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Myasthenia gravis drug trial halted early – only 6 patients enrolled

NCT ID NCT05132569

Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026

Summary

This study tested tolebrutinib, an oral drug, in adults with moderate-to-severe generalized myasthenia gravis. The trial was a Phase 3, double-blind, placebo-controlled study that planned to enroll many participants but was terminated early with only 6 people enrolled. Because it stopped so early, there is no reliable information on whether tolebrutinib helps or is safe for this condition.

What this could mean

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

Active substance
Tolebrutinib (oral tablet)
What could go wrong
The trial was terminated early with only 6 participants, so no conclusions can be drawn about safety or effectiveness. This drug may not work for myasthenia gravis.

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

6 people

The number who actually took part.

Started

Dec 2021

Finished

Feb 2023

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: * Participants were 18 years of age to 85 years of age inclusive, at the time of signing the informed consent. * Participants with a diagnosis of gMG at screening with generalized muscle weakness meeting the clinical criteria for diagnosis of MG, as defined by the myasthenia gravis foundation of America (MGFA) Clinical Classification Class II, III, or IV, and likely not in need of a respirator for the duration of the study, as judged by the Investigator. * Positive serologic testing for anti-acetylcholine receptor (anti-AChR) or anti-muscle-specific kinase (anti-MuSK) autoantibody at screening OR * Seronegative for both anti-AChR and anti-MuSK autoantibodies and with prior diagnosis supported by greater than or equal to (\>=) 1 of the following 3 tests: 1. History of abnormal neuromuscular transmission demonstrated by single-fiber electromyography or repetitive nerve stimulation. 2. History of positive edrophonium chloride test. 3. Participant had demonstrated improvement in gMG signs on oral acetylcholinesterase inhibitors as assessed by the treating physician. * The participant had a total score \>=6 on myasthenia gravis-activities of daily living scale at screening and Day 1 with greater than half of the score attributed to non-ocular items. Exclusion Criteria: * MGFA Class I (ocular MG) or Class V. * Participants had undergone thymectomy within 6 months of screening or having a planned thymectomy during the trial period. * The participant had a history of infection or might be at risk for infection: A history of active or latent tuberculosis (TB); Participants at risk of developing or having reactivation of hepatitis; Persistent chronic or active recurring infection required treatment with antibiotics, antivirals, or antifungals; Fever within 4 weeks of the Screening Visit (\>=38 degree Celsius; however, if due to brief and mild ear, nose, throat viral infection participant might be included based on the Investigator's judgment); A history of infection with human immunodeficiency virus (HIV); A history of T-lymphocyte or T-lymphocyte-receptor vaccination, transplantation (including solid organ, stem cell, and bone marrow transplantation) and/or antirejection therapy. * Any malignancy within the past 5 years prior Screening Visit (except for effectively treated carcinoma in situ of the cervix, adequately treated non-metastatic squamous or basal cell carcinoma of the skin and malignant thymoma that had been resected or were considered as cured by any treatment with no evidence of metastatic disease for \>=3 years) will be exclusionary. * Conditions that might predispose the participant to excessive bleeding. * Clinically significant laboratory abnormalities (including evidence of liver injury) or electrocardiogram abnormalities at Screening. The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

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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.

Myasthenia gravis

Contacts and locations

Locations

  • Georgetown University-Site Number:8400008

    Washington D.C., District of Columbia, 20007, United States

  • Harvard Medical School - Brigham and Women's Hospital-Site Number:8400004

    Boston, Massachusetts, 02115, United States

  • Investigational Site Number :1240003

    London, Ontario, N6A 5A5, Canada

  • Investigational Site Number :1240004

    Edmonton, Alberta, T6G 2B7, Canada

  • Investigational Site Number :1560001

    Shanghai, 200040, China

  • Investigational Site Number :1560002

    Wuhan, 430030, China

  • Investigational Site Number :1560003

    Chengdu, 610041, China

  • Investigational Site Number :3480001

    Szeged, 6725, Hungary

  • Investigational Site Number :3480002

    Pécs, 7623, Hungary

  • Investigational Site Number :3800001

    Milan, 20132, Italy

  • Investigational Site Number :3800002

    Milan, Lombardy, 20133, Italy

  • Investigational Site Number :3800003

    Roma, 00168, Italy

  • Investigational Site Number :3800004

    Naples, 80131, Italy

  • Investigational Site Number :3920002

    Sagamihara-shi, Kanagawa, 252-0392, Japan

  • Investigational Site Number :6160001

    Zabrze, 41-800, Poland

  • Investigational Site Number :7240003

    L'Hospitalet de Llobregat, Catalunya [Cataluña], 08907, Spain

  • Investigational Site Number :7240005

    Madrid, Madrid, Comunidad de, 28046, Spain

  • Investigational Site Number :8260001

    Liverpool, L9 7LJ, United Kingdom

  • Investigational Site Number :8260002

    Exeter, Devon, EX2 5DW, United Kingdom

  • Neurology Center of San Antonio, PA-Site Number:8400009

    San Antonio, Texas, 00000, United States

  • SFM Clinical Research, LLC-Site Number:8400006

    Boca Raton, Florida, 33487, United States

  • University of South Florida Health- Morsani Center for Advanced Healthcare-Site Number:8400001

    Tampa, Florida, 33612-6601, United States

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