Efficacy of Roflumilast in the Treatment of Psoriasis

• Status: Recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bispebjerg Hospital

Criteria

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