Health Trials

Imeroprubart in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

ConditionChronic Inflammatory Demyelinating Polyneuropathy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorImmunovant Sciences GmbH

About this trial

This is a Phase 2b study to evaluate the efficacy and safety of Imeroprubart in adults with CIDP.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Have met clinical diagnostic criteria for typical CIDP or one of the following CIDP variants: multifocal CIDP or motor CIDP per the 2021 European Academy of Neurology/Peripheral Nerve Society (EAN/PNS) Guideline on Diagnosis and Treatment of CIDP.

Have electrodiagnostic test results supporting the diagnosis of CIDP per the EAN/PNS guideline on diagnosis and treatment of CIDP.

Are currently on, and have been receiving chronic, stable doses of systemic corticosteroids (i.e., daily or every other day oral or pulse regimen), or immunoglobulin therapy (IVIg or SCIg) ± low dose oral corticosteroids for at least 3 months for the treatment of CIDP at the time of the Screening Visit.

Disqualifiers

Have current or prior history of IgM paraproteinemia with or without anti-myelin-associated-glycoprotein antibodies.

Have distal, sensory, or focal CIDP, or have a diagnosis of autoimmune nodopathy per the EAN/PNS guideline on diagnosis and treatment of CIDP.

Multifocal motor neuropathy

Hereditary demyelinating neuropathy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Imeroprubart

    Drug

    Dose 1 subcutaneous (SC) once weekly (QW) for 24 weeks (Period 1) and 52 weeks (Period 2)

  • Placebo

    Drug

    Matching placebo SC QW for 24 weeks (Period 1)

Treatment groups

162 Participants
are divided into 2 treatment groups
Group A: ImeroprubartExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of participants remaining Relapse-free by Week 24

Relapse is defined as a worsening (increase) of ≥ 1 point on the adjusted inflammatory neuropathy cause and treatment (aINCAT) score at any time point relative to Period 1 Baseline.

Time frame
Baseline, Week 24

Secondary outcomes

1

Change from baseline to Week 24 in Inflammatory Rasch-Built Overall Disability Scale (I-RODS)

Time frame
Baseline and Up to Week 24
2

Change from baseline to Week 24 in Mean Grip Strength in the dominant hand

Time frame
Baseline and Up to Week 24
3

Change from baseline to Week 24 in Medical Research Council Sum Score (MRC-SS)

Time frame
Baseline and Up to Week 24
4

Change from baseline to Week 24 in aINCAT score

Time frame
Baseline and Up to Week 24

Other outcomes

Sponsors and contacts

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

Immunovant Sciences GmbH

Lead sponsor

Source ClinicalTrials.gov
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