RecruitingPhase 2NCT07233291

A Pilot Study to Assess How Safe and Effective Oral Roflumilast is for Treating Moderate to Severe Psoriasis in Adults

Evaluation of Efficacy and Safety of Oral Roflumilast in Treatment of Moderate to Severe Psoriasis: a Pilot Study

Sponsor

Ahmed Ibrahim

Enrollment

36 participants

Start Date

Aug 20, 2025

Study Type

INTERVENTIONAL

Conditions

Psoriasis (PsO)

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

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.

Exclusion Criteria9

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.
Patients receiving inducers or inhibitors of cytochromes CYP3A4 and CYP1A.
Other systemic diseases other than COPD, especially hepatic impairment.
Hypersensitivity to the active substance of roflumilast or to any of its excipients
The use of contraception with gestodene and ethinylestradiol
Unreliable patients.

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Interventions

DRUGOral roflumilast

Dosage: 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