A phase 3 follow up study of efgartigimod PH20 SC in adult participants with bullous pemphigoid
Research type
Research Study
Full title
An Open-label Extension Study of ARGX-113-2009 to Evaluate the Long term Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid
IRAS ID
1006910
Contact name
Sabine Coppieters
Contact email
Sponsor organisation
argenx BV
Eudract number
2021-003063-10
Research summary
Bullous pemphigoid is a rare autoimmune skin condition, it starts with an itchy raised rash. As the condition develops, large blisters can form on the skin. The blisters can grow big and may contain blood, if the blister burst open, they leave areas of raw unhealed skin that are very painful and at risk of infection. Bullous pemphigoid can affect people of all ages, but is most common in older adults, both men and women, aged 65 years and above. It is not contagious and cannot be passed from one person to another. Bullous pemphigoid is a chronic disease and is difficult to control, with life-threatening potential and it have a serious impact on quality of life.
There is currently no cure for bullous pemphigoid. Treatment with corticosteroids is often used initially to keep the symptoms under control. However, high doses of corticosteroids may be required and they have many side effects which can be severe or life threatening especially in the elderly when taken at high doses for long periods. Other medicines are often prescribed to allow the dose of corticosteroids to be reduced.
This is an open-label extension (OLE) study which means the study doctor and the participant know what treatment is administered. This OLE study is following on from the ARGX-113-2009 study and provides all participants of the ARGX-113-2009 study the option to receive efgartigimod PH20 SC. The aim of this study is to further look at the effectiveness and safety of the study drug (efgartigimod PH20 SC) in people with bullous pemphigoid. It is hoped that the study drug may help improve the symptoms of bullous pemphigoid.
The maximum number of participants in this study will be the number of participants who entered into the preceding study (160 maximum). The study will last up to approximately 56 weeks, including a 48 weeks of treatment period and 8 weeks of treatment free follow-up. Participants will undergo procedures such as physical examination, blood samples and electrocardiogram.REC name
South Central - Hampshire B Research Ethics Committee
REC reference
23/SC/0031
Date of REC Opinion
22 Aug 2023
REC opinion
Further Information Favourable Opinion