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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Chronic Inflammatory Demyelinating Polyneuropathy

In brief

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

Key facts

Study ID

NCT07032662

Run by

Immunovant Sciences GmbH

People needed

162

Starts

2025-03-18

Expected to finish

2030-05-01

Last updated by the study team

2026-07-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• Site Number - 1618 — Carlsbad, California, United States (enrolling)
• Site Number - 1612 — Tucson, Arizona, United States (enrolling)
• Site Number - 1619 — Orange, California, United States (enrolling)
• Site Number - 1607 — Rancho Mirage, California, United States (enrolling)
• Site Number - 1637 — Mission Hills, California, United States (enrolling)
• Site Number - 1626 — Parker, Colorado, United States (enrolling)
• Site Number - 1621 — New Haven, Connecticut, United States (enrolling)
• Site Number - 1630 — Washington D.C., District of Columbia, United States (enrolling)
• Site Number - 1601 — Washington D.C., District of Columbia, United States (enrolling)
• Site Number - 1603 — Maitland, Florida, United States (enrolling)
• Site Number -1608 — San Francisco, California, United States (enrolling)
• Site Number - 1617 — Ormond Beach, Florida, United States (enrolling)
• Site Number - 1620 — Port Charlotte, Florida, United States (enrolling)
• Site Number - 1633 — Rockledge, Florida, United States (enrolling)
• Site Number - 1632 — Chicago, Illinois, United States (enrolling)
• Site Number - 1602 — Kansas City, Kansas, United States (enrolling)
• Site Number - 1611 — Nicholasville, Kentucky, United States (enrolling)
• Site Number - 1623 — Boston, Massachusetts, United States (enrolling)
• Site Number - 1625 — Worcester, Massachusetts, United States (enrolling)
• Site Number - 1629 — Detroit, Michigan, United States (enrolling)
• Site Number - 1634 — Las Vegas, Nevada, United States (enrolling)
• Site Number - 1605 — New York, New York, United States (enrolling)
• Site Number - 1627 — New York, New York, United States (enrolling)
• Site Number - 1606 — Miami, Florida, United States (enrolling)
• Site Number - 1631 — Yukon, Oklahoma, United States (enrolling)

Full record on ClinicalTrials.gov

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