Dipeptidyl Peptidase-4 Inhibition and Narrow-band Ultraviolet-B Light in Psoriasis (DINUP)
Status:
Completed
Trial end date:
2016-12-01
Target enrollment:
Participant gender:
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.