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NCT Number: NCT07032662

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

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

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Key information

About this study

This is a multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Imeroprubart in adult participants with active CIDP.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Additional inclusion criteria are defined in the protocol.

Exclusion criteria

  • 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.
  • Have polyneuropathy of causes other than CIDP including but not limited to:
  • Multifocal motor neuropathy
  • Hereditary demyelinating neuropathy
  • Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin change syndromes (i.e., POEMS)
  • Lumbosacral radiculoplexus neuropathy
  • Systemic illnesses including vitamin deficiency syndromes and paraneoplastic neuropathies
  • Drug- or toxin-induced
  • Have diabetes mellitus (DM) and meets any of the following criteria:
  • Does not have both typical CIDP and strong evidence of demyelination on nerve conduction study.
  • In the opinion of the Investigator, there is evidence of poorly controlled DM preceding the diagnosis of CIDP.
  • In the opinion of the Investigator, there is evidence of poorly controlled DM at screening.
  • Have a history of myelopathy or evidence of central demyelination. Additional exclusion criteria are defined in the protocol.

Treatment and study plan

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)

Primary outcomes

  1. Proportion of participants remaining Relapse-free by Week 24

    Time frame: Baseline, 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.

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

Study contacts

Contact information is provided by the study sponsor or research team.

Study Contact

CONTACT

[email protected]

18007970414

Sponsors and collaborators

Lead sponsor

Immunovant Sciences GmbH

Industry

Registry information

Official study title

A Phase 2b, Multi-center, Randomized, Double-blind, Placebo-controlled Study of IMVT-1402 Treatment in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Important dates

Study start
2025
Primary completion
2028
Study completion
2030
First posted
Jun 24, 2025
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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