This is a Phase 2b study to evaluate the efficacy and safety of IMVT-1402 in adults with CIDP.
This is a multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of IMVT-1402 in adult participants with active CIDP.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
162
Proportion of participants remaining Relapse-free by Week 24
Relapse is defined as a worsening (increase) of ≥ 1 point on the adjusted inflammatory neuropathy cause and treatment (aINCAT) score at any time point relative to Period 1 Baseline.
Time frame: Baseline, Week 24
Change from baseline to Week 24 in Inflammatory Rasch-Built Overall Disability Scale (I-RODS)
Time frame: Baseline and Up to Week 24
Change from baseline to Week 24 in Mean Grip Strength in the dominant hand
Time frame: Baseline and Up to Week 24
Change from baseline to Week 24 in Medical Research Council Sum Score (MRC-SS)
Time frame: Baseline and Up to Week 24
Change from baseline to Week 24 in aINCAT score
Time frame: Baseline and Up to Week 24
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Site Number - 1612
Tucson, Arizona, United States
RECRUITINGSite Number - 1618
Carlsbad, California, United States
RECRUITINGSite Number - 1619
Orange, California, United States
RECRUITINGSite Number - 1607
Rancho Mirage, California, United States
RECRUITINGSite Number -1608
San Francisco, California, United States
RECRUITINGSite Number - 1626
Parker, Colorado, United States
RECRUITINGSite Number - 1621
New Haven, Connecticut, United States
RECRUITINGSite Number - 1630
Washington D.C., District of Columbia, United States
RECRUITINGSite Number - 1601
Washington D.C., District of Columbia, United States
RECRUITINGSite Number - 1603
Maitland, Florida, United States
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