Clinical trials: sponsored by Biogen
Autosomal Dominant Polycystic Kidney, ADPKD
A Trial of Bardoxolone Methyl in Patients With ADPKD - FALCON
This international, multi-center, randomized, double-blind, placebo-controlled Phase 3 trial will study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients with ADPKD.
- Trial name
- FALCON (NCT03918447)
- Testing
- Bardoxolone methyl oral capsule
- Where
- 137 sites in United States, Australia and 8 more
- Volunteers
- 667 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
Alzheimer's Disease
A Study to Verify the Clinical Benefit of Aducanumab in Participants With Early Alzheimer's Disease
The primary objective of this study is to verify the clinical benefit of monthly doses of aducanumab in slowing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating Scale Sum of Boxes…
- Trial name
- ENVISION (NCT05310071)
- Testing
- Aducanumab
- Where
- 265 sites in United States, Australia and 14 more
- Volunteers
- 1,027 people
- Sponsor
- Biogen
Alzheimer's Disease
A Study to Evaluate Safety and Tolerability of Aducanumab in Participants With Alzheimer's Disease Who Had Previously Participated in the Aducanumab Studies 221AD103, 221AD301, 221AD302 and 221AD205
The primary objective is to evaluate the safety and tolerability of aducanumab over 100 weeks of treatment after a wash-out period imposed by discontinuation of feeder studies in participants who had previously received…
- Trial name
- NCT04241068
- Testing
- Aducanumab
- Where
- 297 sites in United States, Australia and 18 more
- Volunteers
- 1,696 people
- Sponsor
- Biogen
Spinal Muscular Atrophy
A Study for Participants With Spinal Muscular Atrophy (SMA) Who Previously Participated in Nusinersen (ISIS 396443) Investigational Studies
The primary objective is to evaluate long-term safety and tolerability of nusinersen (ISIS 396443) administered by intrathecal (IT) injection to participants with Spinal Muscular Atrophy (SMA) who previously participated in…
- Trial name
- SHINE (NCT02594124)
- Testing
- nusinersen
- Where
- 47 sites in United States, Australia and 12 more
- Volunteers
- 292 people
- Sponsor
- Biogen
Major Depressive Disorder
A Study to Evaluate SAGE-217 in Adult Participants With Major Depressive Disorder (MDD)
This is a Phase 3, open-label, 1-year study of the safety, tolerability, and need for re-treatment with SAGE-217 in adult participants with MDD.
- Trial name
- NCT03864614
- Testing
- SAGE-217
- Where
- 52 sites in United States
- Volunteers
- 1,515 people
- Sponsor
- Biogen
Parkinson Disease
A Study to Assess if BIIB122 Tablets Are Safe and Can Slow Worsening of Early-Stage Parkinson's Disease in Participants With Specific LRRK2 Genetic Variants Between the Ages of 30 and 80 Using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale
In this study, researchers will learn more about a study drug called BIIB122 in participants with early-stage Parkinson's disease (PD). The study will focus on participants with a specific genetic variant in their LRRK2 gene.
- Trial name
- LIGHTHOUSE (NCT05418673)
- Testing
- BIIB122
- Where
- 27 sites in United States, France and 4 more
- Volunteers
- 7 people
- Sponsor
- Biogen
Multiple Sclerosis, Relapsing-Remitting
A Study to Evaluate Efficacy, Safety, and Tolerability of EID of Natalizumab (BG00002) in Participants With RRMS Switching From Treatment With Natalizumab SID in Relation to Continued SID Treatment- Followed by Extension Study Comprising SC and IV Natalizumab Administration
Part 1: The primary objective is to evaluate the efficacy of natalizumab extended interval dosing (EID) (every 6 weeks [Q6W]) in participants who have previously been treated with natalizumab standard interval dosing (SID) (every…
- Trial name
- NCT03689972
- Testing
- Natalizumab
- Where
- 107 sites in United States, Australia and 9 more
- Volunteers
- 585 people
- Sponsor
- Biogen
Choroideremia
A Safety Study of Retinal Gene Therapy for Choroideremia With Administration of BIIB111
The objective of the study is to evaluate the safety of bilateral, sequential sub-retinal administration of a single dose of BIIB111 in adult male participants with Choroideremia (CHM).
- Trial name
- GEMINI (NCT03507686)
- Testing
- BIIB111
- Where
- 6 sites in United States, France and 1 more
- Volunteers
- 66 people
- Sponsor
- Biogen
X-Linked Retinitis Pigmentosa
A Clinical Trial of Retinal Gene Therapy for X-linked Retinitis Pigmentosa Using BIIB112
The objective of the study is to evaluate the safety, tolerability and efficacy of a single sub-retinal injection of BIIB112 in participants with X-linked retinitis pigmentosa (XLRP).
- Trial name
- XIRIUS (NCT03116113)
- Testing
- BIIB112
- Where
- 8 sites in United States, United Kingdom
- Volunteers
- 50 people
- Sponsor
- Biogen
Depressive Disorder, Major
A Study to Evaluate the Efficacy of Sage-217 in the Treatment of Adult Participants With Major Depressive Disorder (MDD)
The purpose of this study to evaluate the efficacy of SAGE-217 in the treatment of participants with MDD.
- Trial name
- NCT04442490
- Testing
- SAGE-217
- Where
- 39 sites in United States
- Volunteers
- 543 people
- Sponsor
- Biogen
Depressive Disorder, Major
A Comparative Study of Sage-217 Plus an Antidepressant (ADT) Versus Placebo Plus an ADT in Adults With Major Depressive Disorder
The primary purpose of this study is to evaluate the efficacy of SAGE-217 plus an ADT in the treatment of major depressive disorder (MDD) compared to placebo plus an ADT.
- Trial name
- NCT04476030
- Testing
- SAGE-217, Sertraline, Escitalopram
- Where
- 51 sites in United States
- Volunteers
- 440 people
- Sponsor
- Biogen
Postpartum Depression
A Study to Evaluate SAGE-217 in Participants With Severe Postpartum Depression
The primary purpose of this study was to determine if treatment with SAGE-217 reduces depressive symptoms in participants with severe postpartum depression (PPD) compared to placebo as assessed by the change from baseline in the…
- Trial name
- NCT02978326
- Testing
- SAGE-217 15/20 mg Oral Solution, SAGE 217 30 mg Capsules
- Where
- 27 sites in United States
- Volunteers
- 276 people
- Sponsor
- Biogen
Bipolar Disorder I, Bipolar Disorder II
A Study to Evaluate SAGE-217 in Participants With Bipolar I/II Disorder With a Current Major Depressive Episode
This is an open-label study evaluating the safety, tolerability, pharmacokinetics, and efficacy of SAGE-217 in the treatment of participants with bipolar I/II disorder with a current major depressive episode.
- Conditions
- Bipolar Disorder I, Bipolar Disorder II, Major Depressive Episode
- Trial name
- NCT03692910
- Testing
- SAGE-217
- Where
- 11 sites in United States
- Volunteers
- 35 people
- Sponsor
- Biogen
Choroideremia
Efficacy and Safety of BIIB111 for the Treatment of Choroideremia
The objective of the study is to evaluate the efficacy and safety of a single sub-retinal injection of BIIB111 in participants with choroideremia (CHM).
- Trial name
- STAR (NCT03496012)
- Testing
- BIIB111
- Where
- 18 sites in United States, Canada and 6 more
- Volunteers
- 169 people
- Sponsor
- Biogen
Depression, Postpartum
A Study to Evaluate the Efficacy and Safety of SAGE-217 in Participants With Severe Postpartum Depression (PPD)
The purpose of this study is to determine if treatment with SAGE-217 reduces depressive symptoms in females with severe postpartum depression (PPD) as compared to placebo.
- Trial name
- NCT04442503
- Testing
- SAGE-217
- Where
- 82 sites in United States, Spain and 1 more
- Volunteers
- 200 people
- Sponsor
- Biogen
Parkinson Disease
A Study to Evaluate SAGE-217 in Participants With Parkinson's Disease
This study assesses the safety, tolerability, pharmacokinetics and efficacy of SAGE-217 in 29 participants with moderate to severe Parkinson's Disease.
- Trial name
- NCT03000569
- Testing
- SAGE-217, Levodopa, Antiparkinsonian Agent(s)
- Where
- 11 sites in United States
- Volunteers
- 29 people
- Sponsor
- Biogen
Major Depressive Disorder
A Study to Evaluate the Efficacy of SAGE-217 in the Treatment of Adult Participants With Major Depressive Disorder
This study is a phase 3, multicenter, double-blind, randomized, placebo-controlled study evaluating the efficacy of SAGE-217 in the treatment of adult participants with major depressive disorder (MDD).
- Trial name
- NCT03672175
- Testing
- SAGE-217
- Where
- 53 sites in United States
- Volunteers
- 581 people
- Sponsor
- Biogen
Major Depressive Disorder, Insomnia
A Study to Evaluate the Safety, Tolerability, and Efficacy of SAGE-217 Compared to Placebo in Adult Participants With Comorbid Major Depressive Disorder (MDD) and Insomnia
This study is a randomized, double-blind, placebo-controlled study of the safety, tolerability, and efficacy of SAGE-217 compared to placebo in adult participants with comorbid major depressive disorder (MDD) and insomnia.
- Trial name
- NCT03771664
- Testing
- SAGE-217
- Where
- 28 sites in United States
- Volunteers
- 87 people
- Sponsor
- Biogen
Major Depressive Disorder
A Study to Evaluate SAGE-217 for Prevention of Relapse in Adult Participants With Major Depressive Disorder
This is a study with an Open-Label (OL) phase followed by a randomized, Double-Blind (DB), placebo-controlled phase to assess efficacy and safety of SAGE-217 on relapse prevention in adults with major depressive disorder (MDD).
- Trial name
- NCT04007367
- Testing
- SAGE-217
- Where
- 46 sites in United States
- Volunteers
- 53 people
- Sponsor
- Biogen