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
- Remibrutinib (Blinded) (drug), Placebo (other), Remibrutinib (Open Label) (drug)
- How long the study runs
- Study runs about 96 months (dates as stated)
- About the drug or intervention
- Remibrutinib (Blinded) — drug: Remibrutinib (Blinded) active treatment · Placebo — other: Placebo · Remibrutinib (Open Label) — drug: Remibrutinib (Open Label) active treatment
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years to 85 Years
- Who
- All
- Number of participants
- 180
- Started
- 2025-02-07
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for generalized myasthenia gravis
- • Phase3 - 180 participants
- • A study to evaluate the efficacy, safety and tolerability of Remibrutinib versus placebo in adult patients with Generalized Myasthenia Gravis who are on stable, standard-of-care (SOC) treatment
Who can take part?
- • Ages 18 Years to 85 Years
- • Diagnosed with generalized myasthenia gravis
Where?
- • London - Novartis Investigative Site
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
A study to evaluate the efficacy, safety and tolerability of Remibrutinib versus placebo in adult patients with Generalized Myasthenia Gravis who are on stable, standard-of-care (SOC) treatment.
More detail
This study is a randomized, double-blind, placebo-controlled, multicenter, Phase III study, to evaluate the efficacy, safety and tolerability of remibrutinib in gMG patients who are on stable SOC treatment. Approximately 180 eligible participants will be randomized in a ratio of 1:1, to receive either remibrutinib or matching placebo. The study consists of a Core Part (6-months double-blind treatment) and an Extension Part (up to 60-month open-label treatment).
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 - 85 Years
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Adult patients with gMG (age 18-85 years)
- ✓Confirmed diagnosis of Myasthenia Gravis Foundation of America (MGFA) Class II-IV gMG at screening and likely not in...
- ✓Documented evidence of positive serologic testing for AChR+ antibody or MuSK+ antibody at screening, OR seronegative...
- ✓Baseline MG-ADL score ≥ 6 with ≥ 50% of the total score due to non ocular symptoms
- ✓Participants who have been receiving a standard-of-care treatment as specified in the protocol
Who cannot take part
- ✗Other protocol-defined inclusion/exclusion criteria may apply.
See the full criteria
Where Is This Study? (1 UK site)
Novartis Investigative Site
London SW17 0QT, United Kingdom
