Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2025-12-25 @ 8:40 PM
Study NCT ID:
NCT01460069
Status:
COMPLETED
Last Update Posted:
2013-06-21
First Post:
2011-10-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Glucagon Like Peptide (GLP)-1 in Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069450', 'term': 'Liraglutide'}], 'ancestors': [{'id': 'D052216', 'term': 'Glucagon-Like Peptide 1'}, {'id': 'D004763', 'term': 'Glucagon-Like Peptides'}, {'id': 'D052336', 'term': 'Proglucagon'}, {'id': 'D005768', 'term': 'Gastrointestinal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-19', 'studyFirstSubmitDate': '2011-10-18', 'studyFirstSubmitQcDate': '2011-10-24', 'lastUpdatePostDateStruct': {'date': '2013-06-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PASI (psoriasis area and severity index)', 'timeFrame': 'Baseline and after 2 months'}, {'measure': 'DLQI (dermatology life quality index)', 'timeFrame': 'Baseline and after 2 months'}], 'secondaryOutcomes': [{'measure': 'Body mass index', 'timeFrame': 'Baseline and after 2 months'}, {'measure': 'CRP', 'timeFrame': 'Baseline and after 2 months'}, {'measure': 'Skin biopsies', 'timeFrame': 'Baseline and after 2 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['psoriasis', 'liraglutide', 'morbidity', 'PASI', 'DLQI'], 'conditions': ['Psoriasis']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Caucasians above 18 years of age\n* Plaque psoriasis\n* PASI score \\>10\n* No treatment or stable treatment of psoriasis during at least 3 months before inclusion\n* Steady weight through 3 months with a body mass index (BMI) above 27 kg/m2\n* Normal blood pressure\n* Spiral or hormonal birth control for fertile women during the entire treatment period and at least 3 days after the end of the treatment period (\\~5 times the plasma half-life)\n\nExclusion Criteria:\n\n* Psoriasis arthritis\n* Fasting plasma glucose \\> 7.5 mmol/L or HbA1c \\> 7.5%\n* Type 1 diabetes\n* Treatment for type 2 diabetes with GLP-1-based medicine (DDP-4-inhibitors or GLP-1-receptor-agonists)\n* Heart failure, NYHA class III-IV\n* Uraemia, end-stage renal disease, or any other cause of impaired renal function with s-creatinine \\>150 µM and/or albuminuria\n* Liver disease (alanine amino transferase (ALAT) and/or aspartate amino transferase (ASAT) \\>2 x upper normal serum levels)\n* Anaemia\n* Acute or chronic pancreatitis\n* Struma or thyroid cancer\n* Pregnancy or breast feeding\n* Inability to complete the study'}, 'identificationModule': {'nctId': 'NCT01460069', 'briefTitle': 'The Effect of Glucagon Like Peptide (GLP)-1 in Psoriasis', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Gentofte, Copenhagen'}, 'officialTitle': 'The Effect of GLP-1 in Psoriasis', 'orgStudyIdInfo': {'id': '2011-000571-13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Victoza treatment', 'interventionNames': ['Drug: liraglutide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'The placebo pens contain saline and are administered in the same way and volume as Victoza. The placebo pens are specially prepared for this study and will be used in the study only.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'liraglutide', 'type': 'DRUG', 'description': 'Victoza® is supplied in pens for injection containing 18 mg of the GLP-1 agonist liraglutide in 3 mL sterile water with disodiumphosphate and propylenglycol, and phenol for conservation (pH 8.15). Commercial pens will be used and the information given in the packaging will be applicable. The initial daily dose will be 0.6 mg for one week, 1.2 mg the following week and then 1.8 mg for the remaining treatment period. The injection is administered once daily in the morning. The maximal plasma concentration is reached 8-12 hours after subcutaneous injection. The half-life in plasma is approximately 13 hours. The duration of effect is 24 hours.', 'armGroupLabels': ['Victoza treatment']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'The placebo pens contain saline and are administered in the same way and volume as (liraglutide) Victoza. The placebo pens are specially prepared for this study and will be used in the study only.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2900', 'city': 'Hellerup', 'country': 'Denmark', 'facility': 'Gentofte Hospital', 'geoPoint': {'lat': 55.73204, 'lon': 12.57093}}], 'overallOfficials': [{'name': 'AnneSofie Faurschou, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gentofte Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Annesofie Faurschou', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Copenhagen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD PhD - Resident in dermatology', 'investigatorFullName': 'Annesofie Faurschou', 'investigatorAffiliation': 'University Hospital, Gentofte, Copenhagen'}}}}