Clinical trials: sponsored by Biogen
Muscular Atrophy, Spinal
Pediatric Spinal Muscular Atrophy (SMA) China Registry
The primary objective of the study is to describe the natural history and utilization of disease modifying therapy (DMT) treatments among pediatric Chinese participants with spinal muscular atrophy linked to chromosome 5q…
- Trial name
- NCT05042921
- Where
- 25 sites in China
- Volunteers
- 600 people
- Sponsor
- Biogen
Postpartum Depression
A Long-Term Study of Patient-Reported Changes in Postpartum Depression Symptoms in People Starting Zuranolone
In this study, researchers will learn how postpartum depression symptoms may change after people first start taking zuranolone. This is a drug available for doctors to prescribe for people with postpartum depression, also known…
- Trial name
- NCT07398469
- Testing
- Zuranolone
- Where
- United States
- Volunteers
- 300 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
Muscular Atrophy, Spinal
A Study to Find Out How Nusinersen is Processed in the Body When Given Through the ThecaFlex DRx™ System in Adult and Pediatric Participants With Spinal Muscular Atrophy (PIERRE-PK)
In this PIERRE-PK study, researchers will learn how the body processes nusinersen when it is given through the ThecaFlex DRx™ System, compared to when nusinersen is given by lumbar puncture (LP).
- Trial name
- PIERRE-PK (NCT06555419)
- Testing
- Nusinersen, ThecaFlex DRx System
- Where
- 21 sites in United States, France and 5 more
- Volunteers
- 78 people
- Sponsor
- Biogen
Friedreich Ataxia
A Study to Find Out How BIIB141 (Omaveloxolone) is Processed in the Body and to Learn More About Its Safety in Participants With Friedreich's Ataxia Aged 2 to 15 Years Old
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
- BOLD (NCT06054893)
- Testing
- Omaveloxolone
- Where
- United States
- Volunteers
- 33 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
Amyotrophic Lateral Sclerosis
A Study to Learn More About the Long-Term Safety of Tofersen (Qalsody) in Chinese Participants With SOD-1 Amyotrophic Lateral Sclerosis (ALS)
In this study, researchers will learn more about the safety of tofersen, also known as Qalsody®. This is a drug available for doctors to prescribe for people with a certain type of amyotrophic lateral sclerosis, also known as…
- Trial name
- NCT07223723
- Testing
- Tofersen
- Where
- China
- Volunteers
- 12 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
Multiple Sclerosis
Pregnancy Exposure Registry for Vumerity (Diroximel Fumarate)
The primary objectives of the study are to estimate the risk of major congenital malformations (MCMs) in infants born to women with multiple sclerosis (MS) who were exposed to diroximel fumarate (DRF) at any time from 2 weeks…
- Trial name
- NCT05658497
- Testing
- Diroximel Fumarate, Avonex, Tysabri
- Where
- 8 sites in United States, Australia and 5 more
- Volunteers
- 908 people
- Sponsor
- Biogen
Subacute Cutaneous Lupus Erythematosus, Chronic Cutaneous Lupus Erythematosus
A Long-Term Extension Study to Learn More About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus
In this study, researchers will learn more about a study drug called BIIB059 (litifilimab) in participants with cutaneous lupus erythematosus (CLE).
- Trial name
- AMETHYST LTE (NCT06044337)
- Testing
- BIIB059 (litifilimab)
- Where
- 104 sites in United States, Argentina and 23 more
- Volunteers
- 306 people
- Sponsor
- Biogen
Muscular Atrophy, Spinal
Adult Spinal Muscular Atrophy (SMA) China Registry
The primary objective of the study is to describe the natural history and utilization of disease modifying therapy (DMT) among adult Chinese participants with SMA linked to chromosome 5q (5q-SMA).
- Trial name
- NCT05618379
- Where
- 12 sites in China
- Volunteers
- 200 people
- Sponsor
- Biogen
Healthy Volunteer
A Study to Learn More About the Safety of a Single Dose of BIIB144 and How it is Processed in the Body of Healthy Adult Participants Ages 18 to 55 Years Old as Compared to a Placebo
In this study, researchers will learn how the body processes a study drug called BIIB144. This is a "first-in-human" study. This means that this study drug will be given to people for the first very time in this study.
- Trial name
- NCT07662148
- Testing
- BIIB144
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- 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
Friedreich Ataxia
A Study to Learn How BIIB141 (Omaveloxolone) Affects the Health of Participants With Friedrich's Ataxia Who Took it During Pregnancy and/or During Breastfeeding and About the Health of Their Babies
In this study, researchers will learn more about the safety of BIIB141, also known as omaveloxolone or SKYCLARYS. This is a drug available for doctors to prescribe for people with Friedrich's Ataxia, also known as FA.
- Trial name
- NCT06628687
- Testing
- Omaveloxolone
- Where
- United States
- Volunteers
- 10 people
- 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
Mild Cognitive Impairment Due to Alzheimer's Disease, Alzheimer's Disease Dementia
A Study to Learn About the Safety of Diranersen (BIIB080) Injections and Whether They Can Improve Symptoms of Participants With Mild Cognitive Impairment Due to Alzheimer's Disease (AD) or Mild AD Dementia Between 50 to 80 Years of Age
In this study, researchers will learn more about a study drug called diranersen (BIIB080). The study will focus on participants with mild cognitive impairment or mild dementia due to AD.
- Trial name
- CELIA (NCT05399888)
- Testing
- Diranersen
- Where
- 138 sites in United States, Australia and 15 more
- Volunteers
- 416 people
- Sponsor
- Biogen
Antibody-mediated Rejection
A Study to Learn More About the Effects and Safety of Felzartamab Infusions in Adults With Kidney Transplants Who Have Antibody-Mediated Rejection (AMR)
In this study, researchers will learn more about the use of felzartamab in kidney transplant patients who have antibody-mediated rejection, also known as AMR. Kidney transplants can save lives for people with kidney failure.
- Trial name
- TRANSCEND (NCT06685757)
- Testing
- Felzartamab
- Where
- 56 sites in United States, Argentina and 10 more
- Volunteers
- 132 people
- Sponsor
- Biogen
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