Study identification

PURI

https://redirect.ema.europa.eu/resource/1000000244

EU PAS number

EUPAS1000000244

Study ID

1000000244

Official title and acronym

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)

DARWIN EU® study

No

Study countries

Austria
France
Germany
Greece
Italy
Netherlands
Spain
United Kingdom

Study description

In patients with epidermolysis bullosa (EB), collagen does not form properly, so their skin is very fragile and blisters easily. Such patients are also at greatly increased risk of developing skin cancers. Filsuvez is a topical gel used to promote healing of skin lesions in patients with certain types of EB. In this observational study, patients with either dystrophic EB (DEB) or junctional EB (JEB) will receive standard of care treatment, whether Filsuvez or something else, and will be followed for up to 5 years. The main purpose is to see if the use of Filsuvez affects the likelihood of developing skin malignancies in these patient populations.

Study status

Planned
Research institutions and networks

Institutions

Contact details

Jemima Mellerio

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:

Study start date

Planned:

Data analysis start date

Planned:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 
Study protocol
Initial protocol

ed-amryt-iab23965protocolpassv30 (1).pdf

English (1.26 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 3 (required)