E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
E.1.1.1 | Medical condition in easily understood language |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10071117 |
E.1.2 | Term | Plaque psoriasis |
E.1.2 | System Organ Class | 100000004858 |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To investigate the efficacy of roflumilast in the treatment of psoriasis (PASI75) |
|
E.2.2 | Secondary objectives of the trial |
To investigate safety and efficacy on life quality |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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)
|
|
E.4 | Principal 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
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of patients achieving at least 75% reduction from baseline psoriasis area and severity index (PASI75) at week 12. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
After 0, 4, 8, 12 ,and 24 weeks treatment |
|
E.5.2 | 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)
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
After 0, 4, 8, 12 ,and 24 weeks treatment |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |