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New drug trial aims to ease muscle weakness in myasthenia gravis

NCT ID NCT07250750

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new medicine called IM-101 for adults with myasthenia gravis, a disease that causes muscle weakness. The trial has two parts: first, checking safety and dosing in people with a specific antibody type, then testing how well it works in broader groups. About 96 participants will receive either IM-101 or a placebo to see if it improves daily activities and eye symptoms.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 96 people

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

Started

Feb 2026

Expected to finish

Jun 2028

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 74 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: 1. Able and willing to provide signed informed consent 2. Willingness to consent to screening for genetic muscular diseases 3. Male or female aged ≥ 18 years and \< 75 years 4. Diagnosed with MG 5. On a stable dose of background therapy for the treatment of MG 6. Body weight ≥ 40 kg at screening 7. Vaccinated against meningococcal infection (Neisseria meningitidis), streptococcus pneumoniae, and haemophilus influenzae type B Exclusion Criteria: 1. Previous exposure to IM-101 2. Anti-MuSK antibody Positive 3. History of malignant thymoma, or history of cancer within the past 5 years of screening 4. History of N. meningitidis infection 5. Has been treated with any complement inhibitor, but failed due to intolerability or lack of efficacy Full eligibility criteria is available in the study protocol.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

    25 sites in 6 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • "MHAT Avis - Medica" OOD

    NOT_YET_RECRUITING

    Pleven, 5800, Bulgaria

  • Aqualane Clinical Research

    RECRUITING

    Naples, Florida, 34105, United States

  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)

    NOT_YET_RECRUITING

    Brescia, Brescia, 25123, Italy

  • Clinica Universidad de Navarra

    NOT_YET_RECRUITING

    Pamplona, Navarre, 31008, Spain

  • Fondazione IRCCS Istituto Neurologico Carlo Besta

    NOT_YET_RECRUITING

    Milan, Milano, 20133, Italy

  • General Hospital MSB Medical System Belgrade

    NOT_YET_RECRUITING

    Belgrade, 11000, Serbia

  • Haelan Care 4 Medical Center EOOD

    NOT_YET_RECRUITING

    Varna, 9009, Bulgaria

  • Hospital Universitario Clinico San Carlos

    NOT_YET_RECRUITING

    Madrid, Madrid, 28040, Spain

  • Hospital Universitario La Paz

    NOT_YET_RECRUITING

    Madrid, Madrid, 28046, Spain

  • Houston Methodist Neurological Institute

    NOT_YET_RECRUITING

    Houston, Texas, 77070, United States

  • Medical Center Hera - branch Montana

    NOT_YET_RECRUITING

    Montana, 3400, Bulgaria

  • Medsol Clinical Research Center

    NOT_YET_RECRUITING

    Port Charlotte, Florida, 33952, United States

  • NZOZ Neuro-Kard Ilkowski i Partnerzy Spółka Partnerska Lekarzy

    NOT_YET_RECRUITING

    Poznan, 61-853, Poland

  • Nerve & Muscle Center of Texas

    RECRUITING

    Houston, Texas, 77030, United States

  • Neurologia Slaska Centrum Medyczne

    NOT_YET_RECRUITING

    Katowice, 40-689, Poland

  • Neurology of Central Florida Research Center, LLC

    RECRUITING

    Altamonte Springs, Florida, 32714, United States

    Contact Email: •••••@•••••

  • Ospedale San Raffaele

    NOT_YET_RECRUITING

    Milan, Milano, 20132, Italy

  • SFM Clinical Research, LLC

    RECRUITING

    Boca Raton, Florida, 33487, United States

  • Samodzielny Publiczny Szpital Kliniczny nr 1 im. Prof. Stanislawa Szyszko, SUM

    NOT_YET_RECRUITING

    Zabrze, 41-800, Poland

  • Twoja Przychodnia NCM

    NOT_YET_RECRUITING

    Nowa Sól, 67-100, Poland

  • Twoja Przychodnia PCM

    NOT_YET_RECRUITING

    Poznan, 60-324, Poland

  • UMHAT 'Dr. Georgi Stranski', EAD

    NOT_YET_RECRUITING

    Pleven, 5800, Bulgaria

  • UMHAT 'Tsaritsa Yoanna - ISUL', EAD

    NOT_YET_RECRUITING

    Sofia, 1527, Bulgaria

  • University of Kansas Medical Center Research Institute, Inc.

    NOT_YET_RECRUITING

    Kansas City, Missouri, 66103, United States

  • University of South Florida

    NOT_YET_RECRUITING

    Tampa, Florida, 33612, United States

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