Phase
Condition
Polymyositis (Inflammatory Muscle Disease)
Neuropathy
Myasthenia Gravis Generalised
Treatment
Matching Placebo SC
Batoclimab 340 mg SC weekly
Batoclimab 680 mg SC weekly
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Are ≥ 18 years of age at the Screening Visit.
Have mild to severe gMG by Myasthenia Gravis Foundation of America (MGFA)classification Class II, III, or IVa at the Screening Visit.
Have a QMG score ≥ 11 at the Screening and Baseline Visits.
Have a MG-ADL score of ≥ 5 at the Screening and Baseline Visits.
Additional inclusion criteria are defined in the protocol.
Exclusion
Exclusion Criteria:
Have experienced myasthenic crisis within 3 months of the Screening Visit.
Have had a thymectomy performed < 6 months prior to the Screening Visit or have aplanned thymectomy during the study period.
Have any active or untreated malignant thymoma.
Have received any agent or therapy (exclusive of those identified within inclusioncriteria) with immunosuppressive properties (e.g., stem cell therapy,chemotherapies) within the past year.
Have used anti-FcRn treatment within 3 months prior to the Screening Visit or have adocumented history of non-response to prior anti-FcRn treatment.
Additional exclusion criteria are defined in the protocol.
Study Design
Connect with a study center
Site Number - 5001
Buenos Aires, C1428AQK
ArgentinaSite Not Available
Site Number - 5002
Buenos Aires, 4190
ArgentinaSite Not Available
Site Number - 5003
Rosario, S2000
ArgentinaSite Not Available
Site Number - 5501
Ribeirão Preto, 14051-140
BrazilSite Not Available
Site Number- 5503
Rio De Janeiro, 22640-100
BrazilSite Not Available
Site Number -2001
Edmonton, Alberta T6G 2B7
CanadaSite Not Available
Site Number - 2003
Vancouver, British Columbia V5Z 1M9
CanadaSite Not Available
Site Number - 2002
Toronto, Ontario M5G 2C4
CanadaSite Not Available
Site Number - 2004
Montreal, Quebec H3A 2B4
CanadaSite Not Available
Site Number -2004
Montreal, Quebec H3A 2B4
CanadaActive - Recruiting
Site Number - 8005
Tbilisi, 0179
GeorgiaSite Not Available
Site Number -8001
Tbilisi, 00160
GeorgiaSite Not Available
Site Number -8002
Tbilisi, 00114
GeorgiaSite Not Available
Site Number -8003
Tbilisi, 00186
GeorgiaSite Not Available
Site Number -8004
Tbilisi, 00114
GeorgiaSite Not Available
Site Number - 6507
Berlin, 10117
GermanySite Not Available
Site Number - 6506
Bochum, 44791
GermanySite Not Available
Site Number - 6501
Hamburg, 20246
GermanySite Not Available
Site Number - 6503
Jena, 7747
GermanySite Not Available
Site Number -6504
Leipzig, 04103
GermanySite Not Available
Site Number -6502
Würzburg, 97074
GermanySite Not Available
Site Number -7553
Budapest, 1082
HungarySite Not Available
Site Number - 7552
Kistarcsa, 2143
HungarySite Not Available
Site Number - 6004
Bergamo, 24127
ItalySite Not Available
Site Number -6006
Brescia, 25123
ItalySite Not Available
Site Number - 6002
Genova, 16132
ItalySite Not Available
Site Number - 6003
Milano, 20133
ItalySite Not Available
Site Number - 6007
Napoli, 80131
ItalySite Not Available
Site Number -6001
Napoli, 80131
ItalySite Not Available
Site Number -6005
Roma, 00189
ItalySite Not Available
Site Number - 4020
Asahikawa-shi, 078-8510
JapanSite Not Available
Site Number - 4014
Fuchu-shi, 183-0042
JapanSite Not Available
Site Number -4014
Fuchu-shi, 183-0042
JapanActive - Recruiting
Site Number - 4002
Hanamaki-shi, 025-0082
JapanSite Not Available
Site Number - 4013
Higashimatsushima, 355-0005
JapanSite Not Available
Site Number - 4006
Kagawa, 761-0793
JapanSite Not Available
Site Number - 4009
Kawasaki-shi, 216-8511
JapanSite Not Available
Site Number - 4012
Koriyama-shi, 963-8563
JapanSite Not Available
Site Number - 4007
Koshigaya-shi, 343-8555
JapanSite Not Available
Site Number - 4011
Matsuyama-shi, 791-8026
JapanSite Not Available
Site Number - 4008
Miyagi, 983-8520
JapanSite Not Available
Site Number - 4003
Narita-shi, 286-8520
JapanSite Not Available
Site Number - 4001
Osaka, 589-8511
JapanSite Not Available
Site Number - 4004
Osaka, 565-0871
JapanSite Not Available
Site Number - 4010
Osaka, 534-0021
JapanSite Not Available
Site Number - 4005
Tokyo, 160-0023
JapanSite Not Available
Site Number - 4018
Toyama-shi, 930-0194
JapanSite Not Available
Site Number - 4015
Yokohama, 236-0004
JapanSite Not Available
Site Number - 4016
Yokohama-shi, 222-0036
JapanSite Not Available
Site Number - 4019
Yokohama-shi, 230-8765
JapanSite Not Available
Site Number -4016
Yokohama-shi, 222-0036
JapanActive - Recruiting
Site Number - 4017
Yonago-shi, 683-8504
JapanSite Not Available
Site Number -4017
Yonago-shi, 683-8504
JapanActive - Recruiting
Site Number -4505
Daegu, 41944
Korea, Republic ofSite Not Available
Site Number -4501
Seoul, 06351
Korea, Republic ofSite Not Available
Site Number - 2601
Mexico City, 06700
MexicoSite Not Available
Site Number - 3007
Gdańsk, 80-214
PolandSite Not Available
Site Number -3001
Katowice, 40-123
PolandSite Not Available
Site Number - 3003
Krakow, 31-503
PolandSite Not Available
Site Number -3004
Krakow, 31-324
PolandSite Not Available
Site Number -3002
Kraków, 31-505
PolandSite Not Available
Site Number - 3008
Lublin, 20-701
PolandSite Not Available
Site Number -3006
Poznań, 61-731
PolandSite Not Available
Site Number - 3005
Warszawa, 01-684
PolandSite Not Available
Site Number -7502
Constanta, 900628
RomaniaSite Not Available
Site Number -7501
Targu Mures, 540136
RomaniaSite Not Available
Site Number -7503
Timişoara, 300723
RomaniaSite Not Available
Site Number - 9001
Belgrade, 11000
SerbiaSite Not Available
Site Number - 9002
Niš, 1800
SerbiaSite Not Available
Site Number -3502
Barcelona, 08195
SpainSite Not Available
Site Number -3505
Barcelona, 8041
SpainSite Not Available
Site Number -3504
Cordoba, 14011
SpainSite Not Available
Site Number -3501
Madrid, 028034
SpainSite Not Available
Site Number -3503
Madrid, 28046
SpainSite Not Available
Site Number - 7001
Liverpool, L9 7LJ
United KingdomSite Not Available
Site Number - 7002
Sheffield, S102JF
United KingdomSite Not Available
Site Number -1022
Phoenix, Arizona 85028
United StatesSite Not Available
Site Number -1029
Scottsdale, Arizona 85251
United StatesSite Not Available
Site Number -1002
Carlsbad, California 92011
United StatesSite Not Available
Site Number -1009
Irvine, California 92697
United StatesSite Not Available
Site Number - 1012
Olive View, California 91342
United StatesSite Not Available
Site Number -1032
San Francisco, California 94143
United StatesSite Not Available
Site Number - 1027
Aurora, Colorado 80045
United StatesSite Not Available
Site Number - 1025
New Haven, Connecticut 06519
United StatesSite Not Available
Site Number -1017
Boca Raton, Florida 33487
United StatesSite Not Available
Site Number -1007
Clearwater, Florida 33761
United StatesSite Not Available
Site Number -1010
Maitland, Florida 32751
United StatesSite Not Available
Site Number - 1020
Miami, Florida 33136
United StatesSite Not Available
Site Number -1019
Orlando, Florida 32806
United StatesSite Not Available
Site Number - 1028
Port Charlotte, Florida 33952
United StatesSite Not Available
Site Number - 1015
Tampa, Florida 33612
United StatesSite Not Available
Site Number -1011
Fairway, Kansas 66205
United StatesSite Not Available
Site Number -1003
Lexington, Kentucky 40536
United StatesSite Not Available
Site Number -1013
East Lansing, Michigan 48824
United StatesSite Not Available
Site Number - 1024
Minneapolis, Minnesota 55414
United StatesSite Not Available
Site Number - 1021
Buffalo, New York 14203
United StatesSite Not Available
Site Number - 1018
Chapel Hill, North Carolina 27599
United StatesSite Not Available
Site Number - 1008
Durham, North Carolina 27710
United StatesSite Not Available
Site Number -1004
Cleveland, Ohio 44195
United StatesSite Not Available
Site Number -1006
Portland, Oregon 97239
United StatesSite Not Available
Site Number - 1023
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Site Number - 1030
Charleston, South Carolina 29425
United StatesSite Not Available
Site Number - 1026
Memphis, Tennessee 38120
United StatesSite Not Available
Site Number -1001
Austin, Texas 78759
United StatesSite Not Available
Site Number -1016
Dallas, Texas 75206
United StatesSite Not Available
Site Number - 1034
Houston, Texas 77030
United StatesSite Not Available
Site Number - 1014
Round Rock, Texas 78681
United StatesSite Not Available
Site Number -1031
Murray, Utah 84107
United StatesSite Not Available
Site Number -1005
Charlottesville, Virginia 22908
United StatesSite Not Available
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