Study of ANX005 in Adults With Amyotrophic Lateral Sclerosis (ALS)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-15

Study Completion Date

2024-04-23

Brief Summary

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This study is a multi-center, open-label study of intravenous (IV) ANX005 in participants with ALS.

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Detailed Description

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In this Phase 2a, multi-center, open label, proof-of-biology study, ANX005 will be administered to participants with ALS.

The study consists of approximately 22 weeks of treatment and approximately 14 weeks of follow-up. All participants will be contacted by phone 6 months after study completion.

Conditions

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Amyotrophic Lateral Sclerosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ANX005

Participants will receive induction dosing of ANX005 on Days 1 and 5 or 6, followed by maintenance doses of ANX005 every 2 weeks up to Week 22.

Group Type EXPERIMENTAL

ANX005

Intervention Type DRUG

IV Infusion

Interventions

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ANX005

IV Infusion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of ALS according to the World Federation of Neurology revised EI Escorial criteria.
* Onset of weakness within 3 years prior to Day 1 visit.
* Slow Vital Capacity ≥ 50% of predicted normal adjusted for sex, age, and height (from the sitting position).
* ALS Functional Rating Scale-Revised (ALSFRS-R) ≥ 30 at the Screening visit (Week -2).
* If female, must be postmenopausal, surgically sterilized, or childbearing potential must agree to use highly effective methods of contraception from Screening until 3 months after the last infusion with study medication.
* Males with a woman partner of childbearing potential must agree to use highly effective methods of contraception from Screening until Week until 3 months after the last infusion with study medication.
* Documented history of vaccinations within 5 years prior to Screening visit against encapsulated bacterial pathogens or willing to undergo vaccinations.

Exclusion Criteria

* Clinically significant intercurrent illness, medical condition, or medical history that would jeopardize the safety of the participant, limit participation, or compromise the interpretation of the data derived from the participant.
* Participants with body weight \> 150 kilograms.
* Antinuclear antibodies (ANA) titer ≥ 1:160 (for either of the 2 ANA results a minimum of 2 weeks apart) during the Screening Period.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No