Phase 3 Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants With Generalized Myasthenia Gravis

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

240

Participants

Timeline

Start Date

June 27, 2022

Primary Completion Date

March 31, 2025

Study Completion Date

April 30, 2025

Conditions
Generalized Myasthenia Gravis
Interventions
DRUG

Batoclimab 680 mg SC weekly

Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody

DRUG

Batoclimab 340 mg SC weekly

Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody

DRUG

Matching Placebo SC

Placebo

DRUG

Batoclimab 340 mg SC bi-weekly

Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody

Trial Locations (105)

1082

Site Number -7553, Budapest

1800

Site Number - 9002, Niš

2143

Site Number - 7552, Kistarcsa

4190

Site Number - 5002, Buenos Aires

7747

Site Number - 6503, Jena

8041

Site Number -3505, Barcelona

10117

Site Number - 6507, Berlin

11000

Site Number - 9001, Belgrade

14011

Site Number -3504, Córdoba

14203

Site Number - 1021, Buffalo

16132

Site Number - 6002, Genova

19104

Site Number - 1023, Philadelphia

20133

Site Number - 6003, Milan

20246

Site Number - 6501, Hamburg

22908

Site Number -1005, Charlottesville

24127

Site Number - 6004, Bergamo

25123

Site Number -6006, Brescia

27599

Site Number - 1018, Chapel Hill

27710

Site Number - 1008, Durham

28046

Site Number -3503, Madrid

29425

Site Number - 1030, Charleston

32751

Site Number -1010, Maitland

32806

Site Number -1019, Orlando

33136

Site Number - 1020, Miami

33487

Site Number -1017, Boca Raton

33612

Site Number - 1015, Tampa

33761

Site Number -1007, Clearwater

33952

Site Number - 1028, Port Charlotte

38120

Site Number - 1026, Memphis

40536

Site Number -1003, Lexington

41944

Site Number -4505, Daegu

44195

Site Number -1004, Cleveland

44791

Site Number - 6506, Bochum

48824

Site Number -1013, East Lansing

55414

Site Number - 1024, Minneapolis

66205

Site Number -1011, Fairway

75206

Site Number -1016, Dallas

77030

Site Number - 1034, Houston

78681

Site Number - 1014, Round Rock

78759

Site Number -1001, Austin

80045

Site Number - 1027, Aurora

80131

Site Number - 6007, Napoli

Site Number -6001, Napoli

84107

Site Number -1031, Murray

85028

Site Number -1022, Phoenix

85251

Site Number -1029, Scottsdale

91342

Site Number - 1012, Olive View

92011

Site Number -1002, Carlsbad

92697

Site Number -1009, Irvine

94143

Site Number -1032, San Francisco

97074

Site Number -6502, Würzburg

97239

Site Number -1006, Portland

300723

Site Number -7503, Timișoara

540136

Site Number -7501, Târgu Mureş

900628

Site Number -7502, Constanța

06519

Site Number - 1025, New Haven

C1428AQK

Site Number - 5001, Buenos Aires

S2000

Site Number - 5003, Rosario

14051-140

Site Number - 5501, Ribeirão Preto

22640-100

Site Number- 5503, Rio de Janeiro

T6G 2B7

Site Number -2001, Edmonton

V5Z 1M9

Site Number - 2003, Vancouver

M5G 2C4

Site Number - 2002, Toronto

H3A 2B4

Site Number - 2004, Montreal

00114

Site Number -8002, Tbilisi

Site Number -8004, Tbilisi

00160

Site Number -8001, Tbilisi

00186

Site Number -8003, Tbilisi

0179

Site Number - 8005, Tbilisi

04103

Site Number -6504, Leipzig

00189

Site Number -6005, Roma

078-8510

Site Number - 4020, Asahikawa-shi

183-0042

Site Number - 4014, Fuchu-shi

025-0082

Site Number - 4002, Hanamaki-shi

355-0005

Site Number - 4013, Higashimatsushima

761-0793

Site Number - 4006, Kagawa

216-8511

Site Number - 4009, Kawasaki-shi

963-8563

Site Number - 4012, Koriyama-shi

343-8555

Site Number - 4007, Koshigaya-shi

791-8026

Site Number - 4011, Matsuyama

983-8520

Site Number - 4008, Miyagi

286-8520

Site Number - 4003, Narita-shi

534-0021

Site Number - 4010, Osaka

565-0871

Site Number - 4004, Osaka

589-8511

Site Number - 4001, Osaka

160-0023

Site Number - 4005, Tokyo

930-0194

Site Number - 4018, Toyama

222-0036

Site Number - 4016, Yokohama

230-8765

Site Number - 4019, Yokohama

236-0004

Site Number - 4015, Yokohama

683-8504

Site Number - 4017, Yonago-shi

06700

Site Number - 2601, Mexico City

80-214

Site Number - 3007, Gdansk

40-123

Site Number -3001, Katowice

31-324

Site Number -3004, Krakow

31-503

Site Number - 3003, Krakow

31-505

Site Number -3002, Krakow

20-701

Site Number - 3008, Lublin

61-731

Site Number -3006, Poznan

01-684

Site Number - 3005, Warsaw

06351

Site Number -4501, Seoul

08195

Site Number -3502, Barcelona

028034

Site Number -3501, Madrid

L9 7LJ

Site Number - 7001, Liverpool

S102JF

Site Number - 7002, Sheffield

Sponsors
All Listed Sponsors
lead

Immunovant Sciences GmbH

INDUSTRY

NCT05403541 - Phase 3 Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants With Generalized Myasthenia Gravis | Biotech Hunter | Biotech Hunter