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

NCT07233291 | Recruiting Phase 2

• 1 other identifier: R.25.06.3223.R1
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis (PsO)

Keywords

Psoriasis; Moderate to severe Psoriasis; Roflumilast; Oral Roflumilast; PDE4 Inhibitor; Plaque Psoriasis; Pilot Study; Adults

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to Week 12

Secondary Outcomes (1)

• Change in body mass index (BMI)

  Baseline to Week 12

Study Arms (1)

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.

Drug: Oral roflumilast

Interventions

Oral roflumilast 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

Also known as: Roflumilast (generic name), Daxas (brand name in some countries), Roflumilast 500 mcg tablet (formulation identifier)

Oral Roflumilast for Adults with Moderate-to-Severe Psoriasis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ahmed Ibrahim: lead
• Mansoura University Hospital: collaborator

Study Sites (1)

Mansoura University Hospital

Al Mansurah, Dakahlia Governorate, 35511, Egypt

RECRUITING

MeSH Terms

Conditions

Psoriasis

Interventions

Roflumilast; Tablets

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Abeer Mohamed Elkholy, MD Dermatology

  Faculity of Medicine, Mansoura University

  STUDY CHAIR

Central Study Contacts

Nora Mohamed Abdelrazik, MD dDermatology

CONTACT

+201060291029; noraeldarawany@gmail.com

Ahmed Ibrahim Ali, Master degree of Dermatology

CONTACT

+201011442104; Ahmed.abdelhadi@med.suezuni.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: This is an open-label study: neither the participants nor the investigators are blinded. All participants receive oral roflumilast, and both participants and study staff are aware of the treatment assignment. No placebo or comparator is used.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant lecturer of dermatology, Andrology, & STDs , Suez University.

Model Details: 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.

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 18, 2025
• Study Start: August 20, 2025
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-11

Locations

EG (1)