Efficacy of Roflumilast in the Treatment of Psoriasis

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.

Full Title of Study: “Efficacy of Roflumilast in the Treatment of Psoriasis – a Randomised Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: October 2021

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. 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.

Interventions

  • 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

Primary Measures

  • PASI75
    • 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

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • 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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