IM-101 for Adults With Generalized or Ocular Myasthenia Gravis
Tests the safety and effects of IM-101 in adults with myasthenia gravis.
Plain-language title generated from the registry record
Registry title: A Phase 1b/2 Study of IM-101 in Adult Participants With Generalized Myasthenia Gravis and Ocular Myasthenia Gravis
Key facts
- Where
- Brescia and Milan, ItalySee the 3 sites
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 74 years old?
Source: NCT07250750, who can take part
Where in Italy
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaBrescia, ItalyTaking people
- IRCCS Foundation Istituto Neurologico Carlo BestaMilan, ItalyTaking people
- Ospedale San Raffaele S.r.l.Milan, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- ImmunAbs Inc.
- Trial code
- NCT07250750EU 2025-522406-20-00
- Record updated
- 11 February 2026
- Original description
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.Read full original descriptionShow less
A Phase 1b/2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate A) the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Doses of IM-101 in Adult Participants With Generalized Myasthenia Gravis, and B) the Efficacy and Safety of Treatment of IM-101 in Adult Participants With Generalized Myasthenia Gravis and Ocular Myasthenia Gravis
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.
Inclusion: 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.
Exclusion: Previous exposure to IM-101; Anti-MuSK antibody Positive; 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; History of malignant thymoma, or history of cancer within the past 5 years of screening; History of N. meningitidis infection.