RecruitingPhase 2NCT07032662
Imeroprubart in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
A Phase 2b, Multi-center, Randomized, Double-blind, Placebo-controlled Study of IMVT-1402 Treatment in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Sponsor
Immunovant Sciences GmbH
Enrollment
162 participants
Start Date
Mar 18, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
This is a Phase 2b study to evaluate the efficacy and safety of Imeroprubart in adults with CIDP.
Eligibility
Min Age: 18 Years
Inclusion Criteria3
- 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.
Exclusion Criteria13
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
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)
Locations(135)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07032662
Related Trials
A Study to Evaluate the Efficacy and Safety of DNTH103 in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CAPTIVATE)
NCT06858579167 locations
A Study to Assess the Efficacy and Safety of Empasiprubart in Adults With CIDP
NCT0709163043 locations
A Study to Assess Efficacy and Safety of Empasiprubart Versus IVIg in Adults With CIDP
NCT0692000473 locations
A Study to Test the Efficacy and Safety of Riliprubart Against the Usual Treatment of Intravenous Immunoglobulin (IVIg) in People With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
NCT06290141118 locations
A Study Evaluating the Safety and Efficacy of KITE-363 in Relapsed/Refractory Autoimmune Neurologic Diseases
NCT073041543 locations