A Phase 2b, Multi-center, Randomized, Double-blind, Placebo-controlled Study of IMVT-1402 Treatment in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Immunovant Sciences GmbH

Summary

This is a Phase 2b study to evaluate the efficacy and safety of Imeroprubart in adults with CIDP.

Description

This is a multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Imeroprubart in adult participants with active CIDP.

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: * 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 immunog…

Interventions

Drug
Imeroprubart
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)

Locations (142)

Site Number - 1612
Tucson, Arizona
Site Number - 1618
Carlsbad, California
Site Number - 1637
Mission Hills, California
Site Number - 1619
Orange, California
Site Number - 1607
Rancho Mirage, California
Site Number -1608
San Francisco, California