NCT07188844
An Open-Label Extension Study of Batoclimab in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Enrolling by Invitation
PHASE2Ages 18+InterventionalTreatmentImmunovant Sciences GmbH
~108 participants
Updated 2025-12-26 on ClinicalTrials.gov
What's tested:Batoclimab
At a glance
Recruiting sites
0 of 30 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of Participants with Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Treatment Discontinuation
Measured over Up to 52 weeks
Conditions
Where it's being run
30 sites across 26 statesSanta Fe Province2
Argentina2
Lesser Poland Voivodeship2
Lublin Voivodeship2
Connecticut1
Florida1
Kentucky1
North Carolina1
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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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
What this trial measures
- Proportion of Participants with Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Treatment DiscontinuationUp to 52 weeks