New drug trial aims to ease muscle weakness in myasthenia gravis
NCT ID NCT07250750
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 96 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 74 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
25 sites in 6 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
Show contact details
Enter your email to view the contact information for this study.
Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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"MHAT Avis - Medica" OOD
NOT_YET_RECRUITINGPleven, 5800, Bulgaria
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Aqualane Clinical Research
RECRUITINGNaples, Florida, 34105, United States
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Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
NOT_YET_RECRUITINGBrescia, Brescia, 25123, Italy
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Clinica Universidad de Navarra
NOT_YET_RECRUITINGPamplona, Navarre, 31008, Spain
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Fondazione IRCCS Istituto Neurologico Carlo Besta
NOT_YET_RECRUITINGMilan, Milano, 20133, Italy
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General Hospital MSB Medical System Belgrade
NOT_YET_RECRUITINGBelgrade, 11000, Serbia
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Haelan Care 4 Medical Center EOOD
NOT_YET_RECRUITINGVarna, 9009, Bulgaria
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Hospital Universitario Clinico San Carlos
NOT_YET_RECRUITINGMadrid, Madrid, 28040, Spain
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Hospital Universitario La Paz
NOT_YET_RECRUITINGMadrid, Madrid, 28046, Spain
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Houston Methodist Neurological Institute
NOT_YET_RECRUITINGHouston, Texas, 77070, United States
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Medical Center Hera - branch Montana
NOT_YET_RECRUITINGMontana, 3400, Bulgaria
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Medsol Clinical Research Center
NOT_YET_RECRUITINGPort Charlotte, Florida, 33952, United States
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NZOZ Neuro-Kard Ilkowski i Partnerzy Spółka Partnerska Lekarzy
NOT_YET_RECRUITINGPoznan, 61-853, Poland
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Nerve & Muscle Center of Texas
RECRUITINGHouston, Texas, 77030, United States
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Neurologia Slaska Centrum Medyczne
NOT_YET_RECRUITINGKatowice, 40-689, Poland
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Neurology of Central Florida Research Center, LLC
RECRUITINGAltamonte Springs, Florida, 32714, United States
Contact Email: •••••@•••••
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Ospedale San Raffaele
NOT_YET_RECRUITINGMilan, Milano, 20132, Italy
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SFM Clinical Research, LLC
RECRUITINGBoca Raton, Florida, 33487, United States
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Samodzielny Publiczny Szpital Kliniczny nr 1 im. Prof. Stanislawa Szyszko, SUM
NOT_YET_RECRUITINGZabrze, 41-800, Poland
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Twoja Przychodnia NCM
NOT_YET_RECRUITINGNowa Sól, 67-100, Poland
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Twoja Przychodnia PCM
NOT_YET_RECRUITINGPoznan, 60-324, Poland
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UMHAT 'Dr. Georgi Stranski', EAD
NOT_YET_RECRUITINGPleven, 5800, Bulgaria
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UMHAT 'Tsaritsa Yoanna - ISUL', EAD
NOT_YET_RECRUITINGSofia, 1527, Bulgaria
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University of Kansas Medical Center Research Institute, Inc.
NOT_YET_RECRUITINGKansas City, Missouri, 66103, United States
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University of South Florida
NOT_YET_RECRUITINGTampa, Florida, 33612, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Could targeted exercises turn down fatigue in myasthenia gravis?
- Can tracking daily life unlock myasthenia gravis mysteries?
- Can engineered immune cells tame a debilitating autoimmune disease?
- Can pregnancy and neurological disease coexist safely? a new registry seeks answers
- Can DNA reveal the roots of a rare muscle disease?
- Can a simple blood test unlock the secrets of brain autoimmune diseases?