NCT04494256 (ALSpire) is a Phase 1, PHASE2 clinical trial of BIIB105 in Amyotrophic Lateral Sclerosis, sponsored by Biogen.

Who is sponsoring NCT04494256?

NCT04494256 is sponsored by Biogen.

What drugs are being tested in NCT04494256?

Interventions in NCT04494256: BIIB105, Placebo.

What condition does NCT04494256 study?

NCT04494256 studies Amyotrophic Lateral Sclerosis.

Is NCT04494256 still recruiting?

NCT04494256 is currently terminated. Last updated 9 October 2025.

Are results published for NCT04494256?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-10-09 · How we verify

NCT04494256: ALSpire

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Terminated Phase 1, PHASE2 Results posted Last updated 9 October 2025

What this trial tests

Phase 1, PHASE2 trial testing BIIB105 in Amyotrophic Lateral Sclerosis in 99 participants. Terminated before completion.

Timeline

28 September 2020

Primary endpoint
13 August 2024

13 August 2024

Quick facts

Lead sponsor	Biogen
Phase	Phase 1, PHASE2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	triple
Primary purpose	treatment
Enrollment	99
Start date	28 September 2020
Primary completion	13 August 2024
Estimated completion	13 August 2024
Sites	17 locations across Italy, Canada, United States, Netherlands

Drugs / interventions tested

BIIB105 — full drug profile →
Placebo

Conditions studied

Amyotrophic Lateral Sclerosis — all drugs for Amyotrophic Lateral Sclerosis →

Sponsor

Biogen — full company profile →

Who can join

18 and older, any sex, with Amyotrophic Lateral Sclerosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Part 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) Primary · From first dose of the study drug in Part 1 up to end of follow up period in Part 1 (up to Day 260)

An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An SAE was any untoward medical occurrence that at any dose results in death, places the participant at immediate risk of death, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, or is a medically important event. A TEAE/TESAE was defined as any AE/SA

TEAEs

Group	Value	95% CI
Part 1: Pooled Placebo 1+2	28
Part 1: Cohort A: BIIB105 5 mg	6
Part 1: Cohort B: BIIB105 20 mg	6
Part 1: Cohorts C1+C2: BIIB105 60 mg	11
Part 1: Cohorts D1 + D2: BIIB105 120 mg	48

TESAEs

Group	Value	95% CI
Part 1: Pooled Placebo 1+2	5
Part 1: Cohort A: BIIB105 5 mg	0
Part 1: Cohort B: BIIB105 20 mg	0
Part 1: Cohorts C1+C2: BIIB105 60 mg	1
Part 1: Cohorts D1 + D2: BIIB105 120 mg	7

Part 2: Number of Participants With TEAEs and TESAEs Primary · From first dose of the study in Part 2 up to end of follow up period in Part 2 (up to Day 1184)

TEAEs

Group	Value	95% CI
Part 2: BIIB105 60 mg	19
Part 2: BIIB105 120 mg	49

TESAEs

Group	Value	95% CI
Part 2: BIIB105 60 mg	7
Part 2: BIIB105 120 mg	14

Part 1: Serum Concentrations of BIIB105 Secondary · Pre-dose and 1, 2, 4, 6 hours post-dose on days 1, 15, 29, 57, 85,113, 141, 169 and on days 2, 8, 92, and 176

Day 1: Pre-dose

Group	Value	95% CI
Part 1: Cohort A: BIIB105 5 mg	0.00	± 0.00
Part 1: Cohort B: BIIB105 20 mg	0.00	± 0.00
Part 1: Cohorts C1+C2: BIIB105 60 mg	0.00	± 0.00
Part 1: Cohorts D1 + D2: BIIB105 120 mg	0.00	± 0.00

Day 1: 1 HR post-dose

Group	Value	95% CI
Part 1: Cohort A: BIIB105 5 mg	7.21	± 500.18
Part 1: Cohort B: BIIB105 20 mg	57.70	± 285.30
Part 1: Cohorts C1+C2: BIIB105 60 mg	34.98	± 465.78
Part 1: Cohorts D1 + D2: BIIB105 120 mg	187.14	± 351.05

Day 1: 2 HR post-dose

Group	Value	95% CI
Part 1: Cohort A: BIIB105 5 mg	32.20	± 177.01
Part 1: Cohort B: BIIB105 20 mg	135.71	± 109.27
Part 1: Cohorts C1+C2: BIIB105 60 mg	250.28	± 101.57
Part 1: Cohorts D1 + D2: BIIB105 120 mg	620.38	± 132.37

Day 1: 4 HR post-dose

Group	Value	95% CI
Part 1: Cohort A: BIIB105 5 mg	41.38	± 125.95
Part 1: Cohort B: BIIB105 20 mg	211.34	± 68.29
Part 1: Cohorts C1+C2: BIIB105 60 mg	488.11	± 51.22
Part 1: Cohorts D1 + D2: BIIB105 120 mg	798.21	± 86.03

Day 1: 6 HR post-dose

Group	Value	95% CI
Part 1: Cohort A: BIIB105 5 mg	39.27	± 102.97
Part 1: Cohort B: BIIB105 20 mg	165.05	± 60.63
Part 1: Cohorts C1+C2: BIIB105 60 mg	528.45	± 61.49
Part 1: Cohorts D1 + D2: BIIB105 120 mg	774.73	± 60.51

Day 2

Group	Value	95% CI
Part 1: Cohort A: BIIB105 5 mg	6.76	± 65.90
Part 1: Cohort B: BIIB105 20 mg	29.07	± 76.82
Part 1: Cohorts C1+C2: BIIB105 60 mg	118.70	± 103.89
Part 1: Cohorts D1 + D2: BIIB105 120 mg	260.03	± 67.59

Day 8

Group	Value	95% CI
Part 1: Cohort A: BIIB105 5 mg	0.46	± 18.74
Part 1: Cohort B: BIIB105 20 mg	0.47	± 36.02
Part 1: Cohorts C1+C2: BIIB105 60 mg	1.38	± 74.15
Part 1: Cohorts D1 + D2: BIIB105 120 mg	2.97	± 43.60

Day 15: Pre-dose

Group	Value	95% CI
Part 1: Cohort A: BIIB105 5 mg	0.00	± 0.00
Part 1: Cohort B: BIIB105 20 mg	0.50	± 20.12
Part 1: Cohorts C1+C2: BIIB105 60 mg	0.78	± 52.94
Part 1: Cohorts D1 + D2: BIIB105 120 mg	1.90	± 43.15

Part 1: CSF Concentrations of BIIB105 Secondary · Pre-dose on Days 1, 15, 29, 57, 85, 113, 141, 169, and on days 92, 130, 175, and 176

Day 1 : Pre-dose

Group	Value	95% CI
Part 1: Cohort A: BIIB105 5 mg	0.00	± 0.00
Part 1: Cohort B: BIIB105 20 mg	0.00	± 0.00
Part 1: Cohorts C1+C2: BIIB105 60 mg	0.00	± 0.00
Part 1: Cohorts D1 + D2: BIIB105 120 mg	0.00	± 0.00

Day 15 : Pre-dose

Group	Value	95% CI
Part 1: Cohort A: BIIB105 5 mg	1.93	± 41.54
Part 1: Cohort B: BIIB105 20 mg	2.71	± 55.21
Part 1: Cohorts C1+C2: BIIB105 60 mg	5.75	± 62.33
Part 1: Cohorts D1 + D2: BIIB105 120 mg	14.54	± 82.48

Day 29 : Pre-dose

Group	Value	95% CI
Part 1: Cohort A: BIIB105 5 mg	3.53	± 33.52
Part 1: Cohort B: BIIB105 20 mg	4.32	± 52.42
Part 1: Cohorts C1+C2: BIIB105 60 mg	11.53	± 49.38
Part 1: Cohorts D1 + D2: BIIB105 120 mg	17.53	± 95.18

Day 57 : Pre-dose

Group	Value	95% CI
Part 1: Cohort A: BIIB105 5 mg	2.32	± 28.96
Part 1: Cohort B: BIIB105 20 mg	2.65	± 46.23
Part 1: Cohorts C1+C2: BIIB105 60 mg	4.82	± 59.33
Part 1: Cohorts D1 + D2: BIIB105 120 mg	10.29	± 79.90

Day 85 : Pre-dose

Group	Value	95% CI
Part 1: Cohort A: BIIB105 5 mg	2.37	± 30.35
Part 1: Cohort B: BIIB105 20 mg	3.18	± 72.73
Part 1: Cohorts C1+C2: BIIB105 60 mg	6.50	± 36.23
Part 1: Cohorts D1 + D2: BIIB105 120 mg	14.06	± 77.42

Day 92

Group	Value	95% CI
Part 1: Cohort A: BIIB105 5 mg	5.01	± 30.62
Part 1: Cohort B: BIIB105 20 mg	6.28	± 74.45
Part 1: Cohorts C1+C2: BIIB105 60 mg	25.51	± 66.26

Day 113

Group	Value	95% CI
Part 1: Cohorts D1 + D2: BIIB105 120 mg	17.08	± 86.41

Day 130

Group	Value	95% CI
Part 1: Cohort A: BIIB105 5 mg	2.09	± 32.22
Part 1: Cohort B: BIIB105 20 mg	2.45	± 57.06
Part 1: Cohorts C1+C2: BIIB105 60 mg	5.42	± 40.72

Part 1: Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUCinf) Secondary · Day 1

AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf was reported following dose 1 as planned.

Group	Value	95% CI
Part 1: Cohort A: BIIB105 5 mg	934.22	± 52.89
Part 1: Cohort B: BIIB105 20 mg	3546.89	± 53.50
Part 1: Cohorts C1+C2: BIIB105 60 mg	11258.45	± 14.57
Part 1: Cohorts D1 + D2: BIIB105 120 mg	24466.44	± 30.24

Part 1: Area Under the Serum Concentration-Time Curve From Time Zero to Time of the Last Measurable Concentration (AUClast) Secondary · Day 1

AUClast was reported following dose 1 as planned.

Group	Value	95% CI
Part 1: Cohort A: BIIB105 5 mg	574.59	± 79.16
Part 1: Cohort B: BIIB105 20 mg	3239.40	± 52.73
Part 1: Cohorts C1+C2: BIIB105 60 mg	11758.68	± 21.12
Part 1: Cohorts D1 + D2: BIIB105 120 mg	24289.70	± 30.50

Part 1: Maximum Observed Serum Concentration (Cmax) Secondary · Days 1, 15, 29, 57, 85, 113, 141 and 169

Day 1

Group	Value	95% CI
Part 1: Cohort A: BIIB105 5 mg	52.18	± 123.13
Part 1: Cohort B: BIIB105 20 mg	227.80	± 73.20
Part 1: Cohorts C1+C2: BIIB105 60 mg	644.10	± 55.31
Part 1: Cohorts D1 + D2: BIIB105 120 mg	1019.11	± 76.61

Day 15

Group	Value	95% CI
Part 1: Cohort A: BIIB105 5 mg	31.03	± 78.23
Part 1: Cohort B: BIIB105 20 mg	165.37	± 118.45
Part 1: Cohorts C1+C2: BIIB105 60 mg	495.03	± 76.73
Part 1: Cohorts D1 + D2: BIIB105 120 mg	1312.42	± 93.96

Day 29

Group	Value	95% CI
Part 1: Cohort A: BIIB105 5 mg	34.11	± 119.62
Part 1: Cohort B: BIIB105 20 mg	164.15	± 101.46
Part 1: Cohorts C1+C2: BIIB105 60 mg	616.02	± 61.54
Part 1: Cohorts D1 + D2: BIIB105 120 mg	1173.71	± 75.74

Day 57

Group	Value	95% CI
Part 1: Cohort A: BIIB105 5 mg	31.92	± 136.57
Part 1: Cohort B: BIIB105 20 mg	94.60	± 75.30
Part 1: Cohorts C1+C2: BIIB105 60 mg	513.84	± 98.01
Part 1: Cohorts D1 + D2: BIIB105 120 mg	1052.70	± 99.57

Day 85

Group	Value	95% CI
Part 1: Cohort A: BIIB105 5 mg	31.43	± 117.43
Part 1: Cohort B: BIIB105 20 mg	168.38	± 59.96
Part 1: Cohorts C1+C2: BIIB105 60 mg	476.91	± 75.87
Part 1: Cohorts D1 + D2: BIIB105 120 mg	1009.44	± 84.68

Day 113

Group	Value	95% CI
Part 1: Cohorts D1 + D2: BIIB105 120 mg	949.58	± 83.69

Day 141

Group	Value	95% CI
Part 1: Cohorts D1 + D2: BIIB105 120 mg	1243.75	± 91.13

Day 169

Group	Value	95% CI
Part 1: Cohorts D1 + D2: BIIB105 120 mg	957.24	± 86.51

Part 1: Time to Reach Maximum Observed Serum Concentration (Tmax) Secondary · Days 1, 15, 29, 57, 85, 113, 141 and 169

Day 1

Group	Value	95% CI
Part 1: Cohort A: BIIB105 5 mg	4.2	2 – 6
Part 1: Cohort B: BIIB105 20 mg	4.2	2 – 6
Part 1: Cohorts C1+C2: BIIB105 60 mg	5.8	2 – 23
Part 1: Cohorts D1 + D2: BIIB105 120 mg	4.3	1 – 24

Day 15

Group	Value	95% CI
Part 1: Cohort A: BIIB105 5 mg	5.0	4 – 6
Part 1: Cohort B: BIIB105 20 mg	5.0	2 – 6
Part 1: Cohorts C1+C2: BIIB105 60 mg	5.9	2 – 6
Part 1: Cohorts D1 + D2: BIIB105 120 mg	4.1	1 – 6

Day 29

Group	Value	95% CI
Part 1: Cohort A: BIIB105 5 mg	5.8	4 – 6
Part 1: Cohort B: BIIB105 20 mg	5.8	2 – 6
Part 1: Cohorts C1+C2: BIIB105 60 mg	4.2	2 – 6
Part 1: Cohorts D1 + D2: BIIB105 120 mg	4.1	2 – 6

Day 57

Group	Value	95% CI
Part 1: Cohort A: BIIB105 5 mg	5.8	2 – 6
Part 1: Cohort B: BIIB105 20 mg	5.0	4 – 6
Part 1: Cohorts C1+C2: BIIB105 60 mg	4.2	1 – 6
Part 1: Cohorts D1 + D2: BIIB105 120 mg	4.5	1 – 6

Day 85

Group	Value	95% CI
Part 1: Cohort A: BIIB105 5 mg	5.1	4 – 6
Part 1: Cohort B: BIIB105 20 mg	4.3	4 – 6
Part 1: Cohorts C1+C2: BIIB105 60 mg	5.8	4 – 6
Part 1: Cohorts D1 + D2: BIIB105 120 mg	5.8	2 – 6

Day 113

Group	Value	95% CI
Part 1: Cohorts D1 + D2: BIIB105 120 mg	5.3	1 – 6

Day 141

Group	Value	95% CI
Part 1: Cohorts D1 + D2: BIIB105 120 mg	4.0	1 – 6

Day 169

Group	Value	95% CI
Part 1: Cohorts D1 + D2: BIIB105 120 mg	4.1	1 – 6

Part 1: Elimination Half-Life (t1/2) in Serum Secondary · Day 1

Elimination half-life (t1/2) was reported following dose 1 as planned.

Group	Value	95% CI
Part 1: Cohort A: BIIB105 5 mg	14.0	5 – 23
Part 1: Cohort B: BIIB105 20 mg	26.6	17 – 62
Part 1: Cohorts C1+C2: BIIB105 60 mg	41.7	33 – 62
Part 1: Cohorts D1 + D2: BIIB105 120 mg	39.8	22 – 82

Part 1: Neurofilament Light Chain (NfL) Plasma Concentration Ratio to Baseline Secondary · Days 29, 57, 85, 113, 130 (For cohorts A, B, C1 and C2)/141 (For cohorts D1 and D2), 169 (For cohorts A, B, C1 and C2)/175 (For cohorts D1 and D2) and 241

Plasma NfL ratio to baseline was reported in terms of geometric mean ratio.

Day 29

Group	Value	95% CI
Part 1: Pooled Placebo 1+2	1.04	± 20.32
Part 1: Cohort A: BIIB105 5 mg	1.05	± 8.47
Part 1: Cohort B: BIIB105 20 mg	0.83	± 47.1
Part 1: Cohorts C1+C2: BIIB105 60 mg	1.06	± 11.23
Part 1: Cohorts D1 + D2: BIIB105 120 mg	1.15	± 72.72

Day 57

Group	Value	95% CI
Part 1: Pooled Placebo 1+2	1.08	± 19.91
Part 1: Cohort A: BIIB105 5 mg	0.95	± 14.63
Part 1: Cohort B: BIIB105 20 mg	0.97	± 15.95
Part 1: Cohorts C1+C2: BIIB105 60 mg	1.08	± 20.43
Part 1: Cohorts D1 + D2: BIIB105 120 mg	1.03	± 21.7

Day 85

Group	Value	95% CI
Part 1: Pooled Placebo 1+2	0.99	± 17.27
Part 1: Cohort A: BIIB105 5 mg	0.99	± 15.7
Part 1: Cohort B: BIIB105 20 mg	0.98	± 26.4
Part 1: Cohorts C1+C2: BIIB105 60 mg	1.11	± 19.85
Part 1: Cohorts D1 + D2: BIIB105 120 mg	0.99	± 19.62

Day 113

Group	Value	95% CI
Part 1: Pooled Placebo 1+2	1.06	± 19.95
Part 1: Cohorts D1 + D2: BIIB105 120 mg	1.01	± 21.77

Day 130 (A,B,C1,C2)/Day 141 (D1,D2)

Group	Value	95% CI
Part 1: Pooled Placebo 1+2	1.09	± 20.46
Part 1: Cohort A: BIIB105 5 mg	1.10	± 8.58
Part 1: Cohort B: BIIB105 20 mg	0.92	± 40.79
Part 1: Cohorts C1+C2: BIIB105 60 mg	0.99	± 30.8
Part 1: Cohorts D1 + D2: BIIB105 120 mg	1.03	± 41.35

Day 169 (A,B,C1,C2)/Day 175 (D1,D2)

Group	Value	95% CI
Part 1: Pooled Placebo 1+2	1.10	± 23.67
Part 1: Cohort A: BIIB105 5 mg	1.02	± 22.58
Part 1: Cohort B: BIIB105 20 mg	1.10	± 24.55
Part 1: Cohorts C1+C2: BIIB105 60 mg	1.08	± 29.73
Part 1: Cohorts D1 + D2: BIIB105 120 mg	1.06	± 24.92

Day 214

Group	Value	95% CI
Part 1: Cohorts D1 + D2: BIIB105 120 mg	1.07

Integrated Part 1 and Part 2: CSF PK Concentration of BIIB105 Secondary · Predose on Days 1,15,29,57,85 and on Days 1,15,29,57,85,113,141,169.176,197,210,225,253,281,309,337,365,393,420,448,476,504,532,560,588,616,644,672,700,726,728

Day 1 : Pre-dose

Group	Value	95% CI
Early-start BIIB105 120 mg	0.13	± 0.00

Day 1

Group	Value	95% CI
Placebo/Delayed-start BIIB105 120 mg	0.15	± 37.88

Day 15 : Pre-dose

Group	Value	95% CI
Early-start BIIB105 120 mg	14.54	± 82.48

Day 15

Group	Value	95% CI
Early-start BIIB105 120 mg	31.04
Placebo/Delayed-start BIIB105 120 mg	12.93	± 70.31

Day 29: Pre-dose

Group	Value	95% CI
Early-start BIIB105 120 mg	17.53	± 95.18

Day 29

Group	Value	95% CI
Placebo/Delayed-start BIIB105 120 mg	18.62	± 93.41

Day 57 : Pre-dose

Group	Value	95% CI
Early-start BIIB105 120 mg	10.29	± 79.90

Day 57

Group	Value	95% CI
Placebo/Delayed-start BIIB105 120 mg	9.72	± 49.08

Integrated Part 1 and Part 2: Serum Concentration of BIIB105 Secondary · Up to Day 176

Group	Value	95% CI
Early-start BIIB105 120 mg	NA	± NA
Placebo/Delayed-start BIIB105 120 mg	NA	± NA

Adverse events — posted to ClinicalTrials.gov

Time frame: From first dose of the study drug up to end of follow up period in Part 1 (up to Day 260) and Part 2 (up to Day 1184). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Part 1: Pooled Placebo 1+2

Serious: 5/28 (18%)

Deaths: 0/28

Part 1: Cohort A: BIIB105 5 mg

Serious: 0/6 (0%)

Deaths: 0/6

Part 1: Cohort B: BIIB105 20 mg

Serious: 0/6 (0%)

Deaths: 0/6

Part 1: Cohorts C1+C2: BIIB105 60 mg

Serious: 1/11 (9%)

Deaths: 0/11

Part 1: Cohorts D1 + D2: BIIB105 120 mg

Serious: 7/48 (15%)

Deaths: 0/48

Part 2: BIIB105 60 mg

Serious: 7/19 (37%)

Deaths: 4/19

Part 2: BIIB105 120 mg

Serious: 14/51 (27%)

Deaths: 2/51

Serious adverse events (33 terms)

Reaction	System	Part 1: Pooled Placebo 1+2	Part 1: Cohort A: BIIB105 …	Part 1: Cohort B: BIIB105 …	Part 1: Cohorts C1+C2: BII…	Part 1: Cohorts D1 + D2: B…	Part 2: BIIB105 60 mg	Part 2: BIIB105 120 mg
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—
Fall	Injury, poisoning and procedural complications	—	—	—	—	—	—	—
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—
Respiratory failure	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—
Dysphagia	Gastrointestinal disorders	—	—	—	—	—	—	—
Food poisoning	Gastrointestinal disorders	—	—	—	—	—	—	—
Ileus	Gastrointestinal disorders	—	—	—	—	—	—	—
Cholecystitis acute	Hepatobiliary disorders	—	—	—	—	—	—	—
Covid-19	Infections and infestations	—	—	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—	—	—
Pneumonia aspiration	Infections and infestations	—	—	—	—	—	—	—
Pulmonary sepsis	Infections and infestations	—	—	—	—	—	—	—
Sepsis	Infections and infestations	—	—	—	—	—	—	—
Urosepsis	Infections and infestations	—	—	—	—	—	—	—
Craniofacial fracture	Injury, poisoning and procedural complications	—	—	—	—	—	—	—
Humerus fracture	Injury, poisoning and procedural complications	—	—	—	—	—	—	—
Jaw fracture	Injury, poisoning and procedural complications	—	—	—	—	—	—	—
Procedural pain	Injury, poisoning and procedural complications	—	—	—	—	—	—	—
Subdural haematoma	Injury, poisoning and procedural complications	—	—	—	—	—	—	—
Tendon rupture	Injury, poisoning and procedural complications	—	—	—	—	—	—	—
Dehydration	Metabolism and nutrition disorders	—	—	—	—	—	—	—
Malnutrition	Metabolism and nutrition disorders	—	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—
Seronegative arthritis	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—

Other adverse events (154 terms — click to expand)

Reaction	System	Part 1: Pooled Placebo 1+2	Part 1: Cohort A: BIIB105 …	Part 1: Cohort B: BIIB105 …	Part 1: Cohorts C1+C2: BII…	Part 1: Cohorts D1 + D2: B…	Part 2: BIIB105 60 mg	Part 2: BIIB105 120 mg
Headache	Nervous system disorders	—	—	—	—	—	—	—
Procedural pain	Injury, poisoning and procedural complications	—	—	—	—	—	—	—
Fall	Injury, poisoning and procedural complications	—	—	—	—	—	—	—
Post lumbar puncture syndrome	Injury, poisoning and procedural complications	—	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—
Csf protein increased	Investigations	—	—	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—
Muscular weakness	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—
Csf white blood cell count increased	Investigations	—	—	—	—	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—
Covid-19	Infections and infestations	—	—	—	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—	—	—	—
Weight decreased	Investigations	—	—	—	—	—	—	—
Muscle spasms	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—
Balance disorder	Nervous system disorders	—	—	—	—	—	—	—
Pleocytosis	Nervous system disorders	—	—	—	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—
Asthenia	General disorders	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—
Contusion	Injury, poisoning and procedural complications	—	—	—	—	—	—	—
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—
Urinary retention	Renal and urinary disorders	—	—	—	—	—	—	—
Chills	General disorders	—	—	—	—	—	—	—
Influenza	Infections and infestations	—	—	—	—	—	—	—
Paraesthesia	Nervous system disorders	—	—	—	—	—	—	—
Anxiety	Psychiatric disorders	—	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—
Peripheral swelling	General disorders	—	—	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—	—	—
Bone contusion	Injury, poisoning and procedural complications	—	—	—	—	—	—	—
Skin abrasion	Injury, poisoning and procedural complications	—	—	—	—	—	—	—
Skin laceration	Injury, poisoning and procedural complications	—	—	—	—	—	—	—
Neck pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—

Most-reported serious reactions: Dyspnoea, Fall, Acute respiratory failure, Respiratory failure, Dysphagia, Food poisoning, Ileus, Cholecystitis acute.

Data from ClinicalTrials.gov NCT04494256 adverse events section.

Sponsor's own description

The ALSpire Study is a clinical trial evaluating the investigational drug BIIB105 in adults living with amyotrophic lateral sclerosis (ALS). The ALSpire Study consists of two parts: * Part 1: 6-month placebo-controlled study. During Part 1, participants are randomly assigned to receive either BIIB105 or placebo in a 3:1 or 2:1 ratio (depending on the participant's assigned Cohort). * Part 2: up to 3-year long-term open-label extension. During Part 2, all participants receive BIIB105. The objectives of the study are to evaluate: * The safety and tolerability of BIIB105 in people with ALS * What the body does to BIIB105 (also called "pharmacokinetics") * What BIIB105 does to the body (also called "pharmacodynamics") * Whether BIIB105 can slow the worsening of clinical function

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Amyotrophic lateral sclerosis: a neurodegenerative disorder poised for successful therapeutic translation.
Mead RJ, Shan N, Reiser HJ, Marshall F, et al · · 2023 · cited 323× · PMID 36543887 · DOI 10.1038/s41573-022-00612-2
Emerging insights into the complex genetics and pathophysiology of amyotrophic lateral sclerosis.
Goutman SA, Hardiman O, Al-Chalabi A, Chió A, et al · · 2022 · cited 304× · PMID 35334234 · DOI 10.1016/s1474-4422(21)00414-2
Amyotrophic lateral sclerosis: translating genetic discoveries into therapies.
Akçimen F, Lopez ER, Landers JE, Nath A, et al · · 2023 · cited 162× · PMID 37024676 · DOI 10.1038/s41576-023-00592-y
Gene therapy for ALS: A review.
Amado DA, Davidson BL. · · 2021 · cited 132× · PMID 33839324 · DOI 10.1016/j.ymthe.2021.04.008
Genetics of amyotrophic lateral sclerosis: seeking therapeutic targets in the era of gene therapy.
Suzuki N, Nishiyama A, Warita H, Aoki M. · · 2023 · cited 93× · PMID 35691950 · DOI 10.1038/s10038-022-01055-8
Current State and Future Directions in the Therapy of ALS.
Tzeplaeff L, Wilfling S, Requardt MV, Herdick M. · · 2023 · cited 87× · PMID 37296644 · DOI 10.3390/cells12111523
Antisense Oligonucleotides for the Study and Treatment of ALS.
Boros BD, Schoch KM, Kreple CJ, Miller TM. · · 2022 · cited 81× · PMID 35653060 · DOI 10.1007/s13311-022-01247-2
Landscape of small nucleic acid therapeutics: moving from the bench to the clinic as next-generation medicines.
Liu M, Wang Y, Zhang Y, Hu D, et al · · 2025 · cited 62× · PMID 40059188 · DOI 10.1038/s41392-024-02112-8

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04494256 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Biogen
Last refreshed: 9 October 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04494256.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT04494256: ALSpire

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (33 terms)

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Amyotrophic Lateral Sclerosis

Other Biogen trials

Verify against primary sources