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Clinical Trials in Portugal / NCT07032662
Recruiting Phase 2

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

NCT07032662 · tracked via the Priya Life Science Portugal 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.

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 Portugal