Psoriasis
Conditions
Brief summary
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
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.
Interventions
DRUGRoflumilast
Treatment according to national roflumilast guidelines
Sponsors
Bispebjerg Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PASI75 | 12 weeks | 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. |
Countries
Denmark
Outcome results
None listed