To Assess Efficacy and Safety of Batoclimab in Adult Participants With Active CIDP

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

277

Participants

Timeline

Start Date

December 15, 2022

Primary Completion Date

January 31, 2026

Study Completion Date

January 31, 2027

Conditions
Chronic Inflammatory Demyelinating Polyneuropathy
Interventions
DRUG

Batoclimab 680 milligrams (mg) subcutaneous (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

Placebo

Matching placebo SC

Trial Locations (116)

10032

Site Number - 1605, New York

10117

Site Number - 6706, Berlin

11000

Site Number - 8501, Belgrade

Site Number - 8502, Belgrade

11220

Site Number - 1622, Brooklyn

18000

Site Number - 8500, Niš

19104

Site Number - 1623, Philadelphia

Site Number - 1624, Philadelphia

20010

Site Number - 1630, Washington D.C.

20014

Site Number - 3700, San Sebastián

20132

Site Number - 6307, Milan

20520

Site Number - 3241, Turku

21000

Site Number - 8503, Novi Sad

23298

Site Number - 1627, Richmond

24127

Site Number - 6301, Bergamo

25084

Site Number - 6302, Gussago

27100

Site Number - 6300, Pavia

27559

Site Number - 1635, Chapel Hill

28207

Site Number - 1610, Charlotte

32174

Site Number - 1617, Ormond Beach

32224

Site Number - 1609, Jacksonville

32804

Site Number - 1631, Orlando

32955

Site Number - 1633, Rockledge

33100

Site Number - 6304, Udine

33487

Site Number - 1600, Boca Raton

33713

Site Number - 1604, St. Petersburg

33952

Site Number - 1620, Port Charlotte

40139

Site Number - 6305, Bologna

40356

Site Number - 1611, Nicholasville

41110

Site Number - 6347, Larissa

41914

Site Number - 8406, Bucharest

44791

Site Number - 6705, Bochum

53100

Site Number - 6308, Siena

56126

Site Number - 6303, Pisa

62269

Site Number - 1607, O'Fallon

66160

Site Number - 1602, Kansas City

68100

Site Number - 6343, Alexandroupoli

77030

Site Number - 1606, Houston

78229

Site Number - 1628, San Antonio

78759

Site Number -1601, Austin

80045

Site Number - 1625, Aurora

80337

Site Number - 6704, München

80528

Site Number - 1636, Fort Collins

85028

Site Number - 1603, Scottsdale

91775

Site Number - 8602, Trnava

92011

Site Number - 1618, Carlsbad

92868

Site Number - 1619, Orange

94109

Site Number - 1608, San Francisco

97239

Site Number - 1614, Portland

300736

Site Number - 8403, Timișoara

540136

Site Number - 8401, Târgu Mureş

900591

SIte Number - 8400, Constanța

90033-5330

Site Number - 1634, Los Angeles

06519

Site Number - 1621, New Haven

32806-5411

Site Number - 1629, Orlando

98195-0001

Site Number - 1632, Seattle

53226-3548

Site Number - 1613, Milwaukee

S2000BZL

Site Number - 7753, Rosario

S2000DTP

Site Number - 7751, Rosario

T4000AXL

Site Number - 7752, San Miguel de Tucumán

C1199ABB

Site Number - 7750, Buenos Aires

09000

Site Number - 4681, Ghent

03000

Site Number - 4680, Leuven

70200-730

Site Number - 9103, Brasília

81210-310

Site Number - 9101, Curitiba

14048-900

Site Number - 9100, Ribeirão Preto

22640-100

Site Number - 9102, Rio de Janeiro

01409-000

Site Number - 9105, São Paulo

01527

Site Number - 9111, Sofia

01606

Site Number - 9110, Sofia

05800

Site Number - 9112, Pleven

T6J 1M3

Site Number - 2600, Edmonton

V6Z 1Y6

Site Number - 2603, Vancouver

02100

Site Number - 4740, Copenhagen

01307

Site Number - 6700, Dresden

04103

Site Number - 6702, Leipzig

265 04

Site Number - 6341, Pátrai

115 25

Site Number - 6344, Athens

115 28

Site Number - 6345, Athens

455 00

Site Number - 6346, Ioannina

715 00

Site Number - 6342, Heraklion

00133

Site Number - 6309, Rome

00189

Site Number - 6306, Rome

00424

Site Number - 6491, Oslo

61-731

Site Number - 3207, Poznan

85-065

Site Number - 3211, Bydgoszcz

85-796

Site Number - 3203, Bydgoszcz

30-688

Site Number - 3208, Krakow

31-202

Site Number - 3209, Krakow

31-426

Site Number - 3200, Krakow

50-556

Site Number - 3204, Wroclaw

20-064

Site Number - 3210, Lublin

20-701

Site Number - 3206, Lublin

20-093

Site Number - 3202, Mazurki

80-803

Site Number - 3205, Gdansk

40-123

Site Number - 3201, Katowice

4464-513

Site Number - 3742, Senhora da Hora

4434-502

Site Number - 3745, Vila Nova de Gaia

2805-267

Site Number - 3743, Almada

1300-344

Site Number - 3741, Lisbon

4099-001

Site Number - 3744, Porto

031 23

Site Number - 8600, Liptovský Mikuláš

036 01

Site Number - 8601, Martin

081 81

Site Number - 8603, Prešov

02841

Site Number - 9901, Seoul

06351

Site Number - 9900, Seoul

08907

Site Number - 3701, L'Hospitalet de Llobregat

08190

Site Number - 3704, Sant Cugat del Vallès

08025

Site Number - 3703, Barcelona

413 45

Site Number - 4891, Gothenburg

CB2 0QQ

Site Number - 7405, Cambridge

SO16 6YD

Site Number - 7402, Southampton

G51 4TF

Site Number - 7404, Glasgow

PR2 9HT

Site Number - 7403, Preston

S10 2JF

Site Number - 7401, Sheffield

M6 8HD

Site Number - 7400, Manchester

Sponsors
All Listed Sponsors
lead

Immunovant Sciences GmbH

INDUSTRY

NCT05581199 - To Assess Efficacy and Safety of Batoclimab in Adult Participants With Active CIDP | Biotech Hunter | Biotech Hunter