A Phase III Study to Investigate Efficacy, Safety and Tolerability of Iptacopan Compared With Placebo in Participants Aged 18 to 85 Years With gMG.

Inclusion Criteria:

• Adult patients with generalized Myasthenia Gravis (age 18-85 years) at screening

• Positive serology testing for AChR+ antibody at screening

• Myasthenia Gravis Foundation of America (MGFA) Class II-IV gMG at screening andlikely not in need of a respirator for the duration of the study, as judged by theInvestigator.

• 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 test with short-acting acetylcholinesterase inhibitors (e.g.neostigmine or edrophonium chloride)

• 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 receiving at least one of the following treatments for gMG for ≥ 6months prior to baseline;

• One or more NSISTs or

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

• an approved FcRN antagonist approved for gMG; or

• rituximab or

• other approved gMG disease modifying therapies excluding complement inhibitors.

• Vaccination against Neisseria meningitidis and Streptococcus pneumoniae infection isrequired prior to the start of study treatment. If the participant has not beenpreviously vaccinated, or if a booster was required, the vaccine should be givenaccording to local guidelines at least 2 weeks prior to first study drugadministration. If study treatment has to start earlier than 2 weekspost-vaccination, prophylactic antibiotic treatment should be initiated at the startof study treatment and continued until at least 2 weeks after vaccination or boosterwas completed.

Note: For US sites participating in Study CLNP023Q12301, the completion of the meningococcal vaccination or booster is required for patients with gMG prior to initiating study treatment, irrespective of prophylactic antibiotic use.

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); ActiveHepatitis C Virus (HCV);

• Human Immunodeficiency Virus (HIV) positive serology associated with anAcquired Immune Deficiency Syndrome (AIDS)-defining condition or with a clusterof 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 from menarche until becoming post-menopausal, unless they areusing effective methods of contraception during dosing of study treatment and anadditional one week following cessation of study treatment. Women are consideredpost-menopausal if they have had 12 months of natural (spontaneous) amenorrhea withan appropriate clinical profile (e.g., hormonal profile confirming menopause and/orage-appropriate history of vasomotor symptoms).

• 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