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

  • STATUS
    Recruiting
  • End date
    May 31, 2023
  • participants needed
    24
  • sponsor
    Annexon, Inc.
Updated on 4 October 2022
weakness
primary lateral sclerosis

Summary

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

Description

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.

Details
Condition Amyotrophic Lateral Sclerosis
Treatment ANX005
Clinical Study IdentifierNCT04569435
SponsorAnnexon, Inc.
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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

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
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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