Nummular Ecema is an idiopathic chronic inflammatory skin disease that occurs throughout all life periods. Diagnose is made primarily clinically in correlation with histological findings. Treatment of NE is difficult. Standard treatment consists of the use of emoillants, topical as well as systemic corticosteroids and phototherapy. Nevertheless, remission is hard to achieve and relapse occurs often. Patients usually suffer form severe pruritus. MedDRA version: 20.0 Level: PT Classification code
Conditions
Interventions
Trade Name: Otezla ® 30 mg
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Apremilast
CAS Number: 608141-41-9
Current Sponsor code: CC-10004
Other descriptive name: APREMILAST 30 mg
Conc
Sponsors
Technische Universität München, Fakultät für Medizin, represented by Dean
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Confirmed diagnosis of NE with a PGA = 3 on a 5-point scale, biopsy-proven, age 18-85 years, body weight = 40 kg and = 160 kg, history of continuous use of topical steroids for the last 8 weeks, signed informed consent from patient. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
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, myocardial infarction or cardiac arrhythmia which requires drug therapy, evidence of severe renal dysfunction or significant hepatic disease, history of lymphoproliferative disorders .
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This study aims on investigating the efficacy of Apremilast in NE patients. The primary endpoint is the number of patients achieving an improvement (decrease) in PGA (Physician Global Assessment) by two or more points or achieving an absolute PGA of 0 or 1 at Week 16.;Secondary Objective: Not applicable;Primary end point(s): Number of patients achieving an improvement (decrease) in PGA (Physician Global Assessment) by two or more points or achieving an absolute PGA of 0 or 1 at Week 16.;Timepoint(s) of evaluation of this end point: Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): EASI 50 score at week 16 and 32 (Eczema Area and Severity Index) Change From Baseline in Transepidermal Waterloss (TEWL) at week 16 and 32 Significant histological improvement at week 16 Change From Baseline in the Reduction of the Use of Topical Steroids at week 16 and 32 Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 16 and 32 Change From Baseline in Pruritus Visual Analog Scale (VAS) Score at Week 16 and 32 Change From Baseline in the Global Satisfaction Subscale of the Treatment Satisfaction Questionnaire for Medication (TSQM) Score at Week 16 and 32 Change in PGA score compared to baseline and week 16 for patients in Arm 2 at week 32 Safety of Apremilast will be Assessed by Evaluating Adverse Events (AEs) ;Timepoint(s) of evaluation of this end point: Week 16 Week 32 | — |
Countries
Germany
Contacts
Public ContactStudienzentrum Dermatologie
Department of Dermatology and Allergy, Technische Universität München
Outcome results
None listed