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
- Copenhagen Oe, DenmarkSee the site
- Phase
- Phase 3
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 Denmark
- RigshospitaletCopenhagen Oe, DenmarkTaking 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.