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

Immunovant

Status and phase

Invitation-only

Phase 2

Conditions

Chronic Inflammatory Demyelinating Polyneuropathy

Treatments

Drug: Batoclimab

Study type

Interventional

Funder types

Industry

Identifiers

NCT07188844

IMVT-1401-2402

Details and patient eligibility

About

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.

Enrollment

108 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.