Imeroprubart in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorImmunovant Sciences GmbH
About this trial
This is a Phase 2b study to evaluate the efficacy and safety of Imeroprubart in adults with CIDP.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Multifocal motor neuropathy
Hereditary demyelinating neuropathy
Trial design
Treatments tested in this trial
- Imeroprubart
- Placebo
Treatment groups
162 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov