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Recruiting Phase 2

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

NCT06509984 · tracked via the Priya Life Science France tracker
Phase
Phase 2
Started
2024-08-06
Last updated
2025-02-24

Condition(s) studied

Epidermolysis Bullosa SimplexGenodermatosis

Investigational drug(s) / intervention(s)

Apremilast treatment

Apremilast treatment: treatment of apremilast

Study summary

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.

Eligibility

Sex
ALL
Min age
6 Years
Max age
99 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * \- 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

Primary outcome measure(s)

  • To describe efficacy of apremilast — weeks 20
    number of new blister conting every day

Trial sites (4)

FacilityCityRegionStatus
CHU de Nice Nice France Recruiting
APHP Necker-Enfants-Malades Paris France Not Yet Recruiting
APHP Hôpital Saint-Louis Paris France Not Yet Recruiting
chu de Toulouse Toulouse France Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06509984 on ClinicalTrials.gov ↗ ← All trials in France