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ENROLLING BY INVITATION
NCT07188844
PHASE2

An Open-Label Extension Study of Batoclimab in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Sponsor: Immunovant Sciences GmbH

View on ClinicalTrials.gov

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

DRUG

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