The effect of GLP-1 (glucagon-like peptide-1) in psoriasis

Conditions: Psoriasis
MedDRA version: 14.1Level: PTClassification code 10037153Term: PsoriasisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: EUCTR2011-000571-13-DK

Lead Sponsor: Gentofte Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br><br>;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) <br>DLQI (dermatology life quality index);Timepoint(s) of evaluation of this end point: Day 0, 7, 28, 56, and 84

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Skin biopsy<br>Blood samples<br>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)