At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- IMVT-1402 (drug), IMVT-1402 (drug), Placebo (drug), IMVT-1402 (drug)
- How long the study runs
- Study runs about 43 months (dates as stated)
- About the drug or intervention
- IMVT-1402 — drug: • Dose 1 subcutaneous (SC) once weekly (QW) for 12 weeks (Period 1) · IMVT-1402 — drug: * Dose 2 SC QW for 12 weeks (Period 1) * Dose 2 SC QW for 14 weeks (Period 2) * Dose 2 SC QW for 52 weeks (Period 3) · Placebo — drug: • Placebo SC QW for 12 weeks (Period 1) · IMVT-1402 — drug: * Dose 1 SC QW for 14 weeks (Period 2) * Dose 1 SC QW for 52 weeks (Period 3)
- Patient visit burden
- Not specified by the sponsor
In plain English
This trial is testing a medicine called IMVT-1402 in people with mild to severe generalized myasthenia gravis (often shortened to gMG). The researchers want to find out how well the medicine works and how safe it is. The trial is run and paid for by Immunovant Sciences GmbH.
Who can take part
- You are able to understand what the trial involves, sign a consent form, and follow the trial's procedures.
- You have mild to severe generalized myasthenia gravis, class II, III or IVa on the Myasthenia Gravis Foundation of America (MGFA) scale, checked at the screening visit.
- You score 6 or more on the myasthenia gravis activities of daily living (MG-ADL) scale at the screening visit and at the baseline visit (Day 1).
- There are further rules in the study plan — ask the trial team about these.
Who may not be able to
- You have had a myasthenic crisis within the 12 weeks before the screening visit.
- You had surgery to remove the thymus gland (a thymectomy) less than 6 months before the screening visit, or you have this surgery planned during the study.
- You have an active or untreated malignant (cancerous) thymoma.
- There are further rules in the study plan — ask the trial team about these.
What taking part involves
- • Not stated — ask the trial team
Time commitment: Not stated — ask the trial team about how many visits there are, how long the trial lasts, and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years to 80 Years
- Who
- All
- Number of participants
- 231
- Started
- 2025-05-27
- Last checked
- 2026-07
Plain English Summary
What is this study?
- • Testing a new treatment for generalized myasthenia gravis
- • Phase3 - 231 participants
- • 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
Who can take part?
- • Ages 18 Years to 80 Years
- • Diagnosed with generalized myasthenia gravis
Where?
- • Birmingham - Site Number - 7003
- • Glasgow - Site Number - 7002
- • London - Site Number - 7004
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 80 Years
- Who can join: All genders
What the study is looking for
- ✓Participants with the ability to understand the requirements of the trial, provide written agreement to take part, and...
- ✓Have mild to severe gMG by Myasthenia Gravis Foundation of America (MGFA) classification of Class II, III, or IVa at...
- ✓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.
See the full criteria
Where Is This Study? (3 UK sites)
Site Number - 7003
Birmingham B15 2GW, United Kingdom
Site Number - 7002
Glasgow G51 4TF, United Kingdom
Site Number - 7004
London WC1N 3BG, United Kingdom
How to Get in Touch
Central Study Contact
Sponsor contactCONTACT