Biogen Clinical Trials: 516 Led Studies

Archive historyOct 2022 to Jun 2026

107 recorded changes across Biogen trials

Every status move, completion date shift and enrollment change ComplyRx has recorded across 31 of these trials. One is shown below.

Status changeStatus moved to active not recruiting from recruitingNCT06054893 · recorded 1 Jun 2026

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Most active programmes

The drugs appearing most often across Biogen's recently active trials. Comparator arms are excluded.

Omaveloxolone10 trials
Felzartamab7 trials
Nusinersen6 trials
Litifilimab5 trials
Diroximel Fumarate4 trials
Tofersen4 trials

Upcoming readouts

Next primary completion dates among Biogen's active phase 2 and phase 3 trials. Dates are registry estimates and move often, which is exactly what the tracker watches.

May 2027PREVAIL: A Study to Learn About the Effects of Felzartamab Infusions on Adults With Immunoglobulin A Neph…Phase 3
Nov 2027BRAVE: A Study to Learn More About the Effects and Long-Term Safety of Omaveloxolone (BIIB141) in Child…Phase 3
Feb 2028TRANSPIRE: A Study to Learn About the Effects of Felzartamab Infusions in Adults With Kidney Transplants Wh…Phase 2
Jun 2028SOLAR: A Study to Learn About Salanersen's (BIIB115) Effects on Movement and Its Safety in Participants…Phase 3
Nov 2028STELLAR-1: A Study to Learn About Salanersen's (BIIB115) Effects on Movement and Its Safety When Given Befo…Phase 3
Dec 2028PROMINENT: A Study to Learn More About the Effects and Safety of Felzartamab Infusions in Adults With Prima…Phase 3

Top therapeutic areas

Conditions studied most often across Biogen's recently active trials.

Muscular Atrophy, Spinal11 trials
Friedreich Ataxia5 trials
Renal Insufficiency, Chronic5 trials
Diabetes Mellitus, Type 25 trials
Multiple Sclerosis4 trials
Spinal Muscular Atrophy3 trials

Biogen trials

The 50 most significant of Biogen's recently active trials, soonest estimated readout first.
Select any row for the full record; the change timeline unlocks with tracking.

Trial	Phase	Stability	Status	Enrollment	Est. readout
ONWARDA 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)NCT04729907Nusinersen	Phase 3	Locked · track to reveal	OngoingActive, not recruiting	115 est.	31 Jul 2026
A Study to Learn About the Safety of BIIB142 and How it is Processed in the Body of Healthy Adult Participants Aged 18 to 55 Years OldNCT07133828BIIB142	Phase 1	Locked · track to reveal	OngoingRecruiting	78 est.	6 Aug 2026
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 PregnancyNCT07047820Zuranolone	—	Not yet scored	OngoingRecruiting	200 est.	24 Aug 2026
TOPAZ-2A Study to Learn About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus ErythematosusNCT04961567Litifilimab	Phase 3	Locked · track to reveal	OngoingActive, not recruiting	562 est.	27 Sept 2026
TOPAZ-1A Study to Learn About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus ErythematosusNCT04895241Litifilimab	Phase 3	Locked · track to reveal	OngoingActive, not recruiting	548 est.	30 Sept 2026
AMETHYSTA 2-Part Study to Learn Whether Litifilimab (BIIB059) Injections Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus ErythematosusNCT05531565Litifilimab	Phase 2	Locked · track to reveal	OngoingActive, not recruiting	450 est.	20 Oct 2026
A Study Utilising Data From European Union (EU) National Multiple Sclerosis (MS) Registries to Assess the Incidence of Anti-Natalizumab Antibody Among Participants Who Receive Subcutaneous Administration of Natalizumab for Treatment of Relapsing-remitting Multiple Sclerosis (RRMS)NCT05925049Natalizumab	—	Not yet scored	OngoingActive, not recruiting	400 est.	31 Oct 2026
TRANSCENDA Study to Learn More About the Effects and Safety of Felzartamab Infusions in Adults With Kidney Transplants Who Have Antibody-Mediated Rejection (AMR)NCT06685757Felzartamab	Phase 3	Locked · track to reveal	OngoingActive, not recruiting	132 est.	1 Dec 2026
A Study to Learn More About the Safety of BIIB145 and How it is Processed in the Body of Healthy Adult ParticipantsNCT07225517BIIB145	Phase 1	Locked · track to reveal	OngoingRecruiting	104 est.	2 Feb 2027
STANDARDObservational, Postmarketing Surveillance Study of Spinraza Injection (Nusinersen Sodium)NCT04317794Nusinersen Sodium Injection	—	Not yet scored	OngoingActive, not recruiting	74 est.	5 Feb 2027
A Long-Term Study of Patient-Reported Changes in Postpartum Depression Symptoms in People Starting ZuranoloneNCT07398469Zuranolone	—	Not yet scored	OngoingRecruiting	200 est.	29 Mar 2027
A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon Beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple SclerosisNCT03958877BIIB017 (peginterferon beta-1a)	Phase 3	Locked · track to reveal	OngoingActive, not recruiting	152 est.	20 May 2027
PREVAILA Study to Learn About the Effects of Felzartamab Infusions on Adults With Immunoglobulin A Nephropathy (IgAN)NCT06935357Felzartamab	Phase 3	Locked · track to reveal	OngoingRecruiting	454 est.	31 May 2027
PIERRE-PKA 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)NCT06555419Nusinersen	Phase 1	Locked · track to reveal	OngoingRecruiting	58 est.	25 Jun 2027
ATLASA Study of BIIB067 (Tofersen) Initiated in Clinically Presymptomatic Adults With a Confirmed Superoxide Dismutase 1 MutationNCT04856982Tofersen	Phase 3	Locked · track to reveal	OngoingActive, not recruiting	158 est.	7 Aug 2027
Pediatric Spinal Muscular Atrophy (SMA) China RegistryNCT05042921	—	Not yet scored	OngoingActive, not recruiting	600 est.	2 Sept 2027
ASCENDA Study to Learn About the Effect of Higher Doses of Nusinersen (BIIB058) Given as Injections to Participants With Spinal Muscular Atrophy (SMA) Who Were Previously Treated With Risdiplam (ASCEND)NCT05067790Nusinersen	Phase 3	Locked · track to reveal	OngoingActive, not recruiting	45 est.	24 Sept 2027
BRAVEA Study to Learn More About the Effects and Long-Term Safety of Omaveloxolone (BIIB141) in Children and Teens With Friedreich's AtaxiaNCT06953583Omaveloxolone	Phase 3	Locked · track to reveal	OngoingRecruiting	255 est.	16 Nov 2027
A Study to Learn More About the Long-Term Safety of Tofersen (Qalsody) in Chinese Participants With SOD-1 Amyotrophic Lateral Sclerosis (ALS)NCT07223723Tofersen	Phase 4	Locked · track to reveal	OngoingRecruiting	12 est.	16 Dec 2027
TRANSPIREA Study to Learn About the Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Late Isolated Microvascular InflammationNCT07219043Felzartamab	Phase 2	Locked · track to reveal	OngoingRecruiting	81 est.	10 Feb 2028
Adult Spinal Muscular Atrophy (SMA) China RegistryNCT05618379	—	Not yet scored	OngoingActive, not recruiting	200 est.	1 Jun 2028
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 PlaceboNCT07662148BIIB144	Phase 1	Not yet scored	OngoingNot yet recruiting	48 est.	19 Jun 2028
SOLARA Study to Learn About Salanersen's (BIIB115) Effects on Movement and Its Safety in Participants Aged 15 to 60 Years With Spinal Muscular Atrophy (SMA) Who Are Either New to SMA Treatment or Were Previously Treated With RisdiplamNCT07444476Salanersen	Phase 3	Locked · track to reveal	OngoingRecruiting	90 est.	23 Jun 2028
STELLAR-1A Study to Learn About Salanersen's (BIIB115) Effects on Movement and Its Safety When Given Before Symptoms Appear in Babies With Genetically Diagnosed Spinal Muscular Atrophy (SMA)NCT07221669Salanersen	Phase 3	Locked · track to reveal	OngoingRecruiting	30 est.	28 Nov 2028
PROMINENTA Study to Learn More About the Effects and Safety of Felzartamab Infusions in Adults With Primary Membranous Nephropathy (PMN)NCT06962800Felzartamab	Phase 3	Locked · track to reveal	OngoingRecruiting	180 est.	29 Dec 2028
AMETHYST LTEA 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 ErythematosusNCT06044337BIIB059 (litifilimab)	Phase 3	Locked · track to reveal	OngoingEnrolling by invitation	306 est.	26 Jun 2029
STELLAR-2A Study to Learn About the Safety and Effects of Salanersen (BIIB115) When Given to Babies With Spinal Muscular Atrophy (SMA) Who Were Previously Treated With Onasemnogene AbeparvovecNCT07444450Salanersen	Phase 3	Locked · track to reveal	OngoingNot yet recruiting	42 est.	27 Jul 2029
A Study to Learn More About the Long-Term Safety of BIIB141 (Omaveloxolone) in Participants With Friedreich's Ataxia Who Are Prescribed it by Their Own DoctorsNCT06623890Omaveloxolone	—	Not yet scored	OngoingRecruiting	300 est.	1 Oct 2029
EMERALDAn Extension Study to Learn More About the Long-Term Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus ErythematosusNCT05352919Litifilimab	Phase 3	Locked · track to reveal	OngoingEnrolling by invitation	864 est.	29 Mar 2030
A Study to Learn More About The Safety of Diroximel Fumarate (VUMERITY®) in Participants Who Took it During Pregnancy And About the Health of Their BabiesNCT05688436Diroximel Fumarate	—	Not yet scored	OngoingActive, not recruiting	1,178 est.	17 Jan 2031
A Study to Learn More About the Long-Term Safety and Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Antibody-Mediated Rejection (AMR) or Microvascular Inflammation (MVI) (TRANSCEND/TRANSPIRE LTE)NCT07444489Felzartamab	Phase 3	Locked · track to reveal	OngoingEnrolling by invitation	201 est.	28 May 2031
A Study to Learn About the Safety of BIIB115 Injections and How BIIB115 is Processed in the Bodies of Healthy Adult Male Volunteers and of Pediatric Participants With Spinal Muscular Atrophy Who Previously Took Onasemnogene AbeparvovecNCT05575011BIIB115	Phase 1	Locked · track to reveal	OngoingActive, not recruiting	62 est.	14 Nov 2031
Pregnancy Exposure Registry for Vumerity (Diroximel Fumarate)NCT05658497Diroximel Fumarate	—	Not yet scored	OngoingRecruiting	908 est.	6 Jul 2032
A Study to Learn How Nusinersen (Spinraza) Affects Participants With Spinal Muscular Atrophy (SMA) Who Took it Before or During Pregnancy And About The Health of Their BabiesNCT05789758	—	Not yet scored	OngoingRecruiting	20 est.	31 Oct 2032
A Study to Evaluate Long-Term Safety of Vumerity and Tecfidera in Participants With Multiple Sclerosis (MS)NCT05767736Diroximel Fumarate	—	Not yet scored	OngoingActive, not recruiting	10,500 est.	1 Dec 2032
A Study to Learn More About the Long-Term Safety of Tofersen (Qalsody) in Participants With Superoxide Dismutase 1 (SOD-1) Amyotrophic Lateral Sclerosis (ALS)NCT07259980Tofersen	—	Not yet scored	OngoingRecruiting	125 est.	30 Dec 2033
VOYAGEA Study to Learn About the Safety of Diroximel Fumarate (DRF) and Dimethyl Fumarate (DMF) and Their Effects on Relapses in Pediatric Participants With Relapsing Forms of Multiple Sclerosis (RMS)NCT07483632Diroximel Fumarate	Phase 3	Locked · track to reveal	OngoingNot yet recruiting	185 est.	28 Jul 2034
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 BabiesNCT06628687Omaveloxolone	—	Not yet scored	OngoingRecruiting	10 est.	30 Apr 2035
A Study to Learn More About the Safety and Effects of Felzartamab in Adults With Lupus Nephritis Aged 18 to 75 Years OldNCT06064929Felzartamab	Phase 1	Locked · track to reveal	Completed	14 est.	24 Jun 2026
SOLSTICELong-term Safety and Efficacy Follow-up of BIIB111 for the Treatment of Choroideremia and BIIB112 for the Treatment of X-Linked Retinitis PigmentosaNCT03584165BIIB111	Phase 3	Locked · track to reveal	Completed	277 est.	22 Jun 2026
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 55NCT07297199Omaveloxolone	Phase 1	Locked · track to reveal	Completed	70 est.	1 May 2026
CELIAA 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 AgeNCT05399888Diranersen	Phase 2	Locked · track to reveal	OngoingActive, not recruiting	416 est.	11 Mar 2026
A Study to Find Out How Litifilimab is Processed in the Body in Healthy Participants When Given Under the Skin in 3 Different WaysNCT06741657Litifilimab	Phase 1	Locked · track to reveal	Completed	404 est.	10 Mar 2026
LUMAA 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 80NCT05348785BIIB122	Phase 2	Locked · track to reveal	Completed	650 est.	9 Mar 2026
A Study to Determine the Biodistribution, Safety, and Tolerability of a Microdose of Radiolabeled Diranersen (BIIB080) Co-administered With Diranersen in Healthy AdultsNCT06454721[89Zr]Zr-DFO-Diranersen	Phase 1	Locked · track to reveal	Completed	5 est.	5 Mar 2026
FUSIONA 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)NCT05798520BIIB091	Phase 2	Locked · track to reveal	Completed	127 est.	10 Feb 2026
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 55NCT07149415Omaveloxolone	Phase 1	Locked · track to reveal	Completed	22 est.	16 Oct 2025
RESPONDA 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)NCT04488133Nusinersen	Phase 4	Locked · track to reveal	Completed	46 est.	9 Oct 2025
BOLDA 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 OldNCT06054893Omaveloxolone	Phase 1	Locked · track to reveal	OngoingActive, not recruiting	33 est.	30 Sept 2025
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 55NCT07019064Omaveloxolone	Phase 1	Locked · track to reveal	Completed	52 est.	19 Aug 2025

View all trials516

ONWARD: 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)

Phase 3Active, not recruitingNCT04729907 ↗

Primary completion: Jul 2026; estimated
Enrollment: 115; estimated
Start: Apr 2021; Biogen

Conditions

Muscular Atrophy, Spinal

Interventions

Nusinersen

Brief summary

In this study, researchers will learn more about the use of nusinersen (BIIB058) in participants with spinal muscular atrophy (SMA). This study is an extension study and will enroll only those participants who have completed treatment in the parent study, 232SM203. The main goal of the study is to learn about the…

Full record on ClinicalTrials.gov ↗

Change timeline

4 recorded · latest 1 Oct 2024

Enrollment change · 2

Status change · 1

Completion date move · 1

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A Study to Learn About the Safety of BIIB142 and How it is Processed in the Body of Healthy Adult Participants Aged 18 to 55 Years Old

Phase 1RecruitingNCT07133828 ↗

Primary completion: Aug 2026; estimated
Enrollment: 78; estimated
Start: Aug 2025; Biogen

Conditions

Healthy Volunteer

Interventions

BIIB142
BIIB142-Matching Placebo

Brief summary

In this study, researchers will learn more about the safety of BIIB142 and how it is processed in the body. This is the first time that researchers will learn about BIIB142 and how it affects people. The main question researchers want to answer in this study is: • How many participants have adverse events (AEs) and…

Full record on ClinicalTrials.gov ↗

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1 recorded · latest 1 Oct 2025

Status change · 1

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TOPAZ-2: A Study to Learn About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus Erythematosus

Phase 3Active, not recruitingNCT04961567 ↗

Primary completion: Sept 2026; estimated
Enrollment: 562; estimated
Start: Jul 2021; Biogen

Conditions

Lupus Erythematosus, Systemic

Interventions

Litifilimab
Placebo

Brief summary

In this study, researchers will learn more about a study drug called litifilimab (BIIB059) in participants with systemic lupus erythematosus (SLE). The study will focus on participants who have active disease and are already taking standard of care medications. These may include antimalarials, steroids, and…

Full record on ClinicalTrials.gov ↗

Change timeline

6 recorded · latest 1 Feb 2026

Completion date move · 4

Status change · 1

Enrollment change · 1

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TOPAZ-1: A Study to Learn About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus Erythematosus

Phase 3Active, not recruitingNCT04895241 ↗

Primary completion: Sept 2026; estimated
Enrollment: 548; estimated
Start: May 2021; Biogen

Conditions

Lupus Erythematosus, Systemic

Interventions

Litifilimab
Placebo

Brief summary

Full record on ClinicalTrials.gov ↗

Change timeline

3 recorded · latest 1 Dec 2025

Enrollment change · 1

Status change · 1

Completion date move · 1

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AMETHYST: A 2-Part Study to Learn Whether Litifilimab (BIIB059) Injections Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus

Phase 2Active, not recruitingNCT05531565 ↗

Primary completion: Oct 2026; estimated
Enrollment: 450; estimated
Start: Sept 2022; Biogen

Conditions

Subacute Cutaneous Lupus Erythematosus
Chronic Cutaneous Lupus Erythematosus

Interventions

Litifilimab
Placebo

Brief summary

In this study, researchers will learn more about a study drug called litifilimab (BIIB059) in participants with cutaneous lupus erythematosus (CLE). The study will focus on participants who have either active subacute CLE or chronic CLE, or both. They may also have systemic lupus erythematosus (SLE). The participants…

Full record on ClinicalTrials.gov ↗

Change timeline

1 recorded · latest 1 Jul 2024

Completion date move · 1

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A Study Utilising Data From European Union (EU) National Multiple Sclerosis (MS) Registries to Assess the Incidence of Anti-Natalizumab Antibody Among Participants Who Receive Subcutaneous Administration of Natalizumab for Treatment of Relapsing-remitting Multiple Sclerosis (RRMS)

–Active, not recruitingNCT05925049 ↗

Primary completion: Oct 2026; estimated
Enrollment: 400; estimated
Start: Jun 2023; Biogen

Conditions

Multiple Sclerosis

Interventions

Natalizumab

Brief summary

The primary objective of this study is to estimate the incidence of Anti-Natalizumab Antibodies (ANAs) in the cohort of natalizumab-naïve and other MS monoclonal antibody (mAb)-naive participants who start receiving natalizumab subcutaneous (SC) injections. The secondary objectives of this study are to estimate the…

Full record on ClinicalTrials.gov ↗

Change timeline

No changes recorded on this trial in the observed window.

TRANSCEND: A Study to Learn More About the Effects and Safety of Felzartamab Infusions in Adults With Kidney Transplants Who Have Antibody-Mediated Rejection (AMR)

Phase 3Active, not recruitingNCT06685757 ↗

Primary completion: Dec 2026; estimated
Enrollment: 132; estimated
Start: Dec 2024; Biogen

Conditions

Antibody-mediated Rejection

Interventions

Felzartamab
Placebo

Brief summary

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. But even after a successful transplant, the body's immune system can sometimes attack the new…

Full record on ClinicalTrials.gov ↗

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1 recorded · latest 1 Apr 2025

Completion date move · 1

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A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon Beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis

Phase 3Active, not recruitingNCT03958877 ↗

Primary completion: May 2027; estimated
Enrollment: 152; estimated
Start: Oct 2019; Biogen

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

BIIB017 (peginterferon beta-1a)
Interferon beta type 1a

Brief summary

This study will evaluate the safety, tolerability, and descriptive efficacy of BIIB017 in pediatric participants with relapsing-remitting multiple sclerosis (RRMS) and to assess the pharmacokinetics (PK) of BIIB017 in pediatric participants with RRMS in Part 1. In Part 2, the study will evaluate the long-term safety…

Full record on ClinicalTrials.gov ↗

Change timeline

4 recorded · latest 1 Oct 2025

Completion date move · 2

Enrollment change · 1

Status change · 1

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PIERRE-PK: 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)

Phase 1RecruitingNCT06555419 ↗

Primary completion: Jun 2027; estimated
Enrollment: 58; estimated
Start: Jan 2025; Biogen

Conditions

Muscular Atrophy, Spinal

Interventions

Nusinersen
ThecaFlex DRx System

Brief summary

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). The ThecaFlex DRx system is an investigational implantable medical device developed by Alcyone Therapeutics, Inc. It…

Full record on ClinicalTrials.gov ↗

Change timeline

3 recorded · latest 1 Apr 2026

Completion date move · 2

Status change · 1

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ATLAS: A Study of BIIB067 (Tofersen) Initiated in Clinically Presymptomatic Adults With a Confirmed Superoxide Dismutase 1 Mutation

Phase 3Active, not recruitingNCT04856982 ↗

Primary completion: Aug 2027; estimated
Enrollment: 158; estimated
Start: May 2021; Biogen

Conditions

Amyotrophic Lateral Sclerosis Associated With a SOD1 Gene Mutation

Interventions

Tofersen
Placebo

Brief summary

The primary objective of this study is to evaluate the efficacy of tofersen in presymptomatic adult carriers of a superoxide dismutase 1 (SOD1) mutation with elevated neurofilament (NF). The secondary objectives of this study are to evaluate the safety and tolerability tofersen and to evaluate the effect of tofersen…

Full record on ClinicalTrials.gov ↗

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3 recorded · latest 1 Apr 2025

Enrollment change · 1

Status change · 1

Completion date move · 1

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ASCEND: A Study to Learn About the Effect of Higher Doses of Nusinersen (BIIB058) Given as Injections to Participants With Spinal Muscular Atrophy (SMA) Who Were Previously Treated With Risdiplam (ASCEND)

Phase 3Active, not recruitingNCT05067790 ↗

Primary completion: Sept 2027; estimated
Enrollment: 45; estimated
Start: Jan 2022; Biogen

Conditions

Spinal Muscular Atrophy

Interventions

Nusinersen

Brief summary

In this study, researchers will learn more about the use of a higher dose of nusinersen (BIIB058) in participants with spinal muscular atrophy (SMA). This study will focus on teenagers and adults who are unable to walk on their own and who have previously taken another drug for SMA called risdiplam. The main goal of…

Full record on ClinicalTrials.gov ↗

Change timeline

4 recorded · latest 1 Jun 2026

Enrollment change · 2

Completion date move · 1

Status change · 1

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A Study to Learn More About the Long-Term Safety of Tofersen (Qalsody) in Chinese Participants With SOD-1 Amyotrophic Lateral Sclerosis (ALS)

Phase 4RecruitingNCT07223723 ↗

Primary completion: Dec 2027; estimated
Enrollment: 12; estimated
Start: Dec 2025; Biogen

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Tofersen

Brief summary

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 ALS. This type is in people who have a mutation in the superoxide dismutase 1 gene, also…

Full record on ClinicalTrials.gov ↗

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1 recorded · latest 1 Feb 2026

Status change · 1

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TRANSPIRE: A Study to Learn About the Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Late Isolated Microvascular Inflammation

Phase 2RecruitingNCT07219043 ↗

Primary completion: Feb 2028; estimated
Enrollment: 81; estimated
Start: Jan 2026; Biogen

Conditions

Microvascular Inflammation

Interventions

Felzartamab
Placebo

Brief summary

In this study, researchers will learn more about a drug called felzartamab in people who have received a kidney transplant and later developed a condition called microvascular inflammation (MVI). MVI is a type of injury to small blood vessels in the transplanted kidney and may be a sign of rejection by the body. It…

Full record on ClinicalTrials.gov ↗

Change timeline

1 recorded · latest 1 Feb 2026

Status change · 1

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SOLAR: A Study to Learn About Salanersen's (BIIB115) Effects on Movement and Its Safety in Participants Aged 15 to 60 Years With Spinal Muscular Atrophy (SMA) Who Are Either New to SMA Treatment or Were Previously Treated With Risdiplam

Phase 3RecruitingNCT07444476 ↗

Primary completion: Jun 2028; estimated
Enrollment: 90; estimated
Start: Apr 2026; Biogen

Conditions

Spinal Muscular Atrophy

Interventions

Salanersen

Brief summary

In this study, researchers will learn more about the effects and safety of BIIB115, also known as salanersen. Specifically, researchers will learn more about how salanersen works in individuals with SMA who are between the ages of 15 and 60 years old. In most people living with SMA, changes to or a lack of a gene…

Full record on ClinicalTrials.gov ↗

Change timeline

1 recorded · latest 1 May 2026

Status change · 1

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STELLAR-1: A Study to Learn About Salanersen's (BIIB115) Effects on Movement and Its Safety When Given Before Symptoms Appear in Babies With Genetically Diagnosed Spinal Muscular Atrophy (SMA)

Phase 3RecruitingNCT07221669 ↗

Primary completion: Nov 2028; estimated
Enrollment: 30; estimated
Start: Apr 2026; Biogen

Conditions

Muscular Atrophy, Spinal

Interventions

Salanersen

Brief summary

In this study, researchers will learn more about the effects and safety of BIIB115, also known as salanersen. Specifically, researchers will learn more about how salanersen works in babies who have been diagnosed with SMA through genetic testing but have not yet started showing signs or symptoms. Most people with SMA…

Full record on ClinicalTrials.gov ↗

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1 recorded · latest 1 Feb 2026

Status change · 1

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AMETHYST LTE: 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

Phase 3Enrolling by invitationNCT06044337 ↗

Primary completion: Jun 2029; estimated
Enrollment: 306; estimated
Start: Oct 2023; Biogen

Conditions

Subacute Cutaneous Lupus Erythematosus
Chronic Cutaneous Lupus Erythematosus

Interventions

BIIB059 (litifilimab)

Brief summary

In this study, researchers will learn more about a study drug called BIIB059 (litifilimab) in participants with cutaneous lupus erythematosus (CLE). The study will focus on participants who have either active subacute CLE or chronic CLE, or both. They may also have systemic lupus erythematosus (SLE). The participants…

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1 recorded · latest 1 Jan 2024

Status change · 1

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STELLAR-2: A Study to Learn About the Safety and Effects of Salanersen (BIIB115) When Given to Babies With Spinal Muscular Atrophy (SMA) Who Were Previously Treated With Onasemnogene Abeparvovec

Phase 3Not yet recruitingNCT07444450 ↗

Primary completion: Jul 2029; estimated
Enrollment: 42; estimated
Start: Sept 2026; Biogen

Conditions

Muscular Atrophy, Spinal

Interventions

Salanersen
Sham Procedure

Brief summary

In this study, researchers will learn more about the safety and effects of BIIB115, also known as salanersen. Specifically, researchers will learn more about how salanersen works in babies who have already been treated with onasemnogene abeparvovec (OA) after being diagnosed with SMA. Most people with SMA have…

Full record on ClinicalTrials.gov ↗

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EMERALD: An Extension Study to Learn More About the Long-Term Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus Erythematosus

Phase 3Enrolling by invitationNCT05352919 ↗

Primary completion: Mar 2030; estimated
Enrollment: 864; estimated
Start: Jun 2022; Biogen

Conditions

Systemic Lupus Erythematosus (SLE)

Interventions

Litifilimab
Litifilimab-matching placebo

Brief summary

Full record on ClinicalTrials.gov ↗

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4 recorded · latest 1 Apr 2025

Completion date move · 2

Status change · 2

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A Study to Learn More About The Safety of Diroximel Fumarate (VUMERITY®) in Participants Who Took it During Pregnancy And About the Health of Their Babies

–Active, not recruitingNCT05688436 ↗

Primary completion: Jan 2031; estimated
Enrollment: 1,178; estimated
Start: Sept 2021; Biogen

Conditions

Multiple Sclerosis

Interventions

Diroximel Fumarate
Alemtuzumab
Fingolimod
Glatiramer acetate
Interferon beta
Natalizumab
Ocrelizumab
Ofatumumab

Brief summary

In this study, researchers will learn more about the effects of diroximel fumarate (DRF), also known as VUMERITY®, when taken during pregnancy in people with multiple sclerosis, also known as MS. In MS, the immune system attacks the nerves in the brain and spinal cord. The affected areas are called lesions. The damage…

Full record on ClinicalTrials.gov ↗

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A Study to Learn More About the Long-Term Safety and Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Antibody-Mediated Rejection (AMR) or Microvascular Inflammation (MVI) (TRANSCEND/TRANSPIRE LTE)

Phase 3Enrolling by invitationNCT07444489 ↗

Primary completion: May 2031; estimated
Enrollment: 201; estimated
Start: Apr 2026; Biogen

Conditions

Antibody-mediated Rejection
Microvascular Inflammation

Interventions

Felzartamab

Brief summary

In this study, researchers will learn more about a drug called felzartamab in people who have received a kidney transplant and then developed antibody-mediated rejection (AMR) or microvascular inflammation (MVI). AMR happens when the body's immune system creates donor-specific antibodies (DSAs) that attack the…

Full record on ClinicalTrials.gov ↗

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1 recorded · latest 1 May 2026

Status change · 1

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A Study to Learn About the Safety of BIIB115 Injections and How BIIB115 is Processed in the Bodies of Healthy Adult Male Volunteers and of Pediatric Participants With Spinal Muscular Atrophy Who Previously Took Onasemnogene Abeparvovec

Phase 1Active, not recruitingNCT05575011 ↗

Primary completion: Nov 2031; estimated
Enrollment: 62; estimated
Start: Oct 2022; Biogen

Conditions

Healthy Volunteer
Muscular Atrophy, Spinal

Interventions

BIIB115
BIIB115-Matching Placebo

Brief summary

In this study, researchers will learn about a study drug called BIIB115 in healthy adult male volunteers and in participants with spinal muscular atrophy (SMA). This study will focus on children with SMA. The main objective of the study is to learn about the safety of BIIB115 and how participants respond to different…

Full record on ClinicalTrials.gov ↗

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7 recorded · latest 1 Aug 2025

Completion date move · 4

Enrollment change · 2

Status change · 1

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VOYAGE: A Study to Learn About the Safety of Diroximel Fumarate (DRF) and Dimethyl Fumarate (DMF) and Their Effects on Relapses in Pediatric Participants With Relapsing Forms of Multiple Sclerosis (RMS)

Phase 3Not yet recruitingNCT07483632 ↗

Primary completion: Jul 2034; estimated
Enrollment: 185; estimated
Start: Nov 2026; Biogen

Conditions

Relapsing Forms of Multiple Sclerosis

Interventions

Diroximel Fumarate
Dimethyl Fumarate
Fingolimod
Placebo matching DRF
Placebo matching DMF
Placebo matching fingolimod

Brief summary

In this study, researchers will learn more about the study drugs diroximel fumarate (DRF) and dimethyl fumarate (DMF) in children with MS who may be experiencing relapses. Participants will be divided into 2 groups based on their weight: * Group A will include children who weigh 40 kilograms (kg) or less. They will…

Full record on ClinicalTrials.gov ↗

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A Study to Learn More About the Safety and Effects of Felzartamab in Adults With Lupus Nephritis Aged 18 to 75 Years Old

Phase 1CompletedNCT06064929 ↗

Primary completion: Jun 2026; actual
Enrollment: 14; estimated
Start: Nov 2023; HI-Bio, A Biogen Company

Conditions

Lupus Nephritis

Interventions

Felzartamab

Brief summary

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. Antibodies are proteins in the blood used by the immune system to fight infection. Glomeruli are small filters that…

Full record on ClinicalTrials.gov ↗

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3 recorded · latest 1 Jan 2026

Status change · 1

Enrollment change · 1

Completion date move · 1

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SOLSTICE: Long-term Safety and Efficacy Follow-up of BIIB111 for the Treatment of Choroideremia and BIIB112 for the Treatment of X-Linked Retinitis Pigmentosa

Phase 3CompletedNCT03584165 ↗

Primary completion: Jun 2026; actual
Enrollment: 277; estimated
Start: Jun 2018; NightstaRx Ltd, a Biogen Company

Conditions

Choroideremia
X-Linked Retinitis Pigmentosa

Interventions

BIIB111
BIIB112

Brief summary

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 antecedent study; these treated participants will be compared with untreated control…

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2 recorded · latest 1 Oct 2023

Enrollment change · 1

Completion date move · 1

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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

Phase 1CompletedNCT07297199 ↗

Primary completion: May 2026; actual
Enrollment: 70; estimated
Start: Dec 2025; Biogen

Conditions

Healthy Volunteer

Interventions

Omaveloxolone

Brief summary

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 least 16 years old. Currently, BIIB141 is taken by mouth as capsules or capsule contents…

Full record on ClinicalTrials.gov ↗

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4 recorded · latest 1 Jun 2026

Status change · 2

Completion date move · 1

Enrollment change · 1

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CELIA: 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

Phase 2Active, not recruitingNCT05399888 ↗

Primary completion: Mar 2026; actual
Enrollment: 416; estimated
Start: Aug 2022; Biogen

Conditions

Mild Cognitive Impairment Due to Alzheimer's Disease
Alzheimer's Disease Dementia

Interventions

Diranersen
Diranersen-matching placebo

Brief summary

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. The main question researchers are trying to answer is if diranersen can slow the worsening of AD more than placebo. It will focus…

Full record on ClinicalTrials.gov ↗

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6 recorded · latest 1 Jan 2025

Enrollment change · 2

Status change · 2

Completion date move · 2

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A Study to Find Out How Litifilimab is Processed in the Body in Healthy Participants When Given Under the Skin in 3 Different Ways

Phase 1CompletedNCT06741657 ↗

Primary completion: Mar 2026; actual
Enrollment: 404; estimated
Start: Jan 2025; Biogen

Conditions

Healthy Volunteer

Interventions

Litifilimab
AI
OBI
PFS

Brief summary

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 subcutaneously (SC), also known as under the skin. In this study, researchers want to learn more about…

Full record on ClinicalTrials.gov ↗

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7 recorded · latest 1 Apr 2026

Status change · 3

Completion date move · 2

Enrollment change · 2

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LUMA: 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

Phase 2CompletedNCT05348785 ↗

Primary completion: Mar 2026; actual
Enrollment: 650; estimated
Start: Apr 2022; Biogen

Conditions

Parkinson Disease

Interventions

BIIB122
BIIB122-Matching Placebo

Brief summary

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. The main objective of the study is to learn about the effect BIIB122 has on slowing down the…

Full record on ClinicalTrials.gov ↗

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6 recorded · latest 1 Jun 2026

Completion date move · 3

Status change · 2

Enrollment change · 1

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A Study to Determine the Biodistribution, Safety, and Tolerability of a Microdose of Radiolabeled Diranersen (BIIB080) Co-administered With Diranersen in Healthy Adults

Phase 1CompletedNCT06454721 ↗

Primary completion: Mar 2026; actual
Enrollment: 5; estimated
Start: Jan 2025; Biogen

Conditions

Healthy Volunteer

Interventions

[89Zr]Zr-DFO-Diranersen
Diranersen

Brief summary

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. The main question researchers are trying to answer in this study is how radiolabeled diranersen distributes in the brain and spinal cord.…

Full record on ClinicalTrials.gov ↗

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7 recorded · latest 1 Apr 2026

Status change · 3

Completion date move · 3

Enrollment change · 1

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FUSION: 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)

Phase 2CompletedNCT05798520 ↗

Primary completion: Feb 2026; actual
Enrollment: 127; estimated
Start: Jul 2023; Biogen

Conditions

Relapsing Forms of Multiple Sclerosis

Interventions

BIIB091
DRF
Placebo

Brief summary

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. In Part 1, one set of participants will take either BIIB091 or diroximel fumarate (DRF). In Part 2, a different set of participants will take either a…

Full record on ClinicalTrials.gov ↗

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6 recorded · latest 1 Mar 2026

Status change · 3

Completion date move · 2

Enrollment change · 1

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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

Phase 1CompletedNCT07149415 ↗

Primary completion: Oct 2025; actual
Enrollment: 22; estimated
Start: Sept 2025; Biogen

Conditions

Healthy Volunteer

Interventions

Omaveloxolone
Omeprazole

Brief summary

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 least 16 years old. This is called a "drug-drug interaction" study. In this kind of study,…

Full record on ClinicalTrials.gov ↗

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3 recorded · latest 1 Nov 2025

Enrollment change · 1

Completion date move · 1

Status change · 1

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RESPOND: 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)

Phase 4CompletedNCT04488133 ↗

Primary completion: Oct 2025; actual
Enrollment: 46; estimated
Start: Jan 2021; Biogen

Conditions

Muscular Atrophy, Spinal

Interventions

Nusinersen

Brief summary

In this study, researchers will learn more about the use of nusinersen (BIIB058) in participants with spinal muscular atrophy (SMA). This study will focus on children under the age of 3 who were previously treated with the gene therapy onasemnogene abeparvovec but are still facing health challenges related to their…

Full record on ClinicalTrials.gov ↗

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5 recorded · latest 1 Nov 2025

Completion date move · 2

Status change · 2

Enrollment change · 1

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BOLD: 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

Phase 1Active, not recruitingNCT06054893 ↗

Primary completion: Sept 2025; actual
Enrollment: 33; estimated
Start: Jul 2024; Biogen

Conditions

Friedreich Ataxia

Interventions

Omaveloxolone

Brief summary

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 least 16 years old. But, it is not yet available for children and teens with FA who are…

Full record on ClinicalTrials.gov ↗

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6 recorded · latest 1 Jun 2026

Status change · 2

Completion date move · 2

Enrollment change · 2

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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

Phase 1CompletedNCT07019064 ↗

Primary completion: Aug 2025; actual
Enrollment: 52; estimated
Start: Jun 2025; Biogen

Conditions

Healthy Volunteer

Interventions

Omaveloxolone

Brief summary

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. This drug has been approved, or made available for doctors to prescribe, for people with Friedrich's Ataxia (FA) who are at least 16 years old. Currently,…

Full record on ClinicalTrials.gov ↗

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4 recorded · latest 1 Oct 2025

Status change · 2

Completion date move · 1

Enrollment change · 1

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