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 IMVT-1402 in adults with CIDP.
Description
This is a multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of IMVT-1402 in adult participants with active CIDP.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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…
Interventions
- DrugIMVT-1402
Dose 1 subcutaneous (SC) once weekly (QW) for 24 weeks (Period 1) and 52 weeks (Period 2)
- DrugPlacebo
Matching placebo SC QW for 24 weeks (Period 1)
Locations (135)
- Site Number - 1612Tucson, Arizona
- Site Number - 1618Carlsbad, California
- Site Number - 1619Orange, California
- Site Number - 1607Rancho Mirage, California
- Site Number -1608San Francisco, California
- Site Number - 1626Parker, Colorado