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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
108
Batoclimab 340 mg SC QW
Site Number - 1621
New Haven, Connecticut, United States
Site Number - 1617
Ormond Beach, Florida, United States
Site Number - 1611
Nicholasville, Kentucky, United States
Site Number - 1610
Charlotte, North Carolina, United States
Site Number - 1601
Austin, Texas, United States
Site Number - 7753
Rosario, Santa Fe Province, Argentina
Site Number - 7751
Rosario, Santa Fe Province, Argentina
Site Number - 7750
Buenos Aires, Argentina
Site Number - 7752
San Miguel de Tucumán, Argentina
Site Number - 4680
Leuven, Vlaams Brabant, Belgium
...and 20 more locations
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
Change from Baseline in Adjusted inflammatory Neuropathy Cause and Treatment (aINCAT)
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.
Time frame: Up to 52 weeks
Change from Baseline in Mean Grip Strength
Mean Grip strength provides an objective, quantitative and immediate assessment of strength impairment.
Time frame: Up to 52 weeks
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