NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

NCT07032662

RecruitingPhase 2

Sponsor: Immunovant Sciences GmbH

Conditions: Chronic Inflammatory Demyelinating Polyneuropathy

Interventions: Imeroprubart, Placebo

Countries: United States, Argentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria

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

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (141)

Tucson, Arizona, United States
Carlsbad, California, United States
Mission Hills, California, United States
Orange, California, United States
Rancho Mirage, California, United States
San Francisco, California, United States
Parker, Colorado, United States
New Haven, Connecticut, United States
Washington D.C., District of Columbia, United States
Washington D.C., District of Columbia, United States
Maitland, Florida, United States
Miami, Florida, United States
Ormond Beach, Florida, United States
Port Charlotte, Florida, United States
Rockledge, Florida, United States
Chicago, Illinois, United States
Kansas City, Kansas, United States
Nicholasville, Kentucky, United States
Boston, Massachusetts, United States
Worcester, Massachusetts, United States
Detroit, Michigan, United States
Las Vegas, Nevada, United States
New York, New York, United States
New York, New York, United States
Chapel Hill, North Carolina, United States
Charlotte, North Carolina, United States
Canton, Ohio, United States
Yukon, Oklahoma, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
+ 111 more on CT.gov