Inclusion criteria | Exclusion criteria |
---|---|
1. Patients who have a diagnosis of generalised chronic plaque and/or guttate psoriasis | 1. Patients with photosensitive disorders |
2. Male and female patients aged between 18 and 75Â years inclusive | 2. Patients with diabetes mellitus |
3. Patients with a PASI of 7 or greater at screening or baseline despite use of topical therapies | 3. Patients who are receiving medications that can cause photosensitivity |
4. Patients who are due to undergo NB-UVB light therapy | 4. Patient who are receiving GLP-1 analogue therapy |
5. Patients who have not required systemic psoriasis therapy during the past 8Â weeks | 5. Patients who have conditions that could be made worse by phototherapy (cataracts, epilepsy, etc.) |
6. Patients who are unlikely to require systemic therapy for the duration of clinical trial involvement | 6. Patients with allergy or hypersensitivity to Januvia® |
7. Patients who have a negative pregnancy test at screening (women of child-bearing potential only) | 7. Patients with any of the following conditions: severe kidney disease (estimated glomerular filtration rate of less than 30Â ml/min/1.73Â m2) severe heart disease (left ventricular ejection fraction less than 35Â %) severe liver disease (alanine aminotransferase greater than 150Â IU/L) severe lung disease (forced expiratory volume in 1Â second or a forced vital capacity that is known to be less than 50Â % of that estimated for a person of that age and gender) |
8. Patients who are willing to sign voluntarily a statement of informed consent to participate in the study | 8. Patients who have received NB-UVB light recently (within 8Â weeks) |
 | 9. Patients who are receiving currently or have received systemic therapy for psoriasis recently (within 8 weeks) |
 | 10. Patients who have any other contraindications to Januvia® as stated in its Summary of Product Characteristics |
 | 11. Female patients of child-bearing potential who are pregnant, breastfeeding, or unwilling to practice an acceptable barrier and/or hormonal method of contraception during participation in the study – abstinence will be permitted only if it is in keeping with a person’s lifestyle |
 | 12. Patients with any clinically significant chronic disease that might, in the opinion of the investigator, interfere with the evaluations or preclude completion of the trial |
 | 13. Patients with a current or recent (within the past 4 weeks) acute serious illness, acute psychiatric illness or severe uncontrolled/unstable illness |
 | 14. Patients who have been randomised into this study previously |
 | 15. Patients who are participating in another clinical trial concurrently |
 | 16. Patients who are participating in another clinical trial during the 12 weeks prior to study entry (i.e. screening visit) |