NCT04549870

Efficacy of Roflumilast in the Treatment of Psoriasis

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Bispebjerg Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	Roflumilast	Treatment according to national roflumilast guidelines

Timeline

• Start date: 2021-01-01
• Primary completion: 2022-12-12
• Completion: 2022-12-12
• First posted: 2020-09-16
• Last updated: 2023-06-28

Locations

1 site across 1 country: Denmark