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RecruitingNCT06509984

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

EBULO. a 20-Week Multicentre, Open Study Assessing the Efficacy and Safety of Apremilast in Patients > 6 Years of Age with EB Simplex Generalized

Status
Recruiting
Phase
Phase 2
Study type
Interventional
Enrollment
20 (estimated)
Sponsor
Centre Hospitalier Universitaire de Nice · Academic / Other
Sex
All
Age
6 Years – 99 Years
Healthy volunteers
Not accepted

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.

Detailed description

The patient will have 7 visits. After Confirmation of inclusion criteria and no exclusion criteria, the study will be explain to the patient after signing the inform consent and be included in the study Treatment Period (Period 1); challenge period This period will be the first treatment period that will occur from 8 weeks. During this period the patient will see the doctor at the hospital, he will perform the study procedures The second period : dechallenge (period 2): All patients stop their treatment for 4 weeks. The second treatment period - rechallenge (period 3) the patient will take the treatment for a second 8 weeks period At week 20 - End of study At each visit: The investigator at each visit compliance to the treatment and adverse events, Measure vital signs and perform clinical examination. The patient will assess the different questionnaires, for the study

Conditions

Interventions

TypeNameDescription
DRUGApremilast treatmenttreatment of apremilast

Timeline

Start date
2024-08-06
Primary completion
2025-10-01
Completion
2026-04-01
First posted
2024-07-19
Last updated
2025-02-24

Locations

4 sites across 1 country: France

Source: ClinicalTrials.gov record NCT06509984. Inclusion in this directory is not an endorsement.