A Study to Assess the Incidence of Skin Cancers in Patients With Epidermolysis Bullosa Receiving Filsuvez

Last updated: September 18, 2025
Sponsor: Amryt Pharma
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pemphigus Vulgaris (Pv)

Epidermolysis Bullosa

Treatment

Filsuvez

Clinical Study ID

NCT06423573
AEB-21
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with a confirmed diagnosis of dystrophic EB or junctional EB

Exclusion

Exclusion Criteria:

  • None

Study Design

Total Participants: 580
Treatment Group(s): 1
Primary Treatment: Filsuvez
Phase:
Study Start date:
December 18, 2024
Estimated Completion Date:
August 01, 2032

Study Description

Some forms of EB are associated with a greatly increased incidence of aggressive skin and mucosal squamous cell carcinoma (SCC), as well as increased incidence of other skin malignancies including basal cell carcinoma (BCC) and malignant melanoma (MM). This long-term non-interventional study will assess all types of skin malignancies (SCC, BCC, and MM) in DEB and JEB patients. It is an observational study of real-world treatment practices, in which patients will receive standard of care therapy whatever that may entail. Data will be obtained from two sources: clinical study centers in the European Union (EU) and the United Kingdom (UK), and pre-existing EB registries in the EU. Participants will be followed for up to 5 years, and information about the development and nature of skin malignancies will be collected over this time period both from patients who are taking and those who are not taking Filsuvez.

Connect with a study center

  • CHU de Toulouse, Hôpital Larrey

    Toulouse,
    France

    Site Not Available

  • CHU de Toulouse, Hôpital Larrey

    Toulouse 2972315,
    France

    Active - Recruiting

  • Hospital of Skin and Venereal Diseases of Thessaloniki

    Thessaloniki 734077,
    Greece

    Active - Recruiting

  • Hospital Clinic, Barcelona

    Barcelona 3128760,
    Spain

    Active - Recruiting

  • Hospital San Juan de Dios (Barcelona)

    Barcelona 3128760,
    Spain

    Active - Recruiting

  • Guy's and St Thomas' NHS Foundation Trust

    London 2643743,
    United Kingdom

    Active - Recruiting

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