Pilot Study to Evaluate Safety and Effectiveness of Oral Roflumilast for Adults with Moderate to Severe Plaque Psoriasis

What this Trial Is About

Researchers are evaluating the safety and preliminary effectiveness of oral roflumilast in adults with moderate-to-severe plaque psoriasis in this 12-week pilot study. The study focuses on measuring changes in psoriasis severity using the Psoriasis Area and Severity Index PASI score and includes monitoring changes in body mass index BMI. Both male and female participants will be included and analyzed as subgroups to better understand treatment effects. All participants will receive oral roflumilast starting at 250 mcg once daily for the first 10 days, followed by an increased dose of 500 mcg once daily for the remaining weeks, totaling 12 weeks of treatment. There is no placebo or comparison group. The study is open-label and single-arm, meaning all participants know they receive the active drug. Participants will undergo detailed medical history reviews and clinical exams before starting treatment. During the 12 weeks, they will attend scheduled visits for assessments of psoriasis severity, BMI, and safety monitoring including adverse events and laboratory tests. Data will be collected and analyzed overall and by sex-based subgroups to evaluate treatment effects and safety.

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