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 ALS

Study Purpose:

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

Disease:

Amyotrophic Lateral Sclerosis (ALS),  Familial ALS,  Sporadic ALS

Study Type:

Interventional Trial

Study Category:

Drug Trial

Study Status:

Enrolling

Phase:

Phase III

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

Clinicaltrials.gov ID (11 digit #):

NCT04248465

Neals Affiliated?

No

Coordinating Center Contact Information


Alexion Pharmaceuticals Inc. / .(JavaScript must be enabled to view this email address) / 855-752-2356
.(JavaScript must be enabled to view this email address)

Full Study Summary:

Study Sponsor:

Alexion Pharmaceuticals

Participant Duration:

Estimated Enrollment:

354

Estimated Study Start Date:

03/31/2020

Estimated Study Completion Date:

10/31/2024

Posting Last Modified Date:

05/13/2020

Date Study Added to alsconsortium.org:

02/03/2020
  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    18

    Maximum Age:

    N/A

    Min Vital Capacity (% predicted normal):

    65

    Time since Symptom Onset:

    <36 months

    Time since Diagnosis:

    Can participants use Riluzole?

    Yes


    Inclusion Criteria:

    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.

    Exclusion Criteria:

    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.

  • Site Contact Information

    Las Vegas Clinic
    Las Vegas, Nevada 89145
    United States

    Austin Neuromuscular Center
    Austin, Texas 78756
    United States