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

RecruitingPhase 2

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

Who can join

Ages 18 and older · All sexes

Full eligibility 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.

About the study

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

What is being tested

Sponsor: Immunovant Sciences GmbH · Participants: 162 · Started: Mar 18, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07032662

Locations in the U.S.

ArizonaSite Number - 1612, Tucson
CaliforniaSite Number - 1618, Carlsbad
Site Number - 1637, Mission Hills
Site Number - 1619, Orange
Site Number - 1607, Rancho Mirage
Site Number -1608, San Francisco
ColoradoSite Number - 1626, Parker
ConnecticutSite Number - 1621, New Haven
District of ColumbiaSite Number - 1601, Washington D.C.
Site Number - 1630, Washington D.C.
FloridaSite Number - 1603, Maitland
Site Number - 1606, Miami
Site Number - 1617, Ormond Beach
Site Number - 1620, Port Charlotte
Site Number - 1633, Rockledge
IllinoisSite Number - 1632, Chicago
KansasSite Number - 1602, Kansas City
KentuckySite Number - 1611, Nicholasville
MassachusettsSite Number - 1623, Boston
Site Number - 1625, Worcester
MichiganSite Number - 1629, Detroit
NevadaSite Number - 1634, Las Vegas
New YorkSite Number - 1605, New York
Site Number - 1627, New York
North CarolinaSite Number - 1635, Chapel Hill (Not yet recruiting)
Site Number - 1610, Charlotte
OhioSite Number - 1624, Canton (Not yet recruiting)
OklahomaSite Number - 1631, Yukon
OregonSite Number - 1614, Portland
PennsylvaniaSite Number - 1616, Philadelphia
TexasSite Number - 1622, Houston
Site Number - 1628, San Antonio
WisconsinSite Number - 1613, Milwaukee

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.