The purpose of the study is to evaluate efficacy of riliprubart compared to placebo in adult participants with CIDP whose disease is refractory to standard of care. The study duration will be for a maximum of 111 weeks including screening, treatment phases, and follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
140
Pharmaceutical form: Solution Route of administration: IV Infusion
Pharmaceutical form: Solution Route of administration: IV Infusion
Pharmaceutical form: Solution Route of administration: SC Injection
Pharmaceutical form: Solution Route of administration: SC Injection
Alabama Neurology Associates- Site Number : 8400019
Homewood, Alabama, United States
RECRUITINGUSC Norris Comprehensive Cancer Center- Site Number : 8400002
Los Angeles, California, United States
RECRUITINGUniversity of California Irvine - Manchester Pavilion- Site Number : 8400007
Orange, California, United States
RECRUITINGIMMUNOe International Research Centers - Centennial- Site Number : 8400049
Centennial, Colorado, United States
Percentage of participants experiencing a response
A response is defined as a decrease of ≥1 point from baseline in adjusted INCAT disability score at Week 24.
Time frame: Baseline to week 24
Percentage of participants randomized to riliprubart with lasting response
Lasting response is defined as a decrease of ≥1 point in adjusted INCAT disability score at week 48 versus baseline.
Time frame: Baseline to week 48
Percentage of participants randomized to placebo who experience a response
A response is defined as a decrease of ≥1 point in adjusted INCAT disability score at Week 48 versus week 24.
Time frame: Week 24 to week 48
Change from baseline in Inflammatory Raschbuilt Overall Disability Scale (IRODS) score
Time frame: Baseline to week 24
Change from baseline in adjusted inflammatory neuropathy cause and treatment (INCAT) disability score
Time frame: Baseline to week 24
Change from baseline in grip strength (kilopascals; dominant hand)
Time frame: Baseline to week 24
Change from baseline in Medical Research Council Sum Score (MRC-SS)
Time frame: Baseline to week 24
Percentage of participants refractory to immunoglobulins experiencing a response
A response is defined as a decrease of ≥1 point from baseline in adjusted INCAT disability score at Week 24
Time frame: Baseline to week 24
Change from baseline in the EuroQol 5 Dimension, 5-Level Health Scale (EQ-5D-5L)
Time frame: Baseline to week 24
Change from baseline in the Rasch-built modified fatigue severity scale (RT-FSS)
Time frame: Baseline to week 24
Number of participants with treatment emergent adverse events (TEAEs), including serious adverse events (SAEs) and adverse events of special interest (AESIs) for Part A
Time frame: Baseline to week 24
Incidence and titer of anti-riliprubart antibodies (ADA)
Time frame: Baseline to week 24
Number of participants with TEAEs, including Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) for Part B
Time frame: Week 24 to week 103
Incidence and titer of anti-riliprubart antibodies
Time frame: Week 24 to week 103
Change from baseline in I RODS score
Time frame: Baseline to week 48
Change from baseline in adjusted INCAT score
Time frame: Baseline to week 48
Change from baseline in grip strength (kilopascals; dominant hand)
Time frame: Baseline to week 48
Change from baseline in MRC-SS
Time frame: Baseline to week 48
Change from baseline in EQ-5D-5L score
Time frame: Baseline to week 48
Change from baseline in RT-FSS
Time frame: Baseline to week 48
Percentage of participants randomized to riliprubart who experience a response at Week 48 without prior response in Part A (delayed response)
A delayed response is defined as a decrease of ≥1 point in adjusted INCAT disability score at Week 48 versus baseline.
Time frame: Baseline to week 48
Trial Transparency email recommended (Toll free for US & Canada)
CONTACT
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Yale University School of Medicine- Site Number : 8400018
New Haven, Connecticut, United States
RECRUITINGNova Clinical Research - Bradenton- Site Number : 8400044
Bradenton, Florida, United States
RECRUITINGDesign Neuroscience Center- Site Number : 8400053
Miami Lakes, Florida, United States
RECRUITINGNorthShore University Health System - Glenbrook Hospital- Site Number : 8400024
Glenview, Illinois, United States
RECRUITINGUniversity of Kansas Medical Center- Site Number : 8400010
Kansas City, Kansas, United States
RECRUITINGNeuroMedical Clinic of Central Louisiana- Site Number : 8400031
Alexandria, Louisiana, United States
RECRUITING...and 121 more locations