Palmoplantar pustulosis MedDRA version: 21.0 Level: LLT Classification code 10037158 Term: Psoriasis palm & soles System Organ Class: 100000004858
Conditions
Interventions
Trade Name: Daxas (R), roflumilast
Product Name: Daxas (R), roflumilast
Product Code: R03DX07
Pharmaceutical Form: Tablet
INN or Proposed INN: Roflumilast
CAS Number: 162401-32-3
Other descriptive nam
Sponsors
Bispebjerg and Frederiksberg Hospital, University of Copenhagen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age =18 years • PPP diagnosis for min. 3 months • PPPASI = 10 • Active pustules, n = 10 • Body mass index (BMI) = 20 kg/m2 • Eligibility for systemic PPP treatment • Negative pregnancy test (women) • Safe anticonception during entire study and at least 1 week after end of treatment (~5 times plasma half-life of roflumilast) 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 18 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: • Plaque psoriasis with body surface area (BSA) = 20% • Severe immunological disease, e.g. HIV, systemic lupus, and systemic sclerosis • Current tuberculosis • Current viral hepatitis • Heart failure (NYHA III-IV) • Moderate or severe liver failure (Child-Pugh B-C) • Current or former depression with suicidal ideation • Topical medical PPP therapy 2 weeks before randomization and during study • Systemic PPP therapy 4 weeks before randomization and during study • Treatment with theophylline, phenobarbital, carbamazepine, or phenytoin • Previous treatment with apremilast (Otezla®) • Confirmed pregnancy • Planned pregnancy within 6 months • Breast feeding • Blood donation during study • Inability to complete study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the efficacy and safety of oral roflumilast in the treatment of palmoplantar pustulosis ;Secondary Objective: N/A;Primary end point(s): Proportion of patients achieving at least 75% reduction in baseline Palmoplantar Pustular Psoriasis Area and Severity Index (PPPASI) (PPPASI75) at week 12;Timepoint(s) of evaluation of this end point: Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Percent change in baseline PPPASI at week 12 and 24 • Percent change in active pustules count at week 12 and 24 • Proportion of patients achieving at least 50% reduction in baseline PPPASI (PPPASI50) at week 12 and 24 • Proportion of patients achieving at least 90% reduction in baseline PPPASI (PPPASI90) at week 12 and 24 • Proportion of patients achieving 100% reduction in baseline PPPASI (PPPASI100) at week 12 and 24 • Change from baseline in dermatology life quality index (DLQI) at week 12 and 24. DLQI is a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on patients’ quality of life, based on recall over the past week. • Mean weight loss (kg) at week 12 and 24 • Adverse events (AEs), serious adverse events (SAEs), serious adverse reactions (SARs), and suspected unexpected serious adverse reactions (SUSARs) ;Timepoint(s) of evaluation of this end point: Week 12 and 24 | — |
Countries
Denmark
Contacts
Public ContactAlexander Egeberg
Bispebjerg and Frederiksberg Hospital, University of Copenhagen
Outcome results
None listed