Monoclonal Antibodies
BIIB105 for Amyotrophic Lateral Sclerosis
Houston Methodist Neurological Institute, Houston, TX
BIIB105 +1 morePhase 1 & 2RecruitingResearch Sponsored by BiogenEligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upup to day 820
Awards & highlights
Study Summary
This trial is testing a new drug for safety and how well it works in people with ALS or a related disease.
Eligible Conditions
- ALS (Amyotrophic Lateral Sclerosis)
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to day 820
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 820
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part 1: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Part 2: Number of Participants with AEs and SAEs
Secondary outcome measures
Integrated Parts 1 and 2: CSF Trough PK Concentration of BIIB105
Amyotrophic Lateral Sclerosis
Muscle Tissue
+14 moreTrial Design
9Treatment groups
Experimental Treatment
Placebo Group
Group I: Part 2: Cohorts D1, D2: Open-LabelExperimental Treatment1 Intervention
Participants who complete Cohorts D1 and D2 will have a blinded Loading Dose Period, during which those who received placebo in Part 1 will receive BIIB105 Dose 4, IT, as 3 loading doses on Day 1 and two later days, while those who received BIIB105 in Part 1 will receive 2 loading doses of BIIB105 Dose 4, IT, on Days 1 and one later day, and placebo on Day 15. After the blinded Loading Dose Period, participants will receive BIIB105 Dose 4 as twenty-five maintenance doses on twenty-five later days.
Group II: Part 2: Cohorts A-C2: Open-LabelExperimental Treatment1 Intervention
Participants who complete Cohorts A, B, C1, and C2 will receive BIIB105 Dose 3, IT, as 3 loading doses on Day 1 and two later days, followed by twenty-five maintenance doses on twenty-five later days.
Group III: Part 1: Cohort D2Experimental Treatment1 Intervention
Participants with polyQ-ALS will receive BIIB105 Dose 4, IT, as 3 loading doses on Day 1 and two later days, followed by five maintenance doses on five later days.
Group IV: Part 1: Cohort D1Experimental Treatment1 Intervention
Participants with ALS will receive BIIB105 Dose 4, IT, as 3 loading doses on Day 1 and two later days, followed by five maintenance doses on five later days.
Group V: Part 1: Cohort C2Experimental Treatment1 Intervention
Participants with polyQ-ALS will receive BIIB105 Dose 3, IT, as 3 loading doses on Day 1 and two later days, followed by two maintenance doses on two later days.
Group VI: Part 1: Cohort C1Experimental Treatment1 Intervention
Participants with ALS will receive BIIB105 Dose 3, IT, as 3 loading doses on Day 1 and two later days, followed by two maintenance doses on two later days.
Group VII: Part 1: Cohort BExperimental Treatment1 Intervention
Participants with ALS will receive BIIB105 Dose 2, IT, as 3 loading doses on Day 1 and two later days, followed by two maintenance doses on two later days.
Group VIII: Part 1: Cohort AExperimental Treatment1 Intervention
Participants with ALS will receive BIIB105 Dose 1, intrathecally (IT), as 3 loading doses on Day 1 and two later days, followed by two maintenance doses on two later days.
Group IX: Part 1: Cohorts A-D2: PlaceboPlacebo Group1 Intervention
Participants with ALS and polyQ-ALS for Cohorts A, B, C1 and C2 will receive matching placebo to BIIB105 as 3 loading doses on Day 1 and two later days, followed by two maintenance doses on two later days, and participants with ALS and polyQ-ALS for Cohorts D1 and D2 will receive matching placebo to BIIB105 as 3 loading doses on Day 1 and two later days, followed by five maintenance doses on five later days.
Find a site
Who is running the clinical trial?
BiogenLead Sponsor
568 Previous Clinical Trials
455,548 Total Patients Enrolled
11 Trials studying Amyotrophic Lateral Sclerosis
2,749 Patients Enrolled for Amyotrophic Lateral Sclerosis
Medical DirectorStudy Director
Biogen2,700 Previous Clinical Trials
7,990,245 Total Patients Enrolled
7 Trials studying Amyotrophic Lateral Sclerosis
849 Patients Enrolled for Amyotrophic Lateral Sclerosis
Media Library
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment in this research endeavor still open?
"According to the clinicaltrials.gov website, this research project is in need of participants and has been open since September 28th 2020. The latest update was posted on November 16th 2022."
Answered by AI
Are there numerous healthcare facilities running this clinical experiment domestically?
"Currently, 20 medical centres are running this trial. These sites span from Boston to Salt Lake City to Jacksonville and beyond; thus, you can select the closest site in order to limit travel requirements should you choose to join the study."
Answered by AI
How many participants are involved in this medical experiment?
"For this medical research, 108 eligible participants are necessary. Those interested in taking part can go to the Massachusetts General Hospital located in Boston, MA or Utah's University of Utah situated in Salt Lake City for enrollment."
Answered by AI
Who else is applying?
What state do they live in?
Missouri
How old are they?
65+
What site did they apply to?
Research Site
What portion of applicants met pre-screening criteria?
Met criteria