A Phase III Study to Investigate Efficacy, Safety and Tolerability of Iptacopan Compared With Placebo in Participants Aged 18 to 75 Years With gMG.

Inclusion Criteria:

• Adult patients with generalized Myasthenia Gravis (age 18-75 years)

• Positive serology testing for AChR+ antibody at screening

• Myasthenia Gravis Foundation of America (MGFA) Class II-IV gMG and likely not inneed v of a respirator for the duration of the study, as judged by the Investigator.

• The confirmation of the diagnosis of gMG should be documented and supported by ≥1 ofthe following 3 tests:

• History of abnormal neuromuscular transmission demonstrated by single-fiberelectromyography or repetitive nerve stimulation.

• History of positive edrophonium chloride test

• Patient has demonstrated improvement in MG signs on oral acetylcholinesteraseinhibitors as assessed by the treating physician.

• Baseline MG-ADL score ≥6, with ≥50% of the total score due to non-ocular symptoms

• Participants not optimally controlled for ≥ 6 months on

• just one NSIST; or

• two or more NSISTs; or

• on frequent (at least quarterly) plasmapheresis, plasma exchange, or intravenousimmunoglobulin to control symptoms despite treatment with steroids and NSISTs; or

• one of the following gMG treatments:

• a FcRN antagonist approved for gMG

• rituximab

• other approved gMG therapies excluding complement inhibitors.

• Consistent with all other iptacopan trials, participants will have to be vaccinatedagainst Neisseria meningitidis and Streptococcus pneumoniae. In addition,participants will be vaccinated against Haemophilus influenzae, depending on thelocal regulations and on the availability of this vaccine in the countries of studyconduct. The vaccination will be performed at least 2 weeks prior to first dosingwith iptacopan, covering as many serotypes as possible. If iptacopan treatment willstart earlier than 2 weeks post vaccination, prophylactic antibiotic treatment mustbe initiated and administered until 2 weeks post vaccination.

Exclusion Criteria:

• Have been treated with intravenous immunoglobulin (IVIG)/plasma exchange (PLEX) inthe past month, with rituximab in the past 6 months, eculizumab in the past 2months, ravulizumab or other complement inhibitors in the past 3 months,efgartigimod or other anti- FcRn therapies in the past 3 months, or had a thymectomyin the past 6 months or a planned thymectomy during the trial period.

• Participants with clinically significant active or chronic uncontrolled bacterial,viral, or fungal infection at screening, including patients who test positive for anactive viral infection at screening with: Active Hepatitis B Virus (HBV): serologicpanel test results indicative of an active (acute or chronic) infection; ActiveHepatitis C Virus (HCV): serology positive for HCV-Ab; Human Immunodeficiency Virus (HIV) positive serology associated with an Acquired Immune Deficiency Syndrome (AIDS)-defining condition or with a cluster of differentiation 4 (CD4) count

• 200 cells/mm3

• Female participants who are pregnant or lactating, or are intending to becomepregnant.

• Women of child-bearing potential, defined as all women physiologically capable ofbecoming pregnant, unless they are using effective methods of contraception duringdosing of study treatment.

• Active systemic bacterial, viral (including COVID-19) or fungal infection or anymajor episode of infection that required hospitalization or injectable antimicrobialtherapy within 14 days prior to study drug administration.

• History of recurrent invasive infections caused by encapsulated organisms, e.g., N.meningitidis and S. pneumoniae.

• Presence of fever ≥ 38 °C (100.4 °F) within 7 days prior to study drugadministration