Imeroprubart for adults with CIDP

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Have met clinical diagnostic criteria for typical CIDP (including incomplete 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) ± corticosteroid therapy (either low dose oral corticosteroids or pulse 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 it's running

• Site Number - 1612
  Tucson, Arizona, United States Recruiting
• Site Number - 1618
  Carlsbad, California, United States Recruiting
• Site Number - 1637
  Mission Hills, California, United States Recruiting
• Site Number - 1619
  Orange, California, United States Recruiting
• Site Number - 1607
  Rancho Mirage, California, United States Recruiting
• Site Number -1608
  San Francisco, California, United States Recruiting

+92 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Study Contact
• Email: clinicaltrials@immunovant.com
• Phone: 18007970414

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• KIg10 (intravenous human immune globulin 10%) maintenance therapy for CIDP

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.