Testing oral roflumilast for moderate to severe psoriasis in adults
Tests oral roflumilast, a pill, in adults with moderate to severe psoriasis.
Key facts
- Who runs it
- Ahmed Ibrahim
- Where
- Al Mansurah, EgyptSee the site
- Trial code
- Registry title
- A Pilot Study to Assess How Safe and Effective Oral Roflumilast is for Treating Moderate to Severe Psoriasis in Adults
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 36 people, planned
- Started
- 20 Aug 2025
- Planned end
- 28 Feb 2026
- Type of study
- Interventional
- Treatments tested
- Oral roflumilast
- Record updated
- 2 December 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with long-lasting, stable plaque psoriasis that needs treatment with tablets or injections that work through the whole body. They will take oral roflumilast for 12 weeks.
- Age
- 18 years or older
- Sex
- Women and men can join
- Disease stage
- Chronic stable plaque psoriasis, moderate to severe, where whole-body (systemic) therapy is indicated
- Earlier treatment
- No other whole-body (systemic) psoriasis treatment in the last 2 months, or never had any
Main reasons for not taking part
- Pregnant or breastfeeding women
- Women who can have children and do not use effective contraception
- Taking other whole-body psoriasis treatments such as acitretin or biologics
- Taking drugs that affect CYP3A4 or CYP1A enzymes
- Other whole-body diseases besides COPD, especially liver problems
The registry criteria, word for word
Show all 13 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- Age <18 years
- 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
Where in Egypt
- Mansoura university HospitalAl Mansurah, EgyptContact: Nora Mohamed Abdelrazik, MD degree of DermatologyTaking people
About the trial
What the trial wants to find out
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.
The group in the trial
- Oral Roflumilast for Adults with Moderate-to-Severe PsoriasisTreatment being tested
All participants, both male and female, will receive oral roflumilast. No placebo or comparator is included. Male and female participants will be analyzed as subgroups for exploratory safety and efficacy outcomes.
Treatment: Oral roflumilast
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Evaluation of Efficacy and Safety of Oral Roflumilast in Treatment of Moderate to Severe Psoriasis: a Pilot Study
- Plain-language title
- Testing oral roflumilast for moderate to severe psoriasis in adultsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 2 December 2025