Clinical trials: completed, sponsored by 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
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
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
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
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
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
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
Healthy Male Subjects
A Human AME Study for Omaveloxolone
This study will assess the pharmacokinetics (PK), mass balance, metabolite profiles, and rates and routes of elimination of [14C] omaveloxolone and derived metabolites following administration as a single 150 mg (containing…
- Trial name
- NCT03931590
- Testing
- [14C]-Omaveloxolone
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- 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
Healthy Adult Subjects
An Open-label DDI Study of Omaveloxolone in Healthy Subjects
This is an open-label, single-sequence, 2-period crossover study in healthy subjects. In this study, 20 subjects will be enrolled to allow at least 16 evaluable subjects.
- Trial name
- NCT05909644
- Testing
- Omaveloxolone, Efavirenz
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Biogen
Hepatic Impairment
A Pharmacokinetic Study of Omaveloxolone in Subjects With Hepatic Impairment and Normal Hepatic Function
This study will examine the pharmacokinetics (PK) of omaveloxolone following a single oral dose of omaveloxolone in subjects with mild, moderate, or severe hepatic impairment compared to healthy subjects with normal hepatic…
- Trial name
- NCT03902002
- Testing
- Omaveloxolone 50 mg capsules
- Where
- 3 sites in United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Biogen
Healthy
A Pharmacokinetic Study of Omaveloxolone in Healthy Volunteers
This study will determine the effect of food on the pharmacokinetics of omaveloxolone (150 mg) in healthy adult subjects and will assess the safety, tolerability, and dose proportionality of 50 mg, 100 mg, and 150 mg…
- Trial name
- NCT03664453
- Testing
- omaveloxolone
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Biogen
Healthy Adult Subjects
A Clinical Drug-Drug Interaction (DDI) Study With Omaveloxolone
This study will assess the potential for clinical drug-drug interactions between omaveloxolone and a number of substrates and inhibitors of metabolic enzymes and drug transporters.
- Trial name
- NCT04008186
- Testing
- Omaveloxolone, Midazolam oral solution, Repaglinide 1 MG
- Where
- United States
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- Biogen
Diabetic Nephropathy
Phase IIa Trial to Determine the Effects of Bardoxolone Methyl on Renal Function in Patients With Diabetic Nephropathy
To determine the effects of three different doses of bardoxolone methyl administered orally on the kidney function (glomular filtration rate) in patients with diabetic nephropathy.
- Trial name
- NCT00664027
- Testing
- RTA 402 (Bardoxolone Methyl)
- Where
- 3 sites in United States
- Volunteers
- 80 people
- Sponsor
- Biogen
Healthy Volunteers
An Open-Label Study of the Effect of Bardoxolone Methyl on the Single Dose Pharmacokinetics of Digoxin and Rosuvastatin in Healthy Volunteers
The purpose of this study is to evaluate the potential effect of bardoxolone methyl on the pharmacokinetics of digoxin and rosuvastatin and to assess the safety of the concomitant administration of bardoxolone methyl with digoxin…
- Trial name
- NCT01598363
- Testing
- Digoxin, Rosuvastatin
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Biogen
Chronic Kidney Disease, Type 2 Diabetes
Trial to Determine the Effects of Bardoxolone Methyl on eGFR in Patients With Type 2 Diabetes and Chronic Kidney Disease
This study assesses the effects of bardoxolone methyl (RTA 402) in patients with type 2 diabetes and chronic kidney disease.
- Conditions
- Chronic Kidney Disease, Type 2 Diabetes, Diabetic Nephropathy
- Trial name
- NCT00811889
- Testing
- Bardoxolone Methyl (RTA 402)
- Where
- 42 sites in United States
- Volunteers
- 227 people
- Sponsor
- Biogen
Healthy
A Study of the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of RTA 901 in Healthy Adults
This study will assess the safety, tolerability, and pharmacokinetic profile of RTA 901 following escalating single and multiple oral doses of RTA 901 in healthy adult subjects.
- Trial name
- NCT02666963
- Testing
- RTA 901 Capsules, 10 or 40 mg
- Where
- United States
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- Biogen
Healthy Volunteers
Effect of Itraconazole on the Pharmacokinetics of Bardoxolone Methyl in Healthy Adults
This trial will study the impact of a strong CYP3A4 inhibitor (itraconazole) on the pharmacokinetics of bardoxolone methyl (RTA 402) in healthy adult subjects.
- Trial name
- NCT03264079
- Testing
- Bardoxolone methyl capsules 10 mg, Itraconazole capsules 100 mg
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Biogen