Study of Efficacy and Safety of Twice Daily Oral Iptacopan (LNP023) in Adult PNH Patients Who Are Naive to Complement Inhibitor Therapy

Exclusion Criteria

• •Prior treatment with a complement inhibitor, including anti-C5 antibody
• •Known or suspected hereditary complement deficiency
• •History of hematopoietic stem cell transplantation
• •Patients with laboratory evidence of bone marrow failure (reticulocytes \<100x109/L; platelets \<30x109/L; neutrophils \<0.5x109/L).
• •Active systemic bacterial, viral (incl. COVID-19)or fungal infection within 14 days prior to study drug administration.
• •History of recurrent invasive infections caused by encapsulated organisms, e.g. meningococcus or pneumococcus.
• •Major concurrent comorbidities including but not limited to severe kidney disease (e.g., dialysis), advanced cardiac disease (e.g., NYHA class IV heart failure), severe pulmonary disease (e.g., severe pulmonary hypertension (WHO class IV)), or hepatic disease (e.g., active hepatitis) that in the opinion of the investigator precludes participant's participation in the study.