NCT06509984 A 20-Week Study Assessing the Efficacy of Apremilast in Patients with EB Simplex Generalized
| NCT ID | NCT06509984 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Centre Hospitalier Universitaire de Nice |
| Condition | Epidermolysis Bullosa Simplex |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-08-06 |
| Primary Completion | 2025-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 20 participants in total. It began in 2024-08-06 with a primary completion date of 2025-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Frequently Asked Questions
Who can join the NCT06509984 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 99 Years, studying Epidermolysis Bullosa Simplex. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06509984 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06509984 currently recruiting?
Yes, NCT06509984 is actively recruiting participants. Visit ClinicalTrials.gov or contact Centre Hospitalier Universitaire de Nice to inquire about joining.
Where is the NCT06509984 trial being conducted?
This trial is being conducted at Nice, France, Paris, France, Paris, France, Toulouse, France.
Who is sponsoring the NCT06509984 clinical trial?
NCT06509984 is sponsored by Centre Hospitalier Universitaire de Nice. The trial plans to enroll 20 participants.