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

NCT ID: NCT07188844

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE2

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-28

Study Completion Date

2028-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Inflammatory Demyelinating Polyneuropathy

Keywords

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Chronic Inflammatory Demyelinating Polyneuropathy IMVT-1401 Monoclonal antibody Autoimmune disorders Batoclimab

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Batoclimab

Group Type EXPERIMENTAL

Batoclimab

Intervention Type DRUG

Batoclimab 340 mg SC QW

Interventions

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Batoclimab

Batoclimab 340 mg SC QW

Intervention Type DRUG

Other Intervention Names

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IMVT-1401

Eligibility Criteria

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Inclusion Criteria

* Any participant who has completed Study IMVT-1401-2401
* Female participants of childbearing potential must agree to use a highly effective method of birth control
* Female participants must agree not to donate eggs throughout the study and for 90 days after the final study treatment administration
* Male participants must agree to use 1 highly effective contraception method with partners of childbearing potential throughout the study period and for 90 days after the final study treatment administration
* Male participants must agree not to donate sperm throughout the study period and for 90 days after the final study treatment administration
* Agree not to participate in another interventional study while on treatment

Exclusion Criteria

* Participant has any medical condition (acute or chronic illness) or psychiatric condition, including autoimmune disease or neurologic disease other than CIDP, or known history of drug or alcohol abuse that, in the opinion of the Investigator, could jeopardize the participant's ability to participate in this study, compromise accurate assessment of CIDP symptoms or otherwise interfere with the course and conduct of the study.
* Participant intends to have a live vaccination during the course of the study or within 7 weeks following the final dose of batoclimab
* Participant has an ongoing SAE or a medical condition in the IMVT-1401-2401 study that the Investigator considers putting the participant at a significantly increased risk of participating in Study IMVT-1401-2402
* Participant has received Standard of Care therapy for treatment of a relapse in Study IMVT-1401-2401

Note: Other protocol specified criteria may apply.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Immunovant Sciences GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Site Number - 1621

New Haven, Connecticut, United States

Site Status

Site Number - 1617

Ormond Beach, Florida, United States

Site Status

Site Number - 1611

Nicholasville, Kentucky, United States

Site Status

Site Number - 1610

Charlotte, North Carolina, United States

Site Status

Site Number - 1601

Austin, Texas, United States

Site Status

Site Number - 7753

Rosario, Santa Fe Province, Argentina

Site Status

Site Number - 7751

Rosario, Santa Fe Province, Argentina

Site Status

Site Number - 7750

Buenos Aires, , Argentina

Site Status

Site Number - 7752

San Miguel de Tucumán, , Argentina

Site Status

Site Number - 4680

Leuven, Vlaams Brabant, Belgium

Site Status

Site Number - 9103

Brasília, Federal District, Brazil

Site Status

Site Number - 9101

Curitiba, Paraná, Brazil

Site Status

Site Number - 9100

Ribeirão Preto, São Paulo, Brazil

Site Status

Site Number - 6702

Leipzig, Saxony, Germany

Site Status

Site Number - 6341

Pátrai, Achaïa, Greece

Site Status

Site Number - 6344

Athens, Attica, Greece

Site Status

Site Number - 6347

Larissa, , Greece

Site Status

Site Number - 6305

Bologna, Emilia-Romagna, Italy

Site Status

Site Number - 6309

Rome, Lazio, Italy

Site Status

Site Number - 6307

Milan, Lombardy, Italy

Site Status

Site Number - 3207

Poznan, Greater Poland Voivodeship, Poland

Site Status

Site Number - 3208

Krakow, Lesser Poland Voivodeship, Poland

Site Status

Site Number - 3209

Krakow, Lesser Poland Voivodeship, Poland

Site Status

Site Number - 3210

Lublin, Lublin Voivodeship, Poland

Site Status

Site Number - 3206

Lublin, Lublin Voivodeship, Poland

Site Status

Site Number - 3201

Katowice, Silesian Voivodeship, Poland

Site Status

Site Number - 8403

Timișoara, Timiș County, Romania

Site Status

Site Number - 8400

Constanța, , Romania

Site Status

Site Number - 8501

Belgrade, , Serbia

Site Status

Site Number - 8603

Prešov, , Slovakia

Site Status

Countries

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United States Argentina Belgium Brazil Germany Greece Italy Poland Romania Serbia Slovakia

Other Identifiers

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IMVT-1401-2402

Identifier Type: -

Identifier Source: org_study_id