Phase 3 Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants With Generalized Myasthenia Gravis
NCT ID: NCT05403541
Last Updated: 2024-08-07
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
240 participants
INTERVENTIONAL
2022-06-27
2025-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Batoclimab Induction Dose 1 (Period 1)
Batoclimab 680 mg SC weekly
Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
Batoclimab Induction Dose 2 (Period 1)
Batoclimab 340 mg SC weekly
Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
Placebo Induction Dose (Period 1)
Matching Placebo SC
Placebo
Batoclimab Maintenance Dose 1 (Period 2)
Batoclimab 340 mg SC weekly
Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
Batoclimab Maintenance Dose 2 (Period 2)
Batoclimab 340 mg SC bi-weekly
Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
Placebo Maintenance Dose (Period 2)
Matching Placebo SC
Placebo
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Have mild to severe gMG by Myasthenia Gravis Foundation of America (MGFA) classification Class II, III, or IVa at the Screening Visit.
3. Have a QMG score ≥ 11 at the Screening and Baseline Visits.
4. Have a MG-ADL score of ≥ 5 at the Screening and Baseline Visits.
5. Have used anti-FcRn treatment within 3 months prior to the Screening Visit or have a documented history of non-response to prior anti-FcRn treatment.
Exclusion Criteria
2. Have had a thymectomy performed \< 6 months prior to the Screening Visit or have a planned thymectomy during the study period.
3. Have any active or untreated malignant thymoma.
18 Years
ALL
No
Sponsors
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Immunovant Sciences GmbH
INDUSTRY
Responsible Party
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Locations
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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 -1017
Boca Raton, Florida, 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 - 1030
Charleston, South Carolina, 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 -1031
Murray, Utah, 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 -2001
Edmonton, Alberta, Canada
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 - 6506
Bochum, , Germany
Site Number - 6501
Hamburg, , 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
Napoli, , Italy
Site Number -6001
Napoli, , Italy
Site Number -6005
Roma, , 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 - 4006
Kagawa, , 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 - 4004
Osaka, , Japan
Site Number - 4001
Osaka, , Japan
Site Number - 4005
Tokyo, , Japan
Site Number - 4018
Toyama, , Japan
Site Number - 4016
Yokohama, , Japan
Site Number - 4019
Yokohama, , Japan
Site Number - 4015
Yokohama, , Japan
Site Number - 4017
Yonago-shi, , 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 -3504
Córdoba, , Spain
Site Number -3501
Madrid, , Spain
Site Number -3503
Madrid, , Spain
Site Number - 7001
Liverpool, , United Kingdom
Site Number - 7002
Sheffield, , United Kingdom
Countries
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References
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Benatar M, Wiendl H, Nowak R, Zheng Y, Macias W. Batoclimab as induction and maintenance therapy in patients with myasthenia gravis: rationale and study design of a phase 3 clinical trial. BMJ Neurol Open. 2024 Jan 10;6(1):e000536. doi: 10.1136/bmjno-2023-000536. eCollection 2024.
Other Identifiers
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IMVT-1401-3101
Identifier Type: -
Identifier Source: org_study_id
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