Psoriasis (PsO)Phase 2PSOROFLUNCT07233291
A Pilot Study to Assess How Safe and Effective Oral Roflumilast is for Treating Moderate to Severe Psoriasis in Adults
A Phase 2 study testing Oral roflumilast in people with Psoriasis (PsO), run by Ahmed Ibrahim at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis (PsO)
- What is being tested?
- Oral roflumilast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Aug 2025to 28 Feb 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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.
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- Hypersensitivity to the active substance of roflumilast or to any of its excipients
- The use of contraception with gestodene and ethinylestradiol
- Unreliable patients.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ahmed Ibrahim Ali, Master degree of Dermatology contact
Egypt1 site, 1 recruiting
- Recruiting
Mansoura University Hospital
Al Mansurah, Dakahlia Governorate, 35511
Nora Mohamed Abdelrazik, MD degree of Dermatology, +201060291029, noraeldarawany@gmail.com
Abeer Mohamed Elkholy, MD degree of Dermatology, +201006210646, abeerkholy@hotmail.com
About this study
Official title: Evaluation of Efficacy and Safety of Oral Roflumilast in Treatment of Moderate to Severe Psoriasis: a Pilot Study
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.
Read the 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)
- Being tested
- Oral roflumilast
- Keywords
- Psoriasis, Moderate to severe Psoriasis, Roflumilast, Oral Roflumilast, PDE4 Inhibitor, Plaque Psoriasis, Pilot Study, Adults
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral roflumilastDrug
Also called Roflumilast (generic name), Daxas (brand name in some countries), Roflumilast 500 mcg tablet (formulation identifier)
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
| Study group | Role | What they receive |
|---|---|---|
| Oral Roflumilast for Adults with Moderate-to-Severe Psoriasis | Experimental | 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. Receives: Drug: Oral roflumilast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in Psoriasis Area and Severity Index (PASI) score
The mean difference in PASI score from baseline to Week 12 among adults with moderate-to-severe plaque psoriasis receiving oral roflumilast. PASI is a validated composite measure of psoriasis severity assessing erythema, induration, desquamation, and affected body surface area.
Measured: Baseline to Week 12
Secondary outcomes (1)
Change in body mass index (BMI)
Mean change in BMI (kg/m²), calculated from measured weight and height.
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start20 Aug 2025
- Primary completion28 Feb 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis (PsO)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-arm, open-label pilot study in which all participants, both male and female, receive oral roflumilast. Participants will not be randomized to different treatments. Male and female participants will be analyzed as subgroups to explore potential sex-based differences in safety and efficacy. No placebo or comparator group is included.
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahmed Ibrahim
- Sponsor type
- University, hospital or other
- Collaborators
- Mansoura University Hospital
- Responsible party
- Sponsor-investigator, Ahmed Ibrahim, Mansoura University Hospital
- Investigators
- Abeer Mohamed Elkholy, MD Dermatology, Study chair, Faculity of Medicine, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07233291
- Sponsor's protocol ID
- R.25.06.3223.R1
- Acronym
- PSOROFLU
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy and Safety of Oral Roflumilast in Treatment of Moderate to Severe Psoriasis: a Pilot Study
- ClinicalTrials.gov ID
- NCT07233291
- Acronym / sponsor ID
- PSOROFLU / R.25.06.3223.R1
- Conditions
- Psoriasis (PsO)
- Keywords
- Psoriasis, Moderate to severe Psoriasis, Roflumilast, Oral Roflumilast, PDE4 Inhibitor, Plaque Psoriasis, Pilot Study, Adults
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Ahmed IbrahimUniversity, hospital or other
- Collaborators
- Mansoura University Hospital
- Study start
- 20 Aug 2025 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 18 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-arm, open-label pilot study in which all participants, both male and female, receive oral roflumilast. Participants will not be randomized to different treatments. Male and female participants will be analyzed as subgroups to explore potential sex-based differences in safety and efficacy. No placebo or comparator group is included.
| Arm | Type | Receives |
|---|---|---|
| Oral Roflumilast for Adults with Moderate-to-Severe Psoriasis | Experimental | Drug: Oral roflumilastAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral roflumilastAlso: Roflumilast (generic name), Daxas (brand name in some countries), Roflumilast 500 mcg tablet (formulation identifier)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 | Drug | Oral Roflumilast for Adults with Moderate-to-Severe Psoriasis |
Primary outcome
Mean change in Psoriasis Area and Severity Index (PASI) score
Time frame: Baseline to Week 12
The mean difference in PASI score from baseline to Week 12 among adults with moderate-to-severe plaque psoriasis receiving oral roflumilast. PASI is a validated composite measure of psoriasis severity assessing erythema, induration, desquamation, and affected body surface area.
1 secondary outcome
Change in body mass index (BMI)
Time frame: Baseline to Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ahmed Ibrahim Ali, Master degree of Dermatology contact
Abeer Mohamed Elkholy, MD Dermatology study chair
Faculity of Medicine, Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oral roflumilast in people with Psoriasis (PsO), run by Ahmed Ibrahim at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nora Mohamed Abdelrazik, MD dDermatology (+201060291029, noraeldarawany@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in Psoriasis Area and Severity Index (PASI) score (time frame: Baseline to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.