An Investigator-initiated Study of Apremilast to Demonstrate Efficacy Nummular Eczema (NCT03160248) | Clinical Trial Compass
CompletedPhase 2
An Investigator-initiated Study of Apremilast to Demonstrate Efficacy Nummular Eczema
Germany31 participantsStarted 2017-07-05
Plain-language summary
This is an investigator-initiated, single-center, prospective, randomized, double-blind, interventional phase IIb study. Forty patients with clinically and histologically confirmed nummular eczema will be enrolled according to inclusion and exclusion criteria. Patients will be included after written informed consent is obtained. Prior to randomization, average application rate of class II topical steroids per day will be measured for 4 weeks. Subsequently, patients will be randomized in a 1:1 ratio into one arm to receive Apremilast 30 mg BID (following titration phase) for 16 weeks or a second arm receiving identically matching placebo for 16 weeks. From beginning of week 17, all patients will start an open-label treatment with Apremilast 30 mg BID until week 32. Concomitant use of topical steroids (class II) is allowed during the study. During the treatment period both placebo and Apremilast will be applied p.o. from week 0 until week 32.
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion criteria
✓. Clinically confirmed diagnosis of nummular eczema
✓. Biopsy-proven, meaning histology consistent with eczema (including PAS-staining)
✓. PGA ≥ 3 on a 5 point scale
✓. History of continuous use of topical steroids for the last 8 weeks
✓. Age 18-85 years of age, body weight ≥ 40 kg and ≤ 160 kg
✓. Signed informed consent from patient
Exclusion criteria
✕. Permanent severe diseases, especially those affecting the immune system
✕. Pregnancy or breast feeding
✕. History or presence of epilepsy, significant neurological disorders, depression, suicidal ideation and behaviour, cerebrovascular attacks or ischemia
✕. History or presence of myocardial infarction or cardiac arrhythmia which requires drug therapy