Status:
COMPLETED
A Study of RVT-1401 in Myasthenia Gravis (MG) Patients
Lead Sponsor:
Immunovant Sciences GmbH
Conditions:
Myasthenia Gravis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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-...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
May 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 21 2020
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT03863080
Start Date
May 21 2019
End Date
December 21 2020
Last Update
December 20 2023
Active Locations (20)
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1
IMC/Diagnostic and Medical Clinic
Mobile, Alabama, United States, 36604
2
Phoenix Neurological Associates
Phoenix, Arizona, United States, 85018
3
The Neurology Center of Southern California
Carlsbad, California, United States, 92011
4
UC Irvine - MDA ALS and Neuromuscular Center
Orange, California, United States, 92868