Actively Recruiting
Led by Centre Hospitalier Universitaire de Nice · Updated on 2025-02-24
20
Participants Needed
4
Research Sites
26 weeks
Total Duration
Researchers are evaluating the efficacy and safety of Apremilast in patients aged 6 years and older with Epidermolysis Bullosa Simplex generalized, a genetic skin condition. This phase 2 open-label study aims to describe how well Apremilast works in reducing symptoms, particularly the occurrence of new blisters, over a 20-week period. Participants will undergo three distinct periods: an initial 8-week treatment phase called challenge, followed by a 4-week period without treatment called dechallenge, and a second 8-week treatment phase called rechallenge. During these periods, patients will take Apremilast and have regular visits to the hospital where doctors will perform study procedures and monitor progress. Throughout the study, participants will have seven visits where doctors will check vital signs, perform clinical examinations, review treatment adherence, and monitor for any side effects. Patients will also complete various questionnaires about their condition. The main measure of success is the efficacy of Apremilast at 20 weeks, along with safety assessments. The total study duration for each participant is 20 weeks.
CONDITIONS
A 20-Week Study Assessing the Efficacy of Apremilast in Patients with EB Simplex Generalized
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 8 weeks
Participants receive apremilast treatment and attend hospital visits where study procedures are performed, including clinical examinations and questionnaires.
Visits at the hospital during treatment period
Duration - 4 weeks
Participants stop apremilast treatment for 4 weeks with monitoring of clinical status and adverse events.
Visits at the hospital during dechallenge period
Duration - 8 weeks
Participants receive a second 8-week period of apremilast treatment with hospital visits for clinical examination, questionnaires, and monitoring.
Visits at the hospital during rechallenge treatment period
Total: 4 locations
1
CHU de Nice
Nice, France, France, 06000
Actively Recruiting
2
APHP Necker-Enfants-Malades
Paris, France, France, 75015
Not Yet Recruiting
3
APHP Hôpital Saint-Louis
Paris, France, France, 75018
Not Yet Recruiting
4
chu de Toulouse
Toulouse, France, 31059
Not Yet Recruiting
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Eric Fontas, Thomas Hubiche, Annabel Maruani...
https://pubmed.ncbi.nlm.nih.gov/41224305