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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)

ConditionChronic Inflammatory Demyelinating Polyneuropathy
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • riliprubart

    Drug

    Pharmaceutical form: Solution Route of administration: IV solution

  • Placebo

    Drug

    Pharmaceutical form: Solution Route of administration: IV solution

  • riliprubart

    Drug

    Pharmaceutical form: Solution Route of administration: SC solution

  • Placebo

    Drug

    Pharmaceutical form: Solution Route of administration: SC solution

  • IVIg

    Drug

    Pharmaceutical form: Concentrate for solution for infusion (or any other formulation approved locally) Route of administration: IV solution

  • Placebo

    Drug

    Pharmaceutical form: Placebo to match intravenous immunoglobulin IVIg for IV infusio Route of administration: IV solution

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: Riliprubart ArmExperimental treatment 2 interventions
Group B: IVIg ArmActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

1

Change from baseline in Rasch-built Overall Disability Scale (I-RODS) score

Time frame
Baseline to week 24
2

Change from baseline in adjusted inflammatory neuropathy cause and treatment (INCAT) disability score

Time frame
Baseline to week 24
3

Change from baseline in grip strength (kilopascals, dominant hand)

Time frame
Baseline to week 24
4

Change from baseline in Medical Research Council Sum Score (MRC-SS)

Time frame
Baseline to week 24

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sanofi

Lead sponsor

Source ClinicalTrials.gov
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