Psoriasis MedDRA version: 14.1 Level: PT Classification code 10037153 Term: Psoriasis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Trade Name: Victoza
Pharmaceutical Form: Injection
INN or Proposed INN: LIRAGLUTIDE
CAS Number: 204656-20-2
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 0.6-1.8
Sponsors
Gentofte Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Caucasians above 18 years of age Plaque psoriasis PASI score >10 No treatment or stable treatment of psoriasis during at least 3 months before inclusion Steady weight through 3 months with a body mass index (BMI) of maximum 30kg/m2 Normal blood pressure Spiral or hormonal birth control 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Psoriasis arthritis Fasting plasma glucose > 7.5 mmol/L Type 1 diabetes Type 2 diabetes Treatment for type 2 diabetes with GLP-1-based medicine (DDP-4-inhibitors or GLP-1-receptor-agonists) Heart failure, NYHA class III-IV Uraemia, end-stage renal disease, or any other cause of impaired renal function with s-creatinine >150 µM and/or albuminuria Liver disease (alanine amino transferase (ALAT) and/or aspartate amino transferase (ASAT) >2 x upper normal serum levels) Screening calcitonin >50ng/L Anaemia Acute or chronic pancreatitis Struma or thyroid cancer Pregnancy or breast feeding Inability to complete the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to investigate the effect of the GLP-1 analogue Victoza® on psoriasis in a double-blinded, randomized placebo-controlled clinical trial. ;Secondary Objective: To study the effect of Victoza on the occurrence of GLP-1 receptors in the skin.;Primary end point(s): PASI (psoriasis area and severity index) DLQI (dermatology life quality index);Timepoint(s) of evaluation of this end point: Day 0, 7, 28, 56, and 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Skin biopsy Blood samples Weight, hip and waist measure;Timepoint(s) of evaluation of this end point: Day 0, 7, 28, 56, and 84 (skin biopsy only day 0, 7 and 56) | — |
Countries
Denmark
Contacts
Public ContactClinical Trials Registration
Gentofte Hospital
Outcome results
None listed