Clinical trials: completed, sponsored by Biogen
Muscular Atrophy, Spinal
A Study to Learn About the Effect of Nusinersen (BIIB058) Given as Injections to Children With Spinal Muscular Atrophy (SMA) Who Were Previously Treated With Onasemnogene Abeparvovec (RESPOND)
In this study, researchers will learn more about the use of nusinersen (BIIB058) in participants with spinal muscular atrophy (SMA).
- Trial name
- RESPOND (NCT04488133)
- Testing
- Nusinersen
- Where
- 15 sites in United States, Germany and 3 more
- Volunteers
- 46 people
- Sponsor
- Biogen
Depression, Postpartum
A Study to Learn More About How Zuranolone Affects Postpartum Depression Symptoms in Participants Who Took it Within 1 Year After The End of Their Pregnancy
In this study, researchers will learn more about how zuranolone affects the symptoms of postpartum depression, also known as PPD. Zuranolone is a drug that healthcare professionals can prescribe for adults with PPD.
- Trial name
- NCT07047820
- Testing
- Zuranolone
- Where
- United States
- Volunteers
- 305 people
- Sponsor
- Biogen
Friedreich Ataxia
A Study to Learn About the Effects and Safety of RTA 408 (Omaveloxolone) in People Aged 16 to 40 With Friedreich's Ataxia
In this study, researchers are learning more about RTA 408, also known as omaveloxolone, BIIB141, or SKYCLARYS®. The main goal of this study is to learn more about the safety of RTA 408 and how it affects physical effort…
- Trial name
- NCT02255435
- Testing
- Omaveloxolone Capsules, 2.5 mg, Omaveloxolone Capsules, 5 mg, Omaveloxolone Capsules, 10 mg
- Where
- 11 sites in United States, Australia and 3 more
- Volunteers
- 172 people
- Sponsor
- Biogen
Muscular Atrophy, Spinal
A Study to Learn About the Long-Term Safety of Higher Doses of Nusinersen (BIIB058) Given as Injections to Participants With Spinal Muscular Atrophy (SMA) Who Took Part in an Earlier Nusinersen Trial (ONWARD)
In this study, researchers will learn more about the use of nusinersen (BIIB058) in participants with spinal muscular atrophy (SMA).
- Trial name
- ONWARD (NCT04729907)
- Testing
- Nusinersen
- Where
- 39 sites in United States, Brazil and 14 more
- Volunteers
- 115 people
- Sponsor
- Biogen
Lupus Nephritis
A Study to Learn More About the Safety and Effects of Felzartamab in Adults With Lupus Nephritis Aged 18 to 75 Years Old
In this study, researchers will learn more about the use of felzartamab in people with active lupus nephritis, also known as LN. In people with LN, antibodies build up in the glomeruli of the kidneys.
- Trial name
- NCT06064929
- Testing
- Felzartamab
- Where
- 24 sites in United States, Argentina and 2 more
- Volunteers
- 14 people
- Sponsor
- HI-Bio, A Biogen Company
Healthy Volunteer
A Study to Determine the Biodistribution, Safety, and Tolerability of a Microdose of Radiolabeled Diranersen (BIIB080) Co-administered With Diranersen in Healthy Adults
In this study, researchers will learn more about a study drug called diranersen (BIIB080). Diranersen is currently a drug under investigation for treatment of Alzheimer's disease.
- Trial name
- NCT06454721
- Testing
- [89Zr]Zr-DFO-Diranersen, Diranersen
- Where
- United States
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- Biogen
Choroideremia, X-Linked Retinitis Pigmentosa
Long-term Safety and Efficacy Follow-up of BIIB111 for the Treatment of Choroideremia and BIIB112 for the Treatment of X-Linked Retinitis Pigmentosa
The objective of the study is to evaluate the long-term safety and efficacy of a sub-retinal injection of BIIB111 in participants with Choroideremia (CHM) who have been previously treated with BIIB111 and who have exited an…
- Trial name
- SOLSTICE (NCT03584165)
- Testing
- BIIB111, BIIB112
- Where
- 25 sites in United States, Brazil and 7 more
- Volunteers
- 277 people
- Sponsor
- NightstaRx Ltd, a Biogen Company
Parkinson Disease
A Study to Learn About the Safety of BIIB122 Tablets and Whether They Can Slow the Worsening of Early-Stage Parkinson's Disease in Adults Between the Ages of 30 and 80
In this study, researchers will learn more about BIIB122 in participants with early-stage Parkinson's disease (PD). The study will include adults aged 30 to 80 who were diagnosed with PD within 2 years of starting the study.
- Trial name
- LUMA (NCT05348785)
- Testing
- BIIB122
- Where
- 113 sites in United States, Austria and 11 more
- Volunteers
- 650 people
- Sponsor
- Biogen
Healthy Volunteer
A Study to Find Out How Litifilimab is Processed in the Body in Healthy Participants When Given Under the Skin in 3 Different Ways
In this study, researchers will learn how the body processes litifilimab when it is given under the skin in 3 different ways. Currently, ongoing studies utilize pre-filled syringes (PFS) that can deliver litifilimab…
- Trial name
- NCT06741657
- Testing
- Litifilimab, AI, OBI
- Where
- 2 sites in United States
- Volunteers
- 404 people, healthy volunteers welcome
- Sponsor
- Biogen
Relapsing-Remitting Multiple Sclerosis
Phase 3 Efficacy and Safety Study of BG00012 in Pediatric Participants With Relapsing-Remitting Multiple Sclerosis (RRMS)
The main objectives of Part 1 are as follows: To evaluate the safety, tolerability, and efficacy of BG00012 in pediatric participants with RRMS, as compared with a disease-modifying treatment and to assess health outcomes and…
- Trial name
- CONNECT (NCT02283853)
- Testing
- dimethyl fumarate, Interferon β-1a
- Where
- 62 sites in United States, Belgium and 16 more
- Volunteers
- 156 people
- Sponsor
- Biogen
Healthy Volunteer
A Study to Learn How the Body Processes BIIB141 (Omaveloxolone) When Taken as a Capsule or as a Tablet Dissolved in Liquid, and to Learn About Its Safety in Healthy Adults Ages 18 to 55
In this study, researchers will learn more about BIIB141, also known as omaveloxolone or SKYCLARYS®. This drug has been approved, or made available for doctors to prescribe, for people with Friedrich's Ataxia (FA) who are at…
- Trial name
- NCT07297199
- Testing
- Omaveloxolone
- Where
- United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Biogen
Immunoglobulin A (IgA) Nephropathy
Clinical Trial to Assess Efficacy and Safety of the Human Anti-CD38 Antibody Felzartamab (MOR202) in IgA Nephropathy
Randomized, placebo-controlled, multi-center, double-blind, proof of concept phase IIa trial and dose evaluation trial of felzartamab in IgAN
- Trial name
- IGNAZ (NCT05065970)
- Testing
- Felzartamab
- Where
- 59 sites in United States, Australia and 13 more
- Volunteers
- 54 people
- Sponsor
- HI-Bio, A Biogen Company
Relapsing Forms of Multiple Sclerosis
A Study to Learn About the Safety of BIIB091 and Its Effect on Brain Inflammation When Taken Alone or With Diroximel Fumarate (DRF) in Adults With Relapsing Forms of Multiple Sclerosis (MS)
In this study, researchers will learn more about a study drug called BIIB091 in participants with MS who may be experiencing relapses. It is a 2-part study.
- Trial name
- FUSION (NCT05798520)
- Testing
- BIIB091, DRF
- Where
- 77 sites in United States, Bulgaria and 8 more
- Volunteers
- 127 people
- Sponsor
- Biogen
Relapsing Forms of Multiple Sclerosis
A Study of Diroximel Fumarate (DRF) in Adult Participants From the Asia-Pacific Region With Relapsing Forms of Multiple Sclerosis (RMS)
The primary objectives of this study are to determine the safety and tolerability of DRF administered for up to 24 weeks in adult East Asian participants with RMS (Part 1) and to determine the safety and tolerability of DRF…
- Trial name
- NCT05083923
- Testing
- Diroximel fumarate
- Where
- 52 sites in China, Japan
- Volunteers
- 136 people
- Sponsor
- Biogen
Healthy Volunteer
A Study to Learn if Taking BIIB141 (Omaveloxolone) Affects How Omeprazole is Processed in the Body and About BIIB141's Safety in Healthy Adults Aged 18 to 55
In this study, researchers will learn more about BIIB141, also known as omaveloxolone or SKYCLARYS®. This drug has been approved, or made available for doctors to prescribe, for people with Friedrich's Ataxia (FA) who are at…
- Trial name
- NCT07149415
- Testing
- Omaveloxolone, Omeprazole
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Biogen
Spinal Muscular Atrophy
A Study of Multiple Doses of Nusinersen (ISIS 396443) Delivered to Infants With Genetically Diagnosed and Presymptomatic Spinal Muscular Atrophy
The primary objective of the study is to examine the efficacy of multiple doses of Nusinersen administered intrathecally in preventing or delaying the need for respiratory intervention or death in infants with genetically…
- Trial name
- NURTURE (NCT02386553)
- Testing
- Nusinersen
- Where
- 21 sites in United States, Australia and 5 more
- Volunteers
- 25 people
- Sponsor
- 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
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