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A Phase III Study to Investigate Efficacy, Safety and Tolerability of Iptacopan Compared With Placebo in Participants Aged 18 to 85 Years With gMG.
NCT06517758 · View on ClinicalTrials.gov ↗
Study Summary
The study is a randomized, double-blind, placebo-controlled, multicenter, Phase III study, to evaluate efficacy, safety and tolerability of iptacopan in patients with AChR+ gMG who are on stable SOC treatment. Participants who meet the eligibility criteria will be randomized in a ratio of 1:1, to receive either iptacopan or matching placebo, for 6 months (180 days) while continuing on a stable SOC treatment. The randomization will be stratified based on region.
Conditions Studied
Interventions
- OTHER Matching Placebo
- DRUG Iptacopan
Study Locations (20)
California
- Fullerton Neuro and Headache Ctr — Fullerton
- SC3 Research Pasadena — Pasadena
- California Pacific Medical Center — Sacramento
Florida
- Neurology Offices Of South Florida — Boca Raton
- Superior Associates in Research LLC — Hialeah
Illinois
- University of Chicago Medical Centr — Chicago
- Prairie Heart Institute — Springfield
Ohio
- Neuroscience Research Ctr — Canton
- Ohio State University Medical Center — Columbus
Texas
- Nerve and Muscle Center of Texas — Houston
- Central TX Neuro Consultants P A — Round Rock
Arizona
- Honor Health Research Institute — Scottsdale
Georgia
- Augusta University Georgia — Augusta
Hawaii
- Hawaii Pacific Neuroscience LLC — Honolulu
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 146 participants |
| Start Date | 2024-07-31 |
| Est. Completion | 2032-05-27 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06517758
The ClinicalTrials.gov registry entry for NCT06517758 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 146 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 792 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Generalized Myasthenia Gravis appearing as the primary indexed condition, and to 2 interventions — of which Matching Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06517758 reports 20 study locations spanning 14 distinct geographic areas — top geographies include California, Florida, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06517758 about?
NCT06517758 is a clinical study titled "A Phase III Study to Investigate Efficacy, Safety and Tolerability of Iptacopan Compared With Placebo in Participants Aged 18 to 85 Years With gMG.". The study is a randomized, double-blind, placebo-controlled, multicenter, Phase III study, to evaluate efficacy, safety and tolerability of iptacopan in patients with AChR+ gMG who are on stable SOC treatment. Participants who meet the eligibility criteria will be randomized in a ratio of 1:1, to re...
What is the current status of trial NCT06517758?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 146 participants. The study started on 2024-07-31. Estimated completion is 2032-05-27.
What conditions does trial NCT06517758 study?
This clinical trial studies the following conditions: Generalized Myasthenia Gravis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06517758?
The interventions under investigation include: Matching Placebo (OTHER), Iptacopan (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06517758?
This trial is sponsored by Novartis Pharmaceuticals, which has 792 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06517758 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia, Hawaii. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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