Overview

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

Status:
Recruiting

Trial end date:
2023-05-01

Target enrollment:
0

Participant gender:
All

Summary

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

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Annexon, Inc.

Collaborator:

Worldwide Clinical Trials

Criteria

Inclusion Criteria:

1. Diagnosis of ALS according to the World Federation of Neurology revised E1 Escorial
criteria.

2. Onset of weakness within 3 years prior to enrollment.

3. Slow Vital Capacity ≥ 60% of predicted normal adjusted for sex, age, and height (from
the sitting position).

4. ALSFRS-R ≥ 30 at the Screening Visit.

5. If female, must be postmenopausal, surgically sterilized, or agree to use highly
effective methods of contraception from screening through Week 24.

6. Males with a woman partner of childbearing potential must agree to use highly
effective methods of contraception from Screening through Week 24.

7. Documented history of vaccinations within 5 years prior to screening visit against
encapsulated bacterial pathogens.

Exclusion Criteria:

1. Clinically significant, ongoing illness or medical condition that would jeopardize the
safety of the subject, limit participation, or compromise the interpretation of the
safety data derived from the subject.

2. Subjects with body weight > 150 kg.

3. An ANA titer ≥ 1:160.

4. Clinically significant intercurrent illness, medical condition, or medical history
that would jeopardize the safety of the subject, limit participation, or compromise
the interpretation of the data derived from the subject.