NCT04558918 - Study of Efficacy and Safety of Twice Daily Oral LNP023 in Adult PNH Patients With Residual Anemia Despite Anti-C5 Antibody Treatment | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

January 25, 2021

Primary Completion Date

September 26, 2022

Study Completion Date

March 6, 2023

Conditions

Paroxysmal Nocturnal Hemoglobinuria (PNH)

Interventions

DRUG

LNP023

Taken Orally b.i.d. Dosage Supplied: 200 mg Dosage form: Hard gelatin capsule Route of Administration: Oral

DRUG

Eculizumab

"Administered as intravenous infusion every 2 weeks as per the stable regimen, the maintenance dose is a fixed dose.~Dosage Supplied: 300 mg/30mL Dosage form: Concentrate solution for infusion"

DRUG

Ravulizumab

"Administered as intravenous infusion every 8 weeks, the maintenance dose is based on body weight.~Dosage Supplied: 300 mg/30mL Dosage form: Concentrate solution for infusion"

Trial Locations (39)

970

Novartis Investigative Site, Hualien City

10002

Novartis Investigative Site, Taipei

10126

Novartis Investigative Site, Torino

15706

Novartis Investigative Site, Santiago de Compostela

20080

Novartis Investigative Site, Donostia / San Sebastian

20122

Novartis Investigative Site, Milan

20246

Novartis Investigative Site, Hamburg

28204

Levine Cancer Insitute Carolinas Healthcare System, Charlotte

30912

Augusta University Georgia Patient Treatment, Augusta

31059

Novartis Investigative Site, Toulouse

36061

Novartis Investigative Site, Bassano del Grappa

44195

Cleveland Clinic Foundation Dept.ofTaussigCancer Center, Cleveland

45147

Novartis Investigative Site, Essen

50139

Novartis Investigative Site, Florence

52074

Novartis Investigative Site, Aachen

59037

Novartis Investigative Site, Lille

63100

Novartis Investigative Site, Ascoli Piceno

75475

Novartis Investigative Site, Paris

83100

Novartis Investigative Site, Avellino

89081

Novartis Investigative Site, Ulm

91010

City Of Hope National Med Center City of Hope Medical Center, Duarte

92868

Univ Cali Irvine ALS Neuromuscular, Orange

09090-790

Novartis Investigative Site, Santo André

01323-900

Novartis Investigative Site, São Paulo

708 52

Novartis Investigative Site, Ostrava

01589

Novartis Investigative Site, Riesa

00161

Novartis Investigative Site, Roma

453-8511

Novartis Investigative Site, Nagoya

960 1295

Novartis Investigative Site, Fukushima

920-8641

Novartis Investigative Site, Kanazawa

392-8510

Novartis Investigative Site, Suwa

565 0871

Novartis Investigative Site, Suita

160-0023

Novartis Investigative Site, Shinjuku-ku

606 8507

Novartis Investigative Site, Kyoto

6500 MB

Novartis Investigative Site, Nijmegen

06351

Novartis Investigative Site, Seoul

08036

Novartis Investigative Site, Barcelona

LS9 7TF

Novartis Investigative Site, Leeds

SE5 9RS

Novartis Investigative Site, London