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

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.

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Key information

Conditions

Chronic Inflammatory Demyelinating Polyneuropathy Autoimmune Diseases Autoimmune Diseases of the Nervous System Chronic Disease Demyelinating Diseases Disease Attributes Immune System Diseases Nervous System Diseases Neuromuscular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Polyneuropathies Polyradiculoneuropathy Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Site Number - 7751, Rosario, Santa Fe Province, Argentina

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Batoclimab

Drug

Batoclimab 340 mg SC QW

Other names: IMVT-1401

Primary outcomes

Proportion of Participants with Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Treatment Discontinuation

Time frame: Up to 52 weeks

Secondary outcomes

Change from Baseline in Adjusted inflammatory Neuropathy Cause and Treatment (aINCAT)

Time frame: Up to 52 weeks

The INCAT disability scale is a widely used and validated efficacy assessment of neurologic dysfunction in CIDP and will be used for measurement of clinical response.
Change from Baseline in Mean Grip Strength

Time frame: Up to 52 weeks

Mean Grip strength provides an objective, quantitative and immediate assessment of strength impairment.

Sponsors and collaborators

Lead sponsor

Immunovant Sciences GmbH

Industry

Registry information

Official study title

An Open-Label Extension Study to Assess Long-term Safety and Tolerability of Batoclimab in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Important dates

Study start: 2025
Primary completion: 2028
Study completion: 2028
First posted: Sep 23, 2025
Registry last updated: Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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