Efficacy of Roflumilast in the Treatment of Psoriasis

Phase 2

Completed

• Conditions: Psoriasis
• Interventions: Drug: Roflumilast

• Registration Number: NCT04549870
• Lead Sponsor: Bispebjerg Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2020-09-08
• Study First Submitted QC: 2020-09-14
• Study First Posted: 2020-09-16
• Study Start: 2021-01-01
• Primary Completion: 2022-12-12
• Study Completion: 2022-12-12
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-27
• Last Update Posted: 2023-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Roflumilast	Placebo (capsule)
Roflumilast	Roflumilast	Roflumilast 500 microgram daily (capsule)

Primary Outcome Measures

Name	Time	Method
PASI75	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.

Trial Locations

Locations (1)

Bispebjerg Hospital; 🇩🇰 Copenhagen, Denmark