Efficacy of Roflumilast in the Treatment of Psoriasis (PSORRO)

Bispebjerg Hospital

Status and phase: Completed; Phase 2

Conditions: Psoriasis

Treatments: Drug: Roflumilast

Study type: Interventional

Funder types: Other

Identifiers

NCT04549870

H-20013697

Details and patient eligibility

About

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 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.

Enrollment: 46 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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46 participants in 2 patient groups, including a placebo group

Roflumilast

Active Comparator group

Description:

Roflumilast 500 microgram daily (capsule)

Treatment:

Drug: Roflumilast

Placebo

Placebo Comparator group

Description:

Placebo (capsule)

Treatment:

Drug: Roflumilast