Iptacopan for Myasthenia Gravis

Phase 3

Recruiting

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult patients aged 18-75 years with generalized Myasthenia Gravis

Be older than 18 years old

Must not have

History of recurrent invasive infections caused by encapsulated organisms

Recent treatment with IVIG/PLEX, rituximab, eculizumab, ravulizumab, efgartigimod, or thymectomy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 6 (end of core phase) to month 30 (end of extension phase)

Awards & highlights

Pivotal Trial

Summary

This trial will test a new drug called iptacopan in patients with a certain type of myasthenia gravis. The study will be conducted at multiple centers and will compare the effectiveness and

Who is the study for?

This trial is for adults aged 18 to 75 with generalized Myasthenia Gravis (gMG) who are already on a stable standard of care treatment. It's not suitable for those outside this age range or those not following a consistent treatment regimen.

What is being tested?

The study tests the effectiveness and safety of Iptacopan, compared to a placebo, in gMG patients. Participants will be randomly assigned to receive either Iptacopan or placebo alongside their regular treatments for six months.

What are the potential side effects?

While specific side effects aren't listed here, typical clinical trial risks may include allergic reactions, headaches, nausea, and other drug-related adverse events that will be monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 75 years old with generalized Myasthenia Gravis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had repeated serious infections.

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I recently had treatments like IVIG, PLEX, or specific medications, or a thymectomy.

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I do not have any ongoing serious infections.

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I have had a fever of 38°C or higher in the last week.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 6 (end of core phase) to month 30 (end of extension phase)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 6 (end of core phase) to month 30 (end of extension phase)

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 6 (end of core phase) to month 30 (end of extension phase) for reporting.