IM-101 for adults with generalized and ocular myasthenia gravis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1b/2 randomized, placebo-controlled study tests IM-101, an investigational C5 complement inhibitor, first in AChR antibody–positive generalized myasthenia gravis to characterize safety, tolerability, pharmacokinetics, and pharmacodynamics and to select a dose. After dose selection, the trial expands to evaluate the chosen regimen in AChR antibody–negative generalized MG and in participants with ocular MG compared with placebo. Participants are adults aged 18–74 on stable background MG therapy, must meet weight and vaccination requirements, and cannot be anti‑MuSK positive or previously intolerant to complement inhibitors. Dosing and follow-up occur at three clinical research centers in Florida using IM-101 and matching placebo arms.

Why it matters

Who can join: the full rules

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.

Where it's running

• Neurology of Central Florida Research Center, LLC
  Altamonte Springs, Florida, United States Recruiting
• SFM Clinical Research, LLC
  Boca Raton, Florida, United States Recruiting
• Aqualane Clinical Research
  Naples, Florida, United States Recruiting
• Nerve & Muscle Center of Texas
  Houston, Texas, United States Recruiting
• Medsol Clinical Research Center
  Port Charlotte, Florida, United States Not yet recruiting
• University of South Florida
  Tampa, Florida, United States Not yet recruiting

Study contacts

• Study coordinator: ImmunAbs Clinical Team
• Email: info@immunabs.com
• Phone: 82-2-6951-0584

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.