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ACTIVE NOT RECRUITINGPhase3

A Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib Versus Placebo in Adult Patients With Generalized Myasthenia Gravis

Sponsor: Novartis Pharmaceuticals

NCT ID: NCT06744920

View on ClinicalTrials.gov ↗

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).

Generalized Myasthenia Gravis

How this trial compares with your answers

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What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

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

evidence of positive

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
Inclusion Criteria: * 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 need of a respirator for the duration of the study, as judged by the Investigator * Documented evidence of positive serologic testing for AChR+ antibody or MuSK+ antibody at screening, OR seronegative for both AChR and MuSK antibodies at screening * 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 * Able to safely swallow the study medication according to investigator clinical judgement based on a bedside swallowing test or another formal swallowing test in line with local practice, both at Screening and Baseline Exclusion Criteria: * Prior to baseline have been treated with intravenous immunoglobulins or plasma exchange (IVIg/PLEX) in the past month, with rituximab in the past 6 months, eculizumab in the past 2 months, ravulizumab or other complement inhibitors in the past 3 months, efgartigimod or other anti-FcRn therapies in the past 3 months, or had a thymectomy in the past 6 months or a planned thymectomy during the trial period * Women of child bearing potential, defined as all women physiologically capable of becoming pregnant, from menarche until becoming post-menopausal, unless they are using highly effective methods of contraception during dosing and for 1 week after stopping of study treatment Other protocol-defined inclusion/exclusion criteria may apply.

Where Is This Study? (1 UK site)

Novartis Investigative Site

London SW17 0QT, United Kingdom

Data sourced from ClinicalTrials.gov · Last verified: 2026-09