Dipeptidyl Peptidase-4 Inhibition and Narrow-band Ultraviolet-B Light in Psoriasis (DINUP)

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose of this study is to determine if sitagliptin (Januvia®) improves psoriasis severity after 24 weeks of treatment in 60 participants with psoriasis who do not have type 2 diabetes mellitus, and who are due to receive a course of narrowband ultraviolet-B phototherapy (NB-UVB). The investigators will compare the change in psoriasis severity in 60 participants treated with both sitagliptin and NB-UVB to 60 participants treated with NB-UVB alone. Participants will be recruited from two centres and after a 3 week run-in period will be followed prospectively for 36 weeks. Participants will be stratified by centre, plasma glycated haemoglobin level (HbA1c), obesity status and previous response to NB-UVB, after which they will be randomly allocated to Arm A or Arm B. Participants will be treated with either sitagliptin for 24 weeks and NB-UVB (Arm A), or NB-UVB alone (Arm B).

Both the research participants and the investigators will be aware of the trial arm to which the research participant has been allocated randomly (open-label study). Research participants are prohibited from using systemic psoriasis therapy for the duration of their trial involvement.

Participants will be assessed at 8 study visits over 39 weeks. Participants will complete questionnaires, have a medical history recorded and physical examination, blood sampling and skin biopsies taken (in a small number of willing participants at 2 visits).

The following endpoints will be analysed:

Changes in psoriasis severity at 24 and 36 weeks; changes in validated quality of life scores; incidence of adverse events; incidence of discontinuation of one of the study IMPs, time to relapse of psoriasis; changes in cardiovascular disease risk factor profiles; changes in cytokines, hormones, expression of immune proteins in blood and skin biopsies; and genetic profiles that predicts best response to sitagliptin therapy.

The investigators hypothesize that sitagliptin therapy decreases psoriasis severity.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University College Dublin
• Treatments: Sitagliptin Phosphate

Criteria

Inclusion Criteria:

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.

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. Use of GLP-1 analogue therapy;

5. Conditions that could be made worse by phototherapy (cataract, epilepsy, etc);

6. Allergy or hypersensitivity to Januvia®;

7. 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/1.73m2;

8. Recent (within 8 weeks) receipt of NB-UVB light;

9. Current or recent (within 8 weeks) use of systemic therapy for psoriasis;

10. 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 echocardiogram or cardiac catheterisation study);

11. 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;

12. Severe liver disease as defined by a previous diagnosis of chronic liver disease in the presence of an alanine transferase concentration greater than 150 international units/L (greater than three times the upper limit of the normal reference range);

13. Any other contraindications to Januvia® as stated in its SPC;

14. 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;

15. Any clinically significant chronic disease that might in the opinion of the investigator, interfere with the evaluations or preclude completion of the trial;

16. A current or recent (within the past 4 weeks) acute serious illness, acute psychiatric illness or severe uncontrolled/unstable illness;

17. Previous randomisation into this study;

18. Concurrent participation in another clinical trial; and

19. Participation in another clinical trial during the twelve weeks prior to study entry (i.e. screening visit).