Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
17 participants
INTERVENTIONAL
2019-05-21
2020-12-21
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Regimen A
RVT-1401 680 mg weekly for 6 weeks + optional open-label extension (RVT-1401, 340 mg every 2 weeks for 6 weeks)
RVT-1401
Subcutaneous administration of RVT-1401
Regimen B
RVT-1401 340 mg weekly for 6 weeks + optional open-label extension (RVT-1401, 340 mg every 2 weeks for 6 weeks)
RVT-1401
Subcutaneous administration of RVT-1401
Placebo
Placebo for 6 weeks + optional open-label extension (RVT-1401, 340 mg every 2 weeks for 6 weeks)
RVT-1401
Subcutaneous administration of RVT-1401
Placebo
Subcutaneous administration of Placebo
Interventions
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RVT-1401
Subcutaneous administration of RVT-1401
Placebo
Subcutaneous administration of Placebo
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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).
18 Years
ALL
No
Sponsors
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Immunovant Sciences GmbH
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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RVT-1401-2002
Identifier Type: -
Identifier Source: org_study_id