Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
238 participants
INTERVENTIONAL
2020-10-15
2027-11-29
Brief Summary
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Detailed Description
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All subjects who complete the randomized controlled period (RCP) will have the option to enroll in a 3-year (156 weeks) open-label period.
Study acquired from Horizon in 2023.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Inebilizumab, (AChR-Ab+) MG
Participants will receive inebilizumab administered intravenously (IV) on Days 1, 15, and 183 of the RCP.
Participants who elect to enter the open label phase (OLP) will receive inebilizumab administered IV on OLP Days 1, IV placebo on OLP Day 15 (to avoid potential unblinding), and inebilizumab IV on OLP Days 183, 365, 547, 729, and 911.
inebilizumab
Participants will receive IV inebilizumab
Placebo, (AChR-Ab+) MG
Participants will receive placebo administered IV on Days 1, 15, and 183 of the RCP.
Participants who elect to enter the OLP will receive inebilizumab administered IV on OLP Days 1,15, 183, 365, 547, 729, and 911.
IV Placebo
Participants will receive IV placebo matched to inebilizumab
Inebilizumab, (MuSK-Ab+) MG
Participants will receive inebilizumab administered IV on Days 1 and 15 of the RCP.
Participants who elect to enter the OLP will receive inebilizumab administered IV on OLP Day 1, IV placebo on OLP Day 15 (to avoid potential unblinding), and inebilizumab IV on OLP Days 183, 365, 547, 729, and 911.
inebilizumab
Participants will receive IV inebilizumab
Placebo, (MuSK-Ab+) MG
Participants will receive placebo administered IV on Days 1 and 15 of the RCP. Participants who elect to enter the OLP will receive inebilizumab administered IV on OLP Days 1,15, 183, 365, 547, 729, and 911.
IV Placebo
Participants will receive IV placebo matched to inebilizumab
Interventions
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inebilizumab
Participants will receive IV inebilizumab
IV Placebo
Participants will receive IV placebo matched to inebilizumab
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. MGFA Clinical Classification Class II, III, or IV.
3. MG-ADL score of 6 or greater at screening and at randomization with \> 50% of this score attributed to non-ocular items.
4. QMG score of 11 or greater.
5. Participants must be on:
1. Corticosteroids only, with no dose increase within 4 weeks prior to randomization, or
2. One allowed non-steroidal immunosuppressive therapy (IST), with continuous use for at least 6 months prior to randomization and no dose increase within 4 months prior to randomization, or
3. Combination of (1) corticosteroids with no dose increase within 4 weeks prior to randomization and (2) one allowed non-steroidal IST with continuous use for at least 6 months prior to randomization and no dose increase within 4 months prior to randomization.
Allowed ISTs, alone or in combination with corticosteroids, are azathioprine, mycophenolate mofetil, and mycophenolic acid.
Exclusion Criteria
1. Cyclosporine (except eye drops)
2. Tacrolimus (except topical)
3. Methotrexate
2. Current use of:
1. Corticosteroids (Prednisone \> 40 milligram (mg)/day or \> 80 mg over a 2-day period (or equivalent dose of other corticosteroids).
2. Acetylcholinesterase inhibitors (pyridostigmine) \> 480 mg/day) or unstable dose in the 2 weeks prior to Day 1.
3. Azathioprine \> 3 mg/kilogram (kg)/day
4. Mycophenolate mofetil \> 3 grams/day or mycophenolic acid \> 1440 mg/day
5. Any IST, alone or in combination with corticosteroids, except for azathioprine, mycophenolate mofetil, and mycophenolic acid.
18 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Viela Bio Investigative Site - 1015
Orange, California, United States
Viela Bio Investigative Site - 1002
New Haven, Connecticut, United States
Viela Bio Investigative Center - 1024
Washington D.C., District of Columbia, United States
Viela Bio Investigative Site - 1005
Tampa, Florida, United States
Viela Bio Investigative Site - 1012
Kansas City, Kansas, United States
Viela Bio Investigative Site - 1018
Charlotte, North Carolina, United States
Viela Bio Investigative Site - 1025
Canton, Ohio, United States
Viela Bio Investigative Site - 1001
Cincinnati, Ohio, United States
Viela Bio Investigative Site - 1009
Columbus, Ohio, United States
Viela Bio Investigative Site - 1008
Pittsburgh, Pennsylvania, United States
Viela Bio Investigative Site - 1019
Austin, Texas, United States
Viela Bio Investigative Site - 1003
Houston, Texas, United States
Viela Bio Investigative Site - 1014
San Antonio, Texas, United States
Viela Bio Investigative Site - 1017
Salt Lake City, Utah, United States
Viela Bio Investigative Site - 1004
Burlington, Vermont, United States
Viela Bio Investigative Site - 1006
Richmond, Virginia, United States
Viela Bio Investigative Site - 2001
Buenos Aires, , Argentina
VielaBio Investigative Site - 2002
Buenos Aires, , Argentina
Viela Bio Investigative Site - 2003
Buenos Aires, , Argentina
Viela Bio Investigative Site - 5203
Grodno, , Belarus
Viela Bio Investigative Site - 5204
Minsk, , Belarus
Viela Bio Investigative Site - 5201
Vitebsk, , Belarus
VielaBio Investigative Site - 2201
Porto Alegre, , Brazil
VielaBio Investigative Site - 2203
Porto Alegre, , Brazil
VielaBio Investigative Site - 2207
Ribeirão Preto, , Brazil
VielaBio Investigative Site - 2206
São Paulo, , Brazil
Viela Bio Investigative Site - 2205
São Paulo, , Brazil
Viela Bio Investigative Site - 1102
Toronto, Ontario, Canada
Viela Bio Investigative Site - 1101
Montreal, Quebec, Canada
Viela Bio Investigative Site - 1103
Montreal, Quebec, Canada
Viela Bio Investigative Site 4009
Beijing, , China
Viela Bio Investigative Site - 4007
Beijing, , China
Viela Bio Investigative Site 4003
Beijing, , China
Viela Bio Investigative Site - 4005
Guiyang, , China
Viela Bio Investigative site 4010
Hunan, , China
Viela Bio Investigative Site - 4011
Jinan, , China
Viela Bio Investigative Site - 4006
Shanghai, , China
Viela Bio Investigative Site - 4008
Suzhou, , China
Viela Bio Investigative Site - 4004
Tianjin, , China
Viela Bio Investigative Site 4012
Xi'an, , China
Viela Bio Investigative Site - 5601
Copenhagen, , Denmark
Viela Bio Investigative Site - 3003
Lille, , France
Viela Bio Investigative Site - 3001
Nice, , France
Viela Bio Investigative Site - 3002
Strasbourg, , France
VielaBio Investigative Site - 3101
Essen, , Germany
Viela Bio Investigative Site - 4107
Nagpur, Maharashtra, India
Viela Bio Investigative Site - 4113
Nagpur, Maharashtra, India
Viela Bio Investigative Site - 4112
Hyderabad, Telangana, India
Viela Bio Investigative Site - 4104
Bangalore, , India
Viela Bio investigative Site - 4105
Lucknow, , India
Viela Bio Investigative Site - 4103
Manipal, , India
Viela Bio Investigative Site - 4102
Nashik, , India
Viela Bio Investigative Site - 4109
Pune, , India
Viela Bio Investigative Site - 4101
Surat, , India
Viela Bio Investigative Site - 3204
Milan, , Italy
Viela Bio Investigative Site - 3203
Milan, , Italy
Viela Bio Investigative Site - 3201
Pavia, , Italy
Viela Bio Investigative Site - 3202
Rome, , Italy
Viela Bio Investigative Site - 4402
Chiba, , Japan
Viela Bio Investigative Site - 4410
Chiba, , Japan
Viela Bio Investigative Site 4409
Fukuoka, , Japan
Viela Bio Investigative Site - 4401
Hanamaki, , Japan
VielaBio Investigative Site - 4408
Hokkaido, , Japan
Viela Bio Investigative Site - 4406
Hyōgo, , Japan
Viela Bio Investigative Site 4405
Miyagi, , Japan
Viela Bio Investigative Site - 4413
Moriguchi, , Japan
VielaBio Investigative Site - 4407
Morioka, , Japan
Viela Bio Investigative Site - 4404
Saitama, , Japan
Viela Bio Investigative Site - 3302
Katowice, , Poland
Viela Bio Investigative Site - 3303
Katowice, , Poland
Viela Bio Investigative Site - 3301
Krakow, , Poland
Med Polonia Sp. z o.o - 3311
Poznan, , Poland
Viela Bio Investigative Site - 3310
Warsaw, , Poland
Viela Bio Investigative Site - 5313
Barnaul, Altayskiy Kray, Russia
Viela Bio Investigative Site - 5303
Barnaul, , Russia
Viela Bio Investigative Site - 5302
Nizhny Novgorod, , Russia
Viela Bio Investigative Site - 5304
Novosibirsk, , Russia
Viela Bio Investigative Site - 5311
Rostov-on-Don, , Russia
Viela Bio Investigative Site - 5309
Rostov-on-Don, , Russia
Viela Bio Investigative Site - 5308
Saint Petersburg, , Russia
Viela Bio Investigative Site - 5305
Samara, , Russia
Viela Bio Investigative Site - 5312
Ufa, , Russia
Viela Bio Investigative Site - 4202
Seoul, , South Korea
Viela Bio Investigative Site - 4203
Seoul, , South Korea
Viela Bio Investigative Site - 4201
Seoul, , South Korea
Viela Bio Investigative Site - 3403
Badalona, , Spain
Viela Bio Investigative Site - 3402
Barcelona, , Spain
Viela Bio Investigative Site - 3404
Córdoba, , Spain
Viela Bio investigative Site - 4605
Kaohsiung City, , Taiwan
Viela Bio Investigative Site 4608
New Taipei City, , Taiwan
Viela Bio Investigative Site - 4606
Tainan City, , Taiwan
Viela Bio Investigative Site - 4604
Taipei, , Taiwan
Viela Bio Investigative Site - 4603
Taipei, , Taiwan
Viela Bio Investigative Site -4607
Taipei, , Taiwan
Viela Bio Investigative Site - 4602
Taoyuan, , Taiwan
Viela Bio Investigative Site - 3903
Ankara, , Turkey (Türkiye)
Viela Bio Investigative Site - 3901
Izmir, , Turkey (Türkiye)
Viela Bio Investigative Site - 3902
Izmir, , Turkey (Türkiye)
Viela Bio Investigative Site - 3905
Kocaeli, , Turkey (Türkiye)
Viela Bio Investigative Site - 5103
Dnipro, , Ukraine
Viela Bio Investigative Site - 5108
Dnipro, , Ukraine
Viela Bio Investigative Site - 5105
Ivano-Frankivsk, , Ukraine
Viela Bio Investigative Site - 5104
Lutsk, , Ukraine
Viela Bio Investigative Site - 5106
Vinnytsia, , Ukraine
Countries
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References
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Nowak RJ, Benatar M, Ciafaloni E, Howard JF Jr, Leite MI, Utsugisawa K, Vissing J, Rojavin M, Li Q, Tang F, Wu Y, Rampal N, Cheng S; MINT Investigators. A Phase 3 Trial of Inebilizumab in Generalized Myasthenia Gravis. N Engl J Med. 2025 Jun 19;392(23):2309-2320. doi: 10.1056/NEJMoa2501561. Epub 2025 Apr 8.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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VIB0551.P3.S1
Identifier Type: -
Identifier Source: org_study_id
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