Evaluation of Efficacy and Safety of Oral Roflumilast in Treatment of Moderate to Severe Psoriasis: a Pilot Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Egypt
Mansoura University Hospital
RECRUITING
Al Mansurah
Contact Information
Primary
Nora Mohamed Abdelrazik, MD dDermatology
noraeldarawany@gmail.com
+201060291029
Backup
Ahmed Ibrahim Ali, Master degree of Dermatology
Ahmed.abdelhadi@med.suezuni.edu.eg
+201011442104
Time Frame
Start Date: 2025-08-20
Estimated Completion Date: 2026-02-28
Participants
Target number of participants: 36
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Ahmed Ibrahim
Collaborators: Mansoura University Hospital

This content was sourced from clinicaltrials.gov

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