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

Purpose

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

Condition

Chronic Inflammatory Demyelinating Polyneuropathy

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

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.

Study Design

Phase: Phase 2
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Double (Participant, Investigator)
Masking Description: Sponsor, care provider and outcome assessor will also be blinded.

Arm Groups

Arm	Description	Assigned Intervention
Experimental Imeroprubart		Drug: Imeroprubart Dose 1 subcutaneous (SC) once weekly (QW) for 24 weeks (Period 1) and 52 weeks (Period 2)
Placebo Comparator Placebo		Drug: Placebo Matching placebo SC QW for 24 weeks (Period 1)

Recruiting Locations

Site Number - 1612
Tucson, Arizona 85718

Site Number - 1618
Carlsbad, California 92011

Site Number - 1619
Orange, California 92868

Site Number - 1607
Rancho Mirage, California 92270

Site Number -1608
San Francisco, California 94109

Site Number - 1626
Parker, Colorado 80138

Site Number - 1621
New Haven, Connecticut 06511

Site Number - 1630
Washington D.C., District of Columbia 20010

Site Number - 1601
Washington D.C., District of Columbia 20037

Site Number - 1603
Maitland, Florida 32751

Site Number - 1606
Miami, Florida 33136

Site Number - 1617
Ormond Beach, Florida 32174

Site Number - 1620
Port Charlotte, Florida 33952

Site Number - 1633
Rockledge, Florida 32955

Site Number - 1602
Kansas City, Kansas 66205

Site Number - 1611
Nicholasville, Kentucky 40356

Site Number - 1623
Boston, Massachusetts 02114

Site Number - 1625
Worcester, Massachusetts 01655

Site Number - 1629
Detroit, Michigan 48201

Site Number - 1634
Las Vegas, Nevada 89106

Site Number - 1605
New York, New York 10032

Site Number - 1627
New York, New York 10065

Site Number - 1631
Yukon, Oklahoma 73099

Site Number - 1616
Philadelphia, Pennsylvania 19107

Site Number - 1622
Houston, Texas 77030

Site Number - 1628
San Antonio, Texas 78229

Site Number - 1613
Milwaukee, Wisconsin 53226

More Details

NCT ID: NCT07032662
Status: Recruiting
Sponsor: Immunovant Sciences GmbH

Study Contact

Study Contact
18007970414
clinicaltrials@immunovant.com

Detailed Description

This is a multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Imeroprubart in adult participants with active CIDP.