Efficacy of Roflumilast in the Treatment of Psoriasis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efficacy of Roflumilast in the Treatment of Psoriasis - a Randomised Controlled Trial

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: Roflumilast


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Roflumilast<br>Roflumilast 500 microgram daily (capsule) | Drug: Roflumilast<br>* Treatment according to national roflumilast guidelines<br>* Other names: Daxas;|
| Placebo Comparator: Placebo<br>Placebo (capsule) | Drug: Roflumilast<br>* Treatment according to national roflumilast guidelines<br>* Other names: Daxas;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 weeks |