TerminatedNCT02657356Updated Jun 4, 2025Results posted

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

A Phase 3 interventional study of Placebo capsules and Bardoxolone methyl capsules in Connective Tissue Disease-Associated Pulmonary Arterial Hypertension, sponsored by Biogen. Terminated at 106 sites in 15 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-06-04.

Sponsored by Biogen · Phase 3, Interventional, and Treatment

Why this study was terminated

Exposure of these high-risk patients to clinic or in-person visits during the pandemic presented an unacceptable risk to their health

Phase: Phase 3
Study type: Interventional
Enrollment: 202
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 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.

Read the detailed description

This double-blind, randomized, placebo-controlled trial will study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients with World Health Organization Group I Connective Tissue Disease Pulmonary Arterial Hypertension (WHO Group I CTD-PAH).

Qualified patients will be randomized 1:1 to either bardoxolone methyl or placebo to be administered once daily for 24 weeks. Patients randomized to placebo will remain on placebo throughout the study. Patients randomized to bardoxolone methyl will start at 5 mg and will dose-escalate to 10 mg at Week 4 unless contraindicated clinically. Dose de-escalation is permitted during the study if indicated clinically.

All patients in the study will follow the same visit and assessment schedule. Following randomization, patients will be scheduled to be assessed in person during treatment at Weeks 1, 2, 4, 6, 8, 16, and 24 and by telephone contact on Days 3, 10, 21, 31, 38, 84, and 140. Patients will also be scheduled to be assessed at an in person follow up visit at Week 28, four weeks after the end of treatment.

Conditions studied

Connective Tissue Disease-Associated Pulmonary Arterial Hypertension

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Keywords

Pulmonary Hypertension
Pulmonary Arterial Hypertension
Connective Tissue Disease-Associated Pulmonary Arterial Hypertension
Bardoxolone methyl
PAH
RTA 402
6-minute walk distance

In context

Pulmonary Arterial Hypertension

761 studies on the registry are indexed under Pulmonary Arterial Hypertension; 142 are open to participants now.

This study's enrollment of 202 is above the median of 38 across 509 interventional studies indexed under Pulmonary Arterial Hypertension.

Browse Pulmonary Arterial Hypertension 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

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

Exclusion criteria

Exclusion Criteria:

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;
Hemoglobin (Hgb) concentration \< 8.5 g/dL at Screening;
Diagnosis of Down syndrome;
History of malignancy within 5 years prior to screening, with the exception of localized skin or cervical carcinomas;
Untreated or uncontrolled active bacterial, fungal, or viral infection;
Known or suspected active drug or alcohol abuse, per investigator judgment;
Use of Herbalife supplements within 14 days prior to Day 1;
Major surgery within 30 days prior to Day 1 or planned to occur during the course of the study;
Unwilling to practice acceptable methods of birth control (both males who have partners of childbearing potential and females of childbearing potential) during screening, while taking study drug, and for at least 30 days after the last dose of study drug is ingested;
Use of inhaled nitric oxide within 7 days prior to Screening and Day 1 visits, excluding acute vasodilator testing during diagnostic cardiac catheterization;
Women who are pregnant or breastfeeding;
Any disability or impairment that would prohibit performance of the 6MWT;
Any abnormal laboratory level that, in the opinion of the investigator, would put the patient at risk by trial enrollment;
Patient is, in the opinion of the investigator, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason;
Known hypersensitivity to any component of the study drug;
Unable to communicate or cooperate with the investigator because of language problems, poor mental development, or impaired cerebral function.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 202 participants (actual)

Study arms

Placebo comparator
Placebo capsules
Placebo capsules will be administered orally once a day for 24 weeks.
Drug: Placebo capsules
Experimental
Bardoxolone methyl capsules
Each patient will receive bardoxolone methyl capsules administered orally once a day for 24 weeks. Starting dosage for each patient is 5 mg and will dose-escalate to 10 mg at Week 4, unless contraindicated clinically.
Drug: Bardoxolone methyl capsules

Interventions

DrugPlacebo capsules
DrugBardoxolone methyl capsules
Also known as: RTA 402 capsules

What researchers measure

Primary outcomes

Change From Baseline in Six-minute-walk Distance (6MWD) Relative to Placebo at Week 24
Time frame: Baseline through 24 weeks after participant receives the first dose

Secondary outcomes

Time to First Persistent Clinical Improvement Event
At least one of the following four criteria must have been met: 1. Improvement by at least one WHO functional class coupled with no more than a 15% decrease from baseline in 6MWT 2. Increase from baseline in 6MWT by at least 10% and stability or improvement in the WHO functional class 3. Decrease from baseline in creatine kinase (a surrogate biomarker for muscle injury and inflammation) by at least 10% and no worsening in WHO functional class and no more than a 15% decrease from baseline in 6MWT 4. Improvement in estimated glomerular filtration rate eGFR ≥10% of baseline The persistence of the change in WHO functional class, 6MWT, eGFR, or creatine kinase must be confirmed by a subsequent assessment at least 14 days after the initial assessment, or at the next scheduled assessment. If persistent improvement is confirmed, the date of the event was considered the initial assessment of improved WHO functional class, 6MWT, eGFR, or creatine kinase.
Time frame: Baseline through the end of the study

Results

Posted May 19, 2023

Participant flow

Participant flow — Overall Study
Milestone	Placebo Capsules	Bardoxolone Methyl Capsules
Started	102	100
Completed	82	85
Not completed	20	15
Withdrew: Death	1	0
Withdrew: Withdrawal by subject	5	6
Withdrew: Terminated by sponsor	8	5
Withdrew: Rolled over to eap study	6	4

Outcome measures

PrimaryChange From Baseline in Six-minute-walk Distance (6MWD) Relative to Placebo at Week 24

Time frame:: Baseline through 24 weeks after participant receives the first dose
Reported as:: Least squares mean · meters

Change From Baseline in Six-minute-walk Distance (6MWD) Relative to Placebo at Week 24
meters	Placebo Capsules	Bardoxolone Methyl Capsules
Change From Baseline in Six-minute-walk Distance (6MWD) Relative to Placebo at Week 24	9.25 ± 4.954	-3.61 ± 4.952

Statistical analysis

Placebo Capsules vs Bardoxolone Methyl Capsules · Mixed Models Analysis · p = 0.0683 · Ls mean difference (net): -12.86 · 95% CI -26.69 to 0.98Difference is bardoxolone methyl - placebo

SecondaryTime to First Persistent Clinical Improvement Event

At least one of the following four criteria must have been met: 1. Improvement by at least one WHO functional class coupled with no more than a 15% decrease from baseline in 6MWT 2. Increase from baseline in 6MWT by at least 10% and stability or improvement in the WHO functional class 3. Decrease from baseline in creatine kinase (a surrogate biomarker for muscle injury and inflammation) by at least 10% and no worsening in WHO functional class and no more than a 15% decrease from baseline in 6MWT 4. Improvement in estimated glomerular filtration rate eGFR ≥10% of baseline The persistence of the change in WHO functional class, 6MWT, eGFR, or creatine kinase must be confirmed by a subsequent assessment at least 14 days after the initial assessment, or at the next scheduled assessment. If persistent improvement is confirmed, the date of the event was considered the initial assessment of improved WHO functional class, 6MWT, eGFR, or creatine kinase.

Time frame:: Baseline through the end of the study
Reported as:: Mean · weeks

Time to First Persistent Clinical Improvement Event
weeks	Placebo Capsules	Bardoxolone Methyl Capsules
Time to First Persistent Clinical Improvement Event	17.9 ± 1.263	6.62 ± 0.646

Statistical analysis

Placebo Capsules vs Bardoxolone Methyl Capsules · Chi-squared · p = 0.0004 · Hazard ratio (hr): 1.984 · 95% CI 1.360 to 2.895Estimated from Cox Regression adjusted by baseline PAH medication status (0-1 vs 2) as the covariate. Hazard ratio \>1 indicates a beneficial effect that favors bardoxolone methyl.

Adverse events

Collected over 28 weeks. Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Placebo Capsules	1/102 (1%)	18/102 (17.6%)	79/102 (77.5%)
Bardoxolone Methyl Capsules	0/100 (0%)	16/100 (16%)	85/100 (85%)

Most frequent serious events

Showing 10 of 38

Most frequent serious events
Event	Placebo Capsules	Bardoxolone Methyl Capsules
Pulmonary arterial hypertensionRespiratory, thoracic and mediastinal disorders	1/102	4/100
PneumoniaInfections and infestations	3/102	2/100
Breast cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)	2/102	0/100
Cardiac failure acuteCardiac disorders	0/102	1/100
Cardiac failure congestiveCardiac disorders	0/102	1/100
Right ventricular failureCardiac disorders	0/102	1/100
Food poisoningGastrointestinal disorders	0/102	1/100
GastritisGastrointestinal disorders	0/102	1/100
Small intestinal obstructionGastrointestinal disorders	0/102	1/100
Non-cardiac chest painGeneral disorders	1/102	1/100

Most frequent other events

Showing 10 of 63

Most frequent other events
Event	Placebo Capsules	Bardoxolone Methyl Capsules
DiarrhoeaGastrointestinal disorders	21/102	13/100
HeadacheNervous system disorders	21/102	14/100
Upper respiratory tract infectionInfections and infestations	11/102	19/100
Muscle spasmsMusculoskeletal and connective tissue disorders	6/102	17/100
FatigueGeneral disorders	13/102	9/100
NauseaGastrointestinal disorders	11/102	12/100
Oedema peripheralGeneral disorders	12/102	9/100
ArthralgiaMusculoskeletal and connective tissue disorders	12/102	3/100
DizzinessNervous system disorders	12/102	8/100
DyspnoeaRespiratory, thoracic and mediastinal disorders	12/102	9/100

Baseline characteristics

Intent to treat (ITT) population (all randomized patients categorized by their assigned treatment group regardless of treatment exposure)

Age, Continuous
Age, Continuous(years)	Placebo Capsules	Bardoxolone Methyl Capsules	Total
Mean	56.5 ± 13.17	55 ± 13.57	55.7 ± 13.36

Age, Customized
Age, Customized(years)	Placebo Capsules	Bardoxolone Methyl Capsules	Total
Median Age	60 (21 to 75)	57 (29 to 75)	59 (21 to 75)

Sex: Female, Male
Sex: Female, Male(Participants)	Placebo Capsules	Bardoxolone Methyl Capsules	Total
Female	91	88	179
Male	11	12	23

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Placebo Capsules	Bardoxolone Methyl Capsules	Total
Hispanic or Latino	32	27	59
Not Hispanic or Latino	70	73	143
Unknown or Not Reported	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Placebo Capsules	Bardoxolone Methyl Capsules	Total
American Indian or Alaska Native	0	0	0
Asian	10	16	26
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	10	6	16
White	78	76	154
More than one race	0	0	0
Unknown or Not Reported	4	2	6

Region of Enrollment
Region of Enrollment(participants)	Placebo Capsules	Bardoxolone Methyl Capsules	Total
Argentina	14	12	26
Australia	8	7	15
Belgium	2	1	3
Brazil	5	4	9
Canada	5	5	10
Czechia	1	2	3
Germany	1	5	6
Spain	5	3	8
United Kingdom	1	2	3
Israel	2	2	4
Japan	7	9	16
Mexico	4	8	12
Netherlands	1	1	2
Philippines	1	4	5
United States	45	35	80

Six Minute Walk Distance (6MWD)
Six Minute Walk Distance (6MWD)(meters)	Placebo Capsules	Bardoxolone Methyl Capsules	Total
Mean	380.4 ± 91.19	389.1 ± 107.78	384.7 ± 99.6

Study locations

106 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
Regents of The University of California
Fresno, California 93701, United States
University of California San Diego
La Jolla, California 92093, United States
David Geffen School of Medicine UCLA
Los Angeles, California 90095, United States
Pacific Pulmonary Research, Inc.
San Diego, California 92103, United States
Santa Barbara Pulmonary Associates
Santa Barbara, California 93105, United States
Harbor - UCLA Medical Center
Torrance, California 90502, United States
Georgetown University Medical Center - Department of Rheumatology
Washington, District of Columbia 20007, United States
University of Miami Miller School of Medicine
Miami, Florida 33136, United States
Cleveland Clinic Florida
Weston, Florida 33331, United States
Augusta University
Augusta, Georgia 30912, United States
Piedmont-Georgia Lung
Austell, Georgia 30106, United States
University of Illinois at Chicago
Chicago, Illinois 60612, United States
Kentuckiana Pulmonary Associates
Louisville, Kentucky 40202, United States
Massachusetts General Hospital
Boston, Massachusetts 02114, United States
Boston University School of Medicine
Boston, Massachusetts 02118, United States
University of Michigan
Ann Arbor, Michigan 48109, United States
Washington University School of Medicine
Saint Louis, Missouri 63110, United States
University of Nebraska Medical Center
Omaha, Nebraska 68131, United States
University of New Mexico
Albuquerque, New Mexico 87131, United States
NYU Langone Health
New York, New York 10003, United States
University of Rochester - University of Rochester Medical Center
Rochester, New York 14642, United States
Duke University Medical Center
Durham, North Carolina 27710, United States
University of Cincinnati
Cincinnati, Ohio 45219, United States
Cleveland Clinic
Cleveland, Ohio 44195, United States
Wexner Medical Center at The Ohio State University
Columbus, Ohio 43210, United States
Integris Nazih Zuhdi Transplant Institute
Oklahoma City, Oklahoma 73120, United States
Oregon Health & Science University
Portland, Oregon 97239, United States
University of Pennsylvania
Philadelphia, Pennsylvania 19104, United States
Thomas Jefferson University
Philadelphia, Pennsylvania 19107, United States
Medical University of South Carolina
Charleston, South Carolina 29425, United States
University of Texas Southwestern Medical Center
Dallas, Texas 75390, United States
The Methodist Hospital Research Institute
Houston, Texas 77030, United States
University of Texas Health Science Center at Houston
Houston, Texas 77030, United States
University of Utah
Salt Lake City, Utah 84132, United States
Fundación Favaloro
Buenos Aires, Ciudad Autónoma De BuenosAires C1093AAS, Argentina
Hospital Británico de Buenos Aires
Buenos Aires, Ciudad Autónoma De BuenosAires C1280AEB, Argentina
Centro Médico Dra de Salvo
Buenos Aires, Ciudad Autónoma De BuenosAires C1426ABP, Argentina
Instituto de Investigaciones Clínicas Mar Del Plata
Buenos Aires, Mar Del Plata B7600FZN, Argentina
Instituto De Enfermedades Respiratorias E Investigacion Medica
Buenos Aires, Villa Vatteone B1853AIK, Argentina
Hospital Cordoba
Cordoba, X5004CDP, Argentina
Hospital Privado Centro Médico de Córdoba
Cordoba, X5016KEH, Argentina
Instituto de Cardiologia de Corrientes Juana Francisca Cabral
Corrientes, W3400AMZ, Argentina
Hospital de Alta Complejidad "Pte. J. D. Perón"
Formosa, 3600, Argentina
Royal Prince Alfred Hospital
Camperdown, New South Wales 2050, Australia
St Vincent's Hospital Sydney
Darlinghurst, New South Wales 2010, Australia
John Hunter Hospital
New Lambton, New South Wales 2305, Australia
Princess Alexandra Hospital
Brisbane, Queensland 4102, Australia
Royal Hobart Hospital
Hobart, Tasmania 7000, Australia
UZ Leuven
Leuven, Vlaams Brabant 3000, Belgium
Hôpital Erasme
Brussels, 1070, Belgium
Hospital de Messejana
Fortaleza, Ceara 60864-190, Brazil
Irmandade Da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande Do Sul 90035-074, Brazil
Hospital Dia do Pulmão
Blumenau, Santa Catarina 89010-000, Brazil
Hospital São Paulo
Sao Paulo, 04023-900, Brazil
Instituto do Coração - HCFMUSP
São Paulo, 05403-900, Brazil
Peter Lougheed Centre
Calgary, Alberta T1Y 6J4, Canada
University of Alberta
Edmonton, Alberta T6G 2B7, Canada
Vancouver General Hospital
Vancouver, British Columbia V5Z 1M9, Canada
London Health Sciences Centre
London, Ontario N6A 5W9, Canada
Centre Hospitalier de l'Université Laval
Sainte Foy, Quebec G1V 4G5, Canada
Vseobecna fakultni nemocnice v Praze
Prague, 128 00, Czechia
Institut klinicke a experimentalni mediciny
Prague, 140 00, Czechia
Universitätsklinikum Freiburg
Freiburg im Breisgau, Baden-Württemberg 79106, Germany
Universitatsklinkum Erlangen
Erlangen, Bayern 91054, Germany
Universität Greifswald
Greifswald, Mecklenburg-Vorpommern 17475, Germany
DRK Kliniken Berlin Westend
Berlin, 14050, Germany
Universitätsklinikum Carl Gustav Carus an der TU Dresden
Dresden, 01307, Germany
Universitätsklinikum Hamburg Eppendorf
Hamburg, 20246, Germany
Thorax Klinik
Heidelberg, 69126, Germany
Universitätsklinikum Köln
Köln, 50937, Germany
Hadassah University Hospital Ein Kerem
Jerusalem, 91120, Israel
Rabin Medical Center
Petah Tikva, 49100, Israel
Nippon Medical School Hospital
Tokyo, Bunkyo-ku 113-8603, Japan
Kitasato University Hospital
Sagamihara, Kanagawa 252-0375, Japan
Tohoku University Hospital
Sendai, Miyagi 980-8574, Japan
National Hospital Organization Okayama Medical Center
Okayama-shi, Okayama 701-1192, Japan
Chiba University Hospital
Chiba, 260-8677, Japan
Gunma University School of Medicine
Gunma, 371-8510, Japan
Kobe University Hospital
Kobe, 6500017, Japan
Nagoya Medical Center
Nagoya, 460-0001, Japan
Hokkaido University Hospital
Sapporo, 0608648, Japan
Kurume University Medical Center
Sendai-shi, 980-8574, Japan
National Cerebral and Cardiovascular Center
Suita, 5658565, Japan
Fujita Health University Hospital
Toyoake, 470-1192, Japan
Instituto Nacional de Cardiologia Dr. Ignacio Chavez
Ciudad de Mexico, Distrito Federal 14080, Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, Distrito Federal 14000, Mexico
Hospital Civil Fray Antonio Alcalde
Guadalajara, Jalisco 44280, Mexico
Hospital Universitario Dr. Jose Eleuterio González
Monterrey, Nuevo Leon 64460, Mexico
Unidad de Investigación Clínica En Medicina SC
Monterrey, Nuevo Leon 64718, Mexico
Vrije Universiteit Amsterdam
Amsterdam, Noord-Holland 1007 MB, Netherlands
Angeles University Foundation Medical Center (AUFMC)
Angeles City, Philippines
Mary Mediatrix Medical Center (MMMC)
Lipa, Philippines
Makati Medical Center (MMC)
Makati, Philippines
Philippine General Hospital (PGH)
Manila, Philippines
Philippine Heart Center (PHC)
Quezon City, 1100, Philippines
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, Spain
Hospital Universitario Vall d'Hebron
Barcelona, 08035, Spain

Showing the first 100 of 106 sites across 15 countries.

References and documents

Study documents

Study protocol · Oct 18, 2016
Statistical analysis plan · May 26, 2020

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 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02657356
Lead sponsor: Biogen
Responsible party: Sponsor
First posted: Jan 15, 2016
Start date: Oct 4, 2016
Primary completion: May 7, 2020
Completion: May 7, 2020
Results posted: May 19, 2023
Last update: Jun 4, 2025

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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