Oral roflumilast treatment for adults with moderate-to-severe plaque psoriasis
Official title: Evaluation of Efficacy and Safety of Oral Roflumilast in Treatment of Moderate to Severe Psoriasis: a Pilot Study
Run by Mansoura University Hospital · NCT07233291 · Data updated 2026-11-12
This 12-week pilot will try daily oral roflumilast to see if it safely reduces psoriasis symptoms in adults with moderate-to-severe plaque psoriasis.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 36 (estimated) |
| Sponsor | Mansoura University Hospital Academic / other |
| Locations | 1 site (Al Mansurah, Dakahlia Governorate) |
| Status | Recruiting |
| Started | August 20, 2025 |
| Main results expected | February 28, 2026 |
| Study ends | February 28, 2026 |
| Registry record updated | December 2, 2025 |
| Trial ID | NCT07233291 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with chronic stable moderate-to-severe plaque psoriasis who need systemic therapy, have been off other systemic treatments for at least two months (or are systemic-naïve), and can use effective contraception are ideal candidates.
✕Probably not a fit
Pregnant or breastfeeding women, people with significant hepatic impairment, those taking strong CYP3A4 or CYP1A inducers/inhibitors, or patients who recently received other systemic psoriasis treatments are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-arm, open-label 12-week pilot treats adults with moderate-to-severe plaque psoriasis with oral roflumilast, starting 250 mcg once daily for 10 days then 500 mcg once daily. The primary outcome is mean change in Psoriasis Area and Severity Index (PASI) from baseline to Week 12, with secondary outcomes including BMI change and safety monitoring for adverse events and laboratory abnormalities. Participants undergo detailed medical history, clinical examinations, and scheduled visits, and results will be analyzed overall and by sex-based subgroups. The study is conducted at Mansoura University Hospital and enrolls adults who are eligible for systemic psoriasis therapy and meet contraception and medication-exclusion criteria.
Why it matters
Potential benefit: If successful, oral roflumilast could provide an effective pill-based systemic option to reduce skin plaques and inflammation in moderate-to-severe psoriasis.
How similar studies have gone: Topical roflumilast and other PDE4 inhibitors have shown promise in psoriasis, but oral roflumilast for psoriasis is novel and has limited clinical data so far.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where it's running
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Mansoura University Hospital
Al Mansurah, Dakahlia Governorate, Egypt Recruiting
Study contacts
- Study coordinator: Nora Mohamed Abdelrazik, MD dDermatology
- Email: noraeldarawany@gmail.com
- Phone: +201060291029
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.