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New drug shows promise for blistering skin disease in extended trial

NCT ID NCT05681481

Disease control Sponsor: argenx Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at the long-term safety of a drug called efgartigimod for adults with moderate-to-severe bullous pemphigoid, a condition that causes painful blisters. Participants who finished the main study can continue treatment for up to 48 weeks, with the option to pause and restart if symptoms return. The goal is to see if the drug is safe over time and helps control the disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

64 people

The number who actually took part.

Started

Mar 2023

Finished

Mar 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 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, 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

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Conditions

The condition(s) this trial relates to.

bullous pemphigoid

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bullous pemphigoid

Contacts and locations

Locations

  • Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele

    Catania, 95123, Italy

  • Azienda Sanitaria Di Firenze

    Florence, 50125, Italy

  • Azienda USL Toscana Centro - Ospidale Piero Palagi

    Florence, 50122, Italy

  • Charité - Universitätsmedizin Berlin

    Berlin, 10117, Germany

  • Diagnostic and Consulting Center Aleksandrovska EOOD

    Sofia, 1431, Bulgaria

  • Fakultna nemocnica Trnava

    Trnava, 91702, Slovakia

  • Fakultni nemocnice Bulovka

    Prague, 180 00, Czechia

  • First OC Dermatology

    Fountain Valley, California, 92708, United States

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

    Milan, 20122, Italy

  • Fondazione IRCCS Policlinico San Matteo di Pavia

    Pavia, 27100, Italy

  • Fondazione Policlinico Universitario A. Gemelli

    Rome, 00168, Italy

  • Guy's and St Thomas' NHS Foundation Trust

    London, SE1 9RT, United Kingdom

  • Hokkaido University Hospital

    Sapporo, 060-8648, Japan

  • Hospital Of Skin And Venereal Diseases of Thessaloniki

    Thessaloniki, 54643, Greece

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Clínico San Cecilio

    Granada, 18016, Spain

  • Hospital Universitario Doctor Peset

    Valencia, 46017, Spain

  • Hospital of Venereal and Skin Diseases A.Syggros

    Athens, 16121, Greece

  • IDI IRCCS - Istituto Dermopatico dell'Immacolata

    Roma, 00167, Italy

  • LMU Klinikum der Universität

    München, 80337, Germany

  • Medical Dermatology Specialists

    Phoenix, Arizona, 85006, United States

  • Miami Dermatology and Laser Institute

    Miami, Florida, 33173, United States

  • Ospedale Policlinico San Martino

    Genova, 16132, Italy

  • Poliklinika Solmed

    Zagreb, 10000, Croatia

  • Premier Specialists

    Kogarah, 2217, Australia

  • Ruijin Hospital Shanghai Jiaotong University School of Medicine

    Shanghai, 200025, China

  • Saint Louis University

    St Louis, Missouri, 63110, United States

  • Semmelweis Egyetem

    Budapest, 1085, Hungary

  • Sheba Medical Center - PPDS

    Ramat Gan, 5262100, Israel

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, 400016, China

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 GZ, Netherlands

  • Universitatsklinikum Dusseldorf

    Düsseldorf, 40225, Germany

  • Universitatsklinikum Schleswig-Holstein

    Kiel, 24105, Germany

  • University Clinical Center of Serbia - PPDS

    Belgrade, 11000, Serbia

  • University of Michigan Hospital

    Ann Arbor, Michigan, 48109, United States

  • Universitätsklinikum Carl Gustav Carus an der TU Dresden

    Dresden, 01307, Germany

  • Universitätsklinikum Würzburg

    Würzburg, 97080, Germany

  • Univerzitna nemocnica Bratislava

    Bratislava, 821 06, Slovakia

  • West China Hospital of Sichuan University

    Chengdu, 610041, China

  • Wright State Physicians

    Fairborn, Ohio, 45324, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.