Efficacy of Roflumilast in the Treatment of Psoriasis

Psoriasis Clinical Trial

— PSORRO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04549870
• Other study ID #: H-20013697
• Status: Completed
• Phase: Phase 2
• Start date: January 1, 2021
• Est. completion date: December 12, 2022

Study information

• Verified date: June 2023
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: December 12, 2022
• Est. primary completion date: December 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Roflumilast
Treatment according to national roflumilast guidelines

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PASI75	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.	12 weeks