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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
EU CTIS ID: 2023-508794-83-00
What this study is testing
To study the efficacy of apremilast over the 3 periods of a challenge-dechallenge-rechallenge design like study in patients ≥ 6 years presenting with EBS-sev.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 >4.
- Subject/caregiver agrees not to use any topical therapies other than the investigator approved
You likely can't join if
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.