A Phase 2a Safety, Tolerability, Pharmacokinetic (PK), and Pharmacodynamic (PD) Study of Intravenous ANX005 in Subjects With Amyotrophic Lateral Sclerosis (ALS)

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Study Purpose:

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

Study Status:

Recruiting

Disease:

Amyotrophic Lateral Sclerosis

Study Type:

Interventional

Type of Intervention:

Drug

Intervention Name:

ANX005

Placebo:

Phase:

Phase 2

Study Chair(s)/Principal Investigator(s):

Benjamin Hoehn, MD, PhD, Annexon, Inc.

Clinicaltrials.gov ID:

NCT04569435

Neals Affiliated?

Coordinating Center Contact Information

Study Coordinator / email hidden; JavaScript is required / 650-822-5500

United States

Full Study Summary:

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.

Study Sponsor:

Annexon, Inc.

Estimated Enrollment:

Estimated Study Start Date:

01 / 15 / 2021

Estimated Study Completion Date:

05 / 31 / 2023

Posting Last Modified Date:

07 / 07 / 2022

Date Study Added to neals.org:

09 / 29 / 2020

Minimum Age:

18 Years

Maximum Age:

N/A

Can participants use Riluzole?

Yes

Key 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 agree to use highly effective methods of contraception from Screening through Week 36.

- Males with a woman partner of childbearing potential must agree to use highly effective methods of contraception from Screening through Week 36.

- Documented history of vaccinations within 5 years prior to Screening visit against encapsulated bacterial pathogens or willing to undergo vaccinations.

Key Exclusion Criteria:

- Clinically significant, ongoing or intercurrent illness, medical condition, or medical history that would jeopardize the safety of the participant, limit participation, or compromise the interpretation of the safety 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.

Annexon Investigational Site 04 | Recruiting