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An Open-Label Extension Study of Batoclimab in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Sponsor: Immunovant Sciences GmbH
Summary
This is an open-label extension (OLE) study designed to evaluate the long-term safety and tolerability of batoclimab in participants with CIDP who have completed Study IMVT-1401-2401 (NCT05581199). In this study, participants will receive 340 mg of batoclimab subcutaneously (SC) once weekly (QW) for up to 52 weeks. Upon completion of the Week 52 or early termination (ET) Visit, participants will transition into the 4-week Follow-up Period, which concludes with a Follow-up Visit approximately 28 (± 7) days after the Week 52 or ET Visit.
Official title: An Open-Label Extension Study to Assess Long-term Safety and Tolerability of Batoclimab in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
108
Start Date
2025-08-28
Completion Date
2028-11
Last Updated
2025-12-26
Healthy Volunteers
No
Interventions
Batoclimab
Batoclimab 340 mg SC QW
Locations (30)
Site Number - 1621
New Haven, Connecticut, United States
Site Number - 1617
Ormond Beach, Florida, United States
Site Number - 1611
Nicholasville, Kentucky, United States
Site Number - 1610
Charlotte, North Carolina, United States
Site Number - 1601
Austin, Texas, United States
Site Number - 7753
Rosario, Santa Fe Province, Argentina
Site Number - 7751
Rosario, Santa Fe Province, Argentina
Site Number - 7750
Buenos Aires, Argentina
Site Number - 7752
San Miguel de Tucumán, Argentina
Site Number - 4680
Leuven, Vlaams Brabant, Belgium
Site Number - 9103
Brasília, Federal District, Brazil
Site Number - 9101
Curitiba, Paraná, Brazil
Site Number - 9100
Ribeirão Preto, São Paulo, Brazil
Site Number - 6702
Leipzig, Saxony, Germany
Site Number - 6341
Pátrai, Achaïa, Greece
Site Number - 6344
Athens, Attica, Greece
Site Number - 6347
Larissa, Greece
Site Number - 6305
Bologna, Emilia-Romagna, Italy
Site Number - 6309
Rome, Lazio, Italy
Site Number - 6307
Milan, Lombardy, Italy
Site Number - 3207
Poznan, Greater Poland Voivodeship, Poland
Site Number - 3208
Krakow, Lesser Poland Voivodeship, Poland
Site Number - 3209
Krakow, Lesser Poland Voivodeship, Poland
Site Number - 3210
Lublin, Lublin Voivodeship, Poland
Site Number - 3206
Lublin, Lublin Voivodeship, Poland
Site Number - 3201
Katowice, Silesian Voivodeship, Poland
Site Number - 8403
Timișoara, Timiș County, Romania
Site Number - 8400
Constanța, Romania
Site Number - 8501
Belgrade, Serbia
Site Number - 8603
Prešov, Slovakia