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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05053035
Other study ID # AL001-ALS-201
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date September 2, 2021
Est. completion date October 28, 2022

Study information

Verified date June 2023
Source Alector Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A phase 2 double-blind, placebo-controlled study of AL001 in participants with C9orf72-associated ALS.


Description:

This is a phase 2 double-blind, placebo-controlled trial to test the safety, tolerability, pharmacokinetics, and pharmacodynamics of AL001 in participants with C9orf72-associated Amyotrophic Lateral Sclerosis.


Recruitment information / eligibility

Status Terminated
Enrollment 5
Est. completion date October 28, 2022
Est. primary completion date October 28, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Confirmation of C9orf72 mutation - Diagnosis of ALS by revised El Escorial criteria - Time since onset of muscle weakness due to ALS =36 months at the time of the Screening Visit - Slow Vital Capacity (VC) =50% of predicted capacity at the time of the Screening Visit - If taking riluzole, must be on a stable dose of riluzole for at least 30 days prior to the Screening Visit. Riluzole naive participants are allowed. - If taking edaravone, must have completed at least one cycle of edaravone prior to the Screening Visit and plan to continue edaravone during the study. Edaravone naive participants are allowed. - Females must not be pregnant, breastfeeding or planning to conceive within the study period. Males must agree to use acceptable contraception - Capable of providing informed consent at the Screening visit and complying with study procedures throughout the study Exclusion Criteria: - Clinically significant, unstable, medical condition (other than ALS) - Clinically significant heart disease, liver disease or kidney disease - Cognitive impairment or dementia - Current uncontrolled hypertension - History of unresolved cancer - Any experimental gene therapy - Any experimental vaccine (any vaccine against COVID-19 either approved or administered under an Emergency Use Authorization is allowed)

Study Design


Intervention

Drug:
AL001
Administered via intravenous (IV) infusion
Placebo
Administered via intravenous (IV) infusion

Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts
United States Washington University School of Medicine Saint Louis Missouri
United States University of South Florida Tampa Florida

Sponsors (1)

Lead Sponsor Collaborator
Alector Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluation of safety and tolerability of AL001 measured by number of subjects with adverse events Incidence of adverse events during the study treatment period 32 weeks
Primary Pharmacokinetics (PK) of AL001 Concentration of AL001 at specified time points 32 weeks
Primary Maximum plasma concentration (Cmax) for AL001 Evaluate Cmax for concentration of AL001 at specified time points 32 weeks
Primary Area under the curve concentration (AUC) for AL001 Evaluate AUC for concentration of AL001 at specified time points 32 weeks
Primary Change from baseline in serum progranulin Evaluate serum progranulin levels at pre-specified timepoints 32 weeks
Primary Change from baseline in CSF progranulin Evaluate CSF progranulin levels at pre-specified timepoints 32 weeks
Secondary Change from baseline in plasma neurofilament light chain Evaluate plasma neurofilament light chain levels at pre-specified timepoints 32 weeks
Secondary Change from baseline in CSF neurofilament light chain Evaluate CSF neurofilament light chain levels at pre-specified timepoints 32 weeks
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