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

November 29, 2025 updated by: Ahmed Ibrahim

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Egypt
    • Dakahlia Governorate
      • Al Mansurah, Dakahlia Governorate, Egypt, 35511
        • Recruiting
        • Mansoura university hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Oral Roflumilast for Adults with Moderate-to-Severe Psoriasis

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.
Drug: Oral roflumilast

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

Other Names:
  • Roflumilast (generic name)
  • Daxas (brand name in some countries)
  • Roflumilast 500 mcg tablet (formulation identifier)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline to Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in body mass index (BMI)
Time Frame: Baseline to Week 12
Mean change in BMI (kg/m²), calculated from measured weight and height.
Baseline to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ahmed Ibrahim

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Mansoura University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Abeer Mohamed Elkholy, MD Dermatology, Faculity of Medicine, Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 20, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 14, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 18, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 2, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 29, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R.25.06.3223.R1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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