IM-101 for Myasthenia Gravis
(Synergy-MG Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called IM-101 for individuals with myasthenia gravis (MG), a condition that causes muscle weakness. The researchers aim to determine if IM-101 is safe, how it behaves in the body, and whether it reduces symptoms. Participants will be divided into groups to receive different doses of IM-101 or a placebo (a substance with no active treatment). This trial is for those with confirmed MG who are already on stable treatment and have not tried IM-101 before. As a Phase 1 and Phase 2 trial, the study focuses on understanding how IM-101 works in people and measuring its effectiveness in an initial, smaller group.
Will I have to stop taking my current medications?
The trial requires that you are on a stable dose of your current medication for myasthenia gravis, so you should not stop taking them.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that IM-101 is being tested for its safety in treating myasthenia gravis (MG), a condition that causes muscle weakness. Previous studies have found that treatments like IM-101, which target certain proteins in the immune system, can be well-tolerated by patients. However, since IM-101 is still in early testing, clear safety data is not yet available.
In the early stages of the trial, researchers focus on how well people handle different doses of IM-101, carefully monitoring for any side effects. Before reaching this stage, tests in labs and on animals suggested that IM-101 was safe enough for human trials.
Participants in this trial will help determine the best dose with the fewest side effects. While specific safety data for IM-101 isn't available yet, its progression to this testing phase suggests it showed enough promise in earlier tests to continue studying. For those considering participation, knowing that the trial is closely monitored for safety might be reassuring.12345Why do researchers think this study treatment might be promising for myasthenia gravis?
Researchers are excited about IM-101 for treating Myasthenia Gravis because it offers a novel approach compared to the current options like pyridostigmine, corticosteroids, and immunosuppressants. IM-101 is unique because it potentially targets the disease with a different mechanism, which could mean fewer side effects and better effectiveness. This treatment could provide a breakthrough for patients who do not respond well to existing therapies, offering hope for improved management of this challenging condition.
What evidence suggests that IM-101 might be an effective treatment for myasthenia gravis?
Research has shown that IM-101, which participants in this trial may receive, is a promising treatment for myasthenia gravis (MG), a condition that causes muscle weakness and tiredness. In early studies, IM-101 effectively blocked C5, a part of the immune system linked to MG. After twelve months, patients in those studies improved by an average of 4.8 points in their ability to perform daily tasks, as measured by the myasthenia gravis Activities of Daily Living (MG-ADL) score. IM-101 also reduced C5 activity more than other treatments, suggesting greater effectiveness. These findings indicate that IM-101 could help improve symptoms for people with MG.14678
Are You a Good Fit for This Trial?
Adults aged 18 to 75 with Myasthenia Gravis (MG), weighing at least 40 kg, who have been vaccinated against certain infections and are on a stable MG treatment can join. They must consent to genetic screening and agree to participate.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive multiple ascending doses of IM-101 or placebo to assess safety, tolerability, pharmacokinetics, and pharmacodynamics
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- IM-101
Trial Overview
The trial is testing IM-101's safety and effectiveness for those with antibody-positive generalized MG (gMG). It will also explore the drug in antibody-negative gMG and ocular MG patients after determining the best dose regimen.
How Is the Trial Designed?
7
Treatment groups
Experimental Treatment
IM-101 or Placebo
IM-101 or Placebo
IM-101 or Placebo
IM-101 or Placebo if additional dose is needed per IDMC decision
IM-101 High dose or Placebo
IM-101 Mid dose or Placebo
IM-101 Low dose or Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
ImmunAbs Inc.
Lead Sponsor
Citations
NCT07250750 | A Phase 1b/2 Study of IM-101 in Adult ...
The goal of this clinical trial is to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and potential efficacy of IM-101 in ...
2.
myastheniagravisnews.com
myastheniagravisnews.com/news/fda-clears-phase-2-trial-testing-c5-inhibitor-im-101-mg-patients/FDA clears Phase 2 trial testing C5 inhibitor IM-101 in MG ...
IM-101 showed higher C5 inhibitory activity in preclinical studies. MG is an autoimmune disease characterized by muscle weakness and fatigue. ...
ImmunAbs Announces FDA Phase 2 IND Approval of IM ...
The forthcoming multicenter, randomized, double-blind, placebo-controlled study will enroll up to 90 patients to evaluate the effectiveness and ...
Myasthenia Gravis Treatment: Marketed & Pipeline Therapies
Twelve-month follow-up data demonstrated an average 4.8-point improvement in the myasthenia gravis Activities of Daily Living (MG-ADL) score, ...
ImmunAbs, developing a novel C5 antibody for ...
As a result, IM-101 significantly suppressed the C5 activity of the classical and alternative pathways compared to competing drugs(p<0.0001).
6.
ctv.veeva.com
ctv.veeva.com/study/a-phase-1b-2-study-of-im-101-in-adult-participants-with-generalized-myasthenia-gravis-and-ocular-myaA Phase 1b/2 Study of IM-101 in Adult Participants With ...
The goal of this clinical trial is to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and potential efficacy ...
A Phase 1b/2 Study of IM-101 in Adult Participants With ...
The goal of this clinical trial is to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and potential efficacy of ...
Clinical Trials | Myasthenia Gravis Association
... Safety of Treatment of IM-101 in Adult Participants With Generalized Myasthenia Gravis and Ocular Myasthenia Gravis. Experimental: IM-101. Intravenous ...
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