Efficacy of roflumilast in the treatment of psoriasis – a randomised controlled trial

Phase 1

• Conditions: Psoriasis; MedDRA version: 20.0Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2020-000711-76-DK
• Lead Sponsor: Alexander Egeberg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-18
• Last Update Posted: 3 August 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

•Age =18 years
•Chronic stable plaque psoriasis (min duration 6 months)
•PASI >8
•Body mass index (BMI) > 20 kg/m2
•Candidate for systemic treatment of psoriasis
•Negative pregnancy test (only women)
•Safe anticonception during entire study and at least 1 week after end of treatment (~5 times plasma half-life of roflumilast) (only applying for fertile women)

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 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

•Severe immunological disease, e.g. HIV, systemic lupus, and systemic sclerosis
•Current tuberculosis
•Current viral hepatitis
•Heart failure (NYHA III-IV)
•Current or former malignancy (basal cell carcinoma excluded)
•Current or former depression with suicidal ideation
•Topical therapy for psoriasis during within 2 of randomization or during study
•Systemic therapy for psoriasis or psoriatic arthritis within 4 weeks of
randomization or during study
•Treatment with theophylline, phenobarbital, carbamazepine, or phenytoin
•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
Main Objective: To investigate the efficacy of roflumilast in the treatment of psoriasis (PASI75);Secondary Objective: To investigate safety and efficacy on life quality;Primary end point(s): Proportion of patients achieving at least 75% reduction from baseline psoriasis area and severity index (PASI75) at week 12.;Timepoint(s) of evaluation of this end point: After 0, 4, 8, 12 ,and 24 weeks treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Proportion of patients achieving at least 50% reduction in baseline PASI (PASI50) at week 12. <br>•Proportion of patients achieving at least 90% reduction in baseline PASI (PASI90) at week 12 <br>•Proportion of patients achieving 100% reduction in baseline PASI (PASI100) at week 12<br>•Percent change from baseline in PASI score at week 12<br>•Change (1 or more points) in static physician global assessment (sPGA) at week 12<br>•Percentage change from baseline in affected body surface area (BSA) at week 12<br>•Percentage change from baseline in the product of BSA (%) and the sPGA<br>•Change from baseline in dermatology life quality index (DLQI) at week 12<br>•Reported adverse events (AEs), serious adverse events (SAEs), serious adverse reactions (SARs), and suspected unexpected serious adverse reactions (SUSARs)<br>;Timepoint(s) of evaluation of this end point: After 0, 4, 8, 12 ,and 24 weeks treatment