A Study of RVT-1401 in Myasthenia Gravis (MG) Patients

Completed · Phase 2 · Has a placebo group

Conditions studied: Myasthenia Gravis

In brief

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.

Key facts

Study ID

NCT03863080

Run by

Immunovant Sciences GmbH

People needed

17

Starts

2019-05-21

Expected to finish

2020-12-21

Last updated by the study team

2023-12-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female ≥ 18 years of age.
• 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.
• QMG score ≥12 at Screening and Baseline.
• Other, more specific inclusion criteria are defined in the protocol.

You may not qualify if…

• Use of rituximab, belimumab, eculizumab or any monoclonal antibody for immunomodulation within 6 months prior to first dosing.
• Immunoglobulins given by SC, IV (IVIG), or intramuscular route, or plasmapheresis/plasma exchange (PE) within 4 weeks before Screening.
• Thymectomy performed < 12 months prior to screening.
• Total IgG level <6 g/L (at screening).
• Absolute neutrophil count <1500 cells/mm3(at screening).
• Other, more specific exclusion criteria are defined in the protocol

Where it is running

• IMC/Diagnostic and Medical Clinic — Mobile, Alabama, United States
• Phoenix Neurological Associates — Phoenix, Arizona, United States
• The Neurology Center of Southern California — Carlsbad, California, United States
• UC Irvine - MDA ALS and Neuromuscular Center — Orange, California, United States
• Care Access Research — Pasadena, California, United States
• CSNA — Colorado Springs, Colorado, United States
• Yale School of Medicine Department of Neurology — New Haven, Connecticut, United States
• Neurological Services of Orlando — Orlando, Florida, United States
• Rare Disease Research — Atlanta, Georgia, United States
• University of Minnesota - Department of Neurology — Minneapolis, Minnesota, United States
• Dent Institute — Amherst, New York, United States
• University of Buffalo — Buffalo, New York, United States
• Hospital for Special Surgery — New York, New York, United States
• Allegheny Neurological Associates — Pittsburgh, Pennsylvania, United States
• UTSW James W. Aston Ambulatory Care Center - Neurology Clinic — Dallas, Texas, United States
• University of Alberta Hospitals - Division of Pulmonary Medicine — Edmonton, Alberta, Canada
• London Health Sciences Centre — London, Ontario, Canada
• Ottawa Hospital Research Institute — Ottawa, Ontario, Canada
• University Health Network Toronto General Hospital — Toronto, Ontario, Canada
• Montreal Neurological Institute and Hospital — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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