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

ClinicalTrials.gov ID: NCT03863080

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Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT03863080
Recruitment status: Completed
Study type: Interventional
Phase: Phase 2
Lead sponsor: Immunovant Sciences GmbH; Industry
Enrollment: 17 participants

Conditions and interventions

Conditions

Myasthenia Gravis

Interventions

RVT-1401 Drug
Placebo Drug

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: May 21, 2019 (Actual)
Primary completion: Oct 7, 2020 (Actual)
Completion: Dec 21, 2020 (Actual)
Last update posted: Dec 20, 2023

2019 – 2020

United States locations

U.S. sites: 15
U.S. states: 11
U.S. cities: 15

Facility	City	State	ZIP	Site status
IMC/Diagnostic and Medical Clinic	Mobile	Alabama	36604	—
Phoenix Neurological Associates	Phoenix	Arizona	85018	—
The Neurology Center of Southern California	Carlsbad	California	92011	—
UC Irvine - MDA ALS and Neuromuscular Center	Orange	California	92868	—
Care Access Research	Pasadena	California	91101	—
CSNA	Colorado Springs	Colorado	80907	—
Yale School of Medicine Department of Neurology	New Haven	Connecticut	06510	—
Neurological Services of Orlando	Orlando	Florida	32806	—
Rare Disease Research	Atlanta	Georgia	30318	—
University of Minnesota - Department of Neurology	Minneapolis	Minnesota	55455	—
Dent Institute	Amherst	New York	14221	—
University of Buffalo	Buffalo	New York	14260-1660	—
Hospital for Special Surgery	New York	New York	10021	—
Allegheny Neurological Associates	Pittsburgh	Pennsylvania	15212	—
UTSW James W. Aston Ambulatory Care Center - Neurology Clinic	Dallas	Texas	75390	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 5 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT03863080, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Dec 20, 2023 · Synced Nov 12, 2026