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Imeroprubart for adults with CIDP

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

Phase 2 Interventional Immunovant Sciences GmbH · NCT07032662

This study will test whether the monoclonal antibody Imeroprubart helps adults with active CIDP who are already on stable immunoglobulin or corticosteroid treatment.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment162 (estimated)
Ages18 Years and up
SexAll
SponsorImmunovant Sciences GmbH Industry-sponsored
Locations135 sites (Tucson, Arizona and 134 other locations)
Trial IDNCT07032662 on ClinicalTrials.gov

What this trial studies

This Phase 2b, multi-center, randomized, double-blind, placebo-controlled study compares Imeroprubart to placebo in adults with active CIDP who have been on stable IVIg, SCIg, or corticosteroid regimens. Participants must meet EAN/PNS diagnostic and electrodiagnostic criteria and will be randomized to receive either Imeroprubart or placebo while safety and efficacy outcomes are monitored. The trial focuses on clinical measures of neurologic function and relapse risk, along with safety and tolerability assessments. Enrollment occurs at multiple U.S. sites and follows a predefined protocol for inclusion and exclusion of CIDP variants.

Who should consider this trial

Good fit: Adults with typical, multifocal, or motor CIDP who have electrodiagnostic confirmation and who have been on stable doses of IVIg, SCIg, or systemic corticosteroids for at least three months are the intended participants.

Not a fit: People with distal, sensory, or focal CIDP, autoimmune nodopathy, or IgM paraproteinemia (with or without anti-MAG antibodies), or those not on stable immunotherapy, are not expected to be eligible and would likely not benefit from this specific protocol.

Why it matters

Potential benefit: If successful, Imeroprubart could provide a new treatment option that reduces disability and relapse frequency for adults with CIDP, potentially lowering dependence on chronic IVIg or steroid therapy.

How similar studies have performed: Related monoclonal antibody approaches targeting immune mechanisms have shown promise in other autoimmune neuropathies, but Imeroprubart's effectiveness in CIDP is not yet established and is being tested in this Phase 2b study.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Tucson, Arizona and 134 other locations

+85 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Inflammatory Demyelinating PolyneuropathyIMVT-1402Monoclonal antibodyHuman immunoglobulin G1CIDPImeroprubart
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.