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

NCT ID: NCT07233291

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-20
• Study Completion Date: 2026-02-28

Brief 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 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.

Conditions

Psoriasis (PsO)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Oral roflumilast

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Roflumilast (generic name); Daxas (brand name in some countries); Roflumilast 500 mcg tablet (formulation identifier)

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University Hospital

OTHER

Sponsor Role: collaborator

Ahmed Ibrahim

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Ibrahim

Assistant lecturer of dermatology, Andrology, & STDs , Suez University.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Abeer Mohamed Elkholy, MD Dermatology

Role: STUDY_CHAIR

Faculity of Medicine, Mansoura University

Locations

Mansoura University Hospital

Al Mansurah, Dakahlia Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Nora Mohamed Abdelrazik, MD dDermatology

Role: CONTACT

noraeldarawany@gmail.com

+201060291029

Ahmed Ibrahim Ali, Master degree of Dermatology

Role: CONTACT

Ahmed.abdelhadi@med.suezuni.edu.eg

+201011442104

Facility Contacts

Nora Mohamed Abdelrazik, MD degree of Dermatology

Role: primary

noraeldarawany@gmail.com

+201060291029

Abeer Mohamed Elkholy, MD degree of Dermatology

Role: backup

abeerkholy@hotmail.com

+201006210646

Other Identifiers

R.25.06.3223.R1

Identifier Type: -

Identifier Source: org_study_id