Summary

for people ages 18 years and up (full criteria)
at Orange, California and other locations
study started
estimated completion

Description

Summary

The purpose of the current study is to assess safety/tolerability and key pharmacodynamic (PD) effects that are considered to be associated with clinical benefit (reduction of total IgG and anti-AChR-IgG) in Myasthenia Gravis patients following treatment with RVT-1401 (also known as IMVT-1401) compared to placebo.

Official Title

A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With an Open-Label Extension of RVT-1401 in Myasthenia Gravis Patients

Keywords

Myasthenia Gravis IMVT-1401 Muscle Weakness RVT-1401

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Male or female ≥ 18 years of age.
  2. Myasthenia Gravis Foundation of America (MGFA) Class II-IVa and likely not in need of a respirator for the duration of the study as judged by the Investigator.
  3. QMG score ≥12 at Screening and Baseline.

Other, more specific inclusion criteria are defined in the protocol.

You CAN'T join if...

  1. Use of rituximab, belimumab, eculizumab or any monoclonal antibody for immunomodulation within 6 months prior to first dosing.
  2. Immunoglobulins given by SC, IV (IVIG), or intramuscular route, or plasmapheresis/plasma exchange (PE) within 4 weeks before Screening.
  3. Thymectomy performed < 12 months prior to screening.
  4. Total IgG level <6 g/L (at screening).
  5. Absolute neutrophil count <1500 cells/mm3(at screening).

Other, more specific exclusion criteria are defined in the protocol

Locations

  • UC Irvine - MDA ALS and Neuromuscular Center not yet accepting patients
    Orange California 92868 United States
  • Phoenix Neurological Associates accepting new patients
    Phoenix Arizona 85018 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Immunovant Sciences GmbH
ID
NCT03863080
Phase
Phase 2
Study Type
Interventional
Last Updated