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Study of Efficacy and Safety of Twice Daily Oral LNP023 in Adult PNH Patients With Residual Anemia Despite Anti-C5 Antibody Treatment — APPLY-PNH  

Paroxysmal Nocturnal Hemoglobinuria (PNH) Clinical Trial

Official title:
A Randomized, Multicenter, Active-comparator Controlled, Open-label Trial to Evaluate Efficacy and Safety of Oral, Twice Daily LNP023 in Adult Patients With PNH and Residual Anemia, Despite Treatment With an Intravenous Anti-C5 Antibody.

Clinical Trial Summary

The purpose of this Phase 3 study is to determine whether LNP023 is efficacious and safe for the treatment in PNH through demonstration of superiority of LNP023 compared to anti-C5 antibody treatment in adult PNH patients presenting with residual anemia despite treatment with anti-C5 therapy

Clinical Trial Description

The purpose of this Phase 3 randomized, multicenter, active-comparator controlled, open-label trial is to determine whether LNP023 is efficacious and safe for the treatment in PNH through demonstration of superiority of LNP023 compared to anti-C5 antibody treatment in adult PNH patients presenting with residual anemia despite treatment with anti-C5 therapy. The study is planned to randomize approx. 91 patients in various countries. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04558918
Study type Interventional
Source Novartis
Contact
Status Completed
Phase Phase 3
Start date January 25, 2021
Completion date March 6, 2023
View Details
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