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New treatment option for Myasthenia Gravis
Official title A Phase 1b/2 Study of IM-101 in Adult Participants With Generalized Myasthenia Gravis and Ocular Myasthenia Gravis
ClinicalTrials.gov ID: NCT07250750
What this study is testing
What is IM-101 Part A?
IM-101 Part A is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for myasthenia gravis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and potential efficacy of IM-101 in adult participants with AChR antibody-positive gMG. Subsequently, the safety and efficacy of the selected IM-101 dose-regimen will be tested in participants with AChR antibody-negative gMG and participants with AChR antibody-positive or AChR antibody-negative oMG.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 74
You may be able to join if
- Able and willing to provide signed informed consent
- Willingness to consent to screening for genetic muscular diseases
- Male or female aged ≥ 18 years and \< 75 years
- Diagnosed with MG
- On a stable dose of background therapy for the treatment of MG
You likely can't join if
- Previous exposure to IM-101
- Anti-MuSK antibody Positive
- History of malignant thymoma, or history of cancer within the past 5 years of screening
- History of N. meningitidis infection
- Has been treated with any complement inhibitor, but failed due to intolerability or lack of how well it works Full eligibility criteria is available...
See the full eligibility criteria
- Able and willing to provide signed informed consent
- Willingness to consent to screening for genetic muscular diseases
- Male or female aged ≥ 18 years and \< 75 years
- Diagnosed with MG
- On a stable dose of background therapy for the treatment of MG
- Body weight ≥ 40 kg at screening
- Vaccinated against meningococcal infection (Neisseria meningitidis), streptococcus pneumoniae, and haemophilus influenzae type B
- Previous exposure to IM-101
- Anti-MuSK antibody Positive
- History of malignant thymoma, or history of cancer within the past 5 years of screening
- History of N. meningitidis infection
- Has been treated with any complement inhibitor, but failed due to intolerability or lack of how well it works Full eligibility criteria is available in the study protocol.
The study team makes the final eligibility decision.
Where it's taking place
- Altamonte Springs, Florida, United States
- Boca Raton, Florida, United States
- Naples, Florida, United States
- Port Charlotte, Florida, United States
- Tampa, Florida, United States
- Kansas City, Missouri, United States
- Houston, Texas, United States
- Montana, Bulgaria
- Pleven, Bulgaria
- Sofia, Bulgaria
- Varna, Bulgaria
- Brescia, Brescia, Italy
- Milan, Milano, Italy
- Katowice, Poland
- Nowa Sól, Poland
- Poznan, Poland
- Zabrze, Poland
- Belgrade, Serbia
- Madrid, Madrid, Spain
- Pamplona, Navarre, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 74 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Altamonte Springs, Florida, United States; Boca Raton, Florida, United States; Naples, Florida, United States; Port Charlotte, Florida, United States; Tampa, Florida, United States; Kansas City, Missouri, United States and 14 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.