Estudio de fase 2b, multicéntrico, aleatorizado, doble ciego, controlado con placebo de tratamiento con IMVT-1402 en participantes adultos con polineuropatía desmielinizante inflamatoria crónica (CIDP)

ReclutandoFase 2ClinicalTrials.gov

ID: NCT07032662Tipo: INTERVENTIONALInicio: 18 de mar de 2025Fin estimado: 1 de may de 2030

Resumen

Este es un estudio de fase 2b para evaluar la eficacia y seguridad de IMVT-1402 en adultos con CIDP.

Descripción detallada

Este es un estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo para evaluar la eficacia y seguridad de IMVT-1402 en participantes adultos con CIDP activa.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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.

Intervenciones

drug

IMVT-1402

Dose 1 subcutaneous (SC) once weekly (QW) for 24 weeks (Period 1) and 52 weeks (Period 2)

drug

Placebo

Matching placebo SC QW for 24 weeks (Period 1)

Ubicaciones

Site Number - 5002

Buenos Aires, Argentina

NOT_YET_RECRUITING

Site Number - 5001

Córdoba, Argentina

NOT_YET_RECRUITING

Site Number - 5003

Córdoba, Argentina

NOT_YET_RECRUITING

Site Number - 5000

Rosario, Argentina

RECRUITING

Patrocinadores

PrincipalImmunovant Sciences GmbH

Contactos

Study Contact

CONTACT

clinicaltrials@immunovant.com 18007970414

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