A Phase 3 Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid

Last updated: April 18, 2025
Sponsor: argenx
Overall Status: Terminated

Phase

3

Condition

Pemphigus Vulgaris (Pv)

Epidermolysis Bullosa

Treatment

Prednisone

efgartigimod PH20 SC

Clinical Study ID

NCT05681481
ARGX-113-2010
2024-515832-59-00
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to evaluate the safety of efgartigimod PH20 SC over a longer period of time in adult participants with moderate-to-severe bullous pemphigoid (BP) who have completed ARGX-113-2009 study. The study will also evaluate the efficacy of efgartigimod PH20 SC.

Eligible participants can roll over from the main study (ARGX-113-2009) to this open-label extension study (ARGX-113-2010). The study consists of a treatment period of up to 48 weeks in which participants receive efgartigimod PH20 SC. After the first 5 visits, the participants will visit the study centers at least once every 4 weeks. The participants who are not receiving efgartigimod PH20 SC (after the main study or currently on the study), will enter an observation period with study visits at least once every 8 weeks. If the participant relapses, they can re-enter the treatment period where they will receive efgartigimod PH20 SC. The treatment and observation period is followed by a follow-up period of 8 weeks. Oral or topical corticosterioids can be administered at the investigator's indiscretion

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Has completed the week 36 visit of ARGX-113-2009

  • Is capable of providing signed informed consent and complying with protocolrequirements

  • Agrees to use contraceptive measures consistent with local regulations and thefollowing: Women of childbearing potential must have a negative urine pregnancy testat baseline before receiving the study drug and must use one of the contraceptionmethods described in the protocol from signing the ICF until the last dose of thestudy drug

Exclusion

Exclusion Criteria:

  • Clinically significant disease, recent major surgery (within 3 months of baseline),or intends to have surgery during the study; or any other medical condition that, inthe investigator's opinion would confound the results of the study or put theparticipant at undue risk

  • Known hypersensitivity to the study drug or 1 of its excipients

  • Permanently discontinued IMP in ARGX-113-2009 due to an adverse event (AE)considered related to the study drug and for whom the benefit/risk balance is notconsidered positive

Study Design

Total Participants: 64
Treatment Group(s): 2
Primary Treatment: Prednisone
Phase: 3
Study Start date:
March 22, 2023
Estimated Completion Date:
March 20, 2025

Connect with a study center

  • Premier Specialists

    Kogarah, 2217
    Australia

    Site Not Available

  • Diagnostic and Consulting Center Aleksandrovska EOOD

    Sofia, 1431
    Bulgaria

    Site Not Available

  • Investigator site BG3590010

    Sofia, 1431
    Bulgaria

    Site Not Available

  • West China Hospital of Sichuan University

    Chengdu, 610041
    China

    Site Not Available

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, 400016
    China

    Site Not Available

  • Ruijin Hospital Shanghai Jiaotong University School of Medicine

    Shanghai, 200025
    China

    Site Not Available

  • Investigator site HR3850002

    Zagreb, 10000
    Croatia

    Active - Recruiting

  • Poliklinika Solmed

    Zagreb, 10000
    Croatia

    Site Not Available

  • Fakultni nemocnice Bulovka

    Praha, 180 00
    Czechia

    Site Not Available

  • Charité - Universitätsmedizin Berlin

    Berlin, 10117
    Germany

    Site Not Available

  • Investigator site 4 - DE0490039

    Berlin, 10117
    Germany

    Site Not Available

  • Investigator site 7 - DE0490030

    Dresden, 01307
    Germany

    Active - Recruiting

  • Universitätsklinikum Carl Gustav Carus an der TU Dresden

    Dresden, 01307
    Germany

    Site Not Available

  • Universitatsklinikum Dusseldorf

    Düsseldorf, 40225
    Germany

    Site Not Available

  • Investigator site DE0490028

    Kiel, 24105
    Germany

    Active - Recruiting

  • Universitatsklinikum Schleswig-Holstein

    Kiel, 24105
    Germany

    Site Not Available

  • LMU Klinikum der Universität

    München, 80337
    Germany

    Site Not Available

  • Universitätsklinikum Würzburg

    Würzburg, 97080
    Germany

    Site Not Available

  • Hospital of Venereal and Skin Diseases A.Syggros

    Athens, 16121
    Greece

    Site Not Available

  • Hospital Of Skin And Venereal Diseases of Thessaloniki

    Thessaloníki, 54643
    Greece

    Site Not Available

  • Investigator site HU0360023

    Budapest, 1085
    Hungary

    Active - Recruiting

  • Semmelweis Egyetem

    Budapest, 1085
    Hungary

    Site Not Available

  • Investigator site 8 - IL9720001

    Ramat Gan, 5262100
    Israel

    Active - Recruiting

  • Sheba Medical Center - PPDS

    Ramat Gan, 5262100
    Israel

    Site Not Available

  • Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele

    Catania, 95123
    Italy

    Site Not Available

  • Azienda Sanitaria Di Firenze

    Firenze, 50125
    Italy

    Site Not Available

  • Azienda USL Toscana Centro - Ospidale Piero Palagi

    Firenze, 50122
    Italy

    Site Not Available

  • Ospedale Policlinico San Martino

    Genova, 16132
    Italy

    Site Not Available

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

    Milano, 20122
    Italy

    Site Not Available

  • Fondazione IRCCS Policlinico San Matteo di Pavia

    Pavia, 27100
    Italy

    Site Not Available

  • Investigator site 9 - IT0390061

    Pavia, 27100
    Italy

    Active - Recruiting

  • IDI IRCCS - Istituto Dermopatico dell'Immacolata

    Roma, 00167
    Italy

    Site Not Available

  • Fondazione Policlinico Universitario A. Gemelli

    Rome, 00168
    Italy

    Site Not Available

  • Hokkaido University Hospital

    Sapporo, 060-8648
    Japan

    Site Not Available

  • Investigator site 5 - NL0310015

    Groningen, 9713 GZ
    Netherlands

    Active - Recruiting

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 GZ
    Netherlands

    Site Not Available

  • Investigator site RS3810011

    Belgrade, 11000
    Serbia

    Active - Recruiting

  • University Clinical Center of Serbia - PPDS

    Belgrade, 11000
    Serbia

    Site Not Available

  • Univerzitna nemocnica Bratislava

    Bratislava, 821 06
    Slovakia

    Site Not Available

  • Fakultna nemocnica Trnava

    Trnava, 91702
    Slovakia

    Site Not Available

  • Hospital Universitario Clínico San Cecilio

    Granada, 18016
    Spain

    Site Not Available

  • Investigator site ES0340053

    Granada, 18016
    Spain

    Active - Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • Hospital Universitario Doctor Peset

    Valencia, 46017
    Spain

    Site Not Available

  • Guy's and St Thomas' NHS Foundation Trust

    London, SE1 9RT
    United Kingdom

    Site Not Available

  • Medical Dermatology Specialists

    Phoenix, Arizona 85006
    United States

    Site Not Available

  • First OC Dermatology

    Fountain Valley, California 92708
    United States

    Site Not Available

  • Investigator site US0010017

    Miami, Florida 33173
    United States

    Site Not Available

  • Miami Dermatology and Laser Institute

    Miami, Florida 33173
    United States

    Site Not Available

  • Investigator site 10 - US0010149

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • University of Michigan Hospital

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Investigator site 6 - US0010098

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • Saint Louis University

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Wright State Physicians

    Fairborn, Ohio 45324
    United States

    Site Not Available

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