Clinical trials: completed, sponsored by Biogen
Hepatic Impairment, Healthy
Single-Dose, Open-Label Pharmacokinetic Study of Bardoxolone Methyl in Subjects With Mild, Moderate, and Severe Hepatic Impairment and Normal Hepatic Function
The purpose of this study is to assess the pharmacokinetic profile of bardoxolone methyl following a single oral dose of 20 mg bardoxolone methyl in subjects with mild, moderate, and severe hepatic impairment, as compared to…
- Trial name
- NCT01563562
- Testing
- Bardoxolone Methyl
- Where
- 2 sites in United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Biogen
Renal Insufficiency, Chronic, Diabetes Mellitus, Type 2
Phase II Pharmacodynamic 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 a new formulation of bardoxolone methyl on eGFR in Patients with Chronic Kidney Disease and Type 2 Diabetes.
- Trial name
- NCT01053936
- Testing
- Bardoxolone methyl (amorphous dispersion)
- Where
- 26 sites in United States
- Volunteers
- 129 people
- Sponsor
- Biogen
Healthy Volunteers
Multiple-Dose Study of Effect of Bardoxolone Methyl on QT/QTC Interval Volunteers
This is a single-center, multiple-dose, randomized, double-blind, double-dummy, placebo-controlled, active-comparator, parallel study in healthy volunteers.
- Trial name
- NCT01689116
- Testing
- Bardoxolone Methyl 20mg, Bardoxolone Methyl 80mg, Moxifloxacin 400mg
- Where
- United States
- Volunteers
- 179 people, healthy volunteers welcome
- Sponsor
- Biogen
Healthy Volunteers
A Single-Dose, Open-Label, Randomized, Food Effect and Blinded, Randomized, Dose Proportionality Study in Healthy Volunteers With Bardoxolone Methyl
This study is to determine the effect of food on a single dose of 20 mg bardoxolone methyl administered to normal healthy adult subjects.
- Trial name
- NCT01461161
- Testing
- bardoxolone methyl
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Biogen
Healthy
A Phase I Study to Investigate the Absorption, Metabolism and Excretion in Healthy Male Subjects
The purpose of this study is to determine the absorption and excretion kinetics of bardoxolone methyl and to determine and characterize metabolites present in plasma, urine and feces in men following a single oral does or 20 mg…
- Trial name
- NCT01503866
- Testing
- bardoxolone methyl
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Biogen
Healthy
Safety and PK/PD of RTA 1701 in Healthy Adults
This first-in-human, Phase 1, single-center study will evaluate single ascending doses (SAD) and multiple ascending doses (MAD) of RTA 1701 conducted in 2 parts.
- Trial name
- NCT03579030
- Testing
- RTA 1701 capsules
- Where
- Australia
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Biogen
Metastatic or Incurable Non-small Cell Lung Cancer, Relapsed, Refractory Melanoma
RTA 408 in the Treatment of Advanced Solid Tumors (NSCLC & Melanoma) - DISCOVER
This proposed first-in-human study (408-C-1303) is designed to assess the safety, maximum tolerated dose, pharmacodynamics, and pharmacokinetics of omaveloxolone (RTA 408) in patients with advanced solid tumors that are…
- Trial name
- DISCOVER (NCT02029729)
- Testing
- omaveloxolone
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Biogen
Glioma
A Safety Study of RTA 744 in Patients With Recurrent High-Grade Gliomas
This study assesses the tolerability, safety, efficacy and pharmacokinetics of RTA 744 in recurrent high-grade gliomas.
- Trial name
- NCT00526812
- Testing
- RTA 744, RTA 744 injection
- Where
- 4 sites in United States
- Volunteers
- 54 people
- Sponsor
- Biogen
Healthy
RTA 408 Lotion in Healthy Volunteers
This study is a first-in-human study of a topical dermal lotion formulation of RTA 408, a novel small molecule which suppresses oxidative stress and inflammation.
- Trial name
- NCT02029716
- Testing
- RTA 408 Lotion 0.5%, 1%, 3%
- Where
- United States
- Volunteers
- 109 people, healthy volunteers welcome
- Sponsor
- Biogen
Advanced Solid Tumors, Lymphoid Malignancies
RTA 402 in Patients With Advanced Solid Tumors or Lymphoid Malignancies
This study assesses the tolerability, safety, efficacy and pharmacokinetics of Bardoxolone methyl (RTA 402) in advanced solid tumors and lymphoid malignancies.
- Trial name
- NCT00529438
- Testing
- Bardoxolone methyl
- Where
- 3 sites in United States
- Volunteers
- 47 people
- Sponsor
- Biogen
Multiple Sclerosis
A Study of Dimethyl Fumarate (DMF) in Relapsing Forms of Multiple Sclerosis (RMS) Participants in China
The primary objective of the study is to assess the efficacy of DMF in Chinese participants with RMS at Week 48. The secondary objectives of the study are to assess the efficacy and safety of DMF in Chinese participants with RMS.
- Trial name
- NCT05658484
- Testing
- Dimethyl fumarate
- Where
- 15 sites in China
- Volunteers
- 60 people
- Sponsor
- Biogen
Multiple Sclerosis
TOPIK Study: A Study to Report Progressive Multifocal Leukoencephalopathy and Other Serious Opportunistic Infections in Natalizumab Treated Participants
The primary objective of the study is to estimate the incidence of progressive multifocal leukoencephalopathy (PML) and serious adverse events (SAEs) of other opportunistic infections (OIs) among all participants taking…
- Trial name
- NCT05236777
- Testing
- Natalizumab
- Where
- 15 sites in Czechia
- Volunteers
- 675 people
- Sponsor
- Biogen
Healthy Volunteer
A Study to Find Out How BIIB141 (Omaveloxolone) Moves From the Blood Into the Breastmilk of Healthy Women Who Are Breastfeeding or Pumping Milk
In this study, researchers will learn how BIIB141, also known as omaveloxolone or SKYCLARYS®, moves through the body. This is a drug available for doctors to prescribe for patients with Friedrich's Ataxia.
- Trial name
- NCT06612879
- Testing
- Omaveloxolone
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Biogen
Spinal Muscular Atrophy (SMA)
Virtual Reality for the Mitigation of Anxiety During Intrathecal Administration in Participants With Spinal Muscular Atrophy
The primary objective of the study is to evaluate anxiety level during intrathecal administration (IT) under standard of care (SOC) and virtual reality (VR) conditions using a reliable self-rating scale.
- Trial name
- REALITY (NCT05354414)
- Testing
- Virtual reality, Standard of Care
- Where
- 12 sites in France
- Volunteers
- 63 people
- Sponsor
- Biogen
Healthy Volunteer
A Study to Find Out How Multiple Doses of BIIB091 Affect the Electrical Activity of the Heart in Healthy Participants
In this study, researchers will learn how the heart reacts to multiple doses of BIIB091 in healthy participants. In previous studies looking at BIIB091, researchers have found that a certain range of doses can cause changes in…
- Trial name
- NCT06574828
- Testing
- BIIB091, Moxifloxacin
- Where
- United States
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- Biogen
Major Depressive Disorder
Zuranolone Pharmacokinetics (PK) and Safety Study Adolescent Participants With Major Depressive Disorder (MDD)
The primary purpose of this study is to evaluate the pharmacokinetics and safety of Zuranolone in adolescents (ages 12 to 17 years) with MDD.
- Trial name
- NCT05655507
- Testing
- Zuranolone
- Where
- 4 sites in United States
- Volunteers
- 19 people
- Sponsor
- Biogen
Glomerulonephritis, Membranous, antiPLA2R Positive
Trial to Assess Safety and Efficacy of MOR202 in Anti-PLA2R + Membranous Nephropathy (aMN)
This is an open-label, multicentre study to characterize the safety and efficacy of the human anti-CD38 antibody MOR202 in adult subjects with in Anti-PLA2R Antibody Positive Membranous Nephropathy (newly…
- Trial name
- M-PLACE (NCT04145440)
- Testing
- MOR202
- Where
- 45 sites in United States, Australia and 7 more
- Volunteers
- 31 people
- Sponsor
- HI-Bio, A Biogen Company
Healthy Volunteer
A Study to Find Out How Different Forms of BIIB091 is Processed in The Body With and Without Food in Healthy Participants
In this study, researchers will learn how the body processes new tablet forms of BIIB091 when taken with and without food. One new form of BIIB091 is an "extended release" tablet, also known as "ER." This form helps release…
- Trial name
- NCT06640933
- Testing
- BIIB091
- Where
- 2 sites in United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Biogen
Glomerulonephritis, Membranous Nephropathy
Efficacy, Safety and PK/PD of MOR202 in Anti-PLA2R+ Membranous Nephropathy (aMN) (NewPLACE)
This 2-arm, multi-center, open-label, parallel-group phase II trial will assess the efficacy, safety and pharmacokinetics/pharmacodynamics of the human antibody MOR202 in subjects with anti-PLA2R antibody-positive membranous…
- Conditions
- Glomerulonephritis, Membranous Nephropathy, antiPLA2R Positive
- Trial name
- NewPLACE (NCT04733040)
- Testing
- MOR202
- Where
- 25 sites in Georgia, Germany and 5 more
- Volunteers
- 24 people
- Sponsor
- HI-Bio, A Biogen Company
Immune System Diseases, Autoimmunity
A Study of Safety and Drug Levels of HIB210 in Healthy Volunteers
The goal of this clinical trial is to test safety of the investigational product in healthy volunteers. The main questions it aims to answer is when HIB210 is administered as multiple doses, is it: 1. Safe 2. Well tolerated 3.
- Trial name
- NCT05928585
- Testing
- HIB210
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- HI-Bio, A Biogen Company