A Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of IMVT-1402 in Patients With Mild to Severe Generalized Myasthenia Gravis
Status: Recruiting
Location: See all (21) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
This is a 26-week study to assess the efficacy, safety and tolerability of IMVT-1402 in adult participants with mild to severe generalized myasthenia gravis.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Participants with the ability to understand the requirements of the trial, provide written informed consent, and comply with the trial protocol procedures.
• Have mild to severe gMG by Myasthenia Gravis Foundation of America (MGFA) classification of Class I, II, III, or IV at the Screening Visit
• Have an MG activities of daily living (MG-ADL) score of ≥ 6 at the Screening Visit and Baseline Visit (Day 1)
⁃ Additional inclusion criteria are defined in the protocol.
Locations
United States
Arizona
Site Number - 1017
RECRUITING
Phoenix
Site Number - 1025
RECRUITING
Scottsdale
California
Site Number - 1010
RECRUITING
Carlsbad
Site Number - 1029
RECRUITING
Rancho Mirage
Site Number - 1004
RECRUITING
San Francisco
Colorado
Site Number - 1027
RECRUITING
Fort Collins
Washington, D.c.
Site Number - 1024
RECRUITING
Washington D.c.
Florida
Site Number - 1006
RECRUITING
Clearwater
Site Number - 1037
RECRUITING
Ormond Beach
Site Number - 1002
RECRUITING
Port Charlotte
Georgia
Site Number - 1014
RECRUITING
Atlanta
Michigan
Site Number - 1005
RECRUITING
East Lansing
North Carolina
Site Number - 1020
RECRUITING
Chapel Hill
Site Number - 1013
RECRUITING
Durham
New Jersey
Site Number - 1019
RECRUITING
Totowa
New York
Site Number - 1034
RECRUITING
New York
Oklahoma
Site Number - 1011
RECRUITING
Yukon
Oregon
Site Number - 1031
RECRUITING
Eugene
South Carolina
Site Number - 1015
RECRUITING
Charleston
Texas
Site Number - 1003
RECRUITING
Dallas
Virginia
Site Number - 1009
RECRUITING
Charlottesville
Contact Information
Primary
Central Study Contact
clinicaltrials@immunovant.com
18007970414
Time Frame
Start Date: 2025-05-27
Estimated Completion Date: 2027-12
Participants
Target number of participants: 231
Treatments
Experimental: Group 1: IMVT-1402 Dose 1
Experimental: Group 2: IMVT-1402 Dose 2
Placebo_comparator: Placebo/ IMVT-1402
Related Therapeutic Areas
Sponsors
Leads: Immunovant Sciences GmbH