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Completed

NCT Number: NCT04549870

Efficacy of Roflumilast in the Treatment of Psoriasis

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.

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Bispebjerg Hospital

Copenhagen, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Roflumilast

Drug

Treatment according to national roflumilast guidelines

Other names: Daxas

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Registry information

Official study title

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

Acronym: PSORRO

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 16, 2020
Registry last updated
Jun 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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