01. What is Apremilast? Expand Apremilast is an existing anti-inflammatory drug which is licensed to treat patients with psoriasis.
02. What type of EB is it for? Expand This clinical trial will see an existing licensed treatment for psoriasis (apremilast) clinically tested on children and adults with severe epidermolysis bullosa simplex (EBS).
03. What does it do? Expand Encouraging results published after an initial small trial, showed that it appears to reduce blistering in patients who have the severe form of epidermolysis bullosa simplex.
04. How long will the trial take? Expand The study, which will be led by Dr Christine Chiaverini, a dermatologist who works at the Centre Hospitalier Universitaire de Nice in France, will involve clinical testing with up to twenty people, aged six years or older, who have severe EBS which causes at least four new blisters every day. It is estimated that the study will involve twenty weeks of testing for each person: after an initial screening they will take the tablets for eight weeks, stop for four weeks, then take the tablets again for a further eight weeks. Outcomes such as blistering, pain, itch and quality of life will be measured during periods with and without treatment and compared. Positive results will support the next step of a placebo controlled clinical trial. In total the clinical trial is set to take two years to complete.
05. When will I be able to get it? Expand The clinical trial is set to take two years to complete. If the trial is successful, we will then start discussions with the regulator for it to be prescribed in the NHS for EBS patients. However, additional studies may be needed to meet any regulatory requirements. We will update our members via our website and social media channels on the progress of the study. Read more about how different types of clinical trial work.
06. Will I be able to participate in this clinical trial? Expand The psoriasis tablets drug repurposing clinical trial is funded by DEBRA UK but is being conducted in France and is only open to people living in France. This is however the first of what we hope will be many EB clinical trials as we accelerate our drug repurposing programme to find effective treatments that could help stop the pain of EB. We will share any opportunities to participate in future EB clinical trials as soon as they are open to applications.