A 20-Week Study Assessing the Efficacy of Apremilast in Patients with EB Simplex Generalized

Recruiting now · Phase 2

Conditions studied: Epidermolysis Bullosa Simplex, Genodermatosis

In brief

The goal of this clinical trial is to Assessing the Efficacy and Safety of Apremilast in Patients \> 6 years of age with EB simplex generalized . The main question it aims to answer are: describe efficacity of this treatment. Participants will take treatments and have to use bullets during the study period.

Key facts

Study ID

NCT06509984

Run by

Centre Hospitalier Universitaire de Nice

People needed

20

Starts

2024-08-06

Expected to finish

2026-04-01

Last updated by the study team

2025-02-24

Who can join

Age: 6 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female patients 6 years or older
• Laboratory confirmed diagnosis of EBS-sev due to KRT5 or 14 mutation (autosomal)
• Mean daily number of new blisters >3.
• Subject/caregiver agrees not to use any topical therapies other than the investigator approved

You may not qualify if…

• - EBS lesions requiring oral therapy to treat an infection
• Use of any diacerein containing product within 6 months prior to Visit 1
• Use of systemic immunotherapy or cytotoxic chemotherapy within 60 days prior to Visit 1
• Use of systemic steroidal therapy within 30 days prior to Visit 1
• Use of any systemic product that, in the opinion of the investigator, might put the subject at undue risk by study participation or interferes with the study assessments within 30 days prior to Visit 1

Where it is running

• CHU de Nice — Nice, France, France (enrolling)
• APHP Necker-Enfants-Malades — Paris, France, France
• APHP Hôpital Saint-Louis — Paris, France, France
• chu de Toulouse — Toulouse, France

Full record on ClinicalTrials.gov

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