Psoriasis MedDRA version: 17.1 Level: PT Classification code 10037153 Term: Psoriasis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Sponsors
University College Dublin
Eligibility
Sex/Gender
All
Inclusion criteria
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 or female aged between 18 and 75 years inclusive; 3. Have a psoriasis area and severity index (PASI) greater than 7 at screening or baseline; 4. Have a diagnosis of type 2 diabetes; 5. Have a glycated haemoglobin (HbA1c) level between 48mmol/mol and 80mmol/mol; 6. Are able and willing to stop sulphonylurea, dipeptidyl peptidase-4 [DPP-4] inhibitor and glucagon-like peptide-1 [GLP-1] analogue therapy for the duration of the study; 7. Have a negative pregnancy test at screening (women of child bearing potential only); and 8. Are willing to voluntarily sign 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 32 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8
Exclusion criteria
Exclusion criteria: People with any of the following conditions will be excluded from the study: 1. Allergy or hypersensitivity to Januvia® or Diamicron®; 2. Current or recent (within 8 weeks) receipt of phototherapy; 3. Type 1 diabetes; 4. Severe kidney disease, as defined as an estimated glomerular filtration rate of less than <15ml/min/1.73 m2; 5. Severe heart or liver disease; 6. Any other contraindications, as stated in the SPCs for Januvia® or Diamicron®; 7. Female patients of child bearing potential who are pregnant, breastfeeding, or unwilling to practice an acceptable barrier and/or hormonal method of contraception or abstinence during participation in the study; 8. Any clinically significant chronic disease that might, in the opinion of the investigator, interfere with the evaluations or preclude completion of the trial; 9. Previous randomisation into this study; 10. Concurrent participation in another clinical trial; and 11. Participation in another clinical trial during the twelve weeks prior to study entry (i.e. screening visit).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the research project is to determine the change in the psoriasis area and severity index (?PASI) during 16 weeks of treatment with a dipeptidyl peptidase-4 inhibitor (Januvia®, 100mg daily) in psoriasis patients with type 2 diabetes. This will be compared to the ?PASI in psoriasis patients with type 2 diabetes during 16 weeks of treatment with a comparator (Diamicron®, 80mg to 320mg daily).;Secondary Objective: To determine, and compare, the effects of: 1.16 weeks tmt with Januvia® with Diamicron® on the: a.Incidence of AEs and d/c of one of the IMPs b.Change in QOL scores c.Incidence of achievement of > than 50% reduction in PASI from baseline d.Incidence of PASI-75 & PASI-90 e.Time to achieve PASI-50, PASI-75 & PASI-90 f.Changes in levels of CVD risk factors g.Changes in serum concentrations of cytokines and hormones h.Changes in mononuclear cell expression of immune proteins 2. 32 weeks tmt with Januvia® with 16 weeks Diamicron® followed by 16 weeks Januvia® tmt on the: a.Change in PASI b.Incidence of AEs and d/c of one of the IMPs c.Change in QOL scores d.Incidence of achievement > than 50% reduction in PASI from baseline e.Incidence of PASI-75 & PASI-90 f.Time to achieve PASI-50, PASI-75 & PASI-90 g.Changes in levels of CVD risk factors h.Changes in serum concentrations of cytokines and hormones j.Changes in mononuclear cell expression of immune proteins ;Primary end point(s): The primary efficacy endpoint of the study is the change in the psoriasis area and severity index in psoriasis patients with type 2 diabetes after sixteen weeks of treatment. ;Timepoint(s) of evaluation of this end point: After a 16 week treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary efficacy endpoints are: 1. Change in psoriasis area and severity index after 32 weeks of treatment; 2. Incidence of adverse events within 16 and 32 weeks of treatment commencement; 3. Incidence of discontinuation of one of the study investigational medicinal products (IMPs) within 16 and 32 weeks of treatment commencement; 4. Changes in validated quality of life scores (DLQI, EQ-5D, HADS, and HAQ-8) after 16 and 32 weeks; 5. Proportion of patients who achieve a greater than 50% reduction in PASI from baseline (PASI-50) within 16 and 32 weeks; 6. Proportion of participants who achieve PASI-75 and PASI-90 within 16 and 32 weeks; 7. Times taken to achievement of PASI-50, PASI-75 and PASI-90; 8. Changes in levels of cardiovascular disease risk factors (blood pressure, glycaemic measures lipid fractions, weight etc) after 16 and 32 weeks; 9. Changes in serum concentrations of cytokines (CRP, IL-6, TNFa, IL-1ß, IL-10 etc) after 16 and 32 weeks; 10. Changes in serum concentrations of hormones (GLP-1, PYY etc) after 16 and 32 weeks; and 11. Changes in peripheral blood mononuclear cell expression of immune proteins (IL-6, TNFa, IL-10, IL-27, IFN?, IL-17, TLR-4, TLR-2, JNK-1 MCP-1 etc) after 16 and 32 weeks. ;Timepoint(s) of evaluation of this end point: After 16 and 32 weeks treatment. | — |
Countries
Ireland
Contacts
Public ContactTomas Ahern
UCD Clinical Research Centre, St Vincent's University Hospital
Outcome results
None listed