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

PHASE3CompletedINTERVENTIONAL
Enrollment

222

Participants

Timeline

Start Date

December 1, 2020

Primary Completion Date

August 22, 2023

Study Completion Date

August 22, 2023

Conditions
Pemphigus VulgarisPemphigus Foliaceus
Interventions
BIOLOGICAL

efgartigimod PH20 SC

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

OTHER

Placebo

Subcutaneous injection of placebo

DRUG

prednisone

Oral prednisone tablets

Trial Locations (134)

1085

Investigator site 133 - HU0360023, Budapest

1431

Investigator site 4 - BG3590010, Sofia

1510

Investigator site 2 - BG3590009, Sofia

1606

Investigator site 13 - BG3590011, Sofia

2217

Investigator site 24 - AU0610006, Sydney

3050

Investigator site 5 - AU0610007, Parkville

3065

Investigator site 103 - AU0610013, Melbourne

4000

Investigator site 31 - BG3590013, Plovdiv

4032

Investigator site 22 - HU0360003, Debrecen

4050

Investigator site 16 - UA3800020, Kyiv

4209

Investigator site 18 - UA3800019, Kyiv

5800

Investigator site 30 - BG350012, Pleven

6720

Investigator site 42 - HU0360002, Szeged

7632

Investigator site 14 - HU0360001, Pécs

8036

Investigator site 15 - ES0340032, Barcelona

10117

Investigator site 64 - DE0490029, Berlin

10128

Investigator site 136 - US0010196, New York

11000

Investigator site 116 - RS3810011, Belgrade

Investigator site 122 - RS3810010, Belgrade

11525

Investigator site 40 - GR0300004, Athens

12462

Investigator site 39 - GR0300003, Chaïdári

16121

Investigator site 51 - GR0300006, Athens

Investigator site 69 - GR0300001, Athens

16132

Investigator site 92 - IT0390030, Genova

18000

Investigator site 115 - RS3810012, Niš

18016

Investigator site 130 - ES0340053, Granada

19104

Investigator site 73 - US00100, Philadelphia

19140

Investigator site 101 - US0010097, Philadelphia

21000

Investigator site 114 - RS3810009, Novi Sad

23502

Investigator site 59 - US0010106, Norfolk

23538

Investigator site 37 - DE0490002, Lübeck

24105

Investigator site 38 - DE0490028, Kiel

27310

Investigator site 76 - TR0900020, Gaziantep

27710

Investigator site 60 - US0010096, Durham

28007

Investigator site 67 - ES0340034, Madrid

28009

Investigator site 134 - ES0340057, Málaga

28034

Investigator site 10 - ES0340025, Madrid

28041

Invetistigator site 8 - ES0340029, Madrid

28046

Investigator site 6 - ES0340027, Madrid

31008

Investigator site 23 - ES0340031, Pamplona

32827

Investigator site 78 - US0010109, Orlando

33173

Investigator site 99 - US0010117, Miami

33428

Investigator site 2 - US0010087, Boca Raton

34098

Investigator site 75 - TR0900012, Istanbul

34722

Investigator site 87 - TR0900011, Istanbul

35043

Investigator site 68 - DE0490001, Marburg

35233

Investigator site 77 - US0010086, Birmingham

38700

Investigator site 33 - FR0330027, La Tronche

41013

Investigator site 7 - ES0340028, Seville

42055

Investigator site 32 - FR0330026, Saint-Etienne

47906

Investigator site 127 - US0010155, West Lafayette

49074

Investigator site 89 - UA3800017, Dnipro

50125

Investigator site 52 - IT0390031, Florence

51000

Investigator site 128 - CH0860053, Guangzhou

53100

Investigator site 71 - IT0390040, Siena

54643

Investigator site 50 - GR0300002, Thessaloniki

55455

Investigator site 61 - US0010090, Minneapolis

56429

Investigator site 41 - GR0300005, Thessaloniki

60590

Investigator site 49 - DE0490024, Frankfurt am Main

63110

Investigator site 102 - US0010098, St Louis

64239

Investigator site 12 - ISR9720002, Tel Aviv

69063

Investigator site 17 - UA3800018, Zaporizhzhia

72076

Investigator site 25 - DE0490025, Tübingen

75246

Investigator site 98 - US0010107, Dallas

76018

Investigator site 45 - UA3800023, Ivano-Frankivsk

76031

Investigator site 46 - FR0330029, Rouen

77004

Investigator site 126 - US0010182, Houston

77008

Investigator site 88 - US0010114, Houston

78620

Investigator site 1 - US0010084, Dripping Springs

79013

Investigator site 62 - UA3800021, Lviv

79104

Investigator site 47 - DE0490023, Freiburg im Breisgau

80109

Investigator site 125 - US0010153, Castle Rock

85259

Investigator site 97 - US0010091, Scottsdale

89081

Investigator site 79 - DE0490027, Ulm

93000

Investigator site 34 - FR0330028, Bobigny

94063

Investigator site 121 - US0010092, Redwood City

95123

Investigator site 104 - IT0390039, Catania

97080

Investigator site 21 - DE0490026, Würzburg

100034

Investigator site 110 - CN0860017, Beijing

160012

Investigator site 100 - IN0910001, Chandigarh

191123

Investigator site 56 - RU0070031, Saint Petersburg

197022

Investigator site 65 - RU0070034, Saint Petersburg

200025

Investigator site 112 - CN0860020, Shanghai

200040

Investigator site 108 - CN0860016, Shanghai

226005

Investigator site 90 - IN0910004, Lucknow

344002

Investigator site 53 - RU0070032, Rostov-on-Don

350005

Investigator site 118 - CN0860023, Fujian

350020

Investigator site 55 - RU0070030, Krasnodar

380016

Investigator site 80 - IN0910002, Ahmedabad

400006

Investigator site 105 - RO0400014, Cluj-Napoca

400042

Investigator site 131 - CH0860027, Chongqing

420111

Investigator site 57 - RU0070029, Kazan'

430022

Investigator site 113 - CN0860025, Wuhan

Investigator site 123 - CN0860019, Wuhan

440003

Investigator site 91 - IN0910003, Nagpur

450008

Investigator site 129 - CH0860026, Zhengzhou

454092

Investigator site 54 - RU0070035, Chelyabinsk

510000

Investigator site 120 - CN0860022, Guangzhou

Investigator site 109 - CN0860021, Guanzhou

610000

Investigator site 111 - CN0860018, Chendu

620076

Investigator site 58 - RU0070033, Yekaterinburg

700111

Investigator site 107 - RO0400015, Iași

14203-1070

Investigator site 19 - US0010088, Buffalo

44106-1716

Investigator site 20 - US0010094, Cleveland

Unknown

Investigator site 119 - CN0860024, Nanjing

0159

Investigator site 63 - GE9950014, Tbilisi

0160

Investigator site 132 - GE9950030, Tbilisi

0162

Investigator site 35 - GE9950013, Tbilisi

0179

Investigator site 36 - GE9950015, Tbilisi

01307

Investigator site 48 - DE0490030, Dresden

00167

Investigator site 11 - IT0390006, Rome

06129

Investigator site 70 - IT0390038, Perugia

00168

Investigator site 43 - IT390005, Roma

480-1195

Investigator site 94 - JP0810046, Aichi

734-8551

Investigator site 81 - JP0810040, Hiroshima

400-8506

Investigator site 82 - JP0810042, Kofu

830-001

Investigator site 85 - JP0810050, Kurume

700-8558

Investigator site 84 - JP0810047, Okayama

701-0192

Investigator site 93 - JP0810041, Okayama

545-8586

Investigator site 86 - JP0810049, Osaka

060-8648

Investigator site 74 - JP0810045, Sapporo

980-8574

Investigator site 124 - JP0810067, Sendai

113-8431

Investigator site 83 - JP0810043, Tokyo

40-081

Investigator site 26 - PL0480027, Katowice

90-647

Investigator site 72 - PL0480032, Lodz

60-369

Investigator site 95 - PL0480036, Poznan

35-055

Investigator site 27 - PL0480025, Rzeszów

50-566

Investigator site 28 - PL0480028, Wroclaw

011216

Investigator site 106 - RO0400013, Bucharest

410012/410028

Investigator site 66 - RU0070028, Saratov

08907

Investigator site 29 - ES0340026, Barcelona

B15 2GW

Investigator site 117 - UK0440021, Birmingham

BS2 8HW

Investigator site 96 - UK0440022, Bristol

SO16 6YD

Investigator site 135 - GB0440037, Southampton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

argenx

INDUSTRY