Chronic Inflammatory Demyelinating Polyneuropathy
Conditions
Keywords
Chronic Inflammatory Demyelinating Polyneuropathy, IMVT-1401, Monoclonal antibody, Autoimmune disorders, Batoclimab
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 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.
Interventions
DRUGBatoclimab
Batoclimab 340 mg SC QW
Sponsors
Immunovant Sciences GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of Participants with Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Treatment Discontinuation | Up to 52 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Adjusted inflammatory Neuropathy Cause and Treatment (aINCAT) | 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 | Up to 52 weeks | Mean Grip strength provides an objective, quantitative and immediate assessment of strength impairment. |
Countries
Argentina, Belgium, Brazil, Germany, Greece, Italy, Poland, Romania, Serbia, Slovakia, United States
Outcome results
None listed