Safety and Efficacy Study of Ravulizumab in Adults With Generalized Myasthenia Gravis

Last updated: April 26, 2024
Sponsor: Alexion Pharmaceuticals, Inc.
Overall Status: Completed

Phase

3

Condition

Polymyositis (Inflammatory Muscle Disease)

Neuropathy

Myasthenia Gravis Generalised

Treatment

Ravulizumab

Placebo

Clinical Study ID

NCT03920293
ALXN1210-MG-306
2018-003243-39
  • All Genders

Study Summary

The primary purpose of this study is to evaluate the safety and efficacy of ravulizumab for the treatment of participants with generalized myasthenia gravis (gMG).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Diagnosed with Myasthenia Gravis at least 6 months (180 days) prior to the date ofthe Screening Visit as confirmed by specific criteria.

  2. Myasthenia Gravis Foundation of America Clinical Classification Class II to IV atscreening.

  3. MG-ADL profile must be ≥ 6 at screening and randomization (Day 1).

  4. Vaccinated against meningococcal infections within 3 years prior to, or at the timeof, initiating study drug to reduce the risk of meningococcal infection (Nmeningitidis).

Exclusion

Exclusion Criteria:

Medical Conditions

  1. Any active or untreated thymoma. History of thymic carcinoma or thymic malignancyunless deemed cured by adequate treatment with no evidence of recurrence for ≥ 5years before screening.

  2. History of thymectomy within the 12 months prior to screening.

  3. History of N meningitidis infection.

  4. Use of the following within the time period specified below:

  • IV immunoglobulin within 4 weeks of randomization

  • Use of plasma exchange within 4 weeks of randomization

  • Use of rituximab within 6 months of screening

  1. Participants who have received previous treatment with complement inhibitors (forexample, eculizumab).

Study Design

Total Participants: 175
Treatment Group(s): 2
Primary Treatment: Ravulizumab
Phase: 3
Study Start date:
March 12, 2019
Estimated Completion Date:
May 25, 2023

Connect with a study center

  • Research Site

    Vienna, 1090
    Austria

    Site Not Available

  • Clinical Trial Site

    Wien, 1090
    Austria

    Site Not Available

  • Clinical Trial Site

    Calgary, Alberta T2N 4Z6
    Canada

    Site Not Available

  • Clinical Trial Site

    Edmonton, Alberta T6G 2B7
    Canada

    Site Not Available

  • Research Site

    Edmonton, Alberta T6G 2G3
    Canada

    Site Not Available

  • Clinical Trial Site

    London, Ontario N6A 5A5
    Canada

    Site Not Available

  • Research Site

    London, Ontario N6A 5A5
    Canada

    Site Not Available

  • Clinical Trial Site

    Toronto, Ontario M5G 2C4
    Canada

    Site Not Available

  • Research Site

    Toronto, Ontario M5G 2C4
    Canada

    Site Not Available

  • Research Site

    Montreal, Quebec H3A 2B4
    Canada

    Site Not Available

  • Clinical Trial Site

    Montreal, H3A2B4
    Canada

    Site Not Available

  • Clinical Trial Site

    Ostrava, Moravian-Silesian 708 52
    Czechia

    Site Not Available

  • Clinical Trial Site

    Brno, 62500
    Czechia

    Site Not Available

  • Research Site

    Brno, 625 00
    Czechia

    Site Not Available

  • Research Site

    Ostrava, 708 52
    Czechia

    Site Not Available

  • Clinical Trial Site

    Prague, 140 59
    Czechia

    Site Not Available

  • Research Site

    Praha, 12800
    Czechia

    Site Not Available

  • Clinical Trial Site

    Copenhagen, Hovedstaden 2100
    Denmark

    Site Not Available

  • Clinical Trial Site

    Aarhus N, Jutland 8200
    Denmark

    Site Not Available

  • Clinical Trial Site

    Aalborg, North Jutland Region 9000
    Denmark

    Site Not Available

  • Research Site

    Arhus C, 8000
    Denmark

    Site Not Available

  • Research Site

    Copenhagen, 2100
    Denmark

    Site Not Available

  • Research Site

    Ålborg, 9100
    Denmark

    Site Not Available

  • Clinical Trial Site

    Lille, Cedex 59037
    France

    Site Not Available

  • Clinical Trial Site

    Marseille, Provence-Alpes-Cote d'Azur 13385
    France

    Site Not Available

  • Clinical Trial Site

    Nice, Provence-Alpes-Cote d'Azur 6000
    France

    Site Not Available

  • Clinical Trial Site

    Garches, 92380
    France

    Site Not Available

  • Research Site

    Garches, 92380
    France

    Site Not Available

  • Research Site

    Lille, 59037
    France

    Site Not Available

  • Research Site

    Marseille, 13005
    France

    Site Not Available

  • Research Site

    Nice, 6000
    France

    Site Not Available

  • Clinical Trial Site

    Würzburg, Bavaria 97070
    Germany

    Site Not Available

  • Clinical Trial Site

    Essen, Nordrhein-Westfalen 45147
    Germany

    Site Not Available

  • Clinical Trial Site

    Münster, Nordrhein-Westfalen 48149
    Germany

    Site Not Available

  • Clinical Trial Site

    Halle, Sachsen-Anhalt 6120
    Germany

    Site Not Available

  • Clinical Trial Site

    Leipzig, Saxony 04103
    Germany

    Site Not Available

  • Clinical Trial Site

    Berlin, D-10117
    Germany

    Site Not Available

  • Research Site

    Berlin, 10117
    Germany

    Site Not Available

  • Research Site

    Essen, 45147
    Germany

    Site Not Available

  • Clinical Trial Site

    Hamburg, 20246
    Germany

    Site Not Available

  • Research Site

    Hamburg, 20246
    Germany

    Site Not Available

  • Clinical Trial Site

    Hannover, 30625
    Germany

    Site Not Available

  • Research Site

    Leipzig, 04103
    Germany

    Site Not Available

  • Research Site

    Münster, 48149
    Germany

    Site Not Available

  • Research Site

    Würzburg, 97070
    Germany

    Site Not Available

  • Clinical Trial Site

    Haifa, Hefa 3109601
    Israel

    Site Not Available

  • Clinical Trial Site

    Tel Aviv-Yafo, Tel-Aviv 64239
    Israel

    Site Not Available

  • Research Site

    Haifa, 3109601
    Israel

    Site Not Available

  • Research Site

    Tel Aviv, 6423906
    Israel

    Site Not Available

  • Clinical Trial Site

    Bologna, Emilia-Romagna 40139
    Italy

    Site Not Available

  • Clinical Trial Site

    Genova, Genoa 16132
    Italy

    Site Not Available

  • Clinical Trial Site

    Milan, Lombardia 20133
    Italy

    Site Not Available

  • Clinical Trial Site

    Bergamo, Roma 24127
    Italy

    Site Not Available

  • Clinical Trial Site

    Rome, Roma 00189
    Italy

    Site Not Available

  • Clinical Trial Site

    Messina, Sicilia 98124
    Italy

    Site Not Available

  • Research Site

    Bergamo, 24127
    Italy

    Site Not Available

  • Research Site

    Bologna, 40139
    Italy

    Site Not Available

  • Research Site

    Milano, 20133
    Italy

    Site Not Available

  • Research Site

    Napoli, 80131
    Italy

    Site Not Available

  • Research Site

    Roma, 00168
    Italy

    Site Not Available

  • Research Site

    Rome, 00189
    Italy

    Site Not Available

  • Clinical Trial Site

    Nagoya-shi, Aichi 466-8560
    Japan

    Site Not Available

  • Clinical Trial Site

    Chuo Ku, Chiba 260-8677
    Japan

    Site Not Available

  • Clinical Trial Site

    Fukuoka-shi, Fukuoka 812-8582
    Japan

    Site Not Available

  • Clinical Trial Site

    Sapporo-shi, Hokkaido 060-8543
    Japan

    Site Not Available

  • Clinical Trial Site

    Kanazawa-shi, Ishikawa 920-8641
    Japan

    Site Not Available

  • Clinical Trial Site

    Sendai-shi, Miyagi 120-0047
    Japan

    Site Not Available

  • Clinical Trial Site

    Nagasaki-shi, Nagasaki 852-8501
    Japan

    Site Not Available

  • Clinical Trial Site

    Niigata-shi, Niigata 951-8520
    Japan

    Site Not Available

  • Clinical Trial Site

    Izumi-Shi, Osaka 594-0073
    Japan

    Site Not Available

  • Clinical Trial Site

    Moriguchi-shi, Osaka 570-8507
    Japan

    Site Not Available

  • Clinical Trial Site

    Osaka Sayama-shi, Osaka 5898511
    Japan

    Site Not Available

  • Clinical Trial Site

    Suita-shi, Osaka 565-0871
    Japan

    Site Not Available

  • Clinical Trial Site

    Toyonaka-shi, Osaka 560-8552
    Japan

    Site Not Available

  • Clinical Trial Site

    Kawagoe-shi, Saitama 350-8550
    Japan

    Site Not Available

  • Clinical Trial Site

    Bunkyō-Ku, Tokyo 113-8655
    Japan

    Site Not Available

  • Clinical Trial Site

    Shinjuku-Ku, Tokyo 160-8582
    Japan

    Site Not Available

  • Clinical Trial Site

    Ube-shi, Yamaguchi 755-8505
    Japan

    Site Not Available

  • Research Site

    Bunkyo-ku, 113-8655
    Japan

    Site Not Available

  • Research Site

    Chiba-shi, 260-0877
    Japan

    Site Not Available

  • Research Site

    Fukuoka City, 812-8582
    Japan

    Site Not Available

  • Clinical Trial Site

    Hanamaki-shi, 025-0075
    Japan

    Site Not Available

  • Research Site

    Hanamaki-shi, 025-0075
    Japan

    Site Not Available

  • Research Site

    Kawagoe-shi, 350-8550
    Japan

    Site Not Available

  • Research Site

    Moriguchi-shi, 570-8507
    Japan

    Site Not Available

  • Research Site

    Nagoya-shi, 466-8560
    Japan

    Site Not Available

  • Research Site

    Niigata-shi, 951-8585
    Japan

    Site Not Available

  • Research Site

    Osaka, 565-0871
    Japan

    Site Not Available

  • Research Site

    Sapporo-shi, 063-0005
    Japan

    Site Not Available

  • Research Site

    Sendai-shi, 983-0045
    Japan

    Site Not Available

  • Research Site

    Shinjuku-ku, 160-8582
    Japan

    Site Not Available

  • Clinical Trial Site

    Tokyo, 100-0001
    Japan

    Site Not Available

  • Research Site

    Ube-shi, 755-8505
    Japan

    Site Not Available

  • Clinical Trial Site

    Yangsan, Gyeongsangnam-do 50612
    Korea, Republic of

    Site Not Available

  • Clinical Trial Site

    Daegu, 41404
    Korea, Republic of

    Site Not Available

  • Research Site

    Daegu, 41404
    Korea, Republic of

    Site Not Available

  • Clinical Trial Site

    Seoul, 06351
    Korea, Republic of

    Site Not Available

  • Research Site

    Seoul, 143-729
    Korea, Republic of

    Site Not Available

  • Research Site

    Yangsan-si, 50612
    Korea, Republic of

    Site Not Available

  • Clinical Trial Site

    Amsterdam, Noord-Holland 1105 AZ
    Netherlands

    Site Not Available

  • Clinical Trial Site

    Leiden, Noord-Holland 2333 ZA
    Netherlands

    Site Not Available

  • Research Site

    Amsterdam, 1105 AZ
    Netherlands

    Site Not Available

  • Research Site

    Leiden, 2333 ZA
    Netherlands

    Site Not Available

  • Clinical Trial Site

    Porto, 4099-001
    Portugal

    Site Not Available

  • Research Site

    Porto, 4099-001
    Portugal

    Site Not Available

  • Clinical Trial Site

    Barakaldo, Bizkaia 48903
    Spain

    Site Not Available

  • Clinical Trial Site

    Barcelona, 8036
    Spain

    Site Not Available

  • Research Site

    Barcelona, 08025
    Spain

    Site Not Available

  • Research Site

    L'Hospitalet de Llobregat, 08907
    Spain

    Site Not Available

  • Clinical Trial Site

    Madrid, 28034
    Spain

    Site Not Available

  • Research Site

    Madrid, 28040
    Spain

    Site Not Available

  • Clinical Trial Site

    Murcia, 30120
    Spain

    Site Not Available

  • Research Site

    Murcia, 30120
    Spain

    Site Not Available

  • Clinical Trial Site

    Valencia, 46026
    Spain

    Site Not Available

  • Clinical Trial Site

    Zürich, 8091
    Switzerland

    Site Not Available

  • Research Site

    Zürich, 8091
    Switzerland

    Site Not Available

  • Clinical Trial Site

    Phoenix, Arizona 85018
    United States

    Site Not Available

  • Research Site

    Phoenix, Arizona 85013
    United States

    Site Not Available

  • Research Site

    Irvine, California 92617
    United States

    Site Not Available

  • Clinical Trial Site

    Loma Linda, California 92354
    United States

    Site Not Available

  • Research Site

    Loma Linda, California 92354
    United States

    Site Not Available

  • Clinical Trial Site

    Los Angeles, California 90048
    United States

    Site Not Available

  • Clinical Trial Site

    Orange, California 92868
    United States

    Site Not Available

  • Clinical Trial Site

    Palo Alto, California 94304
    United States

    Site Not Available

  • Research Site

    Palo Alto, California 94304
    United States

    Site Not Available

  • Clinical Trial Site

    San Francisco, California 94109
    United States

    Site Not Available

  • Research Site

    San Francisco, California 94115
    United States

    Site Not Available

  • Clinical Trial Site

    Sylmar, California 91342
    United States

    Site Not Available

  • Research Site

    Sylmar, California 91342
    United States

    Site Not Available

  • Clinical Trial Site

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Research Site

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Clinical Trial Site

    Colorado Springs, Colorado 80907
    United States

    Site Not Available

  • Research Site

    Colorado Springs, Colorado 80907
    United States

    Site Not Available

  • Clinical Trial Site

    Fort Collins, Colorado 80528
    United States

    Site Not Available

  • Research Site

    Fort Collins, Colorado 80528
    United States

    Site Not Available

  • Research Site

    Fairfield, Connecticut 06824
    United States

    Site Not Available

  • Clinical Trial Site

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Clinical Trial Site

    Washington, District of Columbia 20007
    United States

    Site Not Available

  • Research Site

    Washington, District of Columbia 20007
    United States

    Site Not Available

  • Clinical Trial Site

    Clearwater, Florida 33761
    United States

    Site Not Available

  • Clinical Trial Site

    Jacksonville, Florida 32209
    United States

    Site Not Available

  • Research Site

    Jacksonville, Florida 32209
    United States

    Site Not Available

  • Clinical Trial Site

    Tampa, Florida 33612
    United States

    Site Not Available

  • Research Site

    Tampa, Florida 33612
    United States

    Site Not Available

  • Clinical Trial Site

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Clinical Trial Site

    Augusta, Georgia 30912
    United States

    Site Not Available

  • Clinical Trial Site

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Research Site

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Clinical Trial Site

    Rolling Meadows, Illinois 60008
    United States

    Site Not Available

  • Research Site

    Rolling Meadows, Illinois 60008
    United States

    Site Not Available

  • Clinical Trial Site

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Research Site

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Clinical Trial Site

    Fairway, Kansas 66205
    United States

    Site Not Available

  • Research Site

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • Clinical Trial Site

    Lexington, Kentucky 40503
    United States

    Site Not Available

  • Research Site

    Lexington, Kentucky 40503
    United States

    Site Not Available

  • Clinical Trial Site

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Research Site

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Clinical Trial Site

    Boston, Massachusetts 02111
    United States

    Site Not Available

  • Research Site

    Boston, Massachusetts 02116
    United States

    Site Not Available

  • Research Site

    Burlington, Massachusetts 01805
    United States

    Site Not Available

  • Research Site

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Clinical Trial Site

    East Lansing, Michigan 48824
    United States

    Site Not Available

  • Research Site

    East Lansing, Michigan 48824
    United States

    Site Not Available

  • Clinical Trial Site

    Grand Rapids, Michigan 49503
    United States

    Site Not Available

  • Research Site

    Grand Rapids, Michigan 49525
    United States

    Site Not Available

  • Clinical Trial Site

    Detroit Lakes, Minnesota 48201
    United States

    Site Not Available

  • Clinical Trial Site

    Columbia, Missouri 65212
    United States

    Site Not Available

  • Research Site

    Columbia, Missouri 65201
    United States

    Site Not Available

  • Clinical Trial Site

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Clinical Trial Site

    Las Vegas, Nevada 89145
    United States

    Site Not Available

  • Research Site

    Las Vegas, Nevada 89145
    United States

    Site Not Available

  • Clinical Trial Site

    East Setauket, New York 11733
    United States

    Site Not Available

  • Clinical Trial Site

    Great Neck, New York 11021
    United States

    Site Not Available

  • Research Site

    Great Neck, New York 11021
    United States

    Site Not Available

  • Clinical Trial Site

    New York, New York 10075
    United States

    Site Not Available

  • Research Site

    New York, New York 10021
    United States

    Site Not Available

  • Clinical Trial Site

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • Research Site

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • Clinical Trial Site

    Charlotte, North Carolina 28207
    United States

    Site Not Available

  • Research Site

    Charlotte, North Carolina 28207
    United States

    Site Not Available

  • Clinical Trial Site

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Research Site

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Clinical Trial Site

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Research Site

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Clinical Trial Site

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Research Site

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Clinical Trial Site

    Columbus, Ohio 43214
    United States

    Site Not Available

  • Research Site

    Columbus, Ohio 43221
    United States

    Site Not Available

  • Clinical Trial Site

    Springfield, Oregon 97499
    United States

    Site Not Available

  • Clinical Trial Site

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • Research Site

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • Clinical Trial Site

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Research Site

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Research Site

    Pittsburgh, Pennsylvania 15212
    United States

    Site Not Available

  • Clinical Trial Site

    Charleston, South Carolina 29459
    United States

    Site Not Available

  • Research Site

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Research Site

    North Charleston, South Carolina 29406
    United States

    Site Not Available

  • Clinical Trial Site

    Cordova, Tennessee 38018
    United States

    Site Not Available

  • Clinical Trial Site

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Clinical Trial Site

    Austin, Texas 78753
    United States

    Site Not Available

  • Research Site

    Austin, Texas 78756
    United States

    Site Not Available

  • Clinical Trial Site

    Dallas, Texas 75214
    United States

    Site Not Available

  • Research Site

    Dallas, Texas 75206
    United States

    Site Not Available

  • Clinical Trial Site

    Houston, Texas 77030
    United States

    Site Not Available

  • Research Site

    Houston, Texas 77030
    United States

    Site Not Available

  • Clinical Trial Site

    Round Rock, Texas 78681
    United States

    Site Not Available

  • Research Site

    Round Rock, Texas 78681
    United States

    Site Not Available

  • Clinical Trial Site

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Clinical Trial Site

    Burlington, Vermont 05405
    United States

    Site Not Available

  • Clinical Trial Site

    Richmond, Virginia 23298
    United States

    Site Not Available

  • Research Site

    Richmond, Virginia 23298
    United States

    Site Not Available

  • Clinical Trial Site

    Seattle, Washington 98122
    United States

    Site Not Available

  • Clinical Trial Site

    Morgantown, West Virginia 26506
    United States

    Site Not Available

  • Research Site

    Morgantown, West Virginia 26506
    United States

    Site Not Available

  • Clinical Trial Site

    Milwaukee, Wisconsin 53215
    United States

    Site Not Available

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