Safety, Tolerability, and Efficacy of Zilucoplan in Subjects With Generalized Myasthenia Gravis

Last updated: October 1, 2024
Sponsor: Ra Pharmaceuticals, Inc.
Overall Status: Completed

Phase

3

Condition

Sarcopenia

Polymyositis (Inflammatory Muscle Disease)

Neuropathy

Treatment

Placebo

zilucoplan (RA101495)

Clinical Study ID

NCT04115293
RA101495-02.301
  • Ages 18-74
  • All Genders

Study Summary

The RAISE study is a multicenter, randomized, double-blind, placebo controlled study to confirm the efficacy, safety, and tolerability of zilucoplan in subjects with generalized Myasthenia Gravis. Subjects will be randomized in a 1:1 ratio to receive daily SC doses of 0.3 mg/kg zilucoplan or placebo for 12 weeks.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of gMG [Myasthenia Gravis Foundation of America (MGFA) Class II-IV] atScreening

  • Positive serology for acetylcholine receptor (AChR) autoantibodies

  • MG-ADL Score of ≥ 6 at Screening and Baseline

  • QMG score ≥ 12 at Screening and Baseline

  • No change in corticosteroid dose for at least 30 days prior to Baseline oranticipated to occur during the 12-week Treatment Period

  • No change in immunosuppressive therapy, including dose, for at least 30 days priorto Baseline or anticipated to occur during the 12-week Treatment Period

Exclusion

Exclusion Criteria:

  • Thymectomy within 12 months prior to Baseline or scheduled to occur during the 12week Treatment Period

  • History of meningococcal disease

  • Current or recent systemic infection within 2 weeks prior to Baseline or injectionrequiring intravenous (IV) antibiotics within 4 weeks prior to Baseline

Study Design

Total Participants: 174
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
September 17, 2019
Estimated Completion Date:
December 30, 2021

Connect with a study center

  • Site 161: University of Calgary

    Calgary, Alberta AB T2N 1N4
    Canada

    Site Not Available

  • Site 44: London Health Sciences Centre University Hospital

    London, Ontario N6A 5A5
    Canada

    Site Not Available

  • Site 11: Montreal Neurological Institute and Hospital (McGill University)

    Montréal, Quebec H3A 2B4
    Canada

    Site Not Available

  • Site 191: Centre Hosptitalier Universitaire d'Angers

    Angers Cedex 9,
    France

    Site Not Available

  • Site 204: Centre Hospitalier Régional Universitaire de Lille

    Lille,
    France

    Site Not Available

  • Site 181: Hôpital Pierre Wertheimer

    Lyon,
    France

    Site Not Available

  • Site 118: Hôpital Pasteur

    Nice, 06000
    France

    Site Not Available

  • Site 105: Pitié-Salpêtrière University Hospital

    Paris, 75013
    France

    Site Not Available

  • Site 137: Les Hôpitaux Universitaires de Strasbourg

    Strasbourg, 67091
    France

    Site Not Available

  • Site 149: Universitätsklinikum Essen

    Essen, 45147
    Germany

    Site Not Available

  • Site 125: Universitätsklinikum Freiburg

    Freiburg, 79106
    Germany

    Site Not Available

  • Site 150: Universitätsmedizin Göttingen

    Göttingen, 37075
    Germany

    Site Not Available

  • Site 178: InnKlinikum - Haag i. OB

    Haag In Oberbayern,
    Germany

    Site Not Available

  • Site 145: Universitätsklinikum Halle

    Halle, 06120
    Germany

    Site Not Available

  • Site 157: Friedrich-Baur-Institut

    München, 80336
    Germany

    Site Not Available

  • Site 129: Universitätsklinikum Tübingen

    Tübingen, 72076
    Germany

    Site Not Available

  • Site 126: Fondazione IRCCS Istituto Neurologico Carlo Besta

    Milan, 20133
    Italy

    Site Not Available

  • Site 132: Università Cattolica del Sacro Cuore - Campus di Milano

    Roma, 20123
    Italy

    Site Not Available

  • Site 169: International University of Health and Welfare Narita Hospital

    Narita, Chiba 286-8520
    Japan

    Site Not Available

  • Site 151: Chiba University Hospital

    Chiba, 260-8677
    Japan

    Site Not Available

  • Site 136: General Hanamaki Hospital

    Iwata, 025-0075
    Japan

    Site Not Available

  • Site 179: Kagawa University Hospital - Collagen disease/Rheumatic int

    Kita-gun,
    Japan

    Site Not Available

  • Site 146: Nagasaki University Hospital

    Nagasaki, 852-8501
    Japan

    Site Not Available

  • Site 152: Hokkaido Medical Center

    Sapporo, 063-0005
    Japan

    Site Not Available

  • Site 144: Sendai Medical Center

    Sendai, 983-8520
    Japan

    Site Not Available

  • Site 141: Keio University Hospital

    Tokyo, 160-8582
    Japan

    Site Not Available

  • Site 153: Toho University Ohashi Medical Center

    Tokyo, 153-8515
    Japan

    Site Not Available

  • Site 163: Tokyo Medical University Hospital

    Tokyo, 160-0023
    Japan

    Site Not Available

  • Site 165: Osaka University Hospital

    Tokyo, 565-0871
    Japan

    Site Not Available

  • Site 140: Haukeland University Hospital / Health Bergen

    Bergen, 5021
    Norway

    Site Not Available

  • Site 143: Oslo Universitetssykehus

    Oslo, 0450
    Norway

    Site Not Available

  • Site 205: Prywatny Gabinet Lekarski Urszula Chyrchel-Paszkiewicz

    Lublin, Lubelskie 20-093
    Poland

    Site Not Available

  • Site 194: Twoja Przychodnia - Centrum Medyczne Nowa Sól

    Nowa Sól, Lubuskie 67-100
    Poland

    Site Not Available

  • Site 214: AmiCare Centrum Medyczne

    Łódź, Lódzkie 90-644
    Poland

    Site Not Available

  • Site 192: Krakowski Szpital Specjalistyczny im. Jana Pawła II

    Kraków, Malopolskie 31-202
    Poland

    Site Not Available

  • Site 201: Centrum Medyczne Pratia - Warszawa

    Warszawa, Mazowieckie 01-868
    Poland

    Site Not Available

  • Site 195: Wielospecjalistyczna Poradnia Lekarska Synapsis

    Katowice, Slaskie 40-123
    Poland

    Site Not Available

  • Site 213: Niepubliczny Zakład Opieki Zdrowotnej NOVO-MED

    Katowice, Slaskie 40-650
    Poland

    Site Not Available

  • Site 209: Niepubliczny Zakład Opieki Zdrowotnej NEURO - KARD

    Poznań, Wielkopolskie 61-853
    Poland

    Site Not Available

  • Site 193: Krakowska Akademia Neurologii - Centrum Neurologii Kliniczne

    Kraków,
    Poland

    Site Not Available

  • Site 211: Specjalistyczne Gabinety Sp. z o.o.

    Kraków,
    Poland

    Site Not Available

  • Site 210: Clinhouse Centrum Medyczne

    Lublin, 20-093
    Poland

    Site Not Available

  • Site 133: Hospital Universitari Vall d'Hebrón

    Barcelona, 08035
    Spain

    Site Not Available

  • Site 168: Hospital de la Santa Creu i Sant Pau

    Barcelona,
    Spain

    Site Not Available

  • Site 138: Hospital Universitario de Basurto

    Bilbao, 48013
    Spain

    Site Not Available

  • Site 168: Hospital de la Santa Creu i Sant Pau

    Madrid,
    Spain

    Site Not Available

  • Site 159: Hospital Vithas Nisa Sevilla Aljarafe

    Sevilla, 41950
    Spain

    Site Not Available

  • Site 119: Oxford University Hospitals NHS Foundation Trust

    Oxford, OX3 9DU
    United Kingdom

    Site Not Available

  • Site 130: Royal Hallamshire Hospital

    Sheffield, S10 2JF
    United Kingdom

    Site Not Available

  • Site 41: Diagnostic and Medical Clinic

    Mobile, Alabama 36604
    United States

    Site Not Available

  • Site 116: Neuromuscular Clinic and Research Center

    Phoenix, Arizona 85028
    United States

    Site Not Available

  • Site 4: University of Southern California

    Los Angeles, California 90033
    United States

    Site Not Available

  • Site 31: University of California Irvine

    Orange, California 92868
    United States

    Site Not Available

  • Site 220: Investigator Site

    Pasadena, California 91101
    United States

    Site Not Available

  • Site 160: Forbes Norris MDA/ALS Research and Treatment Center

    San Francisco, California 94115
    United States

    Site Not Available

  • Site 197: University of Colorado Hospital - Anschutz Medical Campus

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Site 24: Yale University

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Site 175: New England Institute for Neurology and Headache

    Stamford, Connecticut 06905
    United States

    Site Not Available

  • Site 27: George Washington University

    Washington, District of Columbia 20037
    United States

    Site Not Available

  • Site 29: University of Florida

    Jacksonville, Florida 32209
    United States

    Site Not Available

  • Site 189: Axcess Medical Research

    Loxahatchee Groves, Florida 33470
    United States

    Site Not Available

  • Site 182: Gelasio Baras Neurology

    Miami, Florida 33175
    United States

    Site Not Available

  • Site 25: University of South Florida

    Tampa, Florida 33612
    United States

    Site Not Available

  • Site 135: Augusta University Medical Center

    Augusta, Georgia 30912
    United States

    Site Not Available

  • Site 176: Hawaii Pacific Neuroscience

    Honolulu, Hawaii 96817
    United States

    Site Not Available

  • Site 188: North Shore Medical Group - Glenview

    Glenview, Illinois 60026-1339
    United States

    Site Not Available

  • Site 156: Indiana University Health Neuroscience Center

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Site 156: University of Kansas Medical Center

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • Site 32: Kansas University Medical Center Research Institute

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • Site 147: Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Site 221: Neurology Center of New England

    Foxboro, Massachusetts 02035
    United States

    Site Not Available

  • Site 33: Detroit medical Center - University Health Center

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Site 49: Michigan State University

    East Lansing, Michigan 48824
    United States

    Site Not Available

  • Site 196: Mercy Health Saint Mary´s

    Grand Rapids, Michigan 49503
    United States

    Site Not Available

  • Site 127: University of Minnesota

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • Site 134: Neurology and Sleep Disorders Clinic

    Columbia, Missouri 65212
    United States

    Site Not Available

  • Site 155: Neurology Associates

    Lincoln, Nebraska 68506
    United States

    Site Not Available

  • Site 117: Las Vegas Clinic

    Las Vegas, Nevada 89145
    United States

    Site Not Available

  • Site 30: University of Buffalo

    Buffalo, New York 14202-1102
    United States

    Site Not Available

  • Site 123: Northwell Health Neuroscience Institute

    Great Neck, New York 11021
    United States

    Site Not Available

  • Site 23: Hospital for Special Surgery

    New York, New York 10021
    United States

    Site Not Available

  • Site 47: Mount Sinai Hospital

    New York, New York 10029
    United States

    Site Not Available

  • Site 177: North Suffolk Neurology

    Port Jefferson Station, New York 11776
    United States

    Site Not Available

  • University of Rochester

    Rochester, New York 14627
    United States

    Site Not Available

  • Site 22: University of North Carolina

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • Site 15: Duke University

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Site 186: Wake Forest University Baptist Medical Center

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • Site 122: Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Site 38: Ohio State University

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Site 139: Oregon Health and Science University

    Portland, Oregon 97239-3098
    United States

    Site Not Available

  • Site 40: Allegheny Neurological Associates

    Pittsburgh, Pennsylvania 15212
    United States

    Site Not Available

  • Site 128: Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Site 185: Neurology Clinic Cordova

    Cordova, Tennessee 38018
    United States

    Site Not Available

  • Site 131: Austin Neuromuscular Center

    Austin, Texas 78756
    United States

    Site Not Available

  • Site 19: University of Texas Southwestern

    Dallas, Texas 75390
    United States

    Site Not Available

  • Site 39: University of Utah

    Salt Lake City, Utah 84132
    United States

    Site Not Available

  • Site 164: University of Virginia Health System

    Charlottesville, Virginia 22908
    United States

    Site Not Available

  • Site 154: University of Washington

    Seattle, Washington 98195
    United States

    Site Not Available

  • Site 45: Center for Neurological Disorders

    Milwaukee, Wisconsin 53215
    United States

    Site Not Available

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