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A Phase 1b/2 Study of IM-101 in Adult Participants With Generalized Myasthenia Gravis and Ocular Myasthenia Gravis

RecruitingPhase 1, Phase 2Ages 18 Years - 74 YearsAllImmunAbs Inc.
NCT07250750 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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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What it tests

  • IM-101 Part A
  • Placebo Part A
  • IM-101 Part B
  • Placebo Part B
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Where

25 sites
Neurology of Central Florida Research Center, LLC
Altamonte Springs, United States
SFM Clinical Research, LLC
Boca Raton, United States
Aqualane Clinical Research
Naples, United States
Medsol Clinical Research Center
Port Charlotte, United States
University of South Florida
Tampa, United States
University of Kansas Medical Center Research Institute, Inc.
Kansas City, United States
Nerve & Muscle Center of Texas
Houston, United States
Houston Methodist Neurological Institute
Houston, United States

…and 17 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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