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.
Full Title of Study: “Efficacy of Roflumilast in the Treatment of Psoriasis – a Randomised Controlled Trial”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Double (Participant, Investigator)
- Study Primary Completion Date: October 2021
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. The active group continues 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.
- Drug: Roflumilast
- Treatment according to national roflumilast guidelines
Arms, Groups and Cohorts
- Active Comparator: Roflumilast
- Roflumilast 500 microgram daily (capsule)
- Placebo Comparator: Placebo
- Placebo (capsule)
Clinical Trial Outcome Measures
- Time Frame: 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.
Participating in This Clinical Trial
- 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)
- 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
Gender Eligibility: All
Minimum Age: N/A
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Bispebjerg Hospital
- Provider of Information About this Clinical Study
- Principal Investigator: Mette Gyldenløve, MD, PhD – Bispebjerg Hospital
- Overall Official(s)
- Alexander Egeberg, MD, PhD, Study Director, Bispebjerg Hospital
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