Tests IMVT-1402 in adults with generalized myasthenia gravis
Tests the drug IMVT-1402 against placebo in adults with generalized myasthenia gravis.
Key facts
- Who runs it
- Immunovant Sciences GmbH
- Where
- Belgrade and Niš, SerbiaSee the 2 sitesAlso in 14 other countries, 95 sites
- Trial code
- Registry title
- Study to Assess the Efficacy and Safety of IMVT-1402 in Participants With Mild to Severe Generalized Myasthenia Gravis
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 231 people, planned
- Started
- 27 May 2025
- Expected to end
- Dec 2028
- Type of study
- Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- IMVT-1402
- Placebo
- Record updated
- 13 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with mild to severe generalized myasthenia gravis (gMG), a condition that causes muscle weakness.
- Age
- 18 to 80 years
- Sex
- Men and women can join.
- Disease stage
- Mild to severe generalized myasthenia gravis, MGFA Class II, III, or IVa at the Screening Visit. MG-ADL score of 6 or higher at the Screening Visit and Baseline Visit (Day 1).
Main reasons for not taking part
- Myasthenic crisis within 12 weeks before the Screening Visit
- Thymectomy less than 6 months before the Screening Visit, or one planned during the study
- Active or untreated malignant thymoma
The registry criteria, word for word
Show all 6 criteriaShow less
Who can take part
- 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 II, III, or IVa 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
Who cannot take part
- Have experienced myasthenic crisis within 12 weeks prior to the Screening Visit
- Have had a thymectomy performed < 6 months prior to the Screening Visit or have a planned thymectomy during the study
- Have any active or untreated malignant thymoma; Additional exclusion criteria are defined in the protocol
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Where in Serbia
Also in 14 other countries, 95 sites
- BelgradeHospital not named in the registryTaking people
- NišHospital not named in the registryTaking people
About the trial
What the trial wants to find out
The purpose of the study is to assess the efficacy, safety and tolerability of IMVT-1402 in adult participants with mild to severe generalized myasthenia gravis.
The 3 groups in the trial
- Group 1: IMVT-1402 Dose 1Treatment being tested
Treatment: IMVT-1402
- Group 2: IMVT-1402 Dose 2Treatment being tested
Treatment: IMVT-1402
- Placebo/ IMVT-1402Placebo, for comparison
Treatment: Placebo and IMVT-1402
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official 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
- Plain-language title
- Tests IMVT-1402 in adults with generalized myasthenia gravisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Fit questions
- Built from NCT07039916, who can take part
- Record updated
- 13 November 2026