Study on Long-term Safety and Effects of Efgartigimod PH20 SC for Adults with Bullous Pemphigoid

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What is this study about?

This clinical trial is focused on studying a condition called Bullous Pemphigoid, which is a rare skin disorder that causes large, fluid-filled blisters. The study is testing a treatment called efgartigimod PH20 SC, which is given as a solution for injection under the skin. The purpose of the study is to evaluate the long-term safety and how well people tolerate this treatment.

Participants in the study will receive the treatment over a period of time, and researchers will monitor them to see how their bodies respond. The study will look at how often and how severe any side effects are, as well as how many participants stop the treatment due to safety concerns. The study will also assess how well the treatment works in managing the symptoms of Bullous Pemphigoid over time.

In addition to the main treatment, some participants may receive a substance called placebo, which looks like the treatment but does not contain the active ingredient. This helps researchers compare the effects of the actual treatment with no treatment. The study aims to provide valuable information about the potential benefits and risks of using efgartigimod PH20 SC for people with Bullous Pemphigoid.

1 joining the study

Upon joining the study, ensure that the week 36 visit of ARGX-113-2009 has been completed. This is a requirement to participate in the current study.

Provide signed informed consent, confirming understanding of the study requirements and agreeing to comply with them.

2 contraceptive measures

If male, use a condom as a method of contraception from the time of signing the informed consent form until the last dose of the investigational medicinal product (IMP).

If female and of childbearing potential, ensure a negative urine pregnancy test at baseline before receiving the IMP. Use one of the contraception methods described in the protocol from signing the informed consent form until the last dose of IMP.

3 treatment administration

Receive the medication efgartigimod PH20 SC through a subcutaneous injection. This means the medication is injected under the skin.

The study aims to evaluate the long-term safety and tolerability of this treatment in participants with bullous pemphigoid.

4 monitoring and assessments

Throughout the study, the incidence and severity of any treatment-emergent adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) will be monitored.

The rate of treatment discontinuation due to safety concerns will also be assessed.

5 study duration

The estimated end date of the study is September 9, 2025. Participation will continue until this date unless otherwise specified by the study protocol.

Who Can Join the Study?

The patient must have completed the week 36 visit of the study identified as ARGX-113-2009.
The patient must be capable of providing signed informed consent, which means they understand the study and agree to participate.
The patient must agree to use contraceptive measures as required by local regulations:
- Male participants: Must use a condom from the time they sign the informed consent form until the last dose of the study medication.
- Women of childbearing potential: Must have a negative urine pregnancy test before starting the study medication and use a specified method of contraception from signing the informed consent form until the last dose of the study medication.

Who Cannot Join the Study?

Patients who do not have a confirmed diagnosis of Bullous Pemphigoid cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
Patients who do not meet other specific health criteria set by the study cannot participate.

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
Technische Universitaet Dresden	Dresden	Germany

Other Sites

Site Name	City	Country
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
Hospital Del Mar	Barcelona	Spain
University Hospital Bratislava	Bratislava	Slovakia
Fakultna Nemocnica Trnava	Trnava	Slovakia
Hospital Universitario Dr Peset Aleixandre	Valencia	Spain
Ippokratio General Hospital Of Thessaloniki	Thessaloniki	Greece
401 General Military Hospital Of Athens	Athens	Greece
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
Semmelweis University	Budapest	Hungary
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Andreas Syngros Hospital Of Venereal And Dermatological Diseases	Athens	Greece
Azienda USL Toscana Centro	Prato	Italy
Poliklinika Solmed d.o.o.	Zagreb	Croatia
Uqgfyavosgdn Mqnrkzc Ciphezn Gtytzfugt	Groningen	The Netherlands
Dflghzxedloscidzogxi kcjuyxlf Funipkfz nnizccjhe Bmrhkpd	Prague	Czechia
Uomvxtxphzelqkjmohyef Dhaoyhucndp Awt	Duesseldorf	Germany
Kxjqjpaz dpv Uxsbvjrksvdr Mgmgkkky Afq	Munich	Germany
Uzqlovsxkmicmvpvyytzo Wgjxztkhj Azf	Wuerzburg	Germany
Fupjwuhxv Pvnh Lx Igsytjhukxbta Bpnflsdkh Dxc Hgabhtjr Uwttrdevggkvo Le Pep	Madrid	Spain
Hwghsade Uewwrojarobam Hqhozedj Tyvau y Ptbgcc Ifijxvjn Clpnef dyfmldqxbhvxtzouu (tcxm	Badalona	Spain
Utrmxaebvy Guqmesu Hbvfmvto Apgklru	Athens	Greece

Trial status

Country	Status	Recruitment Start
Bulgaria	Not recruiting	23.03.2023
Croatia	Not recruiting	23.03.2023
Czechia	Not recruiting	23.03.2023
Germany	Not recruiting	23.03.2023
Greece	Not recruiting	23.03.2023
Hungary	Not recruiting	23.03.2023
Italy	Not recruiting	23.03.2023
Slovakia	Not recruiting	23.03.2023
Spain	Not recruiting	23.03.2023
The Netherlands	Not recruiting	23.03.2023

Trial locations

Investigated drugs:

Efgartigimod Alfa

Efgartigimod PH20 SC is a medication being studied for its long-term safety and effectiveness in treating a skin condition called bullous pemphigoid. This condition causes painful blisters on the skin. Efgartigimod PH20 SC works by targeting and reducing certain proteins in the body that are involved in the immune system’s attack on the skin, which helps to decrease the formation of blisters and improve symptoms. The medication is administered under the skin, and the study aims to see how well patients tolerate it over a longer period.

Bullous Pemphigoid – Bullous Pemphigoid is a chronic autoimmune skin disorder characterized by large, fluid-filled blisters. These blisters typically form on areas of the skin that often flex, such as the lower abdomen, upper thighs, or armpits. The disease occurs when the immune system mistakenly attacks a thin layer of tissue below the outer layer of skin, leading to inflammation and blister formation. The blisters are usually tense and do not easily rupture, and they may be accompanied by itching or a rash. Over time, the blisters may heal and leave behind dark spots or scars. The condition can fluctuate, with periods of flare-ups and remission.

Trial ID:

2024-515832-59-00

Protocol code:

ARGX-113-2010

NCT ID:

NCT05681481

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Long-term Safety and Effects of Efgartigimod PH20 SC for Adults with Bullous Pemphigoid

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