A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod PH20 SC in Adults With Pemphigus (Vulgaris or Foliaceus)

PHASE3TerminatedINTERVENTIONAL
Enrollment

183

Participants

Timeline

Start Date

July 15, 2021

Primary Completion Date

March 25, 2024

Study Completion Date

March 25, 2024

Conditions
Pemphigus VulgarisPemphigus Foliaceus
Interventions
BIOLOGICAL

efgartigimod PH20 SC

Subcutaneous injection of efgartigimod using rHuPH20 (PH20) as a permeation enhancer

DRUG

prednisone

Oral prednisone tablets

Trial Locations (127)

1431

Investigator site 2 - BG3590010, Sofia

1510

Investigator site 16 - BG3590009, Sofia

1606

Investigator site 3 - BG3590011, Sofia

2217

Investigator site 15 - AU0610006, Sydney

3050

Investigator site 11 - AU0610007, Parkville

3065

Investigator site 92 - AU0610013, Melbourne

4000

Investigator site 18 - BG3590013, Plovdiv

4032

Investigator site 6 - HU0360003, Debrecen

4209

Investigator site 8 - UA3800019, Kyiv

5800

Investigator site 17 - BG3590012, Pleven

6720

Investigator site 24 - HU0360002, Szeged

7632

Investigator site 5 - HU0360001, Pécs

8036

Investigator site 13 - ES0340032, Barcelona

10117

Investigator site 45 - DE0490029, Berlin

11000

Investigator site 109 - RS3810011, Belgrade

Investigator site 110 - RS3810010, Belgrade

11525

Investigator site 21 - GR030004, Athens

12462

Investigator site 22 - GR030003, Chaïdári

16121

Investigator site 37 - GR030006, Athens

Investigator site 54 - GR0300001, Athens

16132

Investigator site 81 - IT0390030, Genova

18000

Investigator site 105 - RS3810012, Niš

18016

Investigator site 122 - ES0340053, Granada

19104

Investigator site 84 - US0010089, Philadelphia

19140

Investigator site 103 - US0010097, Philadelphia

21000

Investigator site 104 - RS3810009, Novi Sad

23502

Investigator site 44 - US0010106, Norfolk

23538

Investigator site 20 - DE0490002, Lübeck

24105

Investigator site 35 - DE0490028, Kiel

27310

Investigator site 64 - TR0900020, Gaziantep

27710

Investigator site 76 - US0010096, Durham

28007

Investigator site 59 - ES0340034, Madrid

28034

Investigator site 42 - ES0340025, Madrid

28041

Investigator site 7 - ES0340029, Madrid

28046

Investigator site 57 - ES0340027, Madrid

32827

Investigator site 91 - US0010109, Orlando

33173

Investigator site 90 - US0010117, Miami

33428

Investigator site 1 - US0010087, Boca Raton

34098

Investigator site 63 - TR0900012, Istanbul

34722

Investigator site 74 - TR0900011, Istanbul

35005

Investigator site 120 - CH0860023, Fuzhou

35043

Investigator site 52 - DE0490001, Marburg

35233

Investigator site 115 - US0010086, Birmingham

38700

Investigator site 60 - FR0330027, La Tronche

41013

Investigator site 58 - ES0340028, Seville

42055

Investigator site 51 - FR0330026, Saint-Etienne

49074

Investigator site 75 - UA3800017, Dnipro

50125

Investigator site 38 - IT0390031, Florence

51000

Investigator site 116 - CH0860053, Guangzhou

53100

Investigator site 61 - IT0390040, Siena

54643

Investigator site 36 - GR0300002, Thessaloniki

55455

Investigator site 126 - US0010090, Minneapolis

56429

Investigator site 23 - GR030005, Thessaloniki

60590

Investigator site 33 - DE0490024, Frankfurt am Main

63110

Investigator site 111 - US0010098, St Louis

64239

Investigator site 85 - IL9720002, Tel Aviv

69063

Investigator site 9 - UA3800018, Zaporizhzhia

72076

Investigator site 19 - DE0490025, Tübingen

75246

Investigator site 125 - US0010107, Dallas

76018

Investigator site 29 - UA3800023, Ivano-Frankivsk

76031

Investigator site 108 - FR0330029, Rouen

77008

Investigator site 88 - US0010114, Houston

78620

Investigator site 87 - US0010084, Dripping Springs

79013

Investigator site 43 - UA3800021, Lviv

79104

Investigator site 53 - DE0490023, Freiburg im Breisgau

85259

Investigator site 89 - US0010091, Scottsdale

89081

Investigator site 93 - DE0490027, Ulm

93000

Investigator site 77 - FR0330028, Bobigny

94063

Investigator site 124 - US0010092, Redwood City

95123

Investigator site 95 - IT0390039, Catania

97080

Investigator site 4 - DE0490026, Würzburg

100034

Investigator site 101 - CN0860017, Beijing

160012

Investigator site 94 - IN0910001, Chandigarh

191123

Investigator site 46 - RU0070031, Saint Petersburg

197022

Investigator site 50 - RU0070034, Saint Petersburg

200025

Investigator site 102 - CN0860020, Shanghai

200040

Investigator site 99 - CN0860016, Shanghai

210042

Investigator site 113 - CN0860024, Nanjing

226005

Investigator site 79 - IN0910004, Lucknow

344002

Investigator site 39 - RU0070032, Rostov-on-Don

350020

Investigator site 49 - RU0070030, Krasnodar

380016

Investigator site 65 - IN0910002, Ahmedabad

400006

Investigator 96 - RO0400014, Cluj-Napoca

400042

Investigator site 118 - CH0860027, Chongqing

420111

Investigator site 48 - RU0070029, Kazan'

430022

Investigator site 112 - CN0860019, Wuhan

Investigator site 121 - CH0860025, Wuhan

440003

Investigator site 80 - IN0910003, Nagpur

450008

Investigator site 117 - CH0860026, Zhengzhou

454092

Investigator site 40 - RU0070035, Chelyabinsk

510000

Investigator site 119 - CH0860022, Guangzhou

Investigator site 100 - CN0860021, Guanzhou

610000

Investigator site 107 - CN0860018, Chengdu

620076

Investigator site 41 - RU0070033, Yekaterinburg

700111

Investigator site 98 - RO0400015, Iași

14203-1070

Investigator site 10 - US0010088, Buffalo

44106-1716

Investigator site 30 - US0010094, Cleveland

0159

Investigator site 78 - GE9950014, Tbilisi

0160

Investigator site 127 - GE9950030, Tbilisi

0162

Investigator site 32 - GE9950013, Tbilisi

0179

Investigator site 31 - GE9950015, Tbilisi

01307

Investigator site 34 - DE0490030, Dresden

06129

Investigator site 55 - IT0390038, Perugia

00167

Investigator site 12 - IT0390006, Roma

00168

Investigator site 25 - IT-0390005, Roma

480-1195

Investigator site 82 - JP0810046, Aichi

734-8551

Investigator site 68 - JP0810040, Hiroshima

400-8506

Investigator site 66 - JP0810042, Kofu

830-001

Investigator site 69 - JP0810050, Kurume

700-8558

Investigator site 73 - JP0810047, Okayama

701-0192

Investigator site 70 - JP0810041, Okayama

545-8586

Investigator site 71 - JP0810049, Osaka

060-8648

Investigator site 72 - JP0810045, Sapporo

980-8574

Investigator site 114 - JP0810067, Sendai

113-8431

Investigator site 67 - JP0810043, Tokyo

40-081

Investigator site 27 - PL0480027, Katowice

90-647

Investigator site 56 - PL0480032, Lodz

60-369

Investigator site 86 - PL0480036, Poznan

35-055

Investigator site 28 - PL0480025, Rzeszów

50-566

Investigator site 26 - PL0480028, Wroclaw

011216

Investigator site 97 - RO0400013, Bucharest

410012/410028

Investigator site 47 - RU0070028, Saratov

08907

Investigator site 62 - ES0340026, Barcelona

04050

Investigator site 14 - UA3800020, Kyiv

B15 2GW

Investigator site 106 - UK0440021, Birmingham

BS2 8HW

Investigator site 83 - UK0440022, Bristol

SO16 6YD

Investigator site 123 - UK0440037, Southampton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

argenx

INDUSTRY