Calendario›IMVT›Batoclimab 680 milligrams

Batoclimab 680 milligrams

To Assess Efficacy and Safety of Batoclimab in Adult Participants With Active CIDP

Ensayo de Immunovant, Inc. en Chronic Inflammatory Demyelinating Polyneuropathy (del registro, en inglés).

Fase

Fase 2

Estado

Interrumpido

Participantes

94

previstos

Centros

98

Fin del objetivo primario

jul 2026

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en dic 2022.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Sponsor Decision».

Qué mide

Period 2, Cohort A: Proportion of participants who remain relapse-free at Week 36 (del registro, en inglés) (semana 36)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is a multi-center, randomized, quadruple-blind, placebo-controlled study to evaluate the efficacy and safety of batoclimab in adult participants with active CIDP. The study includes an up to 4-week Screening Period, an up to 12-week Washout Period, a 12-week Randomized Treatment Period (Period 1), an up to 24-week Randomized Withdrawal Period (Period 2), an up to 52-week Long-term Extension (LTE) Period (optional), and Safety Follow-up 4 weeks after the last dose of study treatment. The total study duration will be up to approximately 109 weeks. Eligible participants will be assigned to one of four cohorts based upon their baseline CIDP treatment (Cohorts A and D - immunoglobulin \[Ig\] or plasma exchange \[PLEX\]; Cohort B - corticosteroids; Cohort C - naive or untreated in previous 3-24 months) and whether they meet diagnosis according to the European Academy of Neurology/Peripheral Nerve Society (EAN/PNS) criteria (Cohorts A, B, and C) or clinical criteria only (Cohort D) at the time of screening.

Más ensayos de IMVT

Todos los de IMVT, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT05581199), actualizada en ago 2026.