NCT07233291

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Ahmed Ibrahim · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This pilot study is designed to evaluate the safety and preliminary efficacy of oral roflumilast in adults with moderate-to-severe plaque psoriasis. The study was approved by the Mansoura University Faculty of Medicine Institutional Review Board (IRB), Approval Code: R.25.06.3223.R1, and participants will be enrolled only after obtaining informed consent. Each participant will undergo a detailed history and clinical examination, including: Personal history: name, age, sex, occupation, residence, marital status, number of children, and special habits of medical importance. History of present illness: onset, course, duration of psoriasis, and precipitating factors. Medication history: nature, route, dose, compliance, duration, effect, and side effects. Family history: psoriasis or other dermatoses. Past medical history: associated systemic, other dermatological diseases, or major surgical operations. Menstrual and obstetric history (for female participants). A general clinical examination will be performed to assess overall health and exclude any systemic diseases. The study will monitor clinical response using the Psoriasis Area and Severity Index (PASI) and record body mass index (BMI) changes. Safety will be assessed through monitoring of treatment-emergent adverse events, serious adverse events, and routine laboratory tests. Participants will attend scheduled visits throughout the 12-week treatment period, and data will be analyzed overall and by sex-based subgroups.

Conditions

• Psoriasis (PsO)

Interventions

Type	Name	Description
DRUG	Oral 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

Timeline

• Start date: 2025-08-20
• Primary completion: 2026-02-28
• Completion: 2026-02-28
• First posted: 2025-11-18
• Last updated: 2025-12-02

Locations

1 site across 1 country: Egypt