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

Stopped early · Phase 3

Conditions studied: Bullous Pemphigoid

In brief

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 could receive efgartigimod PH20 SC according to their clinical status. After the first 5 visits, the participants will visit the study centres 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 corticosteroids can be administered at the investigator's discretion.

Key facts

Study ID: NCT05681481
Run by: argenx
People needed: 64
Starts: 2023-03-22
Expected to finish: 2025-03-20
Last updated by the study team: 2026-02-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Has completed the week 36 visit of ARGX-113-2009
Is capable of providing signed informed consent and complying with protocol requirements
Agrees to use contraceptive measures consistent with local regulations and the following: Women of childbearing potential must have a negative urine pregnancy test at baseline before receiving the study drug and must use one of the contraception methods described in the protocol from signing the ICF until the last dose of the study drug

You may not qualify if…

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, in the investigator's opinion would confound the results of the study or put the participant 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 not considered positive

Where it is running

Medical Dermatology Specialists — Phoenix, Arizona, United States
First OC Dermatology — Fountain Valley, California, United States
Miami Dermatology and Laser Institute — Miami, Florida, United States
University of Michigan Hospital — Ann Arbor, Michigan, United States
Saint Louis University — St Louis, Missouri, United States
Wright State Physicians — Fairborn, Ohio, United States
Premier Specialists — Kogarah, Australia
Diagnostic and Consulting Center Aleksandrovska EOOD — Sofia, Bulgaria
West China Hospital of Sichuan University — Chengdu, China
The First Affiliated Hospital of Chongqing Medical University — Chongqing, China
Ruijin Hospital Shanghai Jiaotong University School of Medicine — Shanghai, China
Poliklinika Solmed — Zagreb, Croatia
Fakultni nemocnice Bulovka — Prague, Czechia
Charité - Universitätsmedizin Berlin — Berlin, Germany
Universitätsklinikum Carl Gustav Carus an der TU Dresden — Dresden, Germany
Universitatsklinikum Dusseldorf — Düsseldorf, Germany
Universitatsklinikum Schleswig-Holstein — Kiel, Germany
LMU Klinikum der Universität — München, Germany
Universitätsklinikum Würzburg — Würzburg, Germany
Hospital of Venereal and Skin Diseases A.Syggros — Athens, Greece
Hospital Of Skin And Venereal Diseases of Thessaloniki — Thessaloniki, Greece
Semmelweis Egyetem — Budapest, Hungary
Sheba Medical Center - PPDS — Ramat Gan, Israel
Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele — Catania, Italy
Azienda USL Toscana Centro - Ospidale Piero Palagi — Florence, Italy

Full record on ClinicalTrials.gov

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