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Phase 3 Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants With Generalized Myasthenia Gravis
Sponsor: Immunovant Sciences GmbH
Summary
The purpose of this 4-period study is to confirm the efficacy and safety of batoclimab in participants with gMG. In Period 1, participants will be randomized 1:1:1 to receive batoclimab 680 milligrams (mg) subcutaneously (SC) once a week (QW) or 340 mg SC QW or placebo. The primary efficacy endpoint will be assessed by change in the myasthenia gravis activities of daily living (MG- ADL) score in acetylcholine receptor antibody seropositive (AChRAb+) participants. In Period 2, participants previously treated with batoclimab will be re-randomized to stay on batoclimab (340 mg SC QW or 340 mg SC every two weeks) or receive placebo treatment. The secondary endpoint of maintenance of efficacy will be assessed by change in the MG- ADL score in AChRAb+ participants. Participants demonstrating a response to batoclimab during either Period 1 or 2 may enter the long-term extension (Period 3). Participants who complete Period 3 are eligible to participate in Period 4 (Optional Long-Term extension) according to their treatment assignment in Period 3.
Official title: A Phase 3, Multi-center, Randomized, Quadruple-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants With Generalized Myasthenia Gravis (gMG)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
240
Start Date
2022-06-27
Completion Date
2027-02
Last Updated
2026-03-25
Healthy Volunteers
No
Conditions
Interventions
Batoclimab 680 mg SC weekly
Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
Batoclimab 340 mg SC weekly
Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
Matching Placebo SC
Placebo
Batoclimab 340 mg SC bi-weekly
Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
Locations (93)
Site Number -1022
Phoenix, Arizona, United States
Site Number -1029
Scottsdale, Arizona, United States
Site Number -1002
Carlsbad, California, United States
Site Number -1009
Irvine, California, United States
Site Number - 1012
Olive View, California, United States
Site Number -1032
San Francisco, California, United States
Site Number - 1027
Aurora, Colorado, United States
Site Number - 1025
New Haven, Connecticut, United States
Site Number -1007
Clearwater, Florida, United States
Site Number -1010
Maitland, Florida, United States
Site Number - 1020
Miami, Florida, United States
Site Number - 1019
Orlando, Florida, United States
Site Number - 1028
Port Charlotte, Florida, United States
Site Number - 1015
Tampa, Florida, United States
Site Number -1011
Fairway, Kansas, United States
Site Number -1003
Lexington, Kentucky, United States
Site Number -1013
East Lansing, Michigan, United States
Site Number - 1024
Minneapolis, Minnesota, United States
Site Number - 1021
Buffalo, New York, United States
Site Number - 1018
Chapel Hill, North Carolina, United States
Site Number - 1008
Durham, North Carolina, United States
Site Number -1004
Cleveland, Ohio, United States
Site Number -1006
Portland, Oregon, United States
Site Number - 1023
Philadelphia, Pennsylvania, United States
Site Number - 1026
Memphis, Tennessee, United States
Site Number -1001
Austin, Texas, United States
Site Number -1016
Dallas, Texas, United States
Site Number - 1034
Houston, Texas, United States
Site Number - 1014
Round Rock, Texas, United States
Site Number -1005
Charlottesville, Virginia, United States
Site Number - 5002
Buenos Aires, Argentina
Site Number - 5001
Buenos Aires, Argentina
Site Number - 5003
Rosario, Argentina
Site Number - 5501
Ribeirão Preto, Brazil
Site Number- 5503
Rio de Janeiro, Brazil
Site Number - 2003
Vancouver, British Columbia, Canada
Site Number - 2002
Toronto, Ontario, Canada
Site Number - 2004
Montreal, Quebec, Canada
Site Number -8002
Tbilisi, Georgia
Site Number -8004
Tbilisi, Georgia
Site Number -8001
Tbilisi, Georgia
Site Number -8003
Tbilisi, Georgia
Site Number - 8005
Tbilisi, Georgia
Site Number - 6507
Berlin, Germany
Site Number - 6505
Gummersbach, Germany
Site Number - 6503
Jena, Germany
Site Number -6504
Leipzig, Germany
Site Number -6502
Würzburg, Germany
Site Number -7553
Budapest, Hungary
Site Number - 7552
Kistarcsa, Hungary
Site Number - 6004
Bergamo, Italy
Site Number -6006
Brescia, Italy
Site Number - 6002
Genova, Italy
Site Number - 6003
Milan, Italy
Site Number - 6007
Naples, Italy
Site Number -6001
Naples, Italy
Site Number - 4020
Asahikawa-shi, Japan
Site Number - 4014
Fuchu-shi, Japan
Site Number - 4002
Hanamaki-shi, Japan
Site Number - 4013
Higashimatsushima, Japan
Site Number - 4009
Kawasaki-shi, Japan
Site Number - 4012
Koriyama-shi, Japan
Site Number - 4007
Koshigaya-shi, Japan
Site Number - 4011
Matsuyama, Japan
Site Number - 4008
Miyagi, Japan
Site Number - 4003
Narita-shi, Japan
Site Number - 4010
Osaka, Japan
Site Number - 4001
Osaka, Japan
Site Number - 4005
Tokyo, Japan
Site Number - 4016
Yokohama, Japan
Site Number - 4019
Yokohama, Japan
Site Number - 4015
Yokohama, Japan
Site Number - 2601
Mexico City, Mexico
Site Number - 3007
Gdansk, Poland
Site Number -3001
Katowice, Poland
Site Number -3004
Krakow, Poland
Site Number - 3003
Krakow, Poland
Site Number -3002
Krakow, Poland
Site Number - 3008
Lublin, Poland
Site Number -3006
Poznan, Poland
Site Number - 3005
Warsaw, Poland
Site Number -7502
Constanța, Romania
Site Number -7501
Târgu Mureş, Romania
Site Number -7503
Timișoara, Romania
Site Number - 9001
Belgrade, Serbia
Site Number - 9002
Niš, Serbia
Site Number - 4505
Daegu, South Korea
Site Number - 4501
Seoul, South Korea
Site Number -3502
Barcelona, Spain
Site Number -3505
Barcelona, Spain
Site Number -3501
Madrid, Spain
Site Number - 3503
Madrid, Spain
Site Number - 7002
Sheffield, United Kingdom