A study of IM-101 in adults with generalized myasthenia gravis or ocular myasthenia gravis

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What is this study about?

This study is being conducted to investigate the safety and effectiveness of the drug IM-101 in adults living with Myasthenia Gravis. This condition is a disease that causes weakness in the muscles, which can affect how a person moves, speaks, or breathes. The study focuses on two specific types: Generalized Myasthenia Gravis, where muscle weakness affects many parts of the body, and Ocular Myasthenia Gravis, which primarily affects the muscles that control the eyes. Some participants may also have specific AChR antibodies, which are proteins in the blood that contribute to the disease.

Participants in the study will receive either IM-101 or a placebo, which is a substance that does not contain active medication, through an intravenous injection, a method where medicine is delivered directly into a vein. The research will involve different groups of people receiving various amounts of the medication to see how the body processes it and how it affects the disease. The study aims to determine if the treatment is safe, how well it is tolerated, and if it helps improve muscle strength and daily activities over a set period of time.

Who Can Join the Study?

You must be able and willing to provide signed informed consent, which is a written agreement to participate in the study after being fully informed of all details.
You must be able to travel to the study locations for scheduled visits.
Women who may become pregnant and men who have not had a vasectomy (a surgery to prevent pregnancy) must use highly effective contraception (birth control) during the study and for 3 months after the last dose.
Women of childbearing age must have a negative pregnancy test (a test to confirm you are not pregnant) through both blood and urine tests before starting.
For those with generalized Myasthenia Gravis (gMG), which is a condition affecting many muscles, you must have a score of 6 or higher on the MG-ADL scale (a tool used to measure how much the disease affects daily activities) and at least 50% of that score must come from symptoms other than eye problems.
Participants with gMG must be classified as Class II to IVa by the Myasthenia Gravis Foundation of America (MGFA), which describes the severity of the disease.
Participants with AChR antibody-positive gMG must test positive for anti-AChR binding antibodies (proteins in the blood that attack the connection between nerves and muscles).
Participants with AChR antibody-negative gMG must test negative for these same antibodies.
Participants with ocular Myasthenia Gravis (oMG), which only affects the eye muscles, must be classified as MGFA Class I.
Participants with oMG must have an MG-ADL score between 3 and 6, and these symptoms must only affect the eyes.
You must agree to undergo screening for genetic muscular diseases, which are muscle conditions passed down through family DNA.
You must be at least 18 years old but younger than 75 years old.
You must not have had muscle weakness as an infant; instead, weakness must have developed after the age of 16.
You must have been diagnosed with acquired MG (the version of the disease not present from birth) at least 6 months before the study begins.
Your diagnosis must be confirmed through specific medical tests, such as electromyography (a test that measures electrical activity in muscles) or by showing improvement when taking acetylcholinesterase inhibitors (medicines that help improve muscle strength).
Your body weight must be at least 40 kg.
You must be on a stable dose of your current medications, meaning your dosage has not changed recently, for specific periods:
- Oral corticosteroids (steroid medicines used to reduce inflammation) must be at a steady dose for at least 4 weeks, with limits on the daily amount.
- Acetylcholinesterase inhibitors must be at a steady dose for at least 4 weeks.
- Other specific immune-related medicines must have been taken for at least 6 months, with a steady dose for the last 3 months.
You must have received two doses of the meningococcal vaccine (a vaccine to prevent certain bacterial infections) within the last year and at least 2 weeks before starting the study.
You must be vaccinated against streptococcus pneumoniae and haemophilus influenzae type B (bacteria that can cause infections like pneumonia or meningitis) according to local standards.

Who Cannot Join the Study?

Having used the study drug, IM-101, in the past.
A known or suspected history of drug or alcohol abuse or dependence (relying on substances) within 1 year before the study starts.
Having Hepatitis B, Hepatitis C, or HIV (a virus that affects the immune system) at the time of screening.
Having an active bacterial (bacteria), viral (virus), or fungal (fungus) infection within 14 days before the first dose.
Having a fever (a high body temperature) within 7 days before the first dose.
Using certain immunoglobulins (treatments that provide antibodies) or plasma exchange (a process that cleans the blood) within 4 weeks before screening.
Using specific immunosuppressant medications (drugs that lower the immune system response) such as rituximab, tacrolimus, or cyclophosphamide within 6 months before screening.
Using a neonatal Fc receptor (FcRn) blocker (a type of medication) within 6 weeks before screening.
Using C5 inhibitors (medications that block a part of the immune system) such as zilucoplan, eculizumab, or ravulizumab within 2 to 3 months before screening.
Having previously used a complement inhibitor (a medicine that targets part of the immune system) that did not work or was not tolerated well.
Having abnormal liver function tests, specifically high levels of AST, ALT, or total bilirubin (markers that show how well the liver is working).
Having a low estimated glomerular filtration rate (a measure used to see how well the kidneys are filtering the blood).
Participating in another medical study or using experimental therapy (untested treatments) within 30 days before screening.
Being pregnant, breastfeeding, or planning to become pregnant during the study.
Planning to have surgery that requires general anesthesia (medicine that makes you sleep so you do not feel pain) during the study.
Testing positive for Anti-MuSK antibodies (proteins in the blood related to muscle weakness).
Having any medical or mental health condition that the investigator (the doctor in charge of the study) believes might make participation unsafe or interfere with the results.
For those with ocular Myasthenia Gravis (oMG): having fixed ophthalmoplegia (permanent weakness or inability to move certain eye muscles).
For those with oMG: having a history of eyelid retraction surgery (surgery to fix eyelids that pull too far back).
For those with oMG: a family history of ptosis (drooping eyelids), diplopia (double vision), or other diseases that cause muscle weakness or drooping eyelids.
Having had a thymectomy (surgical removal of the thymus gland) within the last 12 months or planning to have one during the study.
A history of malignant thymoma (a tumor in the thymus gland) or having had cancer in the last 5 years, except for certain types of skin cancer that have been treated.
Having any immunologic disorder (a condition where the immune system does not work correctly) other than Myasthenia Gravis that would require long-term use of corticosteroids (steroid medicines).
Having tuberculosis (TB) (a serious bacterial infection), being treated for latent TB (an inactive form of the infection), or having been in contact with someone who has active TB.
A history of N. meningitidis infection (a type of bacteria that can cause serious illness).
Showing signs of a Myasthenia Gravis crisis or exacerbation (a sudden worsening of symptoms) within 28 days before the study begins.
Having a hypersensitivity (an allergic reaction) to any ingredient used in the study drug.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Hospital Clinico San Carlos	Madrid	Spain
Hospital Universitario De Navarra	Pamplona	Spain
Neurologia Slaska Centrum Medyczne	Katowice	Poland
NZOZ Neuro-Kard Ilkowski i Partnerzy Spółka Partnerska Lekarzy	Poznan	Poland

Other Sites

Site Name	City	Country
Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o.	Nowa Sol	Poland
Multiprofile Hospital For Active Treatment Avis Medika OOD	Pleven	Bulgaria
Medical Center Hera EOOD	Sofia	Bulgaria
Ospedale San Raffaele S.r.l.	Milan	Italy
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie	Cracow	Poland
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD	Sofia	Bulgaria
Universita Degli Studi Di Brescia	Brescia	Italy
Multi-profile Hospital for Active Treatment Heart and Brain EAD	Pleven	Bulgaria
Neuroprotect Sp. z o.o.	Warsaw	Poland
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Twoja Przychodnia Poznańskie Centrum Medyczne Sp. z o.o.	Poznan	Poland
Haelan Care 4 Medical Center Ltd.	Varna	Bulgaria
Medical Center Neurocentrum EOOD	Plovdiv	Bulgaria
Sgxykujrlny Pwbymcmva Sbbtdpe Kowivrqzo Nb 1 Iutqvrktqolhtwjjvl Szvlosu Sdnzvrlwg Uoyuiakigppf Mkwiduyoig W Knfeevgglz	Zabrze	Poland
Fgwbqsugt Pzjd Lm Ijpcfkaidrzuy Baroryvap Dtr Hqnjmyfp Udyzkssitkoyo Ll Pbp	Madrid	Spain

Trial status

Country	Status	Recruitment Start
Bulgaria	Recruiting	19.01.2026
Italy	Not yet recruiting	19.01.2026
Poland	Not yet recruiting	19.01.2026
Spain	Not yet recruiting	19.01.2026

Trial locations

Investigated drugs:

IM-101 is the experimental treatment being studied to see if it is safe and effective for treating adults with generalized myasthenia gravis and ocular myasthenia gravis.

Generalized Myasthenia Gravis – This is an autoimmune disorder where the immune system mistakenly attacks the connection between nerves and muscles. It typically causes muscle weakness that worsens with activity and improves after rest. The weakness can affect various parts of the body, including the face, neck, arms, and legs. Over time, the fatigue and weakness may fluctuate or become more persistent.

Ocular Myasthenia Gravis – This form of the condition specifically affects the muscles that control eye movement and eyelid opening. It often presents with drooping eyelids or double vision. The symptoms are primarily localized to the eyes and do not involve other muscle groups. This condition can progress with varying patterns of muscle weakness in the ocular region.

Trial ID:

2025-522406-20-00

Protocol code:

IM-101_MG_2.1

Trial Phase:

Human Pharmacology (Phase I) – Other

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A study of IM-101 in adults with generalized myasthenia gravis or ocular myasthenia gravis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?