E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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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 | 21.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10037158 |
E.1.2 | Term | Psoriasis palm & soles |
E.1.2 | System Organ Class | 100000004858 |
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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 and safety of oral roflumilast in the treatment of palmoplantar pustulosis |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Age ≥18 years • PPP diagnosis for min. 3 months • PPPASI ≥ 10 • Active pustules, n ≥ 10 • Body mass index (BMI) ≥ 20 kg/m2 • Eligibility for systemic PPP treatment • Negative pregnancy test (women) • Safe anticonception during entire study and at least 1 week after end of treatment (~5 times plasma half-life of roflumilast)
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E.4 | Principal exclusion criteria |
• Plaque psoriasis with body surface area (BSA) ≥ 20% • Severe immunological disease, e.g. HIV, systemic lupus, and systemic sclerosis • Current tuberculosis • Current viral hepatitis • Heart failure (NYHA III-IV) • Moderate or severe liver failure (Child-Pugh B-C) • Current or former depression with suicidal ideation • Topical medical PPP therapy 2 weeks before randomization and during study • Systemic PPP therapy 4 weeks before randomization and during study • Treatment with theophylline, phenobarbital, carbamazepine, or phenytoin • Previous treatment with apremilast (Otezla®) • Confirmed pregnancy • Planned pregnancy within 6 months • Breast feeding • Blood donation during study • Inability to complete study |
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of patients achieving at least 75% reduction in baseline Palmoplantar Pustular Psoriasis Area and Severity Index (PPPASI) (PPPASI75) at week 12 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
• Percent change in baseline PPPASI at week 12 and 24 • Percent change in active pustules count at week 12 and 24 • Proportion of patients achieving at least 50% reduction in baseline PPPASI (PPPASI50) at week 12 and 24 • Proportion of patients achieving at least 90% reduction in baseline PPPASI (PPPASI90) at week 12 and 24 • Proportion of patients achieving 100% reduction in baseline PPPASI (PPPASI100) at week 12 and 24 • Change from baseline in dermatology life quality index (DLQI) at week 12 and 24. DLQI is a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on patients’ quality of life, based on recall over the past week. • Mean weight loss (kg) at week 12 and 24 • Adverse events (AEs), serious adverse events (SAEs), serious adverse reactions (SARs), and suspected unexpected serious adverse reactions (SUSARs) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | Yes |
E.6.4 | Safety | Yes |
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 | No |
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 | 2 |
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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |