Danicopan as Add-on Therapy to a C5 Inhibitor in Paroxysmal Nocturnal Hemoglobinuria (PNH) Participants Who Have Clinically Evident Extravascular Hemolysis (EVH)(ALPHA)

PHASE3CompletedINTERVENTIONAL
Enrollment

86

Participants

Timeline

Start Date

December 16, 2020

Primary Completion Date

June 29, 2022

Study Completion Date

January 16, 2024

Conditions
Paroxysmal Nocturnal Hemoglobinuria
Interventions
DRUG

Danicopan

Oral tablet

DRUG

Placebo

Oral tablet

DRUG

C5 Inhibitor

Participants will continue to receive their ongoing C5 inhibitor (eculizumab or ravulizumab) therapy according to their usual dose and schedule.

Trial Locations (62)

100

Research Site, Taipei

10065

Research Site, New York

10330

Research Site, Bangkok

11527

Research Site, Athens

16247

Research Site, Suwon

20122

Research Site, Milan

28040

Research Site, Madrid

28222

Research Site, Majadahonda

31048

Research Site, Haifa

33331

Research Site, Weston

33604

Research Site, Pessac

35015

Research Site, Daejeon

35020

Research Site, Las Palmas de Gran Canaria

36061

Research Site, Bassano del Grappa

41013

Research Site, Seville

49007

Research Site, Kalamazoo

50134

Research Site, Florence

53212

Research Site, Milwaukee

57010

Research Site, Thessaloniki

59037

Research Site, Lille

60612

Research Site, Chicago

69495

Research Site, Pierre-Bénite

75010

Research Site, Paris

75390

Research Site, Dallas

83100

Research Site, Avellino

88586

Research Site, Kota Kinabalu

89081

Research Site, Ulm

89131

Research Site, Reggio Calabria

90089

Research Site, Los Angeles

91120

Research Site, Jerusalem

93586

Research Site, Kuching

98000

Research Site, Miri

20211030

Research Site, Rio de de Janeiro

66053-000

Research Site, Belém

80810-050

Research Site, Curitiba

74605-020

Research Site, Goiânia

90110-270

Research Site, Porto Alegre

M5G 2C4

Research Site, Toronto

625 00

Research Site, Brno

00161

Research Site, Roma

113 8603

Research Site, Bunkyō City

812-8582

Research Site, Fukuoka

277-8567

Research Site, Kashiwa-shi

605-0981

Research Site, Kyoto

480-1195

Research Site, Nagakute-shi

503-8502

Research Site, Ogaki-shi

530-8480

Research Site, Osaka

589-8511

Research Site, Sayama

150-8935

Research Site, Shibuya-ku

646-8588

Research Site, Tanabe-shi

470-1192

Research Site, Toyoake-shi

305-8576

Research Site, Tsukuba

6229 HX

Research Site, Maastricht

80-214

Research Site, Gdansk

03722

Research Site, Seoul

06351

Research Site, Seoul

06591

Research Site, Seoul

08036

Research Site, Barcelona

08916

Research Site, Barcelona

ML6 0JS

Research Site, Airdrie

BD7 1DP

Research Site, Leeds

SE5 9NU

Research Site, London

Sponsors
All Listed Sponsors
lead

Alexion Pharmaceuticals, Inc.

INDUSTRY