CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 20 target
Drug / intervention
Apremilast treatmentdrug
Likely dose
Not stated in record
Key inclusion· 4
  • ✓Age 6 years or older
  • ✓Laboratory confirmed EBS-sev diagnosis due to KRT5 or KRT14 mutation (autosomal)
  • ✓Mean daily number of new blisters greater than 3
  • ✓Subject/caregiver agrees to restrict topical therapies to investigator-approved only
Key exclusion· 5
  • ✕EBS lesions requiring oral therapy to treat infection
  • ✕Use of 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

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06509984
NCT06509984Phase 2RecruitingUpdate OverdueUpdated 16mo ago · Completion was 9mo ago
Enrollment Stalled
Update Overdue
CompareCT.gov

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

Centre Hospitalier Universitaire de Nice·interventional·Posted Jul 19, 2024·Updated Feb 24, 2025

In Brief

A Phase 2 clinical trial evaluating Apremilast treatment for Epidermolysis Bullosa Simplex and Genodermatosis. Currently recruiting, targeting 20 participants across 4 sites.

Signals

Enrollment appears stalled

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpidermolysis Bullosa Simplex, Genodermatosis
CountriesFrance
Collaborators--

Timeline

Phase 2RecruitingOverdue
20252026
First PostedJul 19, 2024
Enrollment StartAug 6, 2024
Primary CompletionOct 1, 2025
Study CompletionApr 1, 2026
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 2.0 years ago

Interventions

Apremilast treatmentdrug

treatment of apremilast