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Clinical Trials in Denmark / NCT07032662
Recruiting Phase 2

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

NCT07032662 · tracked via the Priya Life Science Denmark tracker
Phase
Phase 2
Started
2025-03-18
Last updated
2026-09-30

Condition(s) studied

Chronic Inflammatory Demyelinating Polyneuropathy

Investigational drug(s) / intervention(s)

ImeroprubartPlacebo

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

Placebo: Matching placebo SC QW for 24 weeks (Period 1)

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (142)

FacilityCityRegionStatus
Site Number - 1612 Tucson Arizona Recruiting
Site Number - 1618 Carlsbad California Recruiting
Site Number - 1637 Mission Hills California Recruiting
Site Number - 1619 Orange California Recruiting
Site Number - 1607 Rancho Mirage California Recruiting
Site Number -1608 San Francisco California Recruiting
Site Number - 1626 Parker Colorado Recruiting
Site Number - 1621 New Haven Connecticut Recruiting
Site Number - 1630 Washington D.C. District of Columbia Recruiting
Site Number - 1601 Washington D.C. District of Columbia Recruiting
Site Number - 1603 Maitland Florida Recruiting
Site Number - 1606 Miami Florida Recruiting
Site Number - 1617 Ormond Beach Florida Recruiting
Site Number - 1620 Port Charlotte Florida Recruiting
Site Number - 1633 Rockledge Florida Recruiting
Site Number - 1632 Chicago Illinois Recruiting
Site Number - 1602 Kansas City Kansas Recruiting
Site Number - 1611 Nicholasville Kentucky Recruiting
Site Number - 1623 Boston Massachusetts Recruiting
Site Number - 1625 Worcester Massachusetts Recruiting
Site Number - 1629 Detroit Michigan Recruiting
Site Number - 1634 Las Vegas Nevada Recruiting
Site Number - 1605 New York New York Recruiting
Site Number - 1627 New York New York Recruiting
Site Number - 1635 Chapel Hill North Carolina Not Yet Recruiting
Site Number - 1610 Charlotte North Carolina Recruiting
Site Number - 1624 Canton Ohio Not Yet Recruiting
Site Number - 1631 Yukon Oklahoma Recruiting
Site Number - 1614 Portland Oregon Recruiting
Site Number - 1616 Philadelphia Pennsylvania Recruiting
Site Number - 1622 Houston Texas Recruiting
Site Number - 1628 San Antonio Texas Recruiting
Site Number - 1613 Milwaukee Wisconsin Recruiting
Site Number - 5005 Rosario Santa Fe Province Recruiting
Site Number - 5002 Buenos Aires Argentina Not Yet Recruiting
Site Number - 5006 Buenos Aires Argentina Recruiting
Site Number - 5001 Córdoba Argentina Recruiting
Site Number - 5003 Córdoba Argentina Recruiting
Site Number - 5000 Rosario Argentina Recruiting
Site Number - 5100 Macquarie Park Australia Recruiting

+ 102 more sites — see the full list on the official registry below.

More Immunovant Sciences GmbH trials in Denmark

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07032662 on ClinicalTrials.gov ↗ ← All trials in Denmark