Efficacy of roflumilast in the treatment of psoriasis – a randomised controlled trial

Efficacy of roflumilast in the treatment of psoriasis – a randomised controlled trial - The PSORRO trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-000711-76-DK

Enrollment

Registered

2020-03-18

Start date

2020-07-13

Completion date

Unknown

Last updated

2025-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis MedDRA version: 20.0 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000004858

Interventions

Trade Name: Daxas Product Name: Daxas Product Code: R03DX07 Pharmaceutical Form: Tablet INN or Proposed INN: ROFLUMILAST CAS Number: 162401-32-3 Other descriptive name: Daxas Concentration unit: µg mi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Age =18 years • Chronic stable plaque psoriasis (min duration 6 months) • PASI >8 • Body mass index (BMI) > 20 kg/m2 • Candidate for systemic treatment of psoriasis • Negative pregnancy test (only women) • Safe anticonception during entire study and at least 1 week after end of treatment (~5 times plasma half-life of roflumilast) (only applying for fertile women) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: • Severe immunological disease, e.g. HIV, systemic lupus, and systemic sclerosis • Current tuberculosis • Current viral hepatitis • Heart failure (NYHA III-IV) • Current or former malignancy (basal cell carcinoma excluded) • Current or former depression with suicidal ideation • Topical therapy for psoriasis during within 2 of randomization or during study • Systemic therapy for psoriasis or psoriatic arthritis within 4 weeks of randomization or during study • Treatment with theophylline, phenobarbital, carbamazepine, or phenytoin • Confirmed pregnancy • Planned pregnancy within 6 months • Breast feeding • Blood donation during study • Inability to complete study

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the efficacy of roflumilast in the treatment of psoriasis (PASI75);Secondary Objective: To investigate safety and efficacy on life quality;Primary end point(s): Proportion of patients achieving at least 75% reduction from baseline psoriasis area and severity index (PASI75) at week 12.;Timepoint(s) of evaluation of this end point: After 0, 4, 8, 12 ,and 24 weeks treatment	—

Measure

Time frame

Main Objective: To investigate the efficacy of roflumilast in the treatment of psoriasis (PASI75);Secondary Objective: To investigate safety and efficacy on life quality;Primary end point(s): Proportion of patients achieving at least 75% reduction from baseline psoriasis area and severity index (PASI75) at week 12.;Timepoint(s) of evaluation of this end point: After 0, 4, 8, 12 ,and 24 weeks treatment

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Secondary

Measure	Time frame
Secondary end point(s): • Proportion of patients achieving at least 50% reduction in baseline PASI (PASI50) at week 12. • Proportion of patients achieving at least 90% reduction in baseline PASI (PASI90) at week 12 • Proportion of patients achieving 100% reduction in baseline PASI (PASI100) at week 12 • Percent change from baseline in PASI score at week 12 • Change (1 or more points) in static physician global assessment (sPGA) at week 12 • Percentage change from baseline in affected body surface area (BSA) at week 12 • Percentage change from baseline in the product of BSA (%) and the sPGA • Change from baseline in dermatology life quality index (DLQI) at week 12 • Reported adverse events (AEs), serious adverse events (SAEs), serious adverse reactions (SARs), and suspected unexpected serious adverse reactions (SUSARs) ;Timepoint(s) of evaluation of this end point: After 0, 4, 8, 12 ,and 24 weeks treatment	—

Measure

Time frame

Secondary end point(s): • Proportion of patients achieving at least 50% reduction in baseline PASI (PASI50) at week 12. • Proportion of patients achieving at least 90% reduction in baseline PASI (PASI90) at week 12 • Proportion of patients achieving 100% reduction in baseline PASI (PASI100) at week 12 • Percent change from baseline in PASI score at week 12 • Change (1 or more points) in static physician global assessment (sPGA) at week 12 • Percentage change from baseline in affected body surface area (BSA) at week 12 • Percentage change from baseline in the product of BSA (%) and the sPGA • Change from baseline in dermatology life quality index (DLQI) at week 12 • Reported adverse events (AEs), serious adverse events (SAEs), serious adverse reactions (SARs), and suspected unexpected serious adverse reactions (SUSARs) ;Timepoint(s) of evaluation of this end point: After 0, 4, 8, 12 ,and 24 weeks treatment

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Countries

Denmark

Contacts

Public ContactBispebjerg Hospital

Alexander Egeberg

alexander.egeberg@gmail.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026