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.
Participant must have CIDP or possible CIDP criteria, based on European Academy of Neurology (EAN)/ Peripheral Nerve Society (PNS) Task Force CIDP guidelines, second revision (2021).
Participant must have either typical CIDP, or one of the following two CIDP variants: motor CIDP, multifocal CIDP (also known as Lewis Sumner Syndrome). Diagnosis must be confirmed by the adjudication committee.
Participant must be refractory to either immunoglobulin therapy or corticosteroid therapy, as defined below.
Immunoglobulin-refractory subgroup: Historic evidence of failure or inadequate response to immunoglobulin therapy prior to screening
Polyneuropathy of other causes, including but not limited to: acute demyelinating polyneuropathies (eg, Guillain-Barré syndrome), hereditary demyelinating neuropathies, neuropathies secondary to infection or systemic disease, diabetic neuropathy, drug- or toxin-induced neuropathies, multifocal motor neuropathy, polyneuropathy related to Immunoglobulin M (IgM) monoclonal gammopathy, POEMS syndrome, and lumbosacral radiculoplexus neuropathy.
Sensory CIDP, Distal CIDP and focal CIDP variants.
Any other neurological or systemic disease that can cause symptoms and signs interfering with treatment or outcome assessments
Poorly controlled diabetes
Parallel
Riliprubart
DrugPharmaceutical form: Solution Route of administration: IV Infusion
Placebo
DrugPharmaceutical form: Solution Route of administration: IV Infusion
Riliprubart
DrugPharmaceutical form: Solution Route of administration: SC Injection
Placebo
DrugPharmaceutical form: Solution Route of administration: SC Injection
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.
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.
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.
Change from baseline in Inflammatory Raschbuilt Overall Disability Scale (IRODS) score
Change from baseline in adjusted inflammatory neuropathy cause and treatment (INCAT) disability score
Change from baseline in grip strength (kilopascals; dominant hand)
Change from baseline in Medical Research Council Sum Score (MRC-SS)
