Efficacy and safety of oral roflumilast in the treatment of palmoplantar pustulosis – a randomised controlled trial

Phase 1

• Conditions: Palmoplantar pustulosis; MedDRA version: 21.0Level: LLTClassification code 10037158Term: Psoriasis palm & solesSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2021-006931-25-DK
• Lead Sponsor: Bispebjerg and Frederiksberg Hospital, University of Copenhagen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-01-04
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 28

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

•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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;Main Objective: To investigate the efficacy and safety of oral roflumilast in the treatment of palmoplantar pustulosis

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Percent change in baseline PPPASI at week 12 and 24<br>•Percent change in active pustules count at week 12 and 24<br>•Proportion of patients achieving at least 50% reduction in baseline PPPASI (PPPASI50) at week 12 and 24<br>•Proportion of patients achieving at least 90% reduction in baseline PPPASI (PPPASI90) at week 12 and 24<br>•Proportion of patients achieving 100% reduction in baseline PPPASI (PPPASI100) at week 12 and 24<br>•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.<br>•Mean weight loss (kg) at week 12 and 24<br>•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