About this trial
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.
Eligibility criteria
Qualifiers
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 2 CIDP variants: motor CIDP, multifocal CIDP (also known as Lewis Sumner Syndrome). Diagnosis must be confirmed by the study adjudication committee.
Participants must have responded to IVIg in the past 5 years.
Participant must be on a stable maintenance dosage of IVIg.
Disqualifiers
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 IgM monoclonal gammopathy, POEMS syndrome, 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
Trial design
Treatments tested in this trial
- riliprubart
- Placebo
- riliprubart
- Placebo
- IVIg
- Placebo