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 |
Psoriasis is a common and chronic skin disease. A person with psoriasis generally has patches of raised red skin with thick silvery scales. |
|
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 | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10037153 |
E.1.2 | Term | Psoriasis |
E.1.2 | System Organ Class | 10040785 - Skin and subcutaneous tissue disorders |
|
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 |
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. |
|
E.2.2 | Secondary objectives of the trial |
To determine the effect of treatment with Januvia® and the effect of no additional treatment, on the:
1. ΔPASI 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.
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
|
|
E.4 | Principal 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).
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy endpoint is the change in the psoriasis area and severity index (ΔPASI) after twenty four weeks.
|
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
The secondary endpoints will include the:
1. ΔPASI 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, TNFα, IL-10, IL-27, IL-17, IFNγ, TLR-4, TLR-2, JNK-1, MCP-1 etc) after 24 and 36 weeks.
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
|
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
|
The research participants’ involvement in this study will end following the completion of the End of Study Visit (or early withdrawal visit, if applicable). |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |