A Phase 3 Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid
NCT ID: NCT05681481
Last Updated: 2025-04-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
64 participants
INTERVENTIONAL
2023-03-22
2025-03-20
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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efgartigimod PH20 SC
participants receiving efgartigimod PH20 SC on top of Prednisone
efgartigimod PH20 SC
Subcutaneous injection of efgartigimod coformulated with rHuPH20, a permeation enhancer
Prednisone
Oral Prednisone
Interventions
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efgartigimod PH20 SC
Subcutaneous injection of efgartigimod coformulated with rHuPH20, a permeation enhancer
Prednisone
Oral Prednisone
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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argenx
INDUSTRY
Responsible Party
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Locations
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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
Azienda Sanitaria Di Firenze
Florence, , Italy
Ospedale Policlinico San Martino
Genova, , Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, , Italy
Fondazione IRCCS Policlinico San Matteo di Pavia
Pavia, , Italy
IDI IRCCS - Istituto Dermopatico dell'Immacolata
Roma, , Italy
Fondazione Policlinico Universitario A. Gemelli
Rome, , Italy
Hokkaido University Hospital
Sapporo, , Japan
Universitair Medisch Centrum Groningen
Groningen, , Netherlands
University Clinical Center of Serbia - PPDS
Belgrade, , Serbia
Univerzitna nemocnica Bratislava
Bratislava, , Slovakia
Fakultna nemocnica Trnava
Trnava, , Slovakia
Hospital Universitario Clínico San Cecilio
Granada, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario Doctor Peset
Valencia, , Spain
Guy's and St Thomas' NHS Foundation Trust
London, , United Kingdom
Countries
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Other Identifiers
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2024-515832-59-00
Identifier Type: CTIS
Identifier Source: secondary_id
ARGX-113-2010
Identifier Type: -
Identifier Source: org_study_id
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