A Study of RVT-1401 in Myasthenia Gravis Patients



Status:Not yet recruiting
Conditions:Neurology, Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - Any
Updated:4/3/2019
Start Date:March 2019
End Date:February 2020
Contact:Lori Jones
Email:lori.jones@immunovant.com
Phone:919-767-3282

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

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.


Inclusion Criteria:

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.

Exclusion Criteria:

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
We found this trial at
6
sites
Minneapolis, Minnesota 55455
Principal Investigator: Allen
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Minneapolis, MN
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5090 N 40th St # 250
Phoenix, Arizona 85018
Principal Investigator: Todd Levine
Phone: 602-258-2863
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Phoenix, AZ
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Buffalo, New York 14215
Principal Investigator: Silvestri
Phone: 716-829-5037
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Buffalo, NY
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Dallas, Texas 75390
Principal Investigator: Shaida
Phone: 214-645-8800
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Dallas, TX
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Edmonton, Alberta
Principal Investigator: Siddiqi
Phone: 780-492-0695
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Edmonton,
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535 E 70th St
New York, New York 10021
(212) 606-1000
Principal Investigator: Lange
Phone: 646-797-8917
Hospital for Special Surgery Founded in 1863, Hospital for Special Surgery is the nation
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New York, NY
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