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

Full Study Summary:

• 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