Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange, California and other locations
Dates
study started
estimated completion

Description

Summary

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

Official Title

A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Ravulizumab in Patients With Amyotrophic Lateral Sclerosis (ALS)

Keywords

Amyotrophic Lateral Sclerosis ALS Ravulizumab ALXN1210 Ultomiris Motor Neuron Disease Sclerosis

Eligibility

You can join if…

Open to people ages 18 years and up

  1. A diagnosis of sporadic or familial ALS, defined by the El Escorial criteria (possible, laboratory-supported probable, probable, or definite ALS).
  2. ALS onset ≤ 36 months from Screening.
  3. Documented meningococcal vaccination not more than 3 years prior to, or at the time of, initiating study treatment.
  4. Upright slow vital capacity ≥ 65% predicted at Screening.
  5. 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).
  6. Body weight ≥ 40 kilograms at Screening.
  7. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

You CAN'T join if...

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

Locations

  • University of California-Irvine accepting new patients
    Orange California 92868 United States
  • University of Southern California accepting new patients
    Los Angeles California 90033 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Alexion Pharmaceuticals
ID
NCT04248465
Phase
Phase 3
Study Type
Interventional
Last Updated