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) United States

Full Study Summary:

Study Sponsor:

Alexion Pharmaceuticals

Participant Duration:

Estimated Enrollment:

354

Estimated Study Start Date:

03/30/2020

Estimated Study Completion Date:

10/31/2024

Posting Last Modified Date:

10/15/2020

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

    Barrow Neurological Institute
    Phoenix, Arizona 85013
    United States

    Neuromuscular Research Center and Clinic
    Phoenix, Arizona 85028
    United States

    HonorHealth Research Institute
    Scottsdale, Arizona 85251
    United States

    Loma Linda University Medical Center
    Loma Linda, California 92354
    United States

    University of Southern California
    Los Angeles, California 90033
    United States

    University of California-Irvine
    Orange, California 92868
    United States

    University of Colorado Anschutz Medical Campus School of Medicine
    Aurora, Colorado 80045
    United States

    University of South Florida
    Tampa, Florida 33612
    United States

    Indiana University Medical Center
    Indianapolis, Indiana 46202
    United States

    Johns Hopkins University School Of Medicine
    Baltimore, Maryland 21205
    United States

    Massachusetts General Hospital
    Boston, Massachusetts 02114
    United States

    Las Vegas Clinic
    Las Vegas, Nevada 89145
    United States

    Hospital for Special Surgery
    New York, New York 10021
    United States

    Atrium Health Neuroscience Institute
    Charlotte, North Carolina 28207
    United States

    The Cleveland Clinic Foundation
    Cleveland, Ohio 44195
    United States

    The Ohio State University
    Columbus, Ohio 43221
    United States

    Austin Neuromuscular Center
    Austin, Texas 78756
    United States

    Houston Methodist Neurological Institute
    Houston, Texas 77030
    United States

    Nerve & Muscle Center of Texas
    Houston, Texas 77030
    United States

    Sentara Neurology Specialists
    Virginia Beach, Virginia 23456
    United States

    Swedish Neuroscience Institute
    Seattle, Washington 98122
    United States

    Westmead Hospital
    Westmead, New South Wales
    Australia

    Royal Brisbane and Women's Hospital
    Herston, Queensland
    Australia

    Perron Institute for Neurological and Translational Science
    Nedlands, Western Australia
    Australia

    Stan Cassidy Center for Rehabilitation
    Fredericton, New Brunswick
    Canada

    Montreal Neurological Institute and Hospital
    Montreal, Quebec
    Canada

    Royal University Hospital
    Saskatoon, Saskatchewan
    Canada

    Bispebjerg Hospital
    Copenhagen,
    Denmark

    CHU de Nice Hôpital Pasteur 2
    Nice Cedex 1,, Alpes Maritimes
    France

    CHU de Limoges - Hôpital Dupuytren
    Limoges cedex, Haute Vienne
    France

    Hopital Gui de Chauliac
    Montpellier, Herault
    France

    CHU Tours - Hôpital Bretonneau
    Tours Cedex 9, Indre Et Loire
    France

    Hopital Neurologique Pierre Wertheimer
    Bron cedex, Rhone
    France

    ICS Maugeri IRCCS
    Milano,
    Italy

    Istituto Auxologico Italiano
    Milano,
    Italy

    Chiba University Hospital
    Chiba-shi, Chiba-Ken
    Japan

    Yoshino Neurology Clinic
    Ichikawa-shi, Chiba-Ken
    Japan

    Niigata University Medical & Dental Hospital
    Niigata-shi, Niigata-Ken
    Japan

    Shiga University of Medical Science Hospital
    Ōtsu, Shiga-Ken
    Japan

    Tokushima University Hospital
    Tokushima-shi, Tokushima-Ken
    Japan

    Medical Hospital, Tokyo Medical and Dental University
    Bunkyo-ku, Tokyo-To,
    Japan

    University Medical Centre Utrecht
    Utrecht,
    Netherlands

    Hospital Universitari de Bellvitge
    L'Hospitalet De Llobregat, Barcelona,
    Spain

    Hospital San Rafael
    Madrid,
    Spain

    Hospital Universitari i Politecnic La Fe
    Valencia,
    Spain

    Karolinska Trial Alliance (KTA)
    Huddinge,
    Sweden

    Norrlands universitetssjukhus
    Umeå,
    Sweden

    Kantonsspital St. Gallen
    Saint Gallen,
    Switzerland

    The National Hospital for Neurology & Neurosurgery
    London, Greater London
    United Kingdom