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 ALSStudy Type:
Interventional TrialStudy Category:
Drug TrialStudy Status:
Not enrollingPhase:
Phase IIIStudy Chair(s)/Principal Investigator(s):
Clinicaltrials.gov ID (11 digit #):
NCT04248465Neals Affiliated?
NoCoordinating 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 PharmaceuticalsParticipant Duration:
Estimated Enrollment:
382Estimated Study Start Date:
03/30/2020Estimated Study Completion Date:
03/31/2024Posting Last Modified Date:
03/19/2021Date Study Added to alsconsortium.org:
02/03/2020-
Eligibility Criteria
Time since Symptom Onset:
<36 monthsTime since Diagnosis:
Can participants use Riluzole?
Yes
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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Site Contact Information
Barrow Neurological Institute
Phoenix, Arizona 85013
United StatesNeuromuscular Research Center and Clinic
Phoenix, Arizona 85028
United StatesHonorHealth Research Institute
Scottsdale, Arizona 85251
United StatesLoma Linda University Medical Center
Loma Linda, California 92354
United StatesUniversity of Southern California
Los Angeles, California 90033
United StatesUniversity of California-Irvine
Orange, California 92868
United StatesStanford University Medical Center
Palo Alto, California 94304
United StatesUniversity of California San Diego Medical Center
San Diego, California 92093
United StatesNorris MDA/ALS Center
San Francisco, California 94115
United StatesUniversity of California San Francisco Medical Center
San Francisco, California 94143
United StatesUniversity of Colorado Anschutz Medical Campus School of Medicine
Aurora, Colorado 80045
United StatesUniversity of Florida at Shands Jacksonville
Jacksonville, Florida 32209
United StatesUniversity of South Florida
Tampa, Florida 33612
United StatesUniversity of Chicago Medical Center
Chicago, Illinois 60637
United StatesIndiana University Medical Center
Indianapolis, Indiana 46202
United StatesUniversity of Kansas Medical Center
Kansas City, Kansas 66160
United StatesUniversity of Kentucky
Lexington, Kentucky 40536
United StatesJohns Hopkins University School Of Medicine
Baltimore, Maryland 21205
United StatesMassachusetts General Hospital
Boston, Massachusetts 02114
United StatesLas Vegas Clinic
Las Vegas, Nevada 89145
United StatesBeth Israel Medical Center
New York, New York 10003
United StatesHospital for Special Surgery
New York, New York 10021
United StatesAtrium Health Neuroscience Institute
Charlotte, North Carolina 28207
United StatesThe Cleveland Clinic Foundation
Cleveland, Ohio 44195
United StatesThe Ohio State University
Columbus, Ohio 43221
United StatesAllegheny Neurological Associates
Pittsburgh, Pennsylvania 15212
United StatesVanderbilt University Medical Center
Nashville, Tennessee 37232
United StatesAustin Neuromuscular Center
Austin, Texas 78756
United StatesHouston Methodist Neurological Institute
Houston, Texas 77030
United StatesNerve & Muscle Center of Texas
Houston, Texas 77030
United StatesUniversity of Vermont Medical Center
Burlington, Vermont 05401
United StatesSentara Neurology Specialists
Virginia Beach, Virginia 23456
United StatesSwedish Neuroscience Institute
Seattle, Washington 98122
United StatesWestmead Hospital
Westmead, New South Wales
AustraliaRoyal Brisbane and Women's Hospital
Herston, Queensland
AustraliaPerron Institute for Neurological and Translational Science
Nedlands, Western Australia
AustraliaHeritage Medical Research Centre (HMRC)
Edmonton, Alberta
CanadaStan Cassidy Center for Rehabilitation
Fredericton, New Brunswick
CanadaLHSC - University Hospital
London, Ontario
CanadaMontreal Neurological Institute and Hospital
Montreal, Quebec
CanadaUniversity Hospital of Quebec-Universite Laval
Québec, Quebec
CanadaRoyal University Hospital
Saskatoon, Saskatchewan
CanadaÅlborg Universitets Hospital
Aalborg,
DenmarkAarhus University Hospital Department of Neurology
Aarhus,
DenmarkBispebjerg Hospital
Copenhagen,
DenmarkHopital Roger Salengro - CHU Lille
Lille,
FranceHôpital de la Timone
Marseille,
FranceCHU de Nice Hôpital Pasteur 2
Nice Cedex 1,, Alpes Maritimes
FranceCHU de Limoges - Hôpital Dupuytren
Limoges cedex, Haute Vienne
FranceHopital Gui de Chauliac
Montpellier, Herault
FranceCHU Tours - Hôpital Bretonneau
Tours Cedex 9, Indre Et Loire
FranceHopital Neurologique Pierre Wertheimer
Bron cedex, Rhone
FranceUniversitaetsmedizin Goettingen
Goettigen, Niedersachsen
GermanyICS Maugeri IRCCS
Milano,
ItalyIstituto Auxologico Italiano
Milano,
ItalyOspedale San Raffaele
Milano,
ItalyAzienda Ospedaliero-Universitaria di Modena
Modena,
ItalyAzienda Ospedaliero Universitaria Policlinico Paolo Giaccone
Palermo,
ItalyAzienda Ospedaliero Universitaria Pisana
Pisa,
ItalyUniversity of Turin
Torino,
ItalyNagoya University Hospital
Nagoya-shi, Aichi-Ken
JapanChiba University Hospital
Chiba-shi, Chiba-Ken
JapanYoshino Neurology Clinic
Ichikawa-shi, Chiba-Ken
JapanTohoku University Hospital
Sendai-shi, Miyagi-Ken
JapanNiigata University Medical & Dental Hospital
Niigata-shi, Niigata-Ken
JapanShiga University of Medical Science Hospital
Ōtsu, Shiga-Ken
JapanTokushima University Hospital
Tokushima-shi, Tokushima-Ken
JapanKeio University Hospital
Shinjuku-Ku, Tokyo-To
JapanMedical Hospital, Tokyo Medical and Dental University
Bunkyo-ku, Tokyo-To,
JapanUniversity Medical Centre Utrecht
Utrecht,
NetherlandsCityClinic
Warszawa,
PolandHospital Universitari Vall d'Hebron
Barcelona,
SpainHospital de la Santa Creu i Sant Pau
Barcelona,
SpainHospital Universitari de Bellvitge
L'Hospitalet De Llobregat, Barcelona,
SpainHospital San Rafael
Madrid,
SpainHospital Universitari i Politecnic La Fe
Valencia,
SpainKarolinska Trial Alliance (KTA)
Huddinge,
SwedenNorrlands universitetssjukhus
Umeå,
SwedenKantonsspital St. Gallen
Saint Gallen,
SwitzerlandThe National Hospital for Neurology & Neurosurgery
London, Greater London
United Kingdom