Phase
Condition
Polymyositis (Inflammatory Muscle Disease)
Neuropathy
Sarcopenia
Treatment
IV Placebo
inebilizumab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Diagnosis of MG with anti-AChR or anti-MuSK antibody.
MGFA Clinical Classification Class II, III, or IV.
MG-ADL score of 6 or greater at screening and at randomization with > 50% of thisscore attributed to non-ocular items.
QMG score of 11 or greater.
Participants must be on:
Corticosteroids only, with no dose increase within 4 weeks prior torandomization, or
One allowed non-steroidal immunosuppressive therapy (IST), with continuous usefor at least 6 months prior to randomization and no dose increase within 4months prior to randomization, or
Combination of (1) corticosteroids with no dose increase within 4 weeks priorto randomization and (2) one allowed non-steroidal IST with continuous use forat least 6 months prior to randomization and no dose increase within 4 monthsprior to randomization.
Allowed ISTs, alone or in combination with corticosteroids, are azathioprine, mycophenolate mofetil, and mycophenolic acid.
Exclusion
Exclusion Criteria:
Receipt of the following medications within the 4 weeks prior to Day 1:
Cyclosporine (except eye drops)
Tacrolimus (except topical)
Methotrexate
Current use of:
Corticosteroids (Prednisone > 40 milligram (mg)/day or > 80 mg over a 2-dayperiod (or equivalent dose of other corticosteroids).
Acetylcholinesterase inhibitors (pyridostigmine) > 480 mg/day) or unstable dosein the 2 weeks prior to Day 1.
Azathioprine > 3 mg/kilogram (kg)/day
Mycophenolate mofetil > 3 grams/day or mycophenolic acid > 1440 mg/day
Any IST, alone or in combination with corticosteroids, except for azathioprine,mycophenolate mofetil, and mycophenolic acid.
Study Design
Study Description
Connect with a study center
Viela Bio Investigative Site - 2001
Buenos Aires, C1023AAB
ArgentinaSite Not Available
Viela Bio Investigative Site - 2003
Buenos Aires, C1221ADC
ArgentinaSite Not Available
VielaBio Investigative Site - 2002
Buenos Aires, C1199ABB
ArgentinaSite Not Available
Viela Bio Investigative Site - 5203
Grodno, 230030
BelarusSite Not Available
Viela Bio Investigative Site - 5202
Minsk, 220045
BelarusSite Not Available
Viela Bio Investigative Site - 5204
Minsk, 220114
BelarusSite Not Available
Viela Bio Investigative Site - 5201
Vitebsk, 210009
BelarusSite Not Available
VielaBio Investigative Site - 2201
Porto Alegre, 90035-001
BrazilSite Not Available
VielaBio Investigative Site - 2203
Porto Alegre, 90840-440
BrazilSite Not Available
VielaBio Investigative Site - 2207
Ribeirão Preto, 14051-140
BrazilSite Not Available
VielaBio Investigative Site - 2206
San Paolo, 01228-000
BrazilSite Not Available
Viela Bio Investigative Site - 2205
São Paulo, 08270-120
BrazilSite Not Available
VielaBio Investigative Site - 2206
São Paulo, 01228-000
BrazilSite Not Available
Viela Bio Investigative Site - 1102
Toronto, Ontario M5G 2C4
CanadaSite Not Available
Viela Bio Investigative Site - 1101
Montréal, Quebec H2X 3J4
CanadaSite Not Available
Viela Bio Investigative Site - 1103
Montréal, Quebec H3A 2B4
CanadaSite Not Available
Viela Bio Investigative Site - 1104
West Vancouver, V7T1C5
CanadaSite Not Available
Viela Bio Investigative Site - 4007
Beijing, 100053
ChinaSite Not Available
Viela Bio Investigative Site 4003
Beijing, 100070
ChinaSite Not Available
Viela Bio Investigative Site 4009
Beijing, 100029
ChinaSite Not Available
Viela Bio Investigative Site - 4005
Guiyang, 550004
ChinaSite Not Available
Viela Bio Investigative site 4010
Hunan, 410008
ChinaSite Not Available
Viela Bio Investigative Site - 4011
Jinan, 250012
ChinaSite Not Available
Viela Bio Investigative Site - 4006
Shanghai, 201107
ChinaSite Not Available
Viela Bio Investigative Site - 4008
Suzhou, 215006
ChinaSite Not Available
Viela Bio Investigative Site - 4004
Tianjin, 300052
ChinaSite Not Available
Viela Bio Investigative Site 4012
Xi'an, 710038
ChinaSite Not Available
Viela Bio Investigative Site - 5602
Aarhus, 8200
DenmarkSite Not Available
Viela Bio Investigative Site - 5601
Copenhagen, 2100
DenmarkSite Not Available
Viela Bio Investigative Site - 3003
Lille Cedex, 59037
FranceSite Not Available
Viela Bio Investigative Site - 3001
Nice Cedex 01, 06001
FranceSite Not Available
Viela Bio Investigative Site - 3002
Strasbourg, 67098
FranceSite Not Available
VielaBio Investigative Site - 3101
Essen, 45122
GermanySite Not Available
Viela Bio Investigative Site - 4107
Nagpur, Maharashtra 440003
IndiaSite Not Available
Viela Bio Investigative Site - 4113
Nagpur, Maharashtra 440012
IndiaSite Not Available
Viela Bio Investigative Site - 4111
Vellore, Tamil Nadu 632517
IndiaSite Not Available
Viela Bio Investigative Site - 4112
Hyderabad, Telangana 500082
IndiaSite Not Available
Viela Bio Investigative Site - 4104
Bangalore, 560002
IndiaSite Not Available
Viela Bio investigative Site - 4105
Lucknow, 226014
IndiaSite Not Available
Viela Bio Investigative Site - 4103
Manipal, 576104
IndiaSite Not Available
Viela Bio Investigative Site - 4103
Manipala, 576104
IndiaSite Not Available
Viela Bio Investigative Site - 4102
Nashik, 422002
IndiaSite Not Available
Viela Bio Investigative Site - 4110
Pondicherry, 605 006
IndiaSite Not Available
Viela Bio Investigative Site - 4108
Pune, 411001
IndiaSite Not Available
Viela Bio Investigative Site - 4109
Pune, 411004
IndiaSite Not Available
Viela Bio Investigative Site - 4101
Surat, 395002
IndiaSite Not Available
Viela Bio Investigative Site - 5703
Haifa, 3109601
IsraelSite Not Available
Viela Bio Investigative Site - 5701
Jerusalem, 9112001
IsraelSite Not Available
Viela Bio Investigative Site - 5702
Tel Aviv, 6423906
IsraelSite Not Available
Viela Bio Investigative Site - 3203
Milano, 20133
ItalySite Not Available
Viela Bio Investigative Site - 3204
Milano, 20122
ItalySite Not Available
Viela Bio Investigative Site - 3201
Pavia, 27100
ItalySite Not Available
Viela Bio Investigative Site - 3202
Rome, 168
ItalySite Not Available
Viela Bio Investigative Site - 4402
Chiba, 260-8677
JapanSite Not Available
Viela Bio Investigative Site - 4410
Chiba, 286-8520
JapanSite Not Available
Viela Bio Investigative Site 4409
Fukuoka, 812-8582
JapanSite Not Available
Viela Bio Investigative Site - 4401
Hanamaki, 025-0082
JapanSite Not Available
VielaBio Investigative Site - 4408
Hokkaido, 041-8680
JapanSite Not Available
Viela Bio Investigative Site - 4406
Hyōgo, 663-8501
JapanSite Not Available
Viela Bio Investigative Site 4405
Miyagi, 983-8520
JapanSite Not Available
Viela Bio Investigative Site - 4413
Moriguchi, 570-8507
JapanSite Not Available
VielaBio Investigative Site - 4407
Morioka-shi, 020-8505
JapanSite Not Available
Viela Bio Investigative Site - 4404
Saitama, 350-8550
JapanSite Not Available
VielaBio Investigative Site - 4411
Tokyo, 113-8603
JapanSite Not Available
Viela Bio Investigative Site - 4201
Seoul, 6351
Korea, Republic ofSite Not Available
Viela Bio Investigative Site - 4202
Seoul, 3722
Korea, Republic ofSite Not Available
Viela Bio Investigative Site - 4203
Seoul, 5030
Korea, Republic ofSite Not Available
Viela Bio Investigative Site - 3302
Katowice, 40-635
PolandSite Not Available
Viela Bio Investigative Site - 3303
Katowice, 40-752
PolandSite Not Available
Viela Bio Investigative Site - 3306
Katowice, 40-123
PolandSite Not Available
Viela Bio Investigative Site - 3301
Kraków, 31-505
PolandSite Not Available
Viela Bio Investigative Site - 3305
Nowa Sol, 67-100
PolandSite Not Available
Med Polonia Sp. z o.o - 3311
Poznań, 60-693
PolandSite Not Available
Viela Bio Investigative Site - 3311
Poznań, 60-693
PolandSite Not Available
Viela Bio Investigative Site - 3310
Warszawa, 01-868
PolandSite Not Available
Viela Bio Investigative Site - 5313
Barnaul, Altai Krai 656043
Russian FederationSite Not Available
Viela Bio Investigative Site - 5303
Barnaul, 656045
Russian FederationSite Not Available
Viela Bio Investigative Site - 5302
Nizhny Novgorod, 603126
Russian FederationSite Not Available
Viela Bio Investigative Site - 5304
Novosibirsk, 630087
Russian FederationSite Not Available
Viela Bio Investigative Site - 5309
Rostov-on-Don, 344022
Russian FederationSite Not Available
Viela Bio Investigative Site - 5311
Rostov-on-Don, 344015
Russian FederationSite Not Available
Viela Bio Investigative Site - 5308
Saint Petersburg, 197110
Russian FederationSite Not Available
Viela Bio Investigative Site - 5305
Samara, 443095
Russian FederationSite Not Available
Viela Bio Investigative Site - 5306
Smolensk, 214018
Russian FederationSite Not Available
Viela Bio Investigative Site - 5301
Tomsk, 634009
Russian FederationSite Not Available
Viela Bio Investigative Site - 5312
Ufa, 450083
Russian FederationSite Not Available
Viela Bio Investigative Site - 3403
Badalona, 8916
SpainSite Not Available
Viela Bio Investigative Site - 3402
Barcelona, 8003
SpainSite Not Available
Viela Bio Investigative Site - 3404
Córdoba, 14004
SpainSite Not Available
Viela Bio Investigative Site - 3401
Madrid, 28041
SpainSite Not Available
Viela Bio Investigative Site - 4601
Changhua, 500
TaiwanSite Not Available
Viela Bio investigative Site - 4605
Kaohsiung City, 83301
TaiwanSite Not Available
Viela Bio Investigative Site 4608
New Taipei City, 235
TaiwanSite Not Available
Viela Bio Investigative Site - 4606
Tainan, 704
TaiwanSite Not Available
Viela Bio Investigative Site - 4603
Taipei, 111
TaiwanSite Not Available
Viela Bio Investigative Site - 4604
Taipei, 10002
TaiwanSite Not Available
Viela Bio Investigative Site -4607
Taipei, 11217
TaiwanSite Not Available
Viela Bio Investigative Site - 4602
Taoyuan City, 333
TaiwanSite Not Available
Viela Bio Investigative Site - 3903
Ankara, 6230
TurkeySite Not Available
Viela Bio Investigative Site - 3901
Bornova, 35100
TurkeySite Not Available
Viela Bio Investigative Site - 3905
Kocaeli, 41380
TurkeySite Not Available
Viela Bio Investigative Site - 3901
İzmir, 35100
TurkeySite Not Available
Viela Bio Investigative Site - 3902
İzmir, 35330
TurkeySite Not Available
Viela Bio Investigative Site - 5103
Dnipro, 49005
UkraineSite Not Available
Viela Bio Investigative Site - 5108
Dnipro, 49089
UkraineSite Not Available
Viela Bio Investigative Site - 5105
Ivano-Frankivs'k, 76493
UkraineSite Not Available
Viela Bio Investigative Site - 5104
Lutsk, 43005
UkraineSite Not Available
Viela Bio Investigative Site - 5101
Lviv, 79010
UkraineSite Not Available
Viela Bio Investigative Site - 5106
Vinnytsia, 21050
UkraineSite Not Available
Viela Bio Investigative Site - 1010
Scottsdale, Arizona 85251
United StatesSite Not Available
Viela Bio Investigative Site - 1015
Orange, California 92868
United StatesSite Not Available
Viela Bio Investigative Site - 1013
Aurora, Colorado 80045
United StatesSite Not Available
Viela Bio Investigative Site - 1002
New Haven, Connecticut 06519
United StatesSite Not Available
Viela Bio Investigative Center - 1024
Washington, District of Columbia 20010
United StatesSite Not Available
Viela Bio Investigative Site - 1005
Tampa, Florida 33612
United StatesSite Not Available
Viela Bio Investigative Site - 1016
Augusta, Georgia 30912
United StatesSite Not Available
Viela Bio Investigative Site - 1012
Kansas City, Kansas 66160
United StatesSite Not Available
Viela Bio Investigative Site
Columbia, Maryland 21046
United StatesSite Not Available
Viela Bio Investigative Site - 1011
Minneapolis, Minnesota 55455
United StatesSite Not Available
Viela Bio Investigative Site - 1020
Great Neck, New York 11021
United StatesSite Not Available
Viela Bio Investigative Site - 1007
New York, New York 10021
United StatesSite Not Available
Viela Bio Investigative Site - 1018
Charlotte, North Carolina 28203
United StatesSite Not Available
Viela Bio Investigative Site - 1025
Canton, Ohio 44718
United StatesSite Not Available
Viela Bio Investigative Site - 1001
Cincinnati, Ohio 45219
United StatesSite Not Available
Viela Bio Investigative Site - 1009
Columbus, Ohio 43210
United StatesSite Not Available
Viela Bio Investigative Site - 1008
Pittsburgh, Pennsylvania 15212
United StatesSite Not Available
Viela Bio Investigative Site - 1019
Austin, Texas 78759
United StatesSite Not Available
Viela Bio Investigative Site - 1003
Houston, Texas 77030
United StatesSite Not Available
Viela Bio Investigative Site - 1014
San Antonio, Texas 78229
United StatesSite Not Available
Viela Bio Investigative Site - 1017
Salt Lake City, Utah 84132
United StatesSite Not Available
Viela Bio Investigative Site - 1004
Burlington, Vermont 05401
United StatesSite Not Available
Viela Bio Investigative Site - 1006
Richmond, Virginia 23298
United StatesSite Not Available
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