 Dose-Ranging Bardoxolone methyl 2.5 mg/Part 2: Open-Label | Experimental | Participants received bardoxolone methyl 2.5 mg once-daily in Part 1 (Day 1 to Week 16). Participants who continued to Part 2 continued to receive the same bardoxolone methyl 2.5 mg once-daily in Part 2 (Week 16 and onwards) Receives: Drug: Bardoxolone methyl |
| Part 1: Dose-Ranging Bardoxolone methyl 5 mg/Part 2: Open-Label | Experimental | Participants received bardoxolone methyl 5 mg once-daily in Part 1 (Day 1 to Week 16). Participants who continued to Part 2 continued to receive the same bardoxolone methyl 5 mg once-daily in Part 2 (Week 16 and onwards) Receives: Drug: Bardoxolone methyl |
| Part 1: Dose-Ranging Bardoxolone methyl 10 mg/Part 2: Open-Label | Experimental | Participants received bardoxolone methyl 10 mg once-daily in Part 1 (Day 1 to Week 16). Participants who continued to Part 2 continued to receive the same bardoxolone methyl 10 mg once-daily in Part 2 (Week 16 and onwards) Receives: Drug: Bardoxolone methyl |
| Part 1: Dose-Ranging Bardoxolone methyl 20 mg/Part 2: Open-Label | Experimental | Participants received bardoxolone methyl 20 mg once-daily in Part 1 (Day 1 to Week 16). Participants who continued to Part 2 continued to receive the same bardoxolone methyl 20 mg once-daily in Part 2 (Week 16 and onwards) Receives: Drug: Bardoxolone methyl |
| Part 1: Dose-Ranging Placebo 2.5 mg/Part 2: Bardoxolone methyl 2.5 mg | Placebo comparator | Participants received bardoxolone methyl 2.5 mg matching placebo capsules once-daily in Part 1 (Day 1 to Week 16). Participants who continued to Part 2 received bardoxolone methyl 2.5 mg once-daily in Part 2 (Week 16 and onwards) Receives: Drug: Bardoxolone methyl; Drug: Placebo |
| Part 1: Dose-Ranging Placebo 5 mg/Part 2: Bardoxolone methyl 5 mg | Placebo comparator | Participants received bardoxolone methyl 5 mg matching placebo capsules once-daily in Part 1 (Day 1 to Week 16). Participants who continued to Part 2 received bardoxolone methyl 5 mg once-daily in Part 2 (Week 16 and onwards) Receives: Drug: Bardoxolone methyl; Drug: Placebo |
| Part 1: Dose-Ranging Placebo 10 mg/Part 2: Bardoxolone methyl 10 mg | Placebo comparator | Participants received bardoxolone methyl 10 mg matching placebo capsules once-daily in Part 1 (Day 1 to Week 16). Participants who continued to Part 2 received bardoxolone methyl 10 mg once-daily in Part 2 (Week 16 and onwards) Receives: Drug: Bardoxolone methyl; Drug: Placebo |
| Part 1: Dose-Ranging Placebo 20 mg/Part 2: Bardoxolone methyl 20 mg | Placebo comparator | Participants received bardoxolone methyl 20 mg matching placebo capsules once-daily in Part 1 (Day 1 to Week 16). Participants who continued to Part 2 received bardoxolone methyl 20 mg once-daily in Part 2 (Week 16 and onwards) Receives: Drug: Bardoxolone methyl; Drug: Placebo |
| Part 1: Dose Titration: Bardoxolone methyl 10 mg/Part 2: Bardoxolone methyl 10 mg | Experimental | Participants in Part 1 started with bardoxolone methyl 5 mg once-daily from Day 1 and escalated to bardoxolone methyl 10 mg once-daily starting at Week 4 thru Week 16. Participants who continued to Part 2 continued to receive the same bardoxolone methyl dose once-daily in Part 2 (Week 16 and onwards) Receives: Drug: Bardoxolone methyl |
| Part 1: Dose Titration: Placebo 10 mg/Part 2: Bardoxolone methyl 10 mg | Placebo comparator | Participants in Part 1 received Placebo once-daily from Day 1 thru Week 16. Participants who continued to Part 2 initially received bardoxolone methyl 5 mg once-daily from Week 16 thru Week 20 and bardoxolone methyl 10 mg from week 20 onwards Receives: Drug: Bardoxolone methyl; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline Though Week 16 in 6-Minute Walk Distance (6MWD) for Bardoxolone Methyl Compared to Placebo
Overall treatment effect in exercise capacity, as measured by the total distance walked in 6 minutes (6MWD) mean change from baseline though Week 16. A lower 6MWD reflects greater severity thus, a positive change from baseline suggests an improvement.
Measured: Baseline through Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2014 (estimated)
- Study start31 May 2014
- Primary completion19 Jan 2018
- Study completion16 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02036970
- Sponsor's protocol ID
- RTA 402-C-1302
- Status last verified
- May 2025
- First submitted
- 13 Jan 2014
- Last updated
- 10 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-Ranging Study of the Efficacy and Safety of Bardoxolone Methyl in Patients With Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT02036970
- Acronym / sponsor ID
- RTA 402-C-1302
- Conditions
- Pulmonary Arterial Hypertension, Pulmonary Hypertension, Interstitial Lung Disease, Idiopathic Interstitial Pneumonia, Idiopathic Pulmonary Fibrosis, Sarcoidosis
- Keywords
- Pulmonary Arterial Hypertension, PAH, Bardoxolone methyl, 6-minute walk distance, CDDO-me, RTA 402, Pulmonary Hypertension, Interstitial Lung Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 31 May 2014 (actual)
- Primary completion
- 19 Jan 2018 (actual)
- Study completion
- 16 May 2018 (actual)
- First posted
- 15 Jan 2014 (estimated)
- Results
- Posted 23 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Part 1 Dose-Ranging Bardoxolone methyl 2.5 mg/Part 2: Open-Label | Experimental | Drug: Bardoxolone methylParticipants received bardoxolone methyl 2.5 mg once-daily in Part 1 (Day 1 to Week 16). Participants who continued to Part 2 continued to receive the same bardoxolone methyl 2.5 mg once-daily in Part 2 (Week 16 and onwards) |
| Part 1: Dose-Ranging Bardoxolone methyl 5 mg/Part 2: Open-Label | Experimental | Drug: Bardoxolone methylParticipants received bardoxolone methyl 5 mg once-daily in Part 1 (Day 1 to Week 16). Participants who continued to Part 2 continued to receive the same bardoxolone methyl 5 mg once-daily in Part 2 (Week 16 and onwards) |
| Part 1: Dose-Ranging Bardoxolone methyl 10 mg/Part 2: Open-Label | Experimental | Drug: Bardoxolone methylParticipants received bardoxolone methyl 10 mg once-daily in Part 1 (Day 1 to Week 16). Participants who continued to Part 2 continued to receive the same bardoxolone methyl 10 mg once-daily in Part 2 (Week 16 and onwards) |
| Part 1: Dose-Ranging Bardoxolone methyl 20 mg/Part 2: Open-Label | Experimental | Drug: Bardoxolone methylParticipants received bardoxolone methyl 20 mg once-daily in Part 1 (Day 1 to Week 16). Participants who continued to Part 2 continued to receive the same bardoxolone methyl 20 mg once-daily in Part 2 (Week 16 and onwards) |
| Part 1: Dose-Ranging Placebo 2.5 mg/Part 2: Bardoxolone methyl 2.5 mg | Placebo comparator | Drug: Bardoxolone methyl, Drug: PlaceboParticipants received bardoxolone methyl 2.5 mg matching placebo capsules once-daily in Part 1 (Day 1 to Week 16). Participants who continued to Part 2 received bardoxolone methyl 2.5 mg once-daily in Part 2 (Week 16 and onwards) |
| Part 1: Dose-Ranging Placebo 5 mg/Part 2: Bardoxolone methyl 5 mg | Placebo comparator | Drug: Bardoxolone methyl, Drug: PlaceboParticipants received bardoxolone methyl 5 mg matching placebo capsules once-daily in Part 1 (Day 1 to Week 16). Participants who continued to Part 2 received bardoxolone methyl 5 mg once-daily in Part 2 (Week 16 and onwards) |
| Part 1: Dose-Ranging Placebo 10 mg/Part 2: Bardoxolone methyl 10 mg | Placebo comparator | Drug: Bardoxolone methyl, Drug: PlaceboParticipants received bardoxolone methyl 10 mg matching placebo capsules once-daily in Part 1 (Day 1 to Week 16). Participants who continued to Part 2 received bardoxolone methyl 10 mg once-daily in Part 2 (Week 16 and onwards) |
| Part 1: Dose-Ranging Placebo 20 mg/Part 2: Bardoxolone methyl 20 mg | Placebo comparator | Drug: Bardoxolone methyl, Drug: PlaceboParticipants received bardoxolone methyl 20 mg matching placebo capsules once-daily in Part 1 (Day 1 to Week 16). Participants who continued to Part 2 received bardoxolone methyl 20 mg once-daily in Part 2 (Week 16 and onwards) |
| Part 1: Dose Titration: Bardoxolone methyl 10 mg/Part 2: Bardoxolone methyl 10 mg | Experimental | Drug: Bardoxolone methylParticipants in Part 1 started with bardoxolone methyl 5 mg once-daily from Day 1 and escalated to bardoxolone methyl 10 mg once-daily starting at Week 4 thru Week 16. Participants who continued to Part 2 continued to receive the same bardoxolone methyl dose once-daily in Part 2 (Week 16 and onwards) |
| Part 1: Dose Titration: Placebo 10 mg/Part 2: Bardoxolone methyl 10 mg | Placebo comparator | Drug: Bardoxolone methyl, Drug: PlaceboParticipants in Part 1 received Placebo once-daily from Day 1 thru Week 16. Participants who continued to Part 2 initially received bardoxolone methyl 5 mg once-daily from Week 16 thru Week 20 and bardoxolone methyl 10 mg from week 20 onwards |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Adult male and female patients ≥ 18 to ≤ 75 years of age upon study consent;
- BMI > 18.5 kg/m²
- Symptomatic pulmonary hypertension WHO class II and III;
- WHO Group I, III, or V PH according to the following criteria:
- Had a diagnostic right heart catheterization performed and documented within 36 months prior to Day 1 that confirmed a diagnosis of PH
Key exclusion criteria (24 listed)
- Participation in other interventional clinical studies involving pharmaceutical 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 3 months (90 days) prior to Day 1 or planned initiation during Part 1 of the study;
- Stopped receiving any PH chronic therapy within 60 days prior to Day 1;
- Requirement for receipt of 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 blood pressure > 100 mm Hg during Screening after a period of rest;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bardoxolone methylAlso: RTA 402 capsules | Drug | Part 1 Dose-Ranging Bardoxolone methyl 2.5 mg/Part 2: Open-Label, Part 1: Dose Titration: Bardoxolone methyl 10 mg/Part 2: Bardoxolone methyl 10 mg, Part 1: Dose Titration: Placebo 10 mg/Part 2: Bardoxolone methyl 10 mg, Part 1: Dose-Ranging Bardoxolone methyl 10 mg/Part 2: Open-Label, Part 1: Dose-Ranging Bardoxolone methyl 20 mg/Part 2: Open-Label, Part 1: Dose-Ranging Bardoxolone methyl 5 mg/Part 2: Open-Label, Part 1: Dose-Ranging Placebo 10 mg/Part 2: Bardoxolone methyl 10 mg, Part 1: Dose-Ranging Placebo 2.5 mg/Part 2: Bardoxolone methyl 2.5 mg, Part 1: Dose-Ranging Placebo 20 mg/Part 2: Bardoxolone methyl 20 mg, Part 1: Dose-Ranging Placebo 5 mg/Part 2: Bardoxolone methyl 5 mg |
| Placebo | Drug | Part 1: Dose Titration: Placebo 10 mg/Part 2: Bardoxolone methyl 10 mg, Part 1: Dose-Ranging Placebo 10 mg/Part 2: Bardoxolone methyl 10 mg, Part 1: Dose-Ranging Placebo 2.5 mg/Part 2: Bardoxolone methyl 2.5 mg, Part 1: Dose-Ranging Placebo 20 mg/Part 2: Bardoxolone methyl 20 mg, Part 1: Dose-Ranging Placebo 5 mg/Part 2: Bardoxolone methyl 5 mg |
Primary outcome
Change From Baseline Though Week 16 in 6-Minute Walk Distance (6MWD) for Bardoxolone Methyl Compared to Placebo
Time frame: Baseline through Week 16
Overall treatment effect in exercise capacity, as measured by the total distance walked in 6 minutes (6MWD) mean change from baseline though Week 16. A lower 6MWD reflects greater severity thus, a positive change from baseline suggests an improvement.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
32 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bardoxolone methyl in people with Pulmonary Arterial Hypertension and Pulmonary Hypertension, run by Biogen at 32 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline Though Week 16 in 6-Minute Walk Distance (6MWD) for Bardoxolone Methyl Compared to Placebo (time frame: Baseline through Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2025.