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

Sponsor
Ahmed Ibrahim
Study ID
NCT07233291
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Psoriasis (PsO)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

Start date
Aug 20, 2025
Status verified
Nov 2025
Primary completion
Feb 28, 2026
Completion
Feb 28, 2026

Study Design

Enrollment
36 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Mean change in Psoriasis Area and Severity Index (PASI) score [ Time Frame: Baseline to Week 12 ]

Central Contacts

Related Studies