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Complement Inhibitor

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

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 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.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline to Month 6 in Myasthenia Gravis Activity of Daily Living (MG-ADL) total score
Secondary study objectives
Change from baseline in MG-ADL total score
Change from baseline to Month 6 in EuroQol-5 Dimensions-5 Level (EQ-5D-5L)
Change from baseline to Month 6 in Myasthenia Gravis Composite (MGC) total score
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: IptacopanExperimental Treatment1 Intervention
Iptacopan orally for 6 months (double-blind) followed by open-label iptacopan for an additional 24 months
Group II: Matching PlaceboPlacebo Group1 Intervention
Placebo orally for 6 months (double-blind) followed by open-label iptacopan for 24 months
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Iptacopan
2021
Completed Phase 1
~40

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,889 Previous Clinical Trials
4,201,858 Total Patients Enrolled
1 Trials studying Myasthenia Gravis
44 Patients Enrolled for Myasthenia Gravis
~97 spots leftby Dec 2026
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