The purpose of the study is to evaluate efficacy of riliprubart compared to IVIg in adult participants with CIDP who are receiving maintenance treatment with IVIg. The study duration will be for a maximum of 109 weeks including screening, treatment phases, and follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
160
Pharmaceutical form: Solution Route of administration: IV solution
Pharmaceutical form: Solution Route of administration: IV solution
Pharmaceutical form: Solution Route of administration: SC solution
Percentage of participants experiencing a response
A response is defined as 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 who responded during part A and had a lasting response during the open-label treatment extension period
Lasting response is defined as a decrease of ≥1 point in adjusted INCAT disability score
Time frame: Baseline to week 48
Change from baseline in Rasch-built Overall Disability Scale (I-RODS) 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
Change from baseline in the Rasch-built modified fatigue severity scale (RT-FSS)
Time frame: Baseline to week 24
Percentage of participants experiencing a relapse
A relapse is defined as increase of ≥1 point from baseline in adjusted INCAT disability score
Time frame: Baseline to week 24
Change from baseline in the EuroQol 5 Dimension, 5-Level Health Scale (EQ-5D-5L)
Trial Transparency email recommended (Toll free for US & Canada)
CONTACT
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Pharmaceutical form: Solution Route of administration: SC solution
Pharmaceutical form: Concentrate for solution for infusion (or any other formulation approved locally) Route of administration: IV solution
Pharmaceutical form: Placebo to match intravenous immunoglobulin IVIg for IV infusio Route of administration: IV solution
Alabama Neurology Associates- Site Number : 8400019
Homewood, Alabama, United States
RECRUITINGHonor Health Scottsdale Osborn Medical Center- Site Number : 8400014
Scottsdale, Arizona, United States
RECRUITINGKeck School of Medicine of University of Southern California- Site Number : 8400002
Los Angeles, California, United States
RECRUITINGUniversity of California Irvine Medical Center- Site Number : 8400007
Orange, California, United States
RECRUITINGIMMUNOe International Research Centers - Centennial- Site Number : 8400049
Centennial, Colorado, United States
RECRUITINGYale University School of Medicine- Site Number : 8400018
New Haven, Connecticut, United States
RECRUITINGNova Clinical Research - Bradenton- Site Number : 8400044
Bradenton, Florida, United States
RECRUITINGResearch by Design, LLC- Site Number : 8400053
Miami Lakes, Florida, United States
RECRUITINGAdventHealth Orlando- Site Number : 8400006
Orlando, Florida, United States
RECRUITINGNorthShore University Health System - Glenbrook Hospital- Site Number : 8400024
Glenview, Illinois, United States
RECRUITING...and 123 more locations
Time frame: Baseline to week 24
Number of participants with TEAEs, including SAEs and AESIs for Part A
Time frame: Baseline to week 24
Number of participants with treatment-emergent ADA in participants treated with riliprubart
Time frame: Baseline to week 24
Number of participants with TEAEs, including SAEs and AESIs
Time frame: Week 24 to week 48
Incidence and titer of anti-drug antibodies (ADA) during open-label treatment and follow-up
Time frame: Baseline to week 109
Change from baseline in I-RODS
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
Percentage of participants randomized to IVIg continuation who experienced a response
A response is defined as a decrease of ≥1 point in adjusted INCAT disability scale score at Week 48 versus Week 24
Time frame: Week 24 to week 48
Percentage of participants randomized to riliprubart who experienced a response at Week 48 without prior response in Part A (delayed response)
A delayed response is defined as an 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 riliprubart experiencing a relapse
A relapse is defined as an increase of ≥1 point from baseline in adjusted INCAT disability score at Week 48 versus Baseline
Time frame: Baseline to week 48
Percentage of participants randomized to IVIg continuation experiencing a relapse
A relapse is defined as an increase of ≥1 point from baseline in adjusted INCAT disability score at Week 48 versus Week 24
Time frame: Week 24 to week 48
Change from baseline in RT-FSS
Time frame: Baseline to week 48