Status:
ENROLLING_BY_INVITATION
An Open-Label Extension Study of Batoclimab in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Lead Sponsor:
Immunovant Sciences GmbH
Conditions:
Chronic Inflammatory Demyelinating Polyneuropathy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2028
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT07188844
Start Date
August 28 2025
End Date
November 1 2028
Last Update
December 26 2025
Active Locations (30)
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1
Site Number - 1621
New Haven, Connecticut, United States, 06519
2
Site Number - 1617
Ormond Beach, Florida, United States, 32174
3
Site Number - 1611
Nicholasville, Kentucky, United States, 40356
4
Site Number - 1610
Charlotte, North Carolina, United States, 28207