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NCT07833618

A Phase II Study of ALT001 in Patients With Amyotrophic Lateral Sclerosis (ALS)

StatusNot Yet Recruiting
PhasePhase 2
Primary completion (estimated)
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Record History

All 1 version: 1 with changes below.

  1. Study First Submitted

Endpoints

Primary

Change from baseline in Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) total score
Timeframe: Baseline to Week 24 (Week0, Week 1, Week 5, Week 9, Week 13, Week 17, Week 21, Week 24 after randomization)

Secondary (21)

ALSFRS-R slope from baseline to Week 24 (double-blind period)
ALSFRS-R slope from baseline to Week 48 (overall study period)
ALSFRS-R slope from Week 25 to Week 48 (open-label extension period)
Assessment of Combined Assessment of Function and Survival (CAFS)
Assessment of ventilator-free survival (VAFS)
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Change from baseline in forced vital capacity (FVC) /slow vital capacity (SVC) percent predictedpercent predicted
Concentration of cytokines in serum (IFN-γ, IL-10, IL-13, IL-1β, IL-2, IL-4, IL-5, IL-6, GRO-α, TNF-α, IL-2)
Change from baseline in ALSAQ-40 total score
Change from baseline in ROADS total score
Change from baseline in modified Ashworth scale score
Change from baseline in grip strength (kg)
Change from baseline in muscle strength (MRC sum score)
Change from baseline in ALS Functional Staging System stage
Concentration of neurofilament light chain (NfL) in plasma
Concentration of TAR DNA-binding protein 43 (TDP-43) in plasma
Concentration of superoxide dismutase 1 (SOD1) in plasma
Concentration of immunoglobulins in serum (IgG, IgM, IgA)
Number and percentage of T-cell subsets in blood (CD3+CD4+, CD3+CD8+, CD28+, CD16+)
Plasma proteomics profile
Incidence of treatment-emergent anti-drug antibodies (ADA)
Incidence of adverse events (AEs) and serious adverse events (SAEs)

Arms and interventions

ALT001 1.0 μg/kgExperimental
ALT001 2.0 μg/kgExperimental
PlaceboPlacebo comparator

Drugs: ALT001 1.0 μg/kg, ALT001 2.0 μg/kg, Placebo

Sites

1 site in 1 country

  • Capital Medical University Affiliated Beijing Tiantan HospitalBeijing, Beijing Municipality, China