A Study to Test the Efficacy and Safety of Riliprubart Against the Usual Treatment of Intravenous Immunoglobulin (IVIg) in People With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorSanofi

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

Treatment groups

160 Participants
are divided into 2 treatment groups

Sponsors and collaborators