Psoriasis MedDRA version: 14.1 Level: PT Classification code 10037153 Term: Psoriasis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Sponsors
University College Dublin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: People who satisfy all of the following may be included in the study: 1. Have a diagnosis of generalized chronic plaque and/or guttate psoriasis; 2. Are male and female patients aged between 18 and 75 years inclusive; 3. Have a psoriasis area and severity index (PASI) greater than 7 despite use of topical therapies; 4. Are due to undergo NB-UVB light therapy; 5. Have not required systemic psoriasis therapy during the past eight weeks; 6. Are unlikely to require systemic therapy for the duration of clinical trial involvement; 7. Have a negative pregnancy test at screening (women of child bearing potential only); and 8. Are willing to sign voluntarily a statement of informed consent to participate in the study. 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 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: People with any of the following conditions will be excluded from the study: 1. Photosensitive disorders (lupus erythematosis etc); 2. Diabetes mellitus; 3. Use of medications that can cause photosensitivity; 4. Conditions that could be made worse by phototherapy (cataract, epilepsy, etc); 5. Allergy or hypersensitivity to Januvia®; 6. Severe kidney disease as defined by a previous diagnosis of chronic kidney disease in the presence of an estimated glomerular filtration rate (eGFR) of less than 30ml/min/1.73 m2; 7. Recent (within 8 weeks) receipt of NB-UVB light; 8. Current or recent (within 8 weeks) use of systemic therapy for psoriasis; 9. Severe heart disease as defined by a previous diagnosis of heart disease and a left ventricular ejection fraction which is known to be less than 35% (as measured by echocardiogramme or cardiac catheterisation study); 10. Severe lung disease as defined by a previous diagnosis of chronic lung disease and a forced expiratory volume in 1 second (FEV1) or a forced vital capacity (FVC) that is known to be less than 50% that which would be estimated for a person of that age and gender; 11. Severe liver disease as defined by a previous diagnosis of chronic liver disease in the presence of an alanine transferase concentration greater than 150IU/L (greater than three times the upper limit of the normal reference range); 12. Any other contraindications to Januvia® as stated in its SPC; 13. 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; 14. Any clinically significant chronic disease that might, in the opinion of the investigator, interfere with the evaluations or preclude completion of the trial; 15. A current or recent (within the past 4 weeks) acute serious illness, acute psychiatric illness or severe uncontrolled/unstable illness; 16. Previous randomisation into this study; 17. Concurrent participation in another clinical trial; and 18. Participation in another clinical trial during the twelve weeks prior to study entry (i.e. screening visit).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the research project is to determine the change in the psoriasis area and severity index (?PASI) during twenty four weeks of treatment with a dipeptidyl peptidase-4 inhibitor (Januvia®, 100mg daily, or 50mg daily for participants with moderate kidney disease) in psoriasis patients undergoing narrow-band ultraviolet-B (NB-UVB) light therapy. This will be compared to the ?PASI of psoriasis patients undergoing NB-UVB light therapy who are allocated randomly to not receive any additional treatment. ;Secondary Objective: To determine the effect of treatment with Januvia® and the effect of no additional treatment, on the: 1. ?PASI over thirty six weeks 2. Change in validated QOL scores after 24 and 36 weeks 3. Dosage of NB-UVB light at 36 weeks 4. Number of exposures to NB-UVB light at 36 weeks 5. Proportion of patients who achieve a greater than 50% reduction in PASI from baseline (PASI-50) within 36 weeks of commencement of NB-UVB therapy 6. Proportion of patients who achieve PASI-75 and PASI-90 within 36 weeks of commencement of NB-UVB therapy 7. Proportion of patients who relapse (PASI greater than 50% of original value) within 36 weeks of commencement of NB-UVB light therapy 8. Times taken to achieve PASI-50, PASI-75, PASI-90 and relapse 9. Change in levels of CVD risk factors after 24 and 36 weeks 10. Change in serum concentrations of cytokines and hormones after 24 and 36 weeks 11. Change in peripheral blood mononuclear cell expression of immune proteins after 24 and 36 weeks. ;Primary end point(s): The primary efficacy endpoint is the change in the psoriasis area and severity index (?PASI) after twenty four weeks. ;Timepoint(s) of evaluation of this end point: After 24 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints will include the: 1. ?PASI after thirty six weeks; 2. Change in validated quality of life scores (DLQI, SF-12, EQ-5D, HADS, HAQ-8) after 24 and 36 weeks; 3. NB-UVB light dosage and exposure number at 36 weeks; 4. Proportion of patients who achieve a greater than 50% reduction in PASI from baseline (PASI-50) by 36 weeks; 5. Proportion of participants who achieve PASI-75 and PASI-90 by 36 weeks; 6. Proportion of participants who relapse (PASI greater than 50% of original value) by 36 weeks; 7. Times taken to achieve PASI-50, PASI-75, PASI-90 and relapse; 8. Changes in levels of cardiovascular disease risk factors (blood pressure, glycaemic measures lipid fractions, weight etc) after 24 and 36 weeks; 9. Changes in serum concentrations of cytokines and hormones after 24 and 36 weeks; and 10. Changes in peripheral blood mononuclear cell expression of immune proteins (IL-6, TNFa, IL-10, IL-27, IL-17, IFN?, TLR-4, TLR-2, JNK-1, MCP-1 etc) after 24 and 36 weeks. ;Timepoint(s) of evaluation of this end point: After 24 and 36 weeks. | — |
Countries
Ireland
Contacts
Public ContactDr Tomas Ahern
UCD Clinical Research Centre, St Vincent's University Hospital
Outcome results
None listed