IMVT-1402 in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Purpose
This is a Phase 2b study to evaluate the efficacy and safety of IMVT-1402 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 IMVT-1402 |
|
|
|
Placebo Comparator Placebo |
|
Recruiting Locations
Site Number - 1612
Tucson, Arizona 85718
Tucson, Arizona 85718
Site Number - 1618
Carlsbad, California 92011
Carlsbad, California 92011
Site Number - 1619
Orange, California 92868
Orange, California 92868
Site Number - 1630
Washington, District of Columbia 20010
Washington, District of Columbia 20010
Site Number - 1617
Ormond Beach, Florida 32174
Ormond Beach, Florida 32174
Site Number - 1620
Port Charlotte, Florida 33952
Port Charlotte, Florida 33952
Site Number - 1633
Rockledge, Florida 32955
Rockledge, Florida 32955
More Details
- NCT ID
- NCT07032662
- Status
- Recruiting
- Sponsor
- Immunovant Sciences GmbH
Detailed Description
This is a multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of IMVT-1402 in adult participants with active CIDP.