A Phase 2/3, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid

Who is this study for? Adults with bullous pemphigoid
What treatments are being studied? Efgartigimod PH20+Prednisone
Status: Completed
Location: See all (125) locations...
Intervention Type: Biological, Other, Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

ARGX-113-2009 is an operationally seamless 2-part, phase 2/3, prospective, global, multicenter, randomized, double-blinded, placebo-controlled study to investigate the efficacy, safety, tolerability, immunogenicity, participant-reported outcome measures (including those assessing participant QoL), PK, and PD of efgartigimod PH20 SC administered via subcutaneous (SC) injection in adult participants with moderate to severe BP. This study intends to demonstrate that efgartigimod is an effective and safe treatment for BP, providing participants with control of disease activity (CDA) and eventually remission while reducing their cumulative exposure to OCS. study will consist of 2 parts: * Part A of the study is a phase 2 evaluation that intends to provide proof of concept for the therapeutic activity of efgartigimod PH20 SC in participants with BP. * Part B of the study is a phase 3 evaluation that intends to confirm the results obtained from part A in a separate, larger group of participants with BP. An interim analysis will be performed during part A (on data obtained through week 26 for all Part A participants) to assess the primary endpoint and several secondary endpoints, confirm the appropriate sample size for part B of the study, and determine whether the efficacy results observed through week 26 of part A warrant continued study of efgartigimod PH20 SC for the treatment of participants with BP (futility analysis).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• The participant is willing and able to do the following:

‣ understand the requirements of the study

⁃ provide written informed consent

⁃ comply with the study protocol procedures.

• The participant is male or female and has reached the age of consent at the time of signing the informed consent form (ICF).

• Participants have clinical signs of BP.

• Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies and: Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline before study intervention can be administered.

∙ The full list of inclusion criteria can be found in the protocol.

Locations
United States
Arizona
Investigator site 74 - US0010178
Phoenix
California
Investigator site 6 - US0010138
Fountain Valley
Investigator site 121 - US0010092
Redwood City
Investigator site 72 - US0010186
Santa Monica
Colorado
Investigator site 10 - US0010153
Castle Rock
Florida
Investigator site 2 - US0010087
Boca Raton
Investigator site 21 - US0010152
Clearwater
Investigator site 1 - US0010017
Miami
Indiana
Investigator site 13 - US0010155
West Lafayette
Kentucky
Investigator site 35 - US0010156
Louisville
Michigan
Investigator site 50 - US0010149
Ann Arbor
Missouri
Investigator site 73 - US0010098
St Louis
Mississippi
Investigator site 115 - US0010157
Jackson
New Hampshire
Investigator site 85 - US0010159
Lebanon
New York
Investigator site 5 - US0010088
Buffalo
Investigator site 93 - US0010169
New York
Ohio
Investigator site 4 - US0010137
Fairborn
Pennsylvania
Investigator site 25 - US0010158
Pittsburgh
Texas
Investigator site 34 - US0010182
Houston
Utah
Investigator site 92 - US0010150
Murray
West Virginia
Investigator site 3 - US0010151
Morgantown
Other Locations
Australia
Investigator site 36 - AU0610013
Fitzroy
Investigator site 27 - AU0610006
Kogarah
Investigator site 125 - AU0610019
Woolloongabba
Bulgaria
Investigator site 14 - BG3590010
Sofia
Investigator site 28 - BG3590018
Sofia
Investigator site 15 - BG3590020
Stara Zagora
China
Investigator site 111 - CN0860064
Beijing
Investigator site 91 - CN0860017
Beijing
Investigator site 95 - CN0860018
Chengdu
Investigator site 116 - CN0860027
Chongqing
Investigator site 108 - CN0860023
Fujian
Investigator site 107 - CN0860021
Guangzhou
Investigator site 110 - CN0860053
Guanzhou
Investigator site 128 - CN0860097
Hefei
Investigator site 124 - CN0860098
Nanchang
Investigator site 94 - CN0860066
Nanyang
Investigator site 123 - CN0860095
Shanghai
Investigator site 127 - CN860020
Shanghai
Investigator site 122 - CN0860065
Ürümqi
Investigator site 109 - CN0860025
Wuhan
Investigator site 126 - CN0860026
Zhengzhou
Croatia
Investigator site 22 - HR3850003
Split
Investigator site 16 - HR3850002
Zagreb
Investigator site 37 - HR3850001
Zagreb
France
Investigator site 38 - FR0330040
Nice
Investigator site 29 - FR0330029
Rouen
Germany
Investigator site 46 - DE0490039
Berlin
Investigator site 54 - DE0490030
Dresden
Investigator site 80 - DE0490041
Düsseldorf
Investigator site 57 - DE0490046
Erlangen
Investigator site 51 - DE0490008
Essen
Investigator site 52 - DE0490024
Frankfurt Am Main
Investigator site 53 - DE0490023
Freiburg Im Breisgau
Investigator site 56 - DE0490028
Kiel
Investigator site 45 - DE0490001
Marburg
Investigator site 75 - DE0490047
München
Investigator site 55 - DE0490026
Würzburg
Greece
Investigator site 58 - GR0300001
Athens
Investigator site 60 - GE0300004
Athens
Investigator site 62 - GE0300006
Athens
Investigator site 76 - GR030003
Chaïdári
Investigator site 59 - GR0300005
Thessaloniki
Investigator site 61 - GE0300002
Thessaloniki
Hungary
Investigator site 26 - HU0360023
Budapest
Investigator site 11 - HU0360003
Debrecen
Investigator site 7 - HU0360008
Pécs
Israel
Investigator site 39 - IL9720003
Afula
Investigator site 63 - IL9720018
Haifa
Investigator site 41 - IL9720001
Ramat Gan
Investigator site 40 - IL9720002
Tel Aviv
Italy
Investigator site 65 - IT0390055
Bologna
Investigator site 43 - IT0390060
Brescia
Investigator site 78 - IT0390039
Catania
Investigator site 47 - IT0390031
Florence
Investigator site 86 - IT0390067
Florence
Investigator site 81 - IT0390030
Genova
Investigator site 77 - IT0390062
Milan
Investigator site 119 - IT0390066
Parma
Investigator site 64 - IT0390061
Pavia
Investigator site 23 - IT0390006
Roma
Investigator site 42 - IT0390005
Roma
Investigator site 30 - IT0390040
Siena
Japan
Investigator site 103 - JP0810070
Kumamoto
Investigator site 99 - JP0810050
Kurume
Investigator site 104 - JP0810071
Maebashi
Investigator site 100 - JP0810046
Nagakute
Investigator site 129 - JP0810073
Niigata
Investigator site 101 - JP0810049
Osaka
Investigator site 102 - JP0810069
Ōsaka-sayama
Investigator site 112 - JP0810045
Sapporo
Investigator site 105 - JP0810067
Sendai
Investigator site 98 - JP0810043
Tokyo
Investigator site 106 - JP0810068
Yokohama
Latvia
Investigator site 82 - LV3710003
Riga
Investigator site 87 - LV3710005
Riga
Investigator site 88 - LV3710004
Riga
Netherlands
Investigator site 66 - NL0310015
Groningen
Poland
Investigator site 17 - PL0480047
Lodz
Investigator site 79 - PL0480025
Rzeszów
Investigator site 83 - PL0480050
Warsaw
Investigator site 18 - PL0480048
Wroclaw
Investigator site 19 - PL0480046
Wroclaw
Romania
Investigator site 90 - RO0400014
Cluj-napoca
Investigator site 89 - RO0400015
Iași
Serbia
Investigator 68 - RS381011
Belgrade
Investigator site 84 - RS3810010
Belgrade
Investigator site 67 - RS3810012
Niš
Investigator site 69 - RS3810009
Novi Sad
Slovakia
Investigator site 113 - SK4210002
Bratislava
Investigator site 120 - SK4210004
Košice
Investigator site 114 - SK4210003
Trnava
Spain
Investigator site 32 - ES0340050
Badalona
Investigator 24 - ES0340051
Barcelona
Investigator site 8 - ES0340053
Granada
Investigator 20 - ES0340029
Madrid
Investigator site 12 - ES0340025
Madrid
Investigator site 31 - ES0340057
Málaga
Investigator site 49 - ES0340058
Manises
Investigator site 48 - ES0340059
Mieres
Investigator site 9 - ES0340052
Seville
Investigator site 70 - ES0340061
Valencia
United Kingdom
Investigator site 33 - UK0440022
Bristol
Investigator site 71 - UK0440036
London
Investigator site 44 - UK0440037
Southampton
Time Frame
Start Date: 2022-06-09
Completion Date: 2024-09-13
Participants
Target number of participants: 98
Treatments
Experimental: efgartigimod PH20 SC
participants receiving efgartigimod PH20 SC on top of Prednisone
Placebo_comparator: placebo PH20 SC
participants receiving placebo PH20 SC on top of Prednisone
Sponsors
Leads: argenx

This content was sourced from clinicaltrials.gov