CompletedNCT02036970Updated Jun 10, 2025Results posted

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

A Phase 2 interventional study of Bardoxolone methyl and Placebo in Pulmonary Arterial Hypertension, Pulmonary Hypertension and Interstitial Lung Disease, sponsored by Biogen. Completed at 32 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-06-10.

Sponsored by Biogen · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 166
Allocation: Randomized
Ages: 18 Years to 75 Years
Sex: All

Study 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.

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 studied

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

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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

In context

Pneumonia

2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.

This study's enrollment of 166 is above the median of 106 across 1,247 interventional studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

Biogen is the lead sponsor of 494 studies on the registry; 22 are open to participants now.

Of its 98 completed or terminated interventional studies of FDA-regulated products, 49 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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:
1. If diagnosed with WHO Group I PAH, then on of the following subtypes:
  - Idiopathic or heritable PAH;
  - 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
2. 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
3. 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;

Exclusion criteria

Exclusion Criteria:

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;
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:
1. Congenital or acquired valvular disease if clinically significant apart from tricuspid valvular insufficiency due to pulmonary hypertension;
2. Pericardial constriction;
3. Restrictive or congestive cardiomyopathy;
4. Left ventricular ejection fraction \< 40% per echocardiogram (ECHO) within 60 days of Day 1;
5. 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:
1. Concomitant active opportunistic infections within 180 days prior to Screening;
2. Detectable viral load within 90 days prior to Screening;
3. Cluster designation (CD+) T-cell count \< 200 mm3 within 90 days prior to Screening;
4. Changes in antiretroviral regimen within 90 days prior to Screening;
5. Using inhaled pentamidine

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential assignment
Masking: Double (Participant, Investigator)
Enrollment: 166 participants (actual)

Study arms

Experimental
Part 1 Dose-Ranging Bardoxolone methyl 2.5 mg/Part 2: Open-Label
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)
Drug: Bardoxolone methyl
Experimental
Part 1: Dose-Ranging Bardoxolone methyl 5 mg/Part 2: Open-Label
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)
Drug: Bardoxolone methyl
Experimental
Part 1: Dose-Ranging Bardoxolone methyl 10 mg/Part 2: Open-Label
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)
Drug: Bardoxolone methyl
Experimental
Part 1: Dose-Ranging Bardoxolone methyl 20 mg/Part 2: Open-Label
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)
Drug: Bardoxolone methyl
Placebo comparator
Part 1: Dose-Ranging Placebo 2.5 mg/Part 2: Bardoxolone methyl 2.5 mg
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)
Drug: Bardoxolone methyl · Drug: Placebo
Placebo comparator
Part 1: Dose-Ranging Placebo 5 mg/Part 2: Bardoxolone methyl 5 mg
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)
Drug: Bardoxolone methyl · Drug: Placebo
Placebo comparator
Part 1: Dose-Ranging Placebo 10 mg/Part 2: Bardoxolone methyl 10 mg
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)
Drug: Bardoxolone methyl · Drug: Placebo
Placebo comparator
Part 1: Dose-Ranging Placebo 20 mg/Part 2: Bardoxolone methyl 20 mg
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)
Drug: Bardoxolone methyl · Drug: Placebo
Experimental
Part 1: Dose Titration: Bardoxolone methyl 10 mg/Part 2: Bardoxolone methyl 10 mg
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)
Drug: Bardoxolone methyl
Placebo comparator
Part 1: Dose Titration: Placebo 10 mg/Part 2: Bardoxolone methyl 10 mg
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
Drug: Bardoxolone methyl · Drug: Placebo

Interventions

DrugBardoxolone methyl
Also known as: RTA 402 capsules
DrugPlacebo

What researchers measure

Primary outcomes

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.
Time frame: Baseline through Week 16

Results

Posted Jul 23, 2021

Participant flow

Part 1: Day 1 Through Week 16

Participant flow — Part 1: Day 1 Through Week 16
Milestone	Part 1: Dose-Ranging Bardoxolone Methyl 2.5 mg/Part 2: Open-Label	Part 1: Dose-Ranging Bardoxolone Methyl 5 mg/Part 2: Open-Label	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 Placebo 2.5 mg/Part 2: Bardoxolone Methyl 2.5 mg	Part 1: Dose-Ranging Placebo 5 mg/Part 2: Bardoxolone Methyl 5 mg	Part 1: Dose-Ranging Placebo 10 mg/Part 2: Bardoxolone Methyl 10 mg	Part 1: Dose-Ranging Placebo 20 mg/Part 2: Bardoxolone Methyl 20 mg	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
Started	6	12	11	12	2	4	3	4	74	38
Cohort 1: pah (bl 6mwd <= 450 meters)	6	6	11	6	2	2	3	2	0	0
Cohort 2: pah (bl 6mwd > 450 meters)	0	6	0	6	0	2	0	2	0	0
Cohort 3a: pah ctd	0	0	0	0	0	0	0	0	14	8
Cohort 3b: pah non-ctd	0	0	0	0	0	0	0	0	16	9
Cohort 4a: ph ctd-ild	0	0	0	0	0	0	0	0	17	8
Cohort 4b: ph ctd-ipf	0	0	0	0	0	0	0	0	6	2
Cohort 4c: ph ctd-iip	0	0	0	0	0	0	0	0	4	1
Cohort 4d: ph ctd-sarcoidosis	0	0	0	0	0	0	0	0	17	1
Completed	5	12	7	9	1	3	3	3	66	33
Not completed	1	0	4	3	1	1	0	1	8	5
Withdrew: Adverse event	0	0	3	2	0	1	0	1	3	1
Withdrew: Death	0	0	0	0	0	0	0	0	1	0
Withdrew: Protocol violation	1	0	1	0	0	0	0	0	2	0
Withdrew: Withdrawal by subject	0	0	0	0	1	0	0	0	2	4
Withdrew: Progressive disease	0	0	0	1	0	0	0	0	0	0

Part 2: Week 16 Onwards

Participant flow — Part 2: Week 16 Onwards
Milestone	Part 1: Dose-Ranging Bardoxolone Methyl 2.5 mg/Part 2: Open-Label	Part 1: Dose-Ranging Bardoxolone Methyl 5 mg/Part 2: Open-Label	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 Placebo 2.5 mg/Part 2: Bardoxolone Methyl 2.5 mg	Part 1: Dose-Ranging Placebo 5 mg/Part 2: Bardoxolone Methyl 5 mg	Part 1: Dose-Ranging Placebo 10 mg/Part 2: Bardoxolone Methyl 10 mg	Part 1: Dose-Ranging Placebo 20 mg/Part 2: Bardoxolone Methyl 20 mg	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
Started	5	11	6	9	1	3	3	3	63	33
Cohort 1: pah (bl 6mwd <= 450 meters)	5	5	6	5	1	1	3	2	0	0
Cohort 2: pah (bl 6mwd > 450 meters)	0	6	0	4	0	2	0	1	0	0
Cohort 3a: pah ctd	0	0	0	0	0	0	0	0	12	8
Cohort 3b: pah non-ctd	0	0	0	0	0	0	0	0	12	7
Cohort 4a: ph ctd-ild	0	0	0	0	0	0	0	0	16	7
Cohort 4b: ph ctd-ipf	0	0	0	0	0	0	0	0	5	2
Cohort 4c: ph ctd-iip	0	0	0	0	0	0	0	0	3	1
Cohort 4d: ph ctd-sarcoidosis	0	0	0	0	0	0	0	0	15	8
Completed	5	6	3	7	0	3	2	2	54	28
Not completed	0	5	3	2	1	0	1	1	9	5
Withdrew: Adverse event	0	2	1	1	1	0	1	0	6	3
Withdrew: Protocol violation	0	0	0	0	0	0	0	1	0	0
Withdrew: Withdrawal by subject	0	1	1	0	0	0	0	0	3	0
Withdrew: Progressive disease	0	2	1	1	0	0	0	0	0	2

Outcome measures

PrimaryChange 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.

Time frame:: Baseline through Week 16
Reported as:: Mean · meters

Change From Baseline Though Week 16 in 6-Minute Walk Distance (6MWD) for Bardoxolone Methyl Compared to Placebo
meters	Part 1: Dose-Ranging Bardoxolone Methyl 2.5 mg/Part 2: Open-Label	Part 1: Dose-Ranging Bardoxolone Methyl 5 mg/Part 2: Open-Label	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 Placebo 2.5 mg/Part 2: Bardoxolone Methyl 2.5 mg	Part 1: Dose-Ranging Placebo 5 mg/Part 2: Bardoxolone Methyl 5 mg	Part 1: Dose-Ranging Placebo 10 mg/Part 2: Bardoxolone Methyl 10 mg	Part 1: Dose-Ranging Placebo 20 mg/Part 2: Bardoxolone Methyl 20 mg	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
Change from Baseline though Week 16 for participants with PAH	32.5 ± 29.14	24 ± 30.08	3.4 ± 31.28	-3.2 ± 39.53	20.3 ± 13.08	24.6 ± 59.4	23.8 ± 34.54	-21.8 ± 4.17	13.9 ± 41.15	19.4 ± 21.06
Change from Baseline though Week 16 for participants with PH	—	—	—	—	—	—	—	—	7.6 ± 32.01	10.8 ± 32.01

Statistical analysis

Part 1: Dose-Ranging Bardoxolone Methyl 2.5 mg/Part 2: Open-Label vs Part 1: Dose-Ranging Bardoxolone Methyl 5 mg/Part 2: Open-Label vs Part 1: Dose-Ranging Bardoxolone Methyl 10 mg/Part 2: Open-Label vs Part 1: Dose-Ranging Bardoxolone Methyl 20 mg/Part 2: Open-Label vs Part 1: Dose-Ranging Placebo 2.5 mg/Part 2: Bardoxolone Methyl 2.5 mg vs Part 1: Dose-Ranging Placebo 5 mg/Part 2: Bardoxolone Methyl 5 mg vs Part 1: Dose-Ranging Placebo 10 mg/Part 2: Bardoxolone Methyl 10 mg vs Part 1: Dose-Ranging Placebo 20 mg/Part 2: Bardoxolone Methyl 20 mg vs Part 1: Dose Titration: Bardoxolone Methyl 10 mg/Part 2: Bardoxolone Methyl 10 mg vs Part 1: Dose Titration: Placebo 10 mg/Part 2: Bardoxolone Methyl 10 mg · Mixed Models Analysis · p = 0.8133 (The p-value comparison is for the difference in the change in 6WMD from baseline at Week 16 for bardoxolone methyl relative to placebo in participants with pulmonary arterial hypertension (PAH).) · Mean difference (net): -1.74 · 95% CI -16.22 to 12.74Mean difference (Net) = Bardoxolone methyl - Placebo.
Part 1: Dose Titration: Bardoxolone Methyl 10 mg/Part 2: Bardoxolone Methyl 10 mg vs Part 1: Dose Titration: Placebo 10 mg/Part 2: Bardoxolone Methyl 10 mg · Mixed Models Analysis · p = 0.759 (The p-value comparison is for the difference in the change in 6WMD from baseline at Week 16 for bardoxolone methyl relative to placebo in participants with pulmonary hypertension (PH)) · Mean difference (net): -3.17 · 95% CI -23.54 to 17.20Mean difference (Net) = Bardoxolone methyl - Placebo.

Adverse events

Collected over Part 1: 16-week double-blind, randomized, placebo-controlled treatment period (Day 1 to Week 16). Part 2: Open-label extension period (Week 16 onwards). Part 2 is the extension period and patients were to stay until study drug became available through extended access program [Study 402-C-1602].. Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Part 1 Period of Part 1: Dose-Ranging Bardoxolone Methyl 2.5 mg/Part 2: Open-Label	0/6 (0%)	0/6 (0%)	5/6 (83.3%)
Part 1 Period of Part 1: Dose-Ranging Bardoxolone Methyl 5 mg/Part 2: Open-Label	0/12 (0%)	1/12 (8.3%)	11/12 (91.7%)
Part 1 Period of Part 1: Dose-Ranging Bardoxolone Methyl 10 mg/Part 2: Open-Label	0/11 (0%)	0/11 (0%)	10/11 (90.9%)
Part 1 Period of Part 1: Dose-Ranging Bardoxolone Methyl 20 mg/Part 2: Open-Label	0/12 (0%)	2/12 (16.7%)	12/12 (100%)
Part 1 Period of Part 1: Dose-Ranging Placebo 2.5 mg/Part 2: Bardoxolone Methyl 2.5 mg	0/2 (0%)	0/2 (0%)	2/2 (100%)
Part 1 Period of Part 1: Dose-Ranging Placebo 5 mg/Part 2: Bardoxolone Methyl 5 mg	0/4 (0%)	0/4 (0%)	4/4 (100%)
Part 1 Period of Part 1: Dose-Ranging Placebo 10 mg/Part 2: Bardoxolone Methyl 10 mg	0/3 (0%)	0/3 (0%)	3/3 (100%)
Part 1 Period of Part 1: Dose-Ranging Placebo 20 mg/Part 2: Bardoxolone Methyl 20 mg	0/4 (0%)	1/4 (25%)	4/4 (100%)
Part 1 Period of Part 1: Dose Titration: Bardoxolone Methyl 10 mg/Part 2: Bardoxolone Methyl 10 mg	1/74 (1.4%)	7/74 (9.5%)	64/74 (86.5%)
Part 1 Period of Part 1: Dose Titration: Placebo 10 mg/Part 2: Bardoxolone Methyl 10 mg	0/38 (0%)	2/38 (5.3%)	33/38 (86.8%)
Part 2 Period of Part 1: Dose-Ranging Bardoxolone Methyl 2.5 mg/Part 2: Open-Label	0/5 (0%)	2/5 (40%)	5/5 (100%)
Part 2 Period of Part 1: Dose-Ranging Bardoxolone Methyl 5 mg/Part 2: Open-Label	0/11 (0%)	5/11 (45.5%)	11/11 (100%)
Part 2 Period of Part 1: Dose-Ranging Bardoxolone Methyl 10 mg/Part 2: Open-Label	0/6 (0%)	3/6 (50%)	6/6 (100%)
Part 2 Period of Part 1: Dose-Ranging Bardoxolone Methyl 20 mg/Part 2: Open-Label	0/9 (0%)	6/9 (66.7%)	8/9 (88.9%)
Part 2 Period of Part 1: Dose-Ranging Placebo 2.5 mg/Part 2: Bardoxolone Methyl 2.5 mg	0/1 (0%)	0/1 (0%)	1/1 (100%)
Part 2 Period of Part 1: Dose-Ranging Placebo 5 mg/Part 2: Bardoxolone Methyl 5 mg	0/3 (0%)	1/3 (33.3%)	2/3 (66.7%)
Part 2 Period of Part 1: Dose-Ranging Placebo 10 mg/Part 2: Bardoxolone Methyl 10 mg	0/3 (0%)	2/3 (66.7%)	3/3 (100%)
Part 2 Period of Part 1: Dose-Ranging Placebo 20 mg/Part 2: Bardoxolone Methyl 20 mg	0/3 (0%)	1/3 (33.3%)	3/3 (100%)
Part 2 Period of Part 1: Dose Titration: Bardoxolone Methyl 10 mg/Part 2: Bardoxolone Methyl 10 mg	0/63 (0%)	9/63 (14.3%)	50/63 (79.4%)
Part 2 Period of Part 1: Dose Titration: Placebo 10 mg/Part 2: Bardoxolone Methyl 10 mg	0/33 (0%)	9/33 (27.3%)	30/33 (90.9%)

Most frequent serious events

Showing 10 of 60

Most frequent serious events
Event	Part 1 Period of Part 1: Dose-Ranging Bardoxolone Methyl 2.5 mg/Part 2: Open-Label	Part 1 Period of Part 1: Dose-Ranging Bardoxolone Methyl 5 mg/Part 2: Open-Label	Part 1 Period of Part 1: Dose-Ranging Bardoxolone Methyl 10 mg/Part 2: Open-Label	Part 1 Period of Part 1: Dose-Ranging Bardoxolone Methyl 20 mg/Part 2: Open-Label	Part 1 Period of Part 1: Dose-Ranging Placebo 2.5 mg/Part 2: Bardoxolone Methyl 2.5 mg	Part 1 Period of Part 1: Dose-Ranging Placebo 5 mg/Part 2: Bardoxolone Methyl 5 mg	Part 1 Period of Part 1: Dose-Ranging Placebo 10 mg/Part 2: Bardoxolone Methyl 10 mg	Part 1 Period of Part 1: Dose-Ranging Placebo 20 mg/Part 2: Bardoxolone Methyl 20 mg	Part 1 Period of Part 1: Dose Titration: Bardoxolone Methyl 10 mg/Part 2: Bardoxolone Methyl 10 mg	Part 1 Period of Part 1: Dose Titration: Placebo 10 mg/Part 2: Bardoxolone Methyl 10 mg	Part 2 Period of Part 1: Dose-Ranging Bardoxolone Methyl 2.5 mg/Part 2: Open-Label	Part 2 Period of Part 1: Dose-Ranging Bardoxolone Methyl 5 mg/Part 2: Open-Label	Part 2 Period of Part 1: Dose-Ranging Bardoxolone Methyl 10 mg/Part 2: Open-Label	Part 2 Period of Part 1: Dose-Ranging Bardoxolone Methyl 20 mg/Part 2: Open-Label	Part 2 Period of Part 1: Dose-Ranging Placebo 2.5 mg/Part 2: Bardoxolone Methyl 2.5 mg	Part 2 Period of Part 1: Dose-Ranging Placebo 5 mg/Part 2: Bardoxolone Methyl 5 mg	Part 2 Period of Part 1: Dose-Ranging Placebo 10 mg/Part 2: Bardoxolone Methyl 10 mg	Part 2 Period of Part 1: Dose-Ranging Placebo 20 mg/Part 2: Bardoxolone Methyl 20 mg	Part 2 Period of Part 1: Dose Titration: Bardoxolone Methyl 10 mg/Part 2: Bardoxolone Methyl 10 mg	Part 2 Period of Part 1: Dose Titration: Placebo 10 mg/Part 2: Bardoxolone Methyl 10 mg
Non-cardiac chest painGeneral disorders	0/6	0/12	0/11	0/12	0/2	0/4	0/3	0/4	1/74	0/38	0/5	0/11	0/6	0/9	0/1	0/3	1/3	0/3	0/63	0/33
BronchitisInfections and infestations	0/6	0/12	0/11	0/12	0/2	0/4	0/3	0/4	0/74	0/38	0/5	0/11	0/6	0/9	0/1	0/3	1/3	0/3	0/63	0/33
Subdural haematomaInjury, poisoning and procedural complications	0/6	0/12	0/11	0/12	0/2	0/4	0/3	0/4	0/74	0/38	0/5	0/11	0/6	0/9	0/1	0/3	1/3	0/3	0/63	0/33
Pain in extremityMusculoskeletal and connective tissue disorders	0/6	0/12	0/11	0/12	0/2	0/4	0/3	1/4	0/74	0/38	0/5	0/11	0/6	0/9	0/1	0/3	0/3	1/3	0/63	0/33
DizzinessNervous system disorders	0/6	0/12	0/11	0/12	0/2	0/4	0/3	0/4	0/74	0/38	0/5	0/11	1/6	0/9	0/1	1/3	0/3	0/3	0/63	0/33
DeliriumPsychiatric disorders	0/6	0/12	0/11	0/12	0/2	0/4	0/3	0/4	0/74	0/38	0/5	0/11	0/6	0/9	0/1	0/3	0/3	1/3	0/63	0/33
Fluid overloadMetabolism and nutrition disorders	0/6	0/12	0/11	0/12	0/2	0/4	0/3	1/4	0/74	0/38	0/5	1/11	0/6	0/9	0/1	0/3	0/3	0/3	1/63	0/33
Muscular weaknessMusculoskeletal and connective tissue disorders	0/6	0/12	0/11	0/12	0/2	0/4	0/3	1/4	0/74	0/38	0/5	0/11	0/6	0/9	0/1	0/3	0/3	0/3	0/63	0/33
Hip fractureInjury, poisoning and procedural complications	0/6	0/12	0/11	0/12	0/2	0/4	0/3	0/4	0/74	0/38	1/5	0/11	0/6	0/9	0/1	0/3	0/3	0/3	0/63	0/33
OsteoarthritisMusculoskeletal and connective tissue disorders	0/6	0/12	0/11	0/12	0/2	0/4	0/3	0/4	0/74	0/38	1/5	0/11	0/6	0/9	0/1	0/3	0/3	0/3	0/63	0/33

Most frequent other events

Showing 10 of 310

Most frequent other events
Event	Part 1 Period of Part 1: Dose-Ranging Bardoxolone Methyl 2.5 mg/Part 2: Open-Label	Part 1 Period of Part 1: Dose-Ranging Bardoxolone Methyl 5 mg/Part 2: Open-Label	Part 1 Period of Part 1: Dose-Ranging Bardoxolone Methyl 10 mg/Part 2: Open-Label	Part 1 Period of Part 1: Dose-Ranging Bardoxolone Methyl 20 mg/Part 2: Open-Label	Part 1 Period of Part 1: Dose-Ranging Placebo 2.5 mg/Part 2: Bardoxolone Methyl 2.5 mg	Part 1 Period of Part 1: Dose-Ranging Placebo 5 mg/Part 2: Bardoxolone Methyl 5 mg	Part 1 Period of Part 1: Dose-Ranging Placebo 10 mg/Part 2: Bardoxolone Methyl 10 mg	Part 1 Period of Part 1: Dose-Ranging Placebo 20 mg/Part 2: Bardoxolone Methyl 20 mg	Part 1 Period of Part 1: Dose Titration: Bardoxolone Methyl 10 mg/Part 2: Bardoxolone Methyl 10 mg	Part 1 Period of Part 1: Dose Titration: Placebo 10 mg/Part 2: Bardoxolone Methyl 10 mg	Part 2 Period of Part 1: Dose-Ranging Bardoxolone Methyl 2.5 mg/Part 2: Open-Label	Part 2 Period of Part 1: Dose-Ranging Bardoxolone Methyl 5 mg/Part 2: Open-Label	Part 2 Period of Part 1: Dose-Ranging Bardoxolone Methyl 10 mg/Part 2: Open-Label	Part 2 Period of Part 1: Dose-Ranging Bardoxolone Methyl 20 mg/Part 2: Open-Label	Part 2 Period of Part 1: Dose-Ranging Placebo 2.5 mg/Part 2: Bardoxolone Methyl 2.5 mg	Part 2 Period of Part 1: Dose-Ranging Placebo 5 mg/Part 2: Bardoxolone Methyl 5 mg	Part 2 Period of Part 1: Dose-Ranging Placebo 10 mg/Part 2: Bardoxolone Methyl 10 mg	Part 2 Period of Part 1: Dose-Ranging Placebo 20 mg/Part 2: Bardoxolone Methyl 20 mg	Part 2 Period of Part 1: Dose Titration: Bardoxolone Methyl 10 mg/Part 2: Bardoxolone Methyl 10 mg	Part 2 Period of Part 1: Dose Titration: Placebo 10 mg/Part 2: Bardoxolone Methyl 10 mg
PalpitationsCardiac disorders	0/6	0/12	0/11	2/12	0/2	0/4	0/3	0/4	2/74	0/38	1/5	1/11	0/6	0/9	1/1	1/3	0/3	0/3	0/63	1/33
DiarrhoeaGastrointestinal disorders	0/6	2/12	2/11	2/12	0/2	1/4	0/3	0/4	10/74	3/38	2/5	2/11	0/6	1/9	1/1	0/3	1/3	0/3	1/63	7/33
FatigueGeneral disorders	0/6	1/12	1/11	2/12	0/2	0/4	1/3	0/4	7/74	4/38	0/5	0/11	3/6	1/9	1/1	1/3	1/3	0/3	4/63	4/33
Alanine aminotransferase increasedInvestigations	0/6	0/12	0/11	1/12	0/2	0/4	0/3	0/4	5/74	0/38	0/5	0/11	1/6	0/9	1/1	0/3	1/3	0/3	1/63	2/33
Aspartate aminotransferase increasedInvestigations	0/6	0/12	0/11	1/12	0/2	0/4	0/3	0/4	4/74	0/38	0/5	0/11	1/6	0/9	1/1	0/3	0/3	0/3	1/63	1/33
Burning sensationNervous system disorders	0/6	0/12	0/11	0/12	0/2	0/4	0/3	0/4	0/74	0/38	0/5	0/11	0/6	0/9	1/1	0/3	0/3	0/3	0/63	0/33
DizzinessNervous system disorders	0/6	1/12	1/11	2/12	0/2	0/4	0/3	1/4	4/74	3/38	1/5	1/11	1/6	1/9	1/1	0/3	0/3	0/3	0/63	0/33
ParaesthesiaNervous system disorders	0/6	0/12	0/11	0/12	0/2	0/4	0/3	0/4	0/74	0/38	0/5	0/11	0/6	0/9	1/1	0/3	0/3	0/3	0/63	1/33
TremorNervous system disorders	0/6	0/12	0/11	0/12	0/2	0/4	0/3	0/4	0/74	0/38	0/5	0/11	0/6	0/9	1/1	0/3	0/3	0/3	1/63	0/33
Attention deficit/hyperactivity disorderPsychiatric disorders	0/6	0/12	0/11	0/12	0/2	0/4	0/3	0/4	0/74	0/38	0/5	0/11	0/6	0/9	1/1	0/3	0/3	0/3	0/63	0/33

Baseline characteristics

Intent-to-treat (ITT) population, which included all randomized patients.

Age, Continuous
Age, Continuous(years)	Part 1: Dose-Ranging Bardoxolone Methyl 2.5 mg/Part 2: Open-Label	Part 1: Dose-Ranging Bardoxolone Methyl 5 mg/Part 2: Open-Label	Part 1: Dose-Ranging Bardoxolone Methly 10 mg/Part 2: Open-Label	Part 1: Dose-Ranging Bardoxolone Methyl 20 mg/Part 2: Open-Label	Part 1: Dose-Ranging Placebo 2.5 mg/Part 2: Bardoxolone Methyl 2.5 mg	Part 1: Dose-Ranging Placebo 5 mg/Part 2: Bardoxolone Methyl 5 mg	Part 1: Dose-Ranging Placebo 10 mg/Part 2: Bardoxolone Methyl 10 mg	Part 1: Dose-Ranging Placebo 20 mg/Part 2: Bardoxolone Methyl 20 mg	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	Total
Part 1: 16-week double-blind, randomized, placebo-controlled treatment period (Day 1 to Week 16)	52.5 ± 7.15	52.8 ± 14.84	50.6 ± 16.33	49.6 ± 13.06	53 ± 15.56	39.5 ± 11.27	54.7 ± .58	51.3 ± 8.54	56.4 ± 12.41	55.6 ± 12.7	54.3 ± 12.8
Part 2: Open-label extension period (Week 16 and onwards)	54.6 ± 5.55	53.4 ± 15.4	59.2 ± 10.26	51 ± 14.76	64 ± 0	40 ± 13.75	54.7 ± .58	47.7 ± 5.69	56.5 ± 12.23	56.7 ± 12.44	55.5 ± 12.38

Sex: Female, Male
Sex: Female, Male(Participants)	Part 1: Dose-Ranging Bardoxolone Methyl 2.5 mg/Part 2: Open-Label	Part 1: Dose-Ranging Bardoxolone Methyl 5 mg/Part 2: Open-Label	Part 1: Dose-Ranging Bardoxolone Methly 10 mg/Part 2: Open-Label	Part 1: Dose-Ranging Bardoxolone Methyl 20 mg/Part 2: Open-Label	Part 1: Dose-Ranging Placebo 2.5 mg/Part 2: Bardoxolone Methyl 2.5 mg	Part 1: Dose-Ranging Placebo 5 mg/Part 2: Bardoxolone Methyl 5 mg	Part 1: Dose-Ranging Placebo 10 mg/Part 2: Bardoxolone Methyl 10 mg	Part 1: Dose-Ranging Placebo 20 mg/Part 2: Bardoxolone Methyl 20 mg	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	Total
Part 1: 16-week double-blind, randomized, placebo-controlled treatment period (Day 1 to Week 16) — Female	4	10	8	11	1	4	2	3	54	27	124
Part 1: 16-week double-blind, randomized, placebo-controlled treatment period (Day 1 to Week 16) — Male	2	2	3	1	1	0	1	1	20	11	42
Part 2: Open-label extension period (Week 16 and onwards) — Female	4	9	4	9	1	3	2	3	47	24	106
Part 2: Open-label extension period (Week 16 and onwards) — Male	1	2	2	0	0	0	1	0	16	9	31

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Part 1: Dose-Ranging Bardoxolone Methyl 2.5 mg/Part 2: Open-Label	Part 1: Dose-Ranging Bardoxolone Methyl 5 mg/Part 2: Open-Label	Part 1: Dose-Ranging Bardoxolone Methly 10 mg/Part 2: Open-Label	Part 1: Dose-Ranging Bardoxolone Methyl 20 mg/Part 2: Open-Label	Part 1: Dose-Ranging Placebo 2.5 mg/Part 2: Bardoxolone Methyl 2.5 mg	Part 1: Dose-Ranging Placebo 5 mg/Part 2: Bardoxolone Methyl 5 mg	Part 1: Dose-Ranging Placebo 10 mg/Part 2: Bardoxolone Methyl 10 mg	Part 1: Dose-Ranging Placebo 20 mg/Part 2: Bardoxolone Methyl 20 mg	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	Total
Part 1: 16-week double-blind, randomized, placebo-controlled treatment period (Day 1 to Week 16) — Hispanic or Latino	2	3	0	1	0	1	0	0	12	7	26
Part 1: 16-week double-blind, randomized, placebo-controlled treatment period (Day 1 to Week 16) — Not Hispanic or Latino	4	9	11	11	2	3	3	4	62	31	140
Part 1: 16-week double-blind, randomized, placebo-controlled treatment period (Day 1 to Week 16) — Unknown or Not Reported	0	0	0	0	0	0	0	0	0	0	0
Part 2: Open-label extension period (Week 16 and onwards) — Hispanic or Latino	2	2	0	0	0	0	0	0	10	7	21
Part 2: Open-label extension period (Week 16 and onwards) — Not Hispanic or Latino	3	9	6	9	1	3	3	3	53	26	116
Part 2: Open-label extension period (Week 16 and onwards) — Unknown or Not Reported	0	0	0	0	0	0	0	0	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Part 1: Dose-Ranging Bardoxolone Methyl 2.5 mg/Part 2: Open-Label	Part 1: Dose-Ranging Bardoxolone Methyl 5 mg/Part 2: Open-Label	Part 1: Dose-Ranging Bardoxolone Methly 10 mg/Part 2: Open-Label	Part 1: Dose-Ranging Bardoxolone Methyl 20 mg/Part 2: Open-Label	Part 1: Dose-Ranging Placebo 2.5 mg/Part 2: Bardoxolone Methyl 2.5 mg	Part 1: Dose-Ranging Placebo 5 mg/Part 2: Bardoxolone Methyl 5 mg	Part 1: Dose-Ranging Placebo 10 mg/Part 2: Bardoxolone Methyl 10 mg	Part 1: Dose-Ranging Placebo 20 mg/Part 2: Bardoxolone Methyl 20 mg	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	Total
Part 1: 16-week double-blind, randomized, placebo-controlled treatment period (Day 1 to Week 16) — American Indian or Alaska Native	0	0	0	0	0	0	0	0	0	0	0
Part 1: 16-week double-blind, randomized, placebo-controlled treatment period (Day 1 to Week 16) — Asian	0	0	0	0	0	0	0	0	2	0	2
Part 1: 16-week double-blind, randomized, placebo-controlled treatment period (Day 1 to Week 16) — Native Hawaiian or Other Pacific Islander	0	0	0	0	0	0	0	0	0	1	1
Part 1: 16-week double-blind, randomized, placebo-controlled treatment period (Day 1 to Week 16) — Black or African American	0	1	1	0	0	3	0	0	17	9	31
Part 1: 16-week double-blind, randomized, placebo-controlled treatment period (Day 1 to Week 16) — White	6	11	9	12	2	1	3	4	54	28	130
Part 1: 16-week double-blind, randomized, placebo-controlled treatment period (Day 1 to Week 16) — More than one race	0	0	0	0	0	0	0	0	0	0	0
Part 1: 16-week double-blind, randomized, placebo-controlled treatment period (Day 1 to Week 16) — Unknown or Not Reported	0	0	1	0	0	0	0	0	1	0	2
Part 2: Open-label extension period (Week 16 and onwards) — American Indian or Alaska Native	0	0	0	0	0	0	0	0	0	0	0
Part 2: Open-label extension period (Week 16 and onwards) — Asian	0	0	0	0	0	0	0	0	1	0	1
Part 2: Open-label extension period (Week 16 and onwards) — Native Hawaiian or Other Pacific Islander	0	0	0	0	0	0	0	0	0	0	0
Part 2: Open-label extension period (Week 16 and onwards) — Black or African American	0	1	0	0	0	3	0	0	14	5	23
Part 2: Open-label extension period (Week 16 and onwards) — White	5	10	5	9	1	0	3	3	47	28	111
Part 2: Open-label extension period (Week 16 and onwards) — More than one race	0	0	0	0	0	0	0	0	0	0	0
Part 2: Open-label extension period (Week 16 and onwards) — Unknown or Not Reported	0	0	1	0	0	0	0	0	1	0	2

6-Minute Walk Test (6MWT)
6-Minute Walk Test (6MWT)(meters)	Part 1: Dose-Ranging Bardoxolone Methyl 2.5 mg/Part 2: Open-Label	Part 1: Dose-Ranging Bardoxolone Methyl 5 mg/Part 2: Open-Label	Part 1: Dose-Ranging Bardoxolone Methly 10 mg/Part 2: Open-Label	Part 1: Dose-Ranging Bardoxolone Methyl 20 mg/Part 2: Open-Label	Part 1: Dose-Ranging Placebo 2.5 mg/Part 2: Bardoxolone Methyl 2.5 mg	Part 1: Dose-Ranging Placebo 5 mg/Part 2: Bardoxolone Methyl 5 mg	Part 1: Dose-Ranging Placebo 10 mg/Part 2: Bardoxolone Methyl 10 mg	Part 1: Dose-Ranging Placebo 20 mg/Part 2: Bardoxolone Methyl 20 mg	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	Total
Mean	412 ± 19.7	425.8 ± 81	385.7 ± 55.45	454.5 ± 93.01	358 ± 96.17	418.9 ± 71.18	367 ± 46.02	449.3 ± 84.64	380.8 ± 96.46	395.2 ± 84.99	396.2 ± 88.32

Study locations

32 sites

Banner University Medical Center, Phoenix Advanced Lung Disease Institute
Phoenix, Arizona 85004, United States
Arizona Pulmonary Specialists
Phoenix, Arizona 85012, United States
Cedars Sinai Medical Center
Beverly Hills, California 90211, United States
VA Healthcare System of Greater Los Angeles
Los Angeles, California 90073, United States
University of California Davis Medical Center - Division of Pulmonary and Critical Care
Sacramento, California 95817, United States
Harbor - UCLA Medical Center
Torrance, California 90502, United States
University of Colorado Denver - Division of Pulmonary Sciences
Aurora, Colorado 80045, United States
South Denver Cardiology Associates, P.C
Littleton, Colorado 80120, United States
Georgetown University Medical Center - Department of Rheumatology
Washington, District of Columbia 20007, United States
Cleveland Clinic of Florida
Weston, Florida 33331, United States
University of Chicago
Chicago, Illinois 60637, United States
Maine Medical Center - Division of Pulmonary and Critical Care Medicine
Portland, Maine 04102, United States
Tufts Medical Center
Boston, Massachusetts 02111, United States
Brigham and Women's Hospital
Boston, Massachusetts 02115, United States
Boston University School of Medicine
Boston, Massachusetts 02118, United States
Winthrop University Hospital
Mineola, New York 11501, United States
Mount Sinai, Beth Israel Medical Center
New York, New York 10003, United States
Weill Cornell Medical Center
New York, New York 10021, United States
University of Rochester - University of Rochester Medical Center
Rochester, New York 14642, United States
The Lindner Clinical Trial Center
Cincinnati, Ohio 45219, United States
University of Cincinnati - Department of Internal Medicine Pulmonary, Critical Care & Sleep Medicine
Cincinnati, Ohio 45267, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio 43210, United States
Oklahoma Heart Hospital
Oklahoma City, Oklahoma 73120, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15213, United States
University of Texas Southwestern Medical Center
Dallas, Texas 75390, United States
BreatheAmerica El Paso, Inc.
El Paso, Texas 79912, United States
Houston Methodist Research Institute
Houston, Texas 77030, United States
The University of Texas - Health Science Center & Medical School at Houston
Houston, Texas 77030, United States
University of Texas Houston - Division of Rheumatology and Clinical Immunogenetics
Houston, Texas 77030, United States
University of Utah
Salt Lake City, Utah 84132, United States
University Clinic Carl Gustav Carus
Dresden, 01304, Germany
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, 20246, Germany

References and documents

Study documents

Study protocol · Jan 26, 2017
Statistical analysis plan · Jun 14, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02036970
Lead sponsor: Biogen
Responsible party: Sponsor
First posted: Jan 15, 2014
Start date: May 31, 2014
Primary completion: Jan 19, 2018
Completion: May 16, 2018
Results posted: Jul 23, 2021
Last update: Jun 10, 2025

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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