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 Identifier	NCT04248465
Sponsor	Alexion Pharmaceuticals
Last Modified on	19 February 2024

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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

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Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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Step 3 Enroll in the clinical study

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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Step 4 Get your study results

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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An Efficacy and Safety Study of Ravulizumab in ALS Participants