OncoMatch/Clinical Trials/NCT06517758
A Phase III Study to Investigate Efficacy, Safety and Tolerability of Iptacopan Compared With Placebo in Participants Aged 18 to 85 Years With gMG.
Is NCT06517758 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Iptacopan for generalized myasthenia gravis.
Treatment: Iptacopan — 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.
Check if I qualifyExtracted eligibility criteria
Biomarker criteria
Required: CHRNA1 AChR+ antibody (positive)
Positive serology testing for AChR+ antibody at screening
Disease stage
Required: Stage MGFA CLASS II, MGFA CLASS III, MGFA CLASS IV (MGFA)
Myasthenia Gravis Foundation of America (MGFA) Class II-IV gMG at screening
Prior therapy
Must have received: non-steroidal immunosuppressive therapy
Participants receiving at least one of the following treatments for gMG for 6 months prior to baseline; One or more NSISTs
Must have received: plasmapheresis or plasma exchange
plasmapheresis, plasma exchange, or intravenous immunoglobulin (at least quarterly) to control symptoms despite treatment with steroids and NSISTs
Must have received: intravenous immunoglobulin
plasmapheresis, plasma exchange, or intravenous immunoglobulin (at least quarterly) to control symptoms despite treatment with steroids and NSISTs
Must have received: FcRN antagonist
an approved FcRN antagonist approved for gMG
Must have received: anti-CD20 antibody (rituximab)
rituximab
Must have received: other approved gMG disease modifying therapies excluding complement inhibitors
other approved gMG disease modifying therapies excluding complement inhibitors
Cannot have received: intravenous immunoglobulin
Have been treated with intravenous immunoglobulin (IVIG)/plasma exchange (PLEX) in the past month
Cannot have received: plasmapheresis or plasma exchange
Have been treated with intravenous immunoglobulin (IVIG)/plasma exchange (PLEX) in the past month
Cannot have received: anti-CD20 antibody (rituximab)
with rituximab in the past 6 months
Cannot have received: complement inhibitor (eculizumab)
eculizumab in the past 2 months
Cannot have received: complement inhibitor (ravulizumab)
ravulizumab or other complement inhibitors in the past 3 months
Cannot have received: complement inhibitor
ravulizumab or other complement inhibitors in the past 3 months
Cannot have received: FcRN antagonist (efgartigimod)
efgartigimod or other anti- FcRn therapies in the past 3 months
Cannot have received: FcRN antagonist
efgartigimod or other anti- FcRn therapies in the past 3 months
Cannot have received: surgery
had a thymectomy in the past 6 months or a planned thymectomy during the trial period
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Honor Health Research Institute · Scottsdale, Arizona
- Fullerton Neuro and Headache Ctr · Fullerton, California
- SC3 Research Pasadena · Pasadena, California
- California Pacific Medical Center · Sacramento, California
- Neurology Offices Of South Florida · Boca Raton, Florida
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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