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Monoclonal Antibodies

BIIB105 for ALS (ALSpire Trial)

Phase 1 & 2
Waitlist Available
Research Sponsored by Biogen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Confirmed intermediate cytosine-adenine-guanine/cytosine-adenine-adenine (CAG/CAA) repeat expansion in the ataxin-2 (ATXN2) gene as defined by at least 1 allele carrying 30 to 33 CAG/CAA repeats
In participants in Cohorts C2 and D2, confirmed intermediate cytosine-adenine-guanine/cytosine-adenine-adenine (CAG/CAA) repeat expansion in the ataxin-2 gene or RNA (ATXN2) gene as defined by at least 1 allele carrying 30 to 33 CAG/CAA repeats.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 1184
Awards & highlights

ALSpire Trial Summary

This trial is testing a new drug for safety and how well it works in people with ALS or a related disease.

Who is the study for?
This trial is for adults with ALS, including those with a specific ATXN2 gene mutation. Participants must understand the study and give informed consent, have stable doses of certain ALS medications before starting, and meet criteria for diagnosing ALS. They need an informant/caregiver and should not have certain genetic mutations or history of substance abuse.Check my eligibility
What is being tested?
The ALSpire Study tests BIIB105's safety and effects on ALS progression over two parts: a 6-month phase where participants are randomly given either BIIB105 or placebo, followed by up to three years where all receive BIIB105. The study looks at how the body processes the drug and its impact on clinical function.See study design
What are the potential side effects?
Specific side effects aren't listed here but generally include reactions related to drug tolerance in organs, potential infusion-related issues, changes in blood parameters that will be closely monitored throughout the trial.

ALSpire Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My genetic test shows 30-33 repeats in the ATXN2 gene.
Select...
I have a specific genetic mutation in the ATXN2 gene.
Select...
I don't have, nor does my family, mutations in the SOD1 or FUS genes.
Select...
I don't have, nor does my family, mutations in the SOD1 or FUS genes.

ALSpire Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 1184
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 1184 for reporting.

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
Integrated Parts 1 and 2: Change From Baseline in Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R) Score
Integrated Parts 1 and 2: Change From Baseline in Muscle Strength, as Measured by Handheld Dynamometry (HHD)
+14 more

ALSpire Trial 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 up to thirty-eight maintenance doses, on up to thirty-eight 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 up to thirty-eight maintenance doses, on up to thirty-eight 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 Location

Who is running the clinical trial?

BiogenLead Sponsor
639 Previous Clinical Trials
467,337 Total Patients Enrolled
11 Trials studying Amyotrophic Lateral Sclerosis
2,749 Patients Enrolled for Amyotrophic Lateral Sclerosis
Medical DirectorStudy DirectorBiogen
2,777 Previous Clinical Trials
8,063,387 Total Patients Enrolled
7 Trials studying Amyotrophic Lateral Sclerosis
849 Patients Enrolled for Amyotrophic Lateral Sclerosis

Media Library

BIIB105 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04494256 — Phase 1 & 2
Amyotrophic Lateral Sclerosis Research Study Groups: Part 1: Cohort B, Part 1: Cohort D2, Part 2: Cohorts D1, D2: Open-Label, Part 1: Cohort A, Part 1: Cohort D1, Part 1: Cohorts A-D2: Placebo, Part 2: Cohorts A-C2: Open-Label, Part 1: Cohort C2, Part 1: Cohort C1
Amyotrophic Lateral Sclerosis Clinical Trial 2023: BIIB105 Highlights & Side Effects. Trial Name: NCT04494256 — Phase 1 & 2
BIIB105 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04494256 — Phase 1 & 2

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
Recent research and studies
clinicaltrials.govStudy
A Study to Assess the Safety, Tolerability, and Effect on Disease Progression of BIIB105 in Participants With Amyotrophic Lateral Sclerosis (ALS) and Participants With the ALS Ataxin-2 (ATXN2) Genetic Mutation
2020. "A Study to Assess the Safety, Tolerability, and Effect on Disease Progression of BIIB105 in Participants With Amyotrophic Lateral Sclerosis (ALS) and Participants With the ALS Ataxin-2 (ATXN2) Genetic Mutation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04494256.
All > Lou Gehrigs Disease > Als
~37 spots leftby Jul 2026
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