IM-101 for Adults With Generalized or Ocular Myasthenia Gravis
Tests the safety and effects of IM-101 in adults with myasthenia gravis.
Key facts
- Who runs it
- ImmunAbs Inc.
- Where
- Brescia and Milan, ItalySee the 3 sitesAlso in 5 other countries, 23 sites
- Trial code
- Registry title
- A Phase 1b/2 Study of IM-101 in Adult Participants With Generalized Myasthenia Gravis and Ocular Myasthenia Gravis
- Status
- Recruiting
- Phase
- Phase 1/2
- People taking part
- 96 people, planned
- Started
- 5 Feb 2026
- Expected to end
- Jun 2028
- Type of study
- Interventional, 7 groups
- Treatments tested
- IM-101 Part A
- Placebo Part A
- IM-101 Part B
- Placebo Part B
- Record updated
- 11 February 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with myasthenia gravis who are on a stable dose of their usual treatment. It tests a new drug, IM-101.
- Age
- 18 to 74 years (at least 18 and under 75).
- Sex
- All sexes can join.
- Disease stage
- Diagnosed with myasthenia gravis (generalized or ocular). The first part looks at generalized myasthenia gravis with AChR antibodies.
- Earlier treatment
- Must be on a stable dose of background treatment for myasthenia gravis. Must be vaccinated against meningococcal infection, streptococcus pneumoniae and haemophilus influenzae type B. Cannot join if a complement inhibitor failed because of side effects or lack of effect.
- Biomarker or test result
- The first part is for people positive for AChR antibodies; the later part also includes AChR antibody-negative people. People positive for anti-MuSK antibodies cannot join.
Main reasons for not taking part
- Earlier treatment with IM-101
- Positive for anti-MuSK antibodies
- Malignant thymoma, or cancer in the past 5 years
- Earlier N. meningitidis infection
- A complement inhibitor that failed due to side effects or lack of effect
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Check if you might fit
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?
Where in Italy
Also in 5 other countries, 23 sites
- 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
About the trial
What the trial wants to find out
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.
The 7 groups in the trial
- Part A MAD Cohort 1Treatment being tested
IM-101 Low dose or Placebo
Treatment: IM-101 Part A and Placebo Part A
- Part A MAD Cohort 2Treatment being tested
IM-101 Mid dose or Placebo
Treatment: IM-101 Part A and Placebo Part A
- Part A MAD Cohort 3Treatment being tested
IM-101 High dose or Placebo
Treatment: IM-101 Part A and Placebo Part A
- Part A MAD Cohort 4 (Optional)Treatment being tested
IM-101 or Placebo if additional dose is needed per IDMC decision
Treatment: IM-101 Part A and Placebo Part A
- Part B Expansion AChR positive gMGTreatment being tested
IM-101 or Placebo
Treatment: IM-101 Part B and Placebo Part B
- Part B Expansion AChR negative gMGTreatment being tested
IM-101 or Placebo
Treatment: IM-101 Part B and Placebo Part B
- Part B Expansion oMGTreatment being tested
IM-101 or Placebo
Treatment: IM-101 Part B and Placebo Part B
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- 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
- Plain-language title
- IM-101 for Adults With Generalized or Ocular Myasthenia GravisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT07250750, who can take part
- Record updated
- 11 February 2026