Clinical trials: sponsored by Biogen
Healthy Volunteer
A Study to Evaluate the Pharmacokinetics, Safety and Immunogenicity of BIIB800 Subcutaneously (SC) Compared to Actemra® in Healthy Male Participants
The primary objective of the study is to show equivalence in pharmacokinetics (PK) of BIIB800 and Actemra following SC administration of a single dose to healthy male participants.
- Trial name
- NCT06262477
- Testing
- BIIB800, Actemra
- Where
- 4 sites in United States, United Kingdom
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Biogen
Healthy Volunteer
A Study to Learn How BIIB141 (Omaveloxolone) is Processed in the Body When Taken as Capsules Compared to Sprinkled on Yogurt in Healthy Adults Aged 18 to 55
In this study, researchers will learn more about how BIIB141, also known as omaveloxolone or SKYCLARYS®, is processed in the body when taken in different ways.
- Trial name
- NCT07019064
- Testing
- Omaveloxolone
- Where
- United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Biogen
ALS Caused by Superoxide Dismutase 1 (SOD1) Mutation
Long-Term Evaluation of BIIB067 (Tofersen)
The primary objective of the study is to evaluate the long-term safety and tolerability of BIIB067 (tofersen) in participants with amyotrophic lateral sclerosis (ALS) and confirmed superoxide dismutase 1 (SOD1) mutation.
- Trial name
- NCT03070119
- Testing
- Tofersen
- Where
- 30 sites in United States, Belgium and 7 more
- Volunteers
- 139 people
- Sponsor
- Biogen
Pulmonary Hypertension
Extended Access Program to Assess Long-term Safety of Bardoxolone Methyl in Patients With Pulmonary Hypertension RANGER
This extended access study will assess the long-term safety and tolerability of bardoxolone methyl in qualified patients with pulmonary hypertension (PH) who previously participated in controlled clinical studies with bardoxolone…
- Trial name
- RANGER (NCT03068130)
- Testing
- Bardoxolone methyl
- Where
- 96 sites in United States, Argentina and 13 more
- Volunteers
- 261 people
- Sponsor
- Biogen
Alport Syndrome
A Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients With Alport Syndrome - CARDINAL
This international, multi-center, Phase 2/3 trial will study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients with Alport syndrome.
- Trial name
- CARDINAL (NCT03019185)
- Testing
- Bardoxolone Methyl
- Where
- 63 sites in United States, Australia and 6 more
- Volunteers
- 187 people
- Sponsor
- Biogen
Pulmonary Arterial Hypertension, Pulmonary Hypertension
Bardoxolone Methyl Evaluation in Patients With Pulmonary Hypertension (PH) - LARIAT
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…
- Conditions
- Pulmonary Arterial Hypertension, Pulmonary Hypertension, Interstitial Lung Disease, Idiopathic Interstitial Pneumonia
- Trial name
- NCT02036970
- Testing
- Bardoxolone methyl
- Where
- 32 sites in United States, Germany
- Volunteers
- 166 people
- Sponsor
- Biogen
MItochondrial Myopathies
RTA 408 Capsules in Patients With Mitochondrial Myopathy - MOTOR
Mitochondrial myopathies are a multisystemic group of disorders that are characterized by a wide range of biochemical and genetic mitochondrial defects and variable modes of inheritance.
- Trial name
- NCT02255422
- Testing
- Omaveloxolone capsules, 2.5 mg, omaveloxolone capsules, 5 mg, omaveloxolone capsules, 10 mg
- Where
- 9 sites in United States, Denmark
- Volunteers
- 53 people
- Sponsor
- Biogen
Muscular Atrophy, Spinal
Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy
The primary objectives of this study are to examine the clinical efficacy of nusinersen administered intrathecally at higher doses to participants with spinal muscular atrophy (SMA), as measured by change in Children's Hospital…
- Trial name
- DEVOTE (NCT04089566)
- Testing
- Nusinersen
- Where
- 45 sites in United States, Brazil and 16 more
- Volunteers
- 145 people
- Sponsor
- Biogen
Connective Tissue Disease-Associated Pulmonary Arterial Hypertension
Bardoxolone Methyl in Patients With Connective Tissue Disease-associated Pulmonary Arterial Hypertension - CATALYST
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…
- Trial name
- NCT02657356
- Testing
- Bardoxolone methyl capsules
- Where
- 106 sites in United States, Argentina and 13 more
- Volunteers
- 202 people
- Sponsor
- Biogen
Melanoma, Unresectable (Stage III) Melanoma
RTA 408 Capsules in Patients With Melanoma - REVEAL
Malignant melanoma is a leading cause of death from cutaneous malignancies, accounting for approximately three-fourths of all skin cancer deaths.
- Conditions
- Melanoma, Unresectable (Stage III) Melanoma, Metastatic (Stage IV) Melanoma
- Trial name
- NCT02259231
- Testing
- Omaveloxolone Capsules (2.5 mg/capsule), Ipilimumab (3 mg/kg), Nivolumab (240 mg)
- Where
- 10 sites in United States
- Volunteers
- 41 people
- Sponsor
- Biogen
Corneal Endothelial Cell Loss, Ocular Pain
RTA 408 Ophthalmic Suspension for the Prevention of Corneal Endothelial Cell Loss Following Cataract Surgery - GUARD
This study assesses the efficacy and safety of two concentrations of omaveloxolone (RTA 408) ophthalmic suspension for the prevention of corneal endothelial cell loss following cataract surgery.
- Conditions
- Corneal Endothelial Cell Loss, Ocular Pain, Ocular Inflammation, Cataract Surgery
- Trial name
- NCT02128113
- Testing
- Vehicle Ophthalmic Solution, Omaveloxolone Ophthalmic Suspension 0.5%, Omaveloxolone Ophthalmic Suspension 1%
- Where
- 15 sites in United States
- Volunteers
- 307 people
- Sponsor
- Biogen
IgA Nephropathy, CKD Associated With Type 1 Diabetes
A Phase 2 Trial of the Safety and Efficacy of Bardoxolone Methyl in Patients With Rare Chronic Kidney Diseases - PHOENIX
This multi-center, open-label Phase 2 trial will study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients with the following rare chronic kidney diseases (CKD): CKD associated with type 1 diabetes…
- Conditions
- IgA Nephropathy, CKD Associated With Type 1 Diabetes, Focal Segmental Glomerulosclerosis, Autosomal Dominant Polycystic Kidney
- Trial name
- PHOENIX (NCT03366337)
- Testing
- Bardoxolone methyl capsules
- Where
- 30 sites in United States
- Volunteers
- 103 people
- Sponsor
- Biogen
Autosomal Dominant Polycystic Kidney, ADPKD
A Trial of Bardoxolone Methyl in Patients With ADPKD - FALCON
This international, multi-center, randomized, double-blind, placebo-controlled Phase 3 trial will study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients with ADPKD.
- Trial name
- FALCON (NCT03918447)
- Testing
- Bardoxolone methyl oral capsule
- Where
- 137 sites in United States, Australia and 8 more
- Volunteers
- 667 people
- Sponsor
- Biogen
Chronic Kidney Diseases
A Trial of Bardoxolone Methyl in Patients With CKD at Risk of Rapid Progression (MERLIN)
This multi-center, randomized, double-blind, placebo-controlled, Phase 2 trial will study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients with CKD due to multiple etiologies at risk of rapid…
- Trial name
- MERLIN (NCT04702997)
- Testing
- Bardoxolone methyl oral capsule
- Where
- 12 sites in United States
- Volunteers
- 81 people
- Sponsor
- Biogen
Chronic Kidney Diseases, Alport Syndrome
An Extended Access Program for Bardoxolone Methyl in Patients With CKD (EAGLE)
This extended access study will assess the long-term safety and tolerability of bardoxolone methyl in qualified patients with chronic kidney disease (CKD) who previously participated in one of the qualifying clinical studies with…
- Conditions
- Chronic Kidney Diseases, Alport Syndrome, Autosomal Dominant Polycystic Kidney
- Trial name
- EAGLE (NCT03749447)
- Testing
- Bardoxolone methyl
- Where
- 87 sites in United States, Australia and 4 more
- Volunteers
- 270 people
- Sponsor
- Biogen
Inflammation and Pain Following Ocular Surgery
RTA 408 Ophthalmic Suspension for the Treatment of Ocular Inflammation and Pain Following Ocular Surgery
This study assesses the efficacy and safety of two concentrations of RTA 408 Ophthalmic Suspension in the treatment of patients who have inflammation and pain following ocular surgery.
- Trial name
- NCT02065375
- Testing
- Omaveloxolone Ophthalmic Suspension 1.0%, Omaveloxolone Opthalmic Suspension 0.5%
- Where
- 6 sites in United States
- Volunteers
- 109 people
- Sponsor
- Biogen
Breast Cancer
RTA 408 Lotion in Patients at Risk for Radiation Dermatitis - PRIMROSE
Radiation dermatitis is experienced by almost all patients (up to 95%) receiving radiation therapy for cancer. Radiation dermatitis can be a serious condition because, in addition to its direct physical complications and the…
- Trial name
- NCT02142959
- Testing
- Omaveloxolone Lotion 0.5%, Omaveloxolone Lotion 3%, Vehicle Lotion
- Where
- 27 sites in United States
- Volunteers
- 187 people
- Sponsor
- Biogen
Malignant Melanoma
Study of Two Dose Levels of RTA 402 in Patients With Advanced Malignant Melanoma
The primary purpose of the study is to determine the proportion of patients without progression at 6-months in patients with unresectable Stage III or Stage IV melanoma who are taking RTA 402.
- Trial name
- NCT00535314
- Testing
- RTA 402 Dose1, RTA 402 Dose2
- Sponsor
- Biogen
Melanoma
Expanded Access to Omaveloxolone for Melanoma for Patients Previously Enrolled in 408-C-1401
This is an expanded access program for eligible participants and is designed to provide access to omaveloxolone for the treatment of unresectable or metastatic melanoma to patients who previously participated in the 408-C-1401…
- Trial name
- NCT03593499
- Testing
- omaveloxolone
- Sponsor
- Biogen
Health Adult Subjects
A TQTc Study for Omaveloxolone
This is a randomized, double blind, placebo and active (moxifloxacin open label) controlled study in healthy subjects to assess the effect of the supratherapeutic exposure of omaveloxolone on QTc interval.
- Trial name
- NCT05927649
- Testing
- Omaveloxolone, Moxifloxacin
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Biogen