Tests IMVT-1402 in adults with generalized myasthenia gravis
Tests the drug IMVT-1402 against placebo in adults with generalized myasthenia gravis.
Plain-language title generated from the registry record
Registry title: Study to Assess the Efficacy and Safety of IMVT-1402 in Participants With Mild to Severe Generalized Myasthenia Gravis
Key facts
- Where
- Brasov, Constanta, and Târgu Mureş, RomaniaSee the 3 sites
- Phase
- Phase 3
AI summary: who the study is looking for
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
Read by machine on 9 November 2026.
Could this be for you?
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?
Source: NCT07039916, who can take part
Where in Romania
- Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L.Brasov, RomaniaTaking people
- Brainaxy Clinic S.R.L.Constanta, RomaniaTaking people
- Spitalul Clinic Judetean de Urgenta Targu MuresTârgu Mureş, RomaniaTaking people
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?
Trial details
- Who runs it
- Immunovant Sciences GmbH
- Trial code
- NCT07039916EU 2024-515979-35-00
- Record updated
- 30 July 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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.
Exclusion: 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.