An Efficacy and Safety Study of Ravulizumab in ALS Participants

  • STATUS
    Recruiting
  • participants needed
    354
  • sponsor
    Alexion Pharmaceuticals
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Updated on 19 February 2024
See if I qualify
vaccination
riluzole
edaravone
ravulizumab

Summary

The purpose of the study is to assess the efficacy and safety of ravulizumab for the treatment of adult participants with ALS.

Details
Condition Myelopathy, Amyotrophic Lateral Sclerosis, Antilymphocyte Serum
Age 18years - 100years
Treatment Placebo, Ravulizumab
Clinical Study IdentifierNCT04248465
SponsorAlexion Pharmaceuticals
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

A diagnosis of sporadic or familial ALS, defined by the El Escorial criteria (possible, laboratory-supported probable, probable, or definite ALS)
ALS onset 36 months from Screening
Documented meningococcal vaccination not more than 3 years prior to, or at the time of, initiating study treatment
Upright slow vital capacity 65% predicted at Screening
If on riluzole, participant must be on a stable dose for 30 days; if on edaravone, participant must be on a stable dose for 60 days (2 cycles)
Body weight 40 kilograms at Screening
Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies

Exclusion Criteria

History of Neisseria meningitidis infection
Human immunodeficiency virus (HIV) infection (evidenced by HIV 1 or HIV 2 antibody titer)
Dependence on invasive or non-invasive mechanical ventilation
Previously or currently treated with a complement inhibitor
Exposure to an investigational drug or device within 30 days of Screening or 5 half lives of the study drug, whichever is greater
Clear my responses
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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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