This is a 12-week, single-arm, open-label pilot study to assess the safety and preliminary efficacy of oral roflumilast in adults with moderate-to-severe plaque psoriasis. All participants, both male and female, will receive oral roflumilast starting at 250 mcg once daily for 10 days, followed by 500 mcg once daily for the remainder of the study. The primary outcome is the mean change in Psoriasis Area and Severity Index (PASI) score from baseline to Week 12. Secondary outcomes include change in body mass index (BMI) and safety assessments, including treatment-emergent adverse events, serious adverse events, and laboratory abnormalities. Male and female participants will be analyzed as subgroups.
Psoriatic patients ≥ 18 years in whom systemic therapy is indicated.
Chronic stable plaque psoriasis.
Patients who don't use other systemic therapy for psoriasis in the last 2 months (or naïve who didn't use any systemic therapy before).
Safe contraception during the study.
Pregnant or lactating women, as well as women of childbearing potential not using an effective method of contraception.
Age <18 years.
Other concomitant psoriasis systemic treatments such as Acitretin and biologics.
Previous systemic treatment of psoriasis in the last 2 months.
Single group
Oral roflumilast
DrugDosage: Participants will receive oral roflumilast. The initial dose is 250 mcg once daily for the first 10 days, followed by a dose escalation to 500 mcg once daily for the remainder of the 12-week treatment period. Route: Oral Schedule: Daily for 12 weeks Duration: 12 weeks
Mean change in Psoriasis Area and Severity Index (PASI) score
The mean difference in PASI score from baseline to Week 12 among adults with moderate-to-severe plaque psoriasis receiving oral roflumilast. PASI is a validated composite measure of psoriasis severity assessing erythema, induration, desquamation, and affected body surface area.
Change in body mass index (BMI)
Mean change in BMI (kg/m²), calculated from measured weight and height.
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Ahmed Ibrahim
Lead sponsor
Mansoura University Hospital
Sponsor institution
Mansoura University Hospital
Collaborator
