Efficacy of Roflumilast in the Treatment of Psoriasis - a Randomised Controlled Trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Bispebjerg Hospital
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- PASI75
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥18 years
- •Chronic stable plaque psoriasis (min duration 6 months)
- •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
Arms & Interventions
Roflumilast
Roflumilast 500 microgram daily (capsule)
Intervention: Roflumilast (Drug)
Placebo
Placebo (capsule)
Intervention: Roflumilast (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Mette Gyldenløve
MD, PhD
Bispebjerg Hospital