Chronic Inflammatory Demyelinating Polyneuropathy
Conditions
Keywords
Chronic Inflammatory Demyelinating Polyneuropathy, IMVT-1402, Monoclonal antibody, Human immunoglobulin G1 (IgG1), CIDP, Imeroprubart
Brief summary
This is a Phase 2b study to evaluate the efficacy and safety of Imeroprubart in adults with CIDP.
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.
Interventions
DRUGImeroprubart
Dose 1 subcutaneous (SC) once weekly (QW) for 24 weeks (Period 1) and 52 weeks (Period 2)
DRUGPlacebo
Matching placebo SC QW for 24 weeks (Period 1)
Sponsors
Immunovant Sciences GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Sponsor, care provider and outcome assessor will also be blinded.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants remaining Relapse-free by Week 24 | Baseline, Week 24 | Relapse is defined as a worsening (increase) of ≥ 1 point on the adjusted inflammatory neuropathy cause and treatment (aINCAT) score at any time point relative to Period 1 Baseline. |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to Week 24 in Inflammatory Rasch-Built Overall Disability Scale (I-RODS) | Baseline and Up to Week 24 |
| Change from baseline to Week 24 in Mean Grip Strength in the dominant hand | Baseline and Up to Week 24 |
| Change from baseline to Week 24 in Medical Research Council Sum Score (MRC-SS) | Baseline and Up to Week 24 |
| Change from baseline to Week 24 in aINCAT score | Baseline and Up to Week 24 |
Countries
Argentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Colombia, Denmark, Estonia, Finland, Germany, Greece, Hungary, Ireland, Italy, Mexico, Netherlands, Norway, Peru, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Turkey (Türkiye), United Kingdom, United States
Contacts
CONTACTStudy Contact
Outcome results
None listed