A Phase 3 Study in Mild to Severe Generalized Myasthenia Gravis
Research type
Research Study
Full title
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
IRAS ID
1010828
Contact name
Ron Chamrin
Contact email
Sponsor organisation
Immunovant Sciences GmbH
Clinicaltrials.gov Identifier
Research summary
Generalized myasthenia gravis affects the muscles that people can control. The muscles in our bodies need signals from our nerves to work properly. Many people with generalized myasthenia gravis have harmful proteins in the blood called autoantibodies that can block the signals from their nerves to their muscles. This causes their muscles to feel weak and get tired easily.
This study will test a new treatment for generalized myasthenia gravis called IMVT-1402. Participants will take study treatment along with their current medication(s) to treat generalized myasthenia gravis. IMVT-1402 may help the bodyʼs muscles get the signals they need to work properly.
This study will compare IMVT-1402 to a placebo to assess how well IMVT-1402 treatment works for generalized myasthenia gravis.
This study has three parts:
• Screening: Researchers will check if potential participants can enter the study.
• Treatment: There are two treatment periods in this study. In Period 1, participants will take IMVT-1402 Dose 1, IMVT-1402 Dose 2, or placebo. In Period 2, participants taking IMVT-1402 will continue to take the same dose of IMVT-1402. Participants who took placebo in Period 1 will take IMVT-1402 Dose 1 in Period 2.
• Follow-up: Participants will not take any study treatment.
Participants will take either IMVT-1402 or placebo. The placebo is a look-alike substance that does not have IMVT-1402 in it. Participants will receive study treatment as a shot once a week during the treatment period. Participants will be in one of the following study treatment groups:
• IMVT-1402 Dose 1: Participants will take IMVT-1402 Dose 1 for 26 weeks.
• IMVT-1402 Dose 2: Participants will take IMVT-1402 Dose 2 for 26 weeks.
• Placebo: Participants will take placebo for 12 weeks in Period 1. Then, they will take IMVT-1402 Dose 1 for 14 weeks in Period 2.REC name
Wales REC 5
REC reference
25/WA/0259
Date of REC Opinion
16 Oct 2025
REC opinion
Further Information Favourable Opinion