A study to investigate whether a drug called Januvia, that is licensed to lower blood glucose in diabetic patients, has an effect on psoriasis.
- Conditions
- PsoriasisMedDRA version: 14.1Level: PTClassification code 10037153Term: PsoriasisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2012-005483-10-IE
- Lead Sponsor
- niversity College Dublin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
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).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method