Study on Efgartigimod Alfa and Prednisone for Adults with Bullous Pemphigoid

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What is this study about?

This clinical trial is focused on studying a skin condition called bullous pemphigoid, which causes large, fluid-filled blisters on areas of the skin that often itch. The study is testing a new treatment called efgartigimod PH20 SC, which is given as an injection under the skin. The purpose of the study is to see if this treatment can help people with bullous pemphigoid achieve a long-lasting improvement in their condition.

Participants in the study will receive either the new treatment or a placebo, which looks like the treatment but does not contain any active medicine. The study will last for about 36 weeks, during which time participants will be monitored to see how well the treatment works and to check for any side effects. The study will also look at how the treatment affects the need for other medications, like oral corticosteroids, which are often used to manage bullous pemphigoid.

Throughout the study, participants will have regular check-ups to assess their skin condition and overall health. The goal is to determine if efgartigimod PH20 SC can help control the symptoms of bullous pemphigoid and reduce the need for other treatments. This research could lead to new options for managing this challenging skin condition.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.

A pregnancy test is required for women of childbearing potential to ensure safety before starting the trial.

2 baseline measurements

Baseline measurements are taken to establish a starting point for the study. This includes recording the severity of bullous pemphigoid symptoms and other relevant health indicators.

3 medication administration

Participants receive either efgartigimod PH20 SC or a placebo through a subcutaneous injection. The frequency and dosage are determined by the study protocol.

In addition, prednisone, an oral medication, may be administered as part of the treatment plan. The dosage and frequency depend on individual needs and study requirements.

4 ongoing monitoring

Regular follow-up visits are scheduled to monitor health status and response to treatment. This includes physical examinations and symptom assessments.

Participants are required to report any side effects or changes in health during these visits.

5 evaluation of treatment efficacy

The effectiveness of the treatment is evaluated by measuring the proportion of participants achieving complete remission without oral corticosteroids for at least 8 weeks by week 36.

Additional assessments include changes in symptom severity and quality of life scores.

6 completion of study

The study concludes with a final assessment to evaluate overall health and treatment outcomes.

Participants may be asked to provide feedback on their experience during the trial.

Who Can Join the Study?

  • The participant must be willing and able to understand what the study requires, give written permission to join, and follow the study’s rules and procedures.
  • The participant can be male or female and must be old enough to legally give consent in their area at the time they sign the consent form.
  • The participant must show clinical signs of Bullous Pemphigoid (BP), which is a skin condition.
  • The participant must agree to use birth control methods that follow local laws. Women who can have children must have a negative blood pregnancy test at the start of the study and a negative urine pregnancy test before receiving the study medication.

Who Cannot Join the Study?

  • Having any other serious health condition that could interfere with the study.
  • Being pregnant or breastfeeding.
  • Having a history of drug or alcohol abuse.
  • Having participated in another clinical trial recently.
  • Having an allergy to the study medication or its ingredients.
  • Having a condition that affects the immune system, which is the body’s defense against illness.
  • Having a recent infection that required treatment with antibiotics.
  • Having received a vaccine within a certain time before the study.
  • Having a history of cancer, except for certain types that have been treated successfully.
  • Having a blood disorder, which affects the way blood works in the body.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Spitalul Clinic Judetean De Urgenta Cluj Cluj Napoca Romania
Technische Universitaet Dresden Dresden Germany

Other Sites

Site Name City Country Status
KBC Zagreb Zagreb Croatia
Centre Hospitalier Universitaire Rouen Rouen France
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Catania Italy
Fondazione Luigi Maria Monti Rome Italy
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Hospital Universitario 12 De Octubre Madrid Spain
University Hospital Bratislava Bratislava Slovakia
Fakultni Nemocnice Bulovka Prague Czechia
Fakultna Nemocnica Trnava Trnava Slovakia
Hospital Universitario Dr Peset Aleixandre Valencia Spain
Ippokratio General Hospital Of Thessaloniki Thessaloniki Greece
Uniwersytecki Szpital Kliniczny Nr 2 Uniwersytetu Medycznego W Lodzi SPZOZ Lodz Poland
Spitalul Clinic Judetean De Urgenta Sf. Spiridon Iasi Iasi Romania
401 General Military Hospital Of Athens Athens Greece
Rigas 1. slimnica SIA Riga Latvia
General Hospital Of Thessaloniki Papageorgiou Thessaloniki Greece
Diagnostic-consultative center “Aleksandrovska” EOOD Sofia Bulgaria
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Semmelweis University Budapest Hungary
IRCCS Ospedale Policlinico San Martino Genoa Italy
Andreas Syngros Hospital Of Venereal And Dermatological Diseases Athens Greece
Fakultni Nemocnice U Sv Anny V Brne Brno-Stred Czechia
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Azienda USL Toscana Centro Prato Italy
Centre Hospitalier Universitaire De Nice Nice France
Poliklinika Solmed d.o.o. Zagreb Croatia
University Of Pecs Pecs Hungary
Universita Degli Studi Di Brescia Brescia Italy
Klinika Osipowicz & Turkowski Sp. z o.o. Warsaw Poland
Adknimw Ozfcxznmhex Uxgbuiykuksrp Pgciq Parma Italy
Umohsutjtury Mpldcsh Cqueqqo Gjcezdayz Groningen The Netherlands
Docou Ctksxv Rzcx Skf Riga Latvia
Udbhyisqcwiutivrydwyg Dihndfffled Ahb Duesseldorf Germany
Anzcivc Oxxugfqmxze Unzzkyzdntmoj Sbhcvm Siena Italy
Kgeedcvq dgj Ukqdezfujcxf Mwmydjrb Aie Munich Germany
Uofuxfgngtctkttwycugk Whehnfpgp Aji Wuerzburg Germany
Amzeiub Ulpzy Slvhjexij Lszjad Dx Beajani Bologna Italy
Hqhqnqed Uqesvkenoivhy Htivgtyz Thdqi y Pthats Iyrbgzen Coipyb dqjohuszpmlegwnvp (znxr Badalona Spain
Upiqusxgek Gyhwmzo Hgkqwdfy Apkeocw Athens Greece

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Not recruiting
26.02.2022
Croatia Croatia
Not recruiting
26.02.2022
Czechia Czechia
Not recruiting
26.02.2022
France France
Not recruiting
26.02.2022
Germany Germany
Not recruiting
26.02.2022
Greece Greece
Not recruiting
26.02.2022
Hungary Hungary
Not recruiting
26.02.2022
Italy Italy
Not recruiting
26.02.2022
Latvia Latvia
Not recruiting
26.02.2022
Poland Poland
Not recruiting
26.02.2022
Romania Romania
Not recruiting
26.02.2022
Slovakia Slovakia
Not recruiting
26.02.2022
Spain Spain
Not recruiting
26.02.2022
The Netherlands The Netherlands
Not recruiting
26.02.2022

Trial locations

Efgartigimod PH20 SC is a medication being studied for its effectiveness in treating bullous pemphigoid, a skin condition that causes large, fluid-filled blisters. This medication is designed to help reduce the symptoms of the disease and achieve sustained remission, meaning that the symptoms are reduced or disappear for a period of time. The study aims to determine how well this medication works and how safe it is for patients with this condition.

Bullous Pemphigoid – Bullous pemphigoid is a rare skin condition characterized by large, fluid-filled blisters that develop on areas of the skin that often flex, such as the lower abdomen, upper thighs, or armpits. It primarily affects older adults and is caused by an autoimmune response where the body’s immune system mistakenly attacks the skin’s basement membrane, leading to blister formation. The blisters are usually tense and do not rupture easily, and they may be accompanied by itching or redness. The condition can vary in severity, with some individuals experiencing only mild symptoms, while others may have widespread blistering. Over time, the blisters may heal, but new ones can continue to form, leading to a chronic course.

Trial ID:
2023-508645-40-00
Protocol code:
ARGX-113-2009
NCT ID:
NCT05267600
Trial Phase:
Therapeutic use (Phase IV)

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