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ALT001 in Amyotrophic Lateral Sclerosis
NCT07833618Phase 2
Key facts
- Status
- Not yet recruiting
- Start
- Sep 2026
- Primary completion
- Jan 2028
- Countries
- 1
- Sponsor
- Darwin Biotechnology
- Drugs
- ALT001
- Conditions
- amyotrophic lateral sclerosis (ALS)
01
Overview
Phase 2, randomised, double-blind trial of ALT001 in amyotrophic lateral sclerosis (ALS) (3 arms), sponsored by Darwin Biotechnology. Primary endpoint: Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised total score at 24 weeks. Planned start Sep 2026; status: not yet recruiting.
02
Design
3 arms- Study design
- RandomizedDouble-blind
ALT001 1.0 μg/kg
ALT001 1.0 μg/kg administered by intravenous infusion
ALT001 2.0 μg/kg
ALT001 2.0 μg/kg administered by intravenous infusion
Placebo
Matching placebo administered by intravenous infusion
03
Who it enrols
Adults aged 18-75 with definite or probable ALS, FVC >= 50%, and ALSFRS-R score 30-40. Excludes patients with other motor neuron diseases, cognitive impairment, dependence on ventilation, or recent stem cell/gene therapies.
04
Endpoints
Primary
Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised total score
Secondary
Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised slope
Combined Assessment of Function and Survival
Ventilator-free survival
Forced vital capacity / slow vital capacity percent predicted
Concentration of cytokines in serum
Amyotrophic Lateral Sclerosis Assessment Questionnaire-40 total score
Rasch-Built Overall Amyotrophic Lateral Sclerosis Disability Scale total score
Modified Ashworth scale score
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