Phase 3 Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants With Generalized Myasthenia Gravis
Central Study Contact Kontakt: Phone: 18007970414 E-Mail: clinicaltrials@immunovant.com» Kontaktdaten anzeigen
Studienlocations (3 von 78)
Site Number -6504 04103 Leipzig (Sachsen) GermanyRekrutierend» Google-MapsSite Number -6502 97074 Würzburg (Bayern) GermanyRekrutierend» Google-MapsSite Number -1022 85028 Phoenix United StatesRekrutierend» Google-Maps
Site Number -1029 85251 Scottsdale United StatesRekrutierend» Google-MapsSite Number -1002 92011 Carlsbad United StatesRekrutierend» Google-MapsSite Number -1009 92697 Irvine United StatesRekrutierend» Google-MapsSite Number -1032 94143 San Francisco United StatesRekrutierend» Google-MapsSite Number - 1027 80045 Aurora United StatesRekrutierend» Google-MapsSite Number - 1025 06519 New Haven United StatesRekrutierend» Google-MapsSite Number -1017 33487 Boca Raton United StatesRekrutierend» Google-MapsSite Number -1007 33761 Clearwater United StatesRekrutierend» Google-MapsSite Number -1010 32751 Maitland United StatesRekrutierend» Google-MapsSite Number -1019 32806 Orlando United StatesRekrutierend» Google-MapsSite Number - 1028 33952 Port Charlotte United StatesRekrutierend» Google-MapsSite Number - 1015 33612 Tampa United StatesRekrutierend» Google-MapsSite Number -1011 66205 Fairway United StatesRekrutierend» Google-MapsSite Number -1003 40536 Lexington United StatesRekrutierend» Google-MapsSite Number -1013 48824 East Lansing United StatesRekrutierend» Google-MapsSite Number - 1018 27599 Chapel Hill United StatesRekrutierend» Google-MapsSite Number - 1008 27710 Durham United StatesRekrutierend» Google-MapsSite Number -1004 44195 Cleveland United StatesRekrutierend» Google-MapsSite Number -1006 97239 Portland United StatesRekrutierend» Google-MapsSite Number - 1023 19104 Philadelphia United StatesRekrutierend» Google-MapsSite Number - 1030 29425 Charleston United StatesRekrutierend» Google-MapsSite Number -1001 78759 Austin United StatesRekrutierend» Google-MapsSite Number -1016 75206 Dallas United StatesRekrutierend» Google-MapsSite Number - 1014 78681 Round Rock United StatesRekrutierend» Google-MapsSite Number -1031 84107 Murray United StatesRekrutierend» Google-MapsSite Number -1005 22908 Charlottesville United StatesRekrutierend» Google-MapsSite Number -2001 T6G 2B7 Edmonton CanadaRekrutierend» Google-MapsSite Number -2004 H3A 2B4 Montreal CanadaRekrutierend» Google-MapsSite Number -8002 00114 Tbilisi GeorgiaRekrutierend» Google-MapsSite Number -8004 00114 Tbilisi GeorgiaRekrutierend» Google-MapsSite Number -8001 00160 Tbilisi GeorgiaRekrutierend» Google-MapsSite Number -8003 00186 Tbilisi GeorgiaRekrutierend» Google-MapsSite Number - 8005 0179 Tbilisi GeorgiaRekrutierend» Google-MapsSite Number -7553 1082 Budapest HungaryRekrutierend» Google-MapsSite Number - 7552 2143 Kistarcsa HungaryRekrutierend» Google-MapsSite Number -6006 25123 Brescia ItalyRekrutierend» Google-MapsSite Number - 6002 16132 Genova ItalyRekrutierend» Google-MapsSite Number - 6003 20133 Milano ItalyRekrutierend» Google-MapsSite Number -6001 80131 Napoli ItalyRekrutierend» Google-MapsSite Number -6005 00189 Roma ItalyRekrutierend» Google-MapsSite Number -4014 183-0042 Fuchu-shi JapanRekrutierend» Google-MapsSite Number - 4002 025-0082 Hanamaki-shi JapanRekrutierend» Google-MapsSite Number - 4013 355-0005 Higashimatsushima JapanRekrutierend» Google-MapsSite Number - 4006 761-0793 Kagawa JapanRekrutierend» Google-MapsSite Number - 4009 216-8511 Kawasaki-shi JapanRekrutierend» Google-MapsSite Number - 4012 963-8563 Koriyama-shi JapanRekrutierend» Google-MapsSite Number - 4007 343-8555 Koshigaya-shi JapanRekrutierend» Google-MapsSite Number - 4011 791-8026 Matsuyama-shi JapanRekrutierend» Google-MapsSite Number - 4008 983-8520 Miyagi JapanRekrutierend» Google-MapsSite Number - 4003 286-8520 Narita-shi JapanRekrutierend» Google-MapsSite Number - 4010 534-0021 Osaka JapanRekrutierend» Google-MapsSite Number - 4004 565-0871 Osaka JapanRekrutierend» Google-MapsSite Number - 4001 589-8511 Osaka JapanRekrutierend» Google-MapsSite Number - 4005 160-0023 Tokyo JapanRekrutierend» Google-MapsSite Number -4016 222-0036 Yokohama-shi JapanRekrutierend» Google-MapsSite Number -4017 683-8504 Yonago-shi JapanRekrutierend» Google-MapsSite Number -4505 41944 Daegu Korea, Republic ofRekrutierend» Google-MapsSite Number -4501 06351 Seoul Korea, Republic ofRekrutierend» Google-MapsSite Number -3001 40-123 Katowice PolandRekrutierend» Google-MapsSite Number -3004 31-324 Krakow PolandRekrutierend» Google-MapsSite Number - 3003 31-503 Krakow PolandRekrutierend» Google-MapsSite Number -3002 31-505 Kraków PolandRekrutierend» Google-MapsSite Number - 3008 20-701 Lublin PolandRekrutierend» Google-MapsSite Number -3006 61-731 Poznań PolandRekrutierend» Google-MapsSite Number - 3005 01-684 Warszawa PolandRekrutierend» Google-MapsSite Number -7502 900628 Constanta RomaniaRekrutierend» Google-MapsSite Number -7501 540136 Targu Mures RomaniaRekrutierend» Google-MapsSite Number -7503 300723 Timişoara RomaniaRekrutierend» Google-MapsSite Number - 9001 11000 Belgrade SerbiaRekrutierend» Google-MapsSite Number - 9002 1800 Niš SerbiaRekrutierend» Google-MapsSite Number -3502 08195 Barcelona SpainRekrutierend» Google-MapsSite Number -3505 8041 Barcelona SpainRekrutierend» Google-MapsSite Number -3504 14011 Cordoba SpainRekrutierend» Google-MapsSite Number -3501 28034 Madrid SpainRekrutierend» Google-MapsSite Number -3503 28046 Madrid SpainRekrutierend» Google-Maps
1. Change from Baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) score in acetylcholine receptor (AChR) Ab seropositive (AChRAb+) participants (Time Frame - Baseline (Day 1) to Week 12): MG-ADL is an 8-item, participant-reported questionnaire that assesses gMG symptoms and their effects on activities of daily living. Each item is assessed on a 4-point scale where a score of 0 represents normal function and a score of 3 represents loss of ability to perform that function. Total score ranges from 0 to 24, with higher scores indicating greater functional impairment and disability.
Secondary outcome:
1. Change from Baseline in Quantitative Myasthenia Gravis (QMG) score in AChRAb+ participants (Time Frame - Baseline (Day 1) to Week 12): QMG is clinician-reported assessment to evaluate muscle weakness in participants with MG. The QMG consists of 13 items ranging from 0 to 3 with 3 being the most severe. Total score ranges from 0 to 39, with higher scores representing greater impairment.
2. Change from Baseline in MG-ADL score for AChRAb+ randomized withdrawal participants (Time Frame - Baseline (Week 12) to Week 24)
3. Percentage of AChRAb+ participants with greater than equal to (>=) 3-point improvement in QMG score (Time Frame - Up to Week 12)
4. Percentage of AChRAb+ participants achieving MG-ADL score of 0 or 1 by Week 12 (Time Frame - Up to Week 12)
5. Change from Baseline in MG-ADL score in AChRAB- (AChRAB negative) participants (Time Frame - Baseline (Day 1) to Week 12)
6. Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) (Time Frame - Up to 76 Weeks): An adverse event (AE) is defined as any untoward medical occurrence in a participant who has either been administered a study drug or has undergone study procedures.
7. Percentage of Participants With Clinically Significant Changes in Vital Sign Measurements (Time Frame - Up to 76 Weeks): Vital signs, including systolic and diastolic blood pressures, pulse rate, respiratory rate, and temperature will be obtained and recorded at specified timepoints. All vital sign measures will be obtained with the participant in the supine position and having rested for at least 5 minutes.
8. Number of Participants with Clinically Significant Changes in Laboratory Results (Time Frame - Up to 76 Weeks): Blood samples will be collected at specified timepoints for the analysis of laboratory parameters including clinical chemistry, hematology and urinalysis.
9. Percentage of participants with clinical laboratory-related TEAEs or treatment emergent laboratory abnormalities. (Time Frame - Up to 76 Weeks)
Batoclimab 680 mg SC weekly (IMVT-1401): Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
Batoclimab 340 mg SC weekly (IMVT-1401): Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
Matching Placebo SC: Placebo
Batoclimab 340 mg SC bi-weekly (IMVT-1401): Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
Quelle: ClinicalTrials.gov
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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"
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