Efficacy of Roflumilast in the Treatment of Psoriasis

Bispebjerg Hospital46 enrolled

Overview

Roflumilast (Daxas®), a selective, long-acting inhibitor of the enzyme phosphodiesterase-4 (PDE4), is used for severe chronic obstructive pulmonary disease. Recent research suggest roflumilast is effective in treating psoriasis. The aim of this investigator-initiated trial is to study the efficacy of oral roflumilast in patients with plaque psoriasis. This has not previously been done.

Aim: To investigate the efficacy of roflumilast in the treatment of psoriasis. Design: Multicentre, double-blinded, randomised, placebo-controlled, clinical trial. Participants: Patients ≥18 years with plaque psoriasis. Method: Twelve weeks treatment with either roflumilast or placebo tablets. Both groups continue for an additional 12 weeks open-label treatment. Primary endpoint: Proportion of patients achieving at least 75% reduction from baseline psoriasis area and severity index (PASI75) at week 12.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Psoriasis

Interventions

RoflumilastDRUG

Treatment according to national roflumilast guidelines

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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) Exclusion Criteria: * 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 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

Locations (1)

Bispebjerg Hospital

Copenhagen, Denmark

Outcomes

Primary Outcomes

PASI75

Proportion of patients achieving at least 75% reduction from baseline psoriasis area and severity index (PASI75) at week 12. PASI is a measure of psoriatic disease severity.

Time frame: 12 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.