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New drug trial aims to ease daily struggles of myasthenia gravis

NCT ID NCT06744920

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 30, 2026 · Updated 3 times

Summary

This Phase 3 study tests whether remibrutinib can improve daily function in adults with generalized myasthenia gravis, a condition that causes muscle weakness. About 180 participants will receive either the drug or a placebo for 6 months, followed by an open-label phase where everyone gets the drug. The main goal is to see if symptoms and daily activities get better.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
remibrutinib
What this could lead to
If it works, this could provide a new treatment option to control symptoms and improve daily life for people with generalized myasthenia gravis.
What could go wrong
This is a Phase 3 trial, but it is still experimental. The drug may not work better than placebo, and side effects are possible. Results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 180 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Feb 2033

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

myasthenia gravis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Generalized myasthenia gravis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    129 sites in 20 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AdventHealth

    RECRUITING

    Orlando, Florida, 32804, United States

  • California Pacific Medical Center

    RECRUITING

    Sacramento, California, 94115, United States

  • Center for Neurological Disorders G

    RECRUITING

    Greenfield, Wisconsin, 53228-1321, United States

  • Cleveland Clinic Foundation

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Dent Neurological Institute

    RECRUITING

    Buffalo, New York, 14209, United States

  • Fullerton Neuro and Headache Ctr

    RECRUITING

    Fullerton, California, 92835, United States

  • Homestead Assoc In Research Inc

    RECRUITING

    Homestead, Florida, 33033, United States

  • Honor Health Research Institute

    RECRUITING

    Scottsdale, Arizona, 85258, United States

  • Houston Methodist Hospital

    RECRUITING

    Houston, Texas, 77030, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Medstar Washington Hospital Center

    RECRUITING

    Washington D.C., District of Columbia, 20010-2975, United States

  • Michigan State University-Department of Neurology

    RECRUITING

    East Lansing, Michigan, 48824, United States

  • Mid Atlantic Epilepsy and Sleep Ctr

    RECRUITING

    Bethesda, Maryland, 20817-1807, United States

  • Neurological Services of Orlando PA

    RECRUITING

    Orlando, Florida, 32806, United States

  • Neurology Associates PA

    RECRUITING

    Maitland, Florida, 32751, United States

    Contact Email: •••••@•••••

  • Neuromuscular Research Center

    RECRUITING

    Phoenix, Arizona, 85013, United States

    Contact Email: •••••@•••••

  • Novartis Investigative Site

    RECRUITING

    Rosario, Santa Fe Province, 2000, Argentina

  • Novartis Investigative Site

    RECRUITING

    Caba, C1055AAF, Argentina

  • Novartis Investigative Site

    RECRUITING

    Capital Federal, C1023AAB, Argentina

  • Novartis Investigative Site

    RECRUITING

    San Miguel de Tucumán, T4000AXL, Argentina

  • Novartis Investigative Site

    RECRUITING

    Kogarah, New South Wales, 2217, Australia

  • Novartis Investigative Site

    RECRUITING

    Fitzroy, Victoria, 3065, Australia

  • Novartis Investigative Site

    RECRUITING

    Southport, 4215, Australia

  • Novartis Investigative Site

    RECRUITING

    Leuven, Vlaams Brabant, 3000, Belgium

  • Novartis Investigative Site

    RECRUITING

    Salvador, Estado de Bahia, 40050-410, Brazil

  • Novartis Investigative Site

    RECRUITING

    Brasília, Federal District, 70200-730, Brazil

  • Novartis Investigative Site

    RECRUITING

    Caxias do Sul, Rio Grande do Sul, 95070-560, Brazil

  • Novartis Investigative Site

    RECRUITING

    Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

  • Novartis Investigative Site

    RECRUITING

    Porto Alegre, Rio Grande do Sul, 90480-110, Brazil

  • Novartis Investigative Site

    RECRUITING

    São Paulo, São Paulo, 05403-000, Brazil

  • Novartis Investigative Site

    RECRUITING

    Edmonton, Alberta, T6G 2B7, Canada

  • Novartis Investigative Site

    RECRUITING

    London, Ontario, N6A 5W9, Canada

  • Novartis Investigative Site

    RECRUITING

    Ottawa, Ontario, K1H 8L6, Canada

  • Novartis Investigative Site

    RECRUITING

    Québec, Quebec, G1J 1Z4, Canada

  • Novartis Investigative Site

    RECRUITING

    Hefei, Anhui, 230001, China

  • Novartis Investigative Site

    RECRUITING

    Guangzhou, Guangdong, 510080, China

  • Novartis Investigative Site

    RECRUITING

    Shijiazhuang, Hebei, 50030, China

  • Novartis Investigative Site

    RECRUITING

    Zhengzhou, Henan, 450003, China

  • Novartis Investigative Site

    RECRUITING

    Wuhan, Hubei, 430030, China

  • Novartis Investigative Site

    RECRUITING

    Wuxi, Jiangsu, 214023, China

  • Novartis Investigative Site

    RECRUITING

    Changchun, Jilin, 130021, China

  • Novartis Investigative Site

    RECRUITING

    Beijing, 100034, China

  • Novartis Investigative Site

    RECRUITING

    Beijing, 100730, China

  • Novartis Investigative Site

    RECRUITING

    Qingdao, 266000, China

  • Novartis Investigative Site

    RECRUITING

    Shanghai, 200040, China

  • Novartis Investigative Site

    RECRUITING

    Shanghai, 200080, China

  • Novartis Investigative Site

    RECRUITING

    Bordeaux, 33076, France

  • Novartis Investigative Site

    RECRUITING

    Nice, 06000, France

  • Novartis Investigative Site

    RECRUITING

    Paris, 75013, France

  • Novartis Investigative Site

    RECRUITING

    Paris, 75940, France

  • Novartis Investigative Site

    RECRUITING

    Strasbourg, 67081, France

  • Novartis Investigative Site

    RECRUITING

    Toulouse, 31059, France

  • Novartis Investigative Site

    RECRUITING

    Kutaisi, 4600, Georgia

  • Novartis Investigative Site

    RECRUITING

    Tbilisi, 0114, Georgia

  • Novartis Investigative Site

    RECRUITING

    Tbilisi, 0144, Georgia

  • Novartis Investigative Site

    RECRUITING

    Frankfurt am Main, Hesse, 60590, Germany

  • Novartis Investigative Site

    RECRUITING

    Gummersbach, 51643, Germany

  • Novartis Investigative Site

    RECRUITING

    Hamburg, 20246, Germany

  • Novartis Investigative Site

    RECRUITING

    Münster, 48149, Germany

  • Novartis Investigative Site

    RECRUITING

    Gurugram, Haryana, 122011, India

  • Novartis Investigative Site

    RECRUITING

    Mangalore, Karnataka, 575002, India

  • Novartis Investigative Site

    RECRUITING

    Nashik, Maharashtra, 422005, India

  • Novartis Investigative Site

    RECRUITING

    New Delhi, National Capital Territory of Delhi, 110029, India

  • Novartis Investigative Site

    RECRUITING

    Ludhiana, Punjab, 141001, India

  • Novartis Investigative Site

    RECRUITING

    Vellore, Tamil Nadu, 632 004, India

  • Novartis Investigative Site

    RECRUITING

    Hyderabad, Telangana, 500082, India

  • Novartis Investigative Site

    RECRUITING

    Lucknow, Uttar Pradesh, 226007, India

  • Novartis Investigative Site

    RECRUITING

    Bergamo, BG, 24127, Italy

  • Novartis Investigative Site

    RECRUITING

    Orbassano, TO, 10043, Italy

  • Novartis Investigative Site

    RECRUITING

    Naples, 80131, Italy

  • Novartis Investigative Site

    RECRUITING

    Chiba, Chiba, 2608677, Japan

  • Novartis Investigative Site

    RECRUITING

    Sapporo, Hokkaido, 0608543, Japan

  • Novartis Investigative Site

    RECRUITING

    Sapporo, Hokkaido, 0630005, Japan

  • Novartis Investigative Site

    RECRUITING

    Nishinomiya, Hyōgo, 6638501, Japan

  • Novartis Investigative Site

    RECRUITING

    Hanamaki, Iwate, 0250082, Japan

  • Novartis Investigative Site

    RECRUITING

    Sendai, Miyagi, 9838520, Japan

  • Novartis Investigative Site

    RECRUITING

    Suita, Osaka, 5650871, Japan

  • Novartis Investigative Site

    RECRUITING

    Higashi-Matsuyama, Saitama, 355-0005, Japan

  • Novartis Investigative Site

    RECRUITING

    Koshigaya, Saitama, 343-8555, Japan

  • Novartis Investigative Site

    RECRUITING

    Shinjuku Ku, Tokyo, 160-0023, Japan

  • Novartis Investigative Site

    RECRUITING

    Fukuoka, 8128582, Japan

  • Novartis Investigative Site

    RECRUITING

    Fukushima, 9601295, Japan

  • Novartis Investigative Site

    RECRUITING

    Hiroshima, 7348551, Japan

  • Novartis Investigative Site

    RECRUITING

    Lublin, Lublin Voivodeship, 20-064, Poland

  • Novartis Investigative Site

    RECRUITING

    Lublin, Lublin Voivodeship, 20-080, Poland

  • Novartis Investigative Site

    RECRUITING

    Krakow, POL, 31-505, Poland

  • Novartis Investigative Site

    RECRUITING

    Bydgoszcz, Woj Kujawsko Pomorskie, 85-796, Poland

  • Novartis Investigative Site

    RECRUITING

    Bydgoszcz, 85-065, Poland

  • Novartis Investigative Site

    RECRUITING

    Katowice, 40-689, Poland

  • Novartis Investigative Site

    RECRUITING

    Lodz, 93-113, Poland

  • Novartis Investigative Site

    RECRUITING

    Lublin, 20-410, Poland

  • Novartis Investigative Site

    RECRUITING

    Lublin, 20-701, Poland

  • Novartis Investigative Site

    RECRUITING

    Poznan, 61-731, Poland

  • Novartis Investigative Site

    RECRUITING

    Rzeszów, 35-323, Poland

  • Novartis Investigative Site

    RECRUITING

    Skorzewo, 60-185, Poland

  • Novartis Investigative Site

    RECRUITING

    Szczecin, 71-252, Poland

  • Novartis Investigative Site

    RECRUITING

    Warsaw, 01-684, Poland

  • Novartis Investigative Site

    RECRUITING

    Warsaw, 02-172, Poland

  • Novartis Investigative Site

    RECRUITING

    Brasov, 500283, Romania

  • Novartis Investigative Site

    RECRUITING

    Bucharest, 040215, Romania

  • Novartis Investigative Site

    RECRUITING

    Sibiu, 550245, Romania

  • Novartis Investigative Site

    RECRUITING

    Belgrade, 11000, Serbia

  • Novartis Investigative Site

    RECRUITING

    Niš, 18108, Serbia

  • Novartis Investigative Site

    RECRUITING

    Novi Sad, 21000, Serbia

  • Novartis Investigative Site

    RECRUITING

    Seoul, Seoul, 03080, South Korea

  • Novartis Investigative Site

    RECRUITING

    Busan, 49241, South Korea

  • Novartis Investigative Site

    RECRUITING

    Seoul, 03722, South Korea

  • Novartis Investigative Site

    RECRUITING

    Seoul, 134 727, South Korea

  • Novartis Investigative Site

    RECRUITING

    Santiago Compostela, A Coruna, 15706, Spain

  • Novartis Investigative Site

    RECRUITING

    L'Hospitalet de Llobregat, Barcelona, 08907, Spain

  • Novartis Investigative Site

    RECRUITING

    Barcelona, 08035, Spain

  • Novartis Investigative Site

    RECRUITING

    Lleida, 25198, Spain

  • Novartis Investigative Site

    RECRUITING

    Madrid, 28034, Spain

  • Novartis Investigative Site

    RECRUITING

    Málaga, 29010, Spain

  • Novartis Investigative Site

    RECRUITING

    Valencia, 46026, Spain

  • Novartis Investigative Site

    RECRUITING

    Kaohsiung City, 833, Taiwan

  • Novartis Investigative Site

    RECRUITING

    Tainan, 704302, Taiwan

  • Novartis Investigative Site

    RECRUITING

    Taipei, 10002, Taiwan

  • Novartis Investigative Site

    RECRUITING

    Taipei, 111045, Taiwan

  • Novartis Investigative Site

    RECRUITING

    Taoyuan, 33305, Taiwan

  • Novartis Investigative Site

    WITHDRAWN

    London, NW1 2BU, United Kingdom

  • Novartis Investigative Site

    RECRUITING

    London, SW17 0QT, United Kingdom

  • SFM Clinical Research LLC

    RECRUITING

    Boca Raton, Florida, 33487, United States

  • UT Health Science Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Univ Cali Irvine ALS Neuromuscular

    RECRUITING

    Orange, California, 92868, United States

  • Univ of Cincinnati Medical Center

    RECRUITING

    Cincinnati, Ohio, 45219, United States

  • University Of Southern California

    RECRUITING

    Los Angeles, California, 90033, United States

  • University of Chicago Medical Centr

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Pittsburgh Medical Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • University of WA Division of Cardio

    RECRUITING

    Seattle, Washington, 98195, United States

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