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Trial record 4 of 810 for:    Psoriasis 4

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

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ClinicalTrials.gov Identifier: NCT02347501
Recruitment Status : Completed
First Posted : January 27, 2015
Last Update Posted : April 28, 2017
Sponsor:
Information provided by (Responsible Party):
University College Dublin

Brief 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.


Condition or disease Intervention/treatment Phase
Psoriasis Drug: Sitagliptin (Januvia) Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dipeptidyl Peptidase-4 Inhibition and Narrow-band Ultraviolet-B Light in Psoriasis (DINUP): A Randomised Clinical Trial
Study Start Date : November 2013
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: A

Sitagliptin 100mg once daily orally or 50mg once daily for participants with moderate kidney disease for 24 weeks and narrowband ultraviolet-B (NBUVB) phototherapy.

NBUVB light therapy is continued until the participants' psoriasis clears (<1% body surface area involved).

Drug: Sitagliptin (Januvia)
Sitagliptin 100mg tablet once daily (or 50mg once daily for participants with moderate kidney disease) for twenty four weeks in patients due to undergo NBUVB light therapy.
Other Name: Januvia

No Intervention: B

No additional treatment other than narrowband ultraviolet-B (NBUVB) phototherapy.

NBUVB light therapy is continued until the participants' psoriasis clears (<1% body surface area involved).




Primary Outcome Measures :
  1. The change in PASI during treatment with sitagliptin for participants with psoriasis undergoing NB-UVB light therapy compared to psoriasis patients undergoing NB-UVB light therapy who are allocated randomly to not receive any additional treatment. [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. The incidence of adverse events in the patients treated with sitagliptin and in the patients receiving no additional treatment [ Time Frame: 24 and 36 weeks ]
  2. The change in DLQI in patients receiving treatment with sitagliptin compared to the change in DLQI in patients receiving no additional treatment. [ Time Frame: 24 and 36 weeks ]
    DLQI: dermatology life quality index

  3. The change in PASI over 36 weeks in patients treated with sitagliptin compared to patients receiving no additional treatment. [ Time Frame: 36 weeks ]
  4. The change in blood pressure in patients treated with sitagliptin compared to patients receiving no additional treatment. [ Time Frame: 24 and 36 weeks ]
  5. The change in serum cytokines in patients treated with sitagliptin compared to patients receiving no additional treatment. [ Time Frame: 24 and 36 weeks ]
    Changes in serum concentrations of cytokines (C-reactive protein, interleukin-6 (IL-6), tumour necrosis factor alpha (TNFα) etc) Changes in serum concentrations of hormones (GLP-1, peptide YY (PYY) etc); and Changes in peripheral blood mononuclear cell expression of immune proteins (IL-6, TNFα, IL-10, IL-27 etc).

  6. The incidence of discontinuation of the study investigational medicinal product (IMP). [ Time Frame: 24 weeks ]
  7. The change in HADS in patients receiving treatment with sitagliptin compared to the change in HADS in patients receiving no additional treatment. [ Time Frame: 24 and 36 weeks ]
    HADS: Hospital Anxiety and Depression Scale

  8. The change in HAQ8 in patients receiving treatment with sitagliptin compared to the change in HAQ8 in patients receiving no additional treatment. [ Time Frame: 24 and 36 weeks ]
    HAQ8: Stanford Health Assessment Questionnaire 8-item disability scale

  9. The change in EQ-5D in patients receiving treatment with sitagliptin compared to the change in EQ-5D in patients receiving no additional treatment. [ Time Frame: 24 and 36 weeks ]
    EQ-5D: EuroQOL five item questionnaire

  10. The incidence of achievement of a greater than 50% reduction in PASI from baseline (PASI-50) in patients receiving sitagliptin and in patients receiving no additional treatment. [ Time Frame: 36 weeks ]
  11. The incidence of achievement of a greater than 75% reduction in PASI from baseline (PASI-75) in patients receiving sitagliptin and in patients receiving no additional treatment. [ Time Frame: 36 weeks ]
  12. The incidence of achievement of a greater than 90% reduction in PASI from baseline (PASI-90) in patients receiving sitagliptin and in patients receiving no additional treatment. [ Time Frame: 36 weeks ]
  13. The dosage of narrow-band ultraviolet-B light received by patients receiving sitagliptin and by patients receiving no additional treatment. [ Time Frame: 36 weeks ]
  14. The number of exposures of narrow-band ultraviolet-B light received by patients receiving sitagliptin and by patients receiving no additional treatment. [ Time Frame: 36 weeks ]
  15. The proportion of patients who relapse (PASI greater than 50% of original value) within 36 weeks of commencement of NBUVB light therapy in patients receiving sitagliptin and in patients receiving no additional treatment. [ Time Frame: 36 weeks ]
  16. The times taken to achieve PASI-50, PASI-75, PASI-90 and relapse in patients receiving sitagliptin and in patients receiving no additional treatment. [ Time Frame: 36 weeks ]
  17. The change in glycaemic measures in patients treated with sitagliptin compared to patients receiving no additional treatment. [ Time Frame: 24 and 36 weeks ]
  18. The change in lipid fractions in patients treated with sitagliptin compared to patients receiving no additional treatment. [ Time Frame: 24 and 36 weeks ]
  19. The change in weight in patients treated with sitagliptin compared to patients receiving no additional treatment. [ Time Frame: 24 and 36 weeks ]

Other Outcome Measures:
  1. The changes in skin levels of cells in patients treated with sitagliptin and in patients receiving no additional treatment in a sub-group of patients willing to undergo skin biopsies. [ Time Frame: 24 weeks ]
  2. The genetic, and/or epigenetic, profile that predicts best response to NB-UVB light therapy and to sitagliptin therapy. [ Time Frame: Baseline ]
  3. The changes in expression of cells in skin in patients treated with sitagliptin and in patients receiving no additional treatment in a sub-group of patients willing to undergo skin biopsies. [ Time Frame: 24 weeks ]
  4. The changes in expression of hormones in skin in patients treated with sitagliptin and in patients receiving no additional treatment in a sub-group of patients willing to undergo skin biopsies. [ Time Frame: 24 weeks ]
  5. The changes in expression of receptors in skin in patients treated with sitagliptin and in patients receiving no additional treatment in a sub-group of patients willing to undergo skin biopsies. [ Time Frame: 24 weeks ]
  6. The changes in expression of enzymes in skin in patients treated with sitagliptin and in patients receiving no additional treatment in a sub-group of patients willing to undergo skin biopsies. [ Time Frame: 24 weeks ]
  7. The changes in expression of immune proteins in skin in patients treated with sitagliptin and in patients receiving no additional treatment in a sub-group of patients willing to undergo skin biopsies. [ Time Frame: 24 weeks ]
  8. The changes in skin levels of hormones in patients treated with sitagliptin and in patients receiving no additional treatment in a sub-group of patients willing to undergo skin biopsies. [ Time Frame: 24 weeks ]
  9. The changes in skin levels of receptors in patients treated with sitagliptin and in patients receiving no additional treatment in a sub-group of patients willing to undergo skin biopsies. [ Time Frame: 24 weeks ]
  10. The changes in skin levels of enzymes in patients treated with sitagliptin and in patients receiving no additional treatment in a sub-group of patients willing to undergo skin biopsies. [ Time Frame: 24 weeks ]
  11. The changes in skin levels of immune proteins in patients treated with sitagliptin and in patients receiving no additional treatment in a sub-group of patients willing to undergo skin biopsies. [ Time Frame: 24 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02347501


Locations
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Ireland
UCD Clinical Research Centre, St Vincent's University Hospital
Dublin 4, Ireland
Sponsors and Collaborators
University College Dublin
Investigators
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Principal Investigator: Brian Kirby, MD FRCPI University College Dublin

Additional Information:
Publications of Results:
Lamanna C, Monami M, Bartoli N, Zannoni S, Mannucci E. Dipeptidyl peptidase- 4 inhibitors and cardiovascular events: a protective effect? Diabetologia. 2011;54:S109.
Ahern T, Tobin AM, Corrigan MA, Hogan AE, Kirby B, O'Shea D. Liraglutide Decreases Psoriasis Severity. Irish Journal of Medical Science. 2011;180(Supplement 13):S506.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University College Dublin
ClinicalTrials.gov Identifier: NCT02347501     History of Changes
Other Study ID Numbers: DPIP-2012-02
2012-005483-10 ( EudraCT Number )
First Posted: January 27, 2015    Key Record Dates
Last Update Posted: April 28, 2017
Last Verified: April 2017
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action