EBUL0. A 20-Week Multicentre, Open Study Assessing the Efficacy and Safety of Apremilast in Patients > 6 years of age with Epidermolysis bullosa simplex generalized

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-508794-83-00

Enrollment

Registered

2024-06-18

Start date

2025-01-10

Completion date

Unknown

Last updated

2025-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epidermolysis bullosa simplex

Brief summary

The aim of this study is to assess the efficacy of apremilast in the treatment of patients with EBS-sev.

Detailed description

Safety and tolerability will be assessed through the description of the following specific events occurring during the treatment periods of the study plus 1 week to be conservative, Secondary efficacy and health outcomes measures:Severity, itch, pain, Duration of dressing, Quality of life, compliance, Validation of a new severity scale for EBS-sev patients

Interventions

DRUGOtezla 10mg

DRUG20mg

DRUG30 mg film-coated tablets

DRUGOtezla 30 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The aim of this study is to assess the efficacy of apremilast in the treatment of patients with EBS-sev.	—

Secondary

Measure	Time frame
Safety and tolerability will be assessed through the description of the following specific events occurring during the treatment periods of the study plus 1 week to be conservative, Secondary efficacy and health outcomes measures:Severity, itch, pain, Duration of dressing, Quality of life, compliance, Validation of a new severity scale for EBS-sev patients	—

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026