NCT07233291RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 2 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- First submitted
- 14 Nov 2025
- Start date
- 20 Aug 2025
- Primary completion date
- 28 Feb 2026
- Lead sponsor
- Ahmed Ibrahim
- Diseases
- Psoriasis
- NCT number
- NCT07233291
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 36
- From 20 Aug 2025 to the primary completion date, 28 Feb 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 illness
- Other systemic diseases other than COPD, especially hepatic impairment.
- Hypersensitivity to the active substance of roflumilast or to any of its excipients
Age
- Age \<18 years.
Other
- Pregnant or lactating women, as well as women of childbearing potential not using an effective method of contraception.
- The use of contraception with gestodene and ethinylestradiol
- Unreliable patients.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mansoura university Hospital Coordinator of this site? Confirm its status | Al Mansurah | Egypt | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.