BIIB105 for Amyotrophic Lateral Sclerosis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Amyotrophic Lateral Sclerosis+3 More
BIIB105 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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
  • Amyotrophic Lateral Sclerosis

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Amyotrophic Lateral Sclerosis

Study Objectives

3 Primary · 23 Secondary · Reporting Duration: Part 1-Cohorts A, B, C1, C2- Predose and at multiple time points up to 6 hours postdose from Day 1 to Day 92, Cohorts D1, D2- Predose and at multiple time points up to 6 hours postdose from Day 1 to Day 176; Part 2- Prior dosing on Day 1 up to Day 673

Day 673
Area Under the Concentration-Time Curve From Time Zero to Time of the Last Measurable Concentration (AUClast)
Area Under the Concentration-Time Curve from Time Zero to Infinity (AUCinf)
Elimination Half-Life (t1/2)
Maximum Observed Concentration (Cmax)
Serum Concentration of BIIB105
Time to Reach Maximum Observed Concentration (Tmax)
Day 820
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Up to Day 176
Part 1: Area Under the Serum Concentration-Time Curve From Time Zero to Time of the Last Measurable Concentration (AUClast)
Part 1: Area Under the Serum Concentration-Time Curve from Time Zero to Infinity (AUCinf)
Part 1: Elimination Half-Life (t1/2) in Serum
Part 1: Maximum Observed Serum Concentration (Cmax)
Serum
Part 1: Time to Reach Maximum Observed Serum Concentration (Tmax)
Up to Day 259
Part 1: CSF Concentrations of BIIB105
Neurofilaments
Up to Day 260
Part 1: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Up to Day 673
Serum
Up to Day 819
Integrated Parts 1 and 2: CSF Trough PK Concentration of BIIB105
Amyotrophic Lateral Sclerosis
Muscle Tissue
Integrated Parts 1 and 2: Change From Part 1 Baseline in Plasma Levels of NfL
Vital capacity
Up to Day 820
Integrated Parts 1 and 2: Time to Death
Continuous Positive Airway Pressure
Integrated Parts 1 and 2: Time to Death, Incorporating Post-Study Withdrawal or Study Completion Vital Status Data
Part 2: Number of Participants with AEs and SAEs

Trial Safety

Safety Progress

1 of 3

Other trials for Amyotrophic Lateral Sclerosis

Trial Design

17 Treatment Groups

Part 2: Cohorts A-C2: Open-Label (pending sponsor approval)
1 of 17
Cohort C2
1 of 17
Cohort C1
1 of 17
Cohort D1
1 of 17
Part 2: Cohorts A-C2: Open-Label
1 of 17
Cohort A
1 of 17
Cohort D2
1 of 17
Part 1: Cohort D2
1 of 17
Part 1: Cohort B
1 of 17
Part 1: Cohort D1
1 of 17
Part 2: Cohorts D1, D2: Open-Label
1 of 17
Cohort B
1 of 17
Part 1: Cohort C2
1 of 17
Part 1: Cohort A
1 of 17
Part 1: Cohort C1
1 of 17
Cohorts A-D2
1 of 17
Part 1: Cohorts A-D2: Placebo
1 of 17
Experimental Treatment
Non-Treatment Group

108 Total Participants · 17 Treatment Groups

Primary Treatment: BIIB105 · Has Placebo Group · Phase 1 & 2

Part 2: Cohorts A-C2: Open-Label (pending sponsor approval)
Drug
Experimental Group · 1 Intervention: BIIB105 · Intervention Types: Drug
Cohort C2
Drug
Experimental Group · 1 Intervention: BIIB105 · Intervention Types: Drug
Cohort C1
Drug
Experimental Group · 1 Intervention: BIIB105 · Intervention Types: Drug
Cohort D1
Drug
Experimental Group · 1 Intervention: BIIB105 · Intervention Types: Drug
Part 2: Cohorts A-C2: Open-Label
Drug
Experimental Group · 1 Intervention: BIIB105 · Intervention Types: Drug
Cohort A
Drug
Experimental Group · 1 Intervention: BIIB105 · Intervention Types: Drug
Cohort D2
Drug
Experimental Group · 1 Intervention: BIIB105 · Intervention Types: Drug
Part 1: Cohort D2
Drug
Experimental Group · 1 Intervention: BIIB105 · Intervention Types: Drug
Part 1: Cohort B
Drug
Experimental Group · 1 Intervention: BIIB105 · Intervention Types: Drug
Part 1: Cohort D1
Drug
Experimental Group · 1 Intervention: BIIB105 · Intervention Types: Drug
Part 2: Cohorts D1, D2: Open-Label
Drug
Experimental Group · 1 Intervention: BIIB105 · Intervention Types: Drug
Cohort B
Drug
Experimental Group · 1 Intervention: BIIB105 · Intervention Types: Drug
Part 1: Cohort C2
Drug
Experimental Group · 1 Intervention: BIIB105 · Intervention Types: Drug
Part 1: Cohort A
Drug
Experimental Group · 1 Intervention: BIIB105 · Intervention Types: Drug
Part 1: Cohort C1
Drug
Experimental Group · 1 Intervention: BIIB105 · Intervention Types: Drug
Cohorts A-D2
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Part 1: Cohorts A-D2: Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: part 1-cohorts a, b, c1, c2- predose and at multiple time points up to 6 hours postdose from day 1 to day 92, cohorts d1, d2- predose and at multiple time points up to 6 hours postdose from day 1 to day 176; part 2- prior dosing on day 1 up to day 673

Who is running the clinical trial?

BiogenLead Sponsor
553 Previous Clinical Trials
443,408 Total Patients Enrolled
12 Trials studying Amyotrophic Lateral Sclerosis
2,926 Patients Enrolled for Amyotrophic Lateral Sclerosis
Medical DirectorStudy DirectorBiogen
2,618 Previous Clinical Trials
7,936,717 Total Patients Enrolled
8 Trials studying Amyotrophic Lateral Sclerosis
1,026 Patients Enrolled for Amyotrophic Lateral Sclerosis

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have no known mutations in the SOD1 or FUS genes.
You have a platelet count of 50,000 or more per microliter of blood, an INR of less than 1.5, a PT of less than 15 seconds, and an aPTT of less than 50 seconds.
SVC ≥60% of predicted value as adjusted for sex, age, and height (from the sitting position).
You are able to understand the purpose and risks of the study and provide informed consent
Women must be of childbearing potential and men must ensure that highly effective contraception is used during the study and for at least 6 months for female participants and 8 months for male participants after their last dose of study treatment.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 1st, 2021

Last Reviewed: October 1st, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Missouri100.0%
How old are they?
65+100.0%
What site did they apply to?
Research Site100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%