Tests imeroprubart in adults with a nerve disorder causing weakness and numbness
Tests imeroprubart against placebo in adults with chronic inflammatory demyelinating polyneuropathy.
Plain-language title generated from the registry record
Registry title: Imeroprubart in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Key facts
- Where
- Bergamo, Bologna, Gussago, Milan, Pavia, Pisa, Rome, and Siena, ItalySee the 12 sites
- Phase
- Phase 2
Where in Italy
- Azienda Socio Sanitaria Territoriale Papa Giovanni XXIIIBergamo, ItalyTaking people
- Azienda Unita Sanitaria Locale Di BolognaBologna, ItalyTaking people
- Centro Clinico NemoGussago, ItalyTaking people
- ASST Grande Ospedale Metropolitano NiguardaMilan, ItalyTaking people
- Fondazione IRCCS Cà Granda Ospedale Maggiore PoliclinicoMilan, ItalyTaking people
- IRCCS Foundation Istituto Neurologico Carlo BestaMilan, ItalyTaking people
- Ospedale San Raffaele S.r.l.Milan, ItalyTaking people
- Fondazione Istituto Neurologico Nazionale Casimiro MondinoPavia, ItalyTaking people
- Azienda Ospedaliero Universitaria PisanaPisa, ItalyTaking people
- Azienda Ospedaliero-Universitaria Policlinico Umberto IRome, ItalyTaking people
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, ItalyTaking people
- Azienda Ospedaliero Universitaria SeneseSiena, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Immunovant Sciences GmbH
- Trial code
- NCT07032662EU 2024-517614-14-00
- Record updated
- 30 September 2026
- Original description
This is a Phase 2b study to evaluate the efficacy and safety of Imeroprubart in adults with CIDP.Read full original descriptionShow less
A Phase 2b, Multi-center, Randomized, Double-blind, Placebo-controlled Study of IMVT-1402 Treatment in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
This is a Phase 2b study to evaluate the efficacy and safety of Imeroprubart in adults with CIDP.
Inclusion: Have met clinical diagnostic criteria for typical CIDP (including incomplete 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) ± corticosteroid therapy (either low dose oral corticosteroids or pulse 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: 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.