Palmoplantar Pustulosis MedDRA version: 20.0 Level: LLT Classification code 10050185 Term: Palmoplantar pustulosis System Organ Class: 100000004858
Conditions
Interventions
Trade Name: Skilarence 30 mg
Product Name: Skilarence
Product Code: EMEA/H/C/002157
Pharmaceutical Form: Gastro-resistant tablet
INN or Proposed INN: Dimethyl Fumarate
CAS Number: 624-49-7
Other desc
Sponsors
Medical University of Vienna
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Men or women = 18 years and = 80 years of age at time of screening - Palmoplantar pustulosis (PPP) for at least 6 months - moderate - severe disease as defined by a ppPASI score of = 10 for affection of palms and soles, =4 for palms only and =6 for feet only. - candidates for systemic treatment after failure of topical treatments - negative serum pregnancy before enrollment and during the study 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 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: - use of prohibited psoriasis treatments - pregant or nursing women - WBC count < 3,000 cells/ mm3, lymphocyte count < 1.000/µl - significant gastrointestinal problems (e.g., ulcer) - severe renal impairment (eGFR = 30ml/min) - abnormal liver enzymes - active infectious diseases - history of alcohol or intravenous drug abuse - Immunosuppressive conditions (HIV, organ transplant recipients) - Known to be hypersensitive to ingredients of the investigational products - Participation in any other drug investigational trial - Not willing to give informed consent - Unable to comply with the requirements of the study or who in the opinion of the investigator should not participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Effectiveness of Dimethylfumarate in terms of 75% reduction of the Palmoplantar Pustulosis Psoriasis Area and Severity Index (ppPASI-75 response);Secondary Objective: - Effectiveness of DMF in patients with nail involvement - Health-related quality of life - clinical safety and tolerability ;Primary end point(s): Proportion of patients with a ppPASI-75 response ;Timepoint(s) of evaluation of this end point: week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Objective measures of disease severity: - Mean reduction in ppPASI and logarithmic ppPASI score - Mean reduction in target finger- and toenail Nail Area and Severity Index (NAPSI) - Change in Investigator’s Global Assessment (IGA) for palms, soles, toe- and fingernails - Proportion of patients achieving an IGA of 0 or 1 Patient reported outcomes: - Mean reduction in pain- and itch-scale - Mean reduction in Dermatology Life Quality Index (DLQI) - Proportion of patients achieving DLQI 0 or 1 - Global Patient Satisfaction - Change in Subject’s Global Assessment (SGA) for palms/soles and nails To evaluate the clinical safety and tolerability of DMF as assessed by clinical laboratory variables and adverse events monitoring ;Timepoint(s) of evaluation of this end point: week 24 | — |
Countries
Austria
Contacts
Public ContactDepartment of Dermatology
Medical University of Vienna
Outcome results
None listed