FOSteR EB
Research type
Research Study
Full title
A long-term non-interventional study to assess the incidence of skin malignancies in patients with dystrophic and junctional epidermolysis bullosa receiving treatment with Filsuvez (FOSTER)
IRAS ID
346619
Contact name
Jemima Mellerio
Contact email
Sponsor organisation
Chiesi Canada Corp.
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
http://www.ClinicalTrials.gov, NCT06423573; https://catalogues.ema.europa.eu/search, EUPAS1000000244
Duration of Study in the UK
7 years, 0 months, 1 days
Research summary
Amryt is performing this Category 3 post-authorisation safety study (PASS) as an additional pharmacovigilance activity to further evaluate Filsuvez, with a focus on the risk of skin malignancies (identified as an important potential risk).
This is an observational, multi-country, non-interventional, cohort study based on primary data collection and secondary use of patient registry data, investigating the long-term safety of Filsuvez in real-world clinical practice. The use of these data sources will enable the collection of patient-level data, including data on Filsuvez exposure, skin malignancies, medical history, and other clinical characteristics.
The study population will include patients with a confirmed diagnosis of DEB and JEB, regardless of Filsuvez use, and aligned with the approved indication for Filsuvez. The patient population will consist of adults and children.
Patients who were previously exposed to Filsuvez during clinical trials or via early access or compassionate programs are eligible to participate in this study.
The study plans to enrol approximately 580 patients diagnosed with DEB or JEB from approximately 8 specialist dermatology sites in 5 countries (Austria, France, Germany, Spain, and United Kingdom), and from 2 existing EB registries (in Italy and Netherlands) with potential for additional sites in these or other countries if required to meet enrolment targets.
There are no protocol–mandated visits or procedures associated with the study. It is anticipated that the frequency of patient visits will differ according to local standard practice and patient need.
REC name
North West - Preston Research Ethics Committee
REC reference
24/NW/0328
Date of REC Opinion
10 Jan 2025
REC opinion
Further Information Favourable Opinion