Ignite Creation Date:
2025-12-24 @ 5:42 PM
Ignite Modification Date:
2026-02-25 @ 8:50 PM
Study NCT ID:
NCT01001468
Status:
COMPLETED
Last Update Posted:
2011-11-16
First Post:
2009-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Assess VB-201 in Patients With 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': 'C552500', 'term': '1-palmityl-2-(4-carboxybutyl)-sn-glycero-3-phosphocholine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 185}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-15', 'studyFirstSubmitDate': '2009-10-20', 'studyFirstSubmitQcDate': '2009-10-23', 'lastUpdatePostDateStruct': {'date': '2011-11-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in the Psoriasis Area and Severity Index(PASI 75)from baseline at Week 12', 'timeFrame': '20 weeks'}], 'secondaryOutcomes': [{'measure': 'Change in PGA (Physician Global Assessment) scores from baseline to Week 12', 'timeFrame': '20 weeks'}, {'measure': 'Change in Patient Psoriasis Global Assessment scores from baseline to Week 12', 'timeFrame': '20 weeks'}, {'measure': 'Change in affected Body Surface Area (BSA) from baseline to Week 12', 'timeFrame': '20 weeks'}, {'measure': 'Measurement of improvement in the PASI (50) from baseline at Week 12', 'timeFrame': '20 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Psoriasis'], 'conditions': ['Active Plaque Psoriasis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the efficacy, safety and tolerability of VB-201 as compared with placebo on measures of disease activity in patients with psoriasis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female Patients, ≥18 to ≤75 years of age, who have a diagnosis of chronic plaque psoriasis for at least 6 months\n* Non-anorexic subjects with a BMI ≥20\n* Psoriasis Area and Severity Index (PASI) score of ≥12\n* Plaque psoriasis covering ≥10% of body surface area (BSA)\n* Psoriasis severity at least moderate, scoring at least 3 on the 0 to 5 point Physician Global Assessment (PGA) scale\n\nExclusion Criteria:\n\n* The subject presents with the predominant type of psoriasis as guttate, erythrodermic, inverse, pustular or palmo-plantar or an unstable form of psoriasis\n* The subject has not undergone wash-out periods of sufficient duration for the following treatments at Baseline: Topical psoriasis treatments; Systemic, oral or injected, psoriasis treatments; Phototherapy\n* The subject anticipates getting enough ultra-violet light during the study to cause psoriasis to improve\n* The subject has a known allergy or sensitivity to the study treatment(s) or to any of the excipients contained in the study drug formulation\n* History of cancer, the exception is skin cancer\n* Has a clinically significant systemic infection within 30 days of Day 0, or a history or presence of recurrent or chronic infection\n* Evidence of tuberculosis as indicated by a positive tuberculin skin test or a quantiferon test in subjects known to have a + PPD and a negative chest x-ray at screening\n* History of clinically significant hypoglycemia\n* Subjects with currently active peptic ulcer / gastroesophageal reflux disease'}, 'identificationModule': {'nctId': 'NCT01001468', 'briefTitle': 'Study to Assess VB-201 in Patients With Psoriasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vascular Biogenics Ltd. operating as VBL Therapeutics'}, 'officialTitle': 'A Randomized, Double-Blind, 12-Week, Dose-Ranging Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral VB-201 in Patients With Moderate to Severe Plaque Psoriasis', 'orgStudyIdInfo': {'id': 'VB-201-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VB-201 20 mg', 'interventionNames': ['Drug: VB-201']}, {'type': 'EXPERIMENTAL', 'label': 'VB-201 80 mg', 'interventionNames': ['Drug: VB-201']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Single daily dose of oral placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'VB-201', 'type': 'DRUG', 'description': 'Single daily dose of oral VB-201 20 mg', 'armGroupLabels': ['VB-201 20 mg']}, {'name': 'VB-201', 'type': 'DRUG', 'description': 'Single daily dose or oral VB-201 80 mg', 'armGroupLabels': ['VB-201 80 mg']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Single daily dose of oral placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Alexa Kimball, MD, Massachusetts General and Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02135', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Mark Amster, MD, Boston Clinical Trials', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '01830', 'city': 'Haverhill (Boston)', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'David Greenstein, MD, ActivMed Practices and Research', 'geoPoint': {'lat': 42.7762, 'lon': -71.07728}}, {'zip': '63117', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Craig Leonardi, MD, Central Dermatology', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Bruce Strober, MD, New York University Medical Center, Dermatologic Associates', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Gary Goldenberg, MD, Mount Sinai School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Julian MacKay Wiggan, MD, Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10467', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Steven Cohen, MD, Montefiore Medical Center, Dermatology', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10901', 'city': 'Suffern', 'state': 'New York', 'country': 'United States', 'facility': 'Joseph D. Sutton, MD, PC', 'geoPoint': {'lat': 41.11482, 'lon': -74.14959}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Kristina Callis-Duffin, MD, University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Sandra Philipp, MD, Charité Campus Mitte, Universitaetsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '48249', 'city': 'Dülmen', 'country': 'Germany', 'facility': 'Rolf Dominicus, MD, Praxisklinik und Gemeinschaftspraxis', 'geoPoint': {'lat': 51.83149, 'lon': 7.28075}}, {'zip': '40225', 'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'Bernhard Homey, MD, Universitaetsklinikum Duesseldorf', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'zip': '60590', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Diamant Thaci, MD, Klinikum der Johann Wolfgang Goethe-Universität', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '24105', 'city': 'Kiel', 'country': 'Germany', 'facility': 'Ulrich Mrowietz, MD, Universitaetsklinikum Schleswig-Holstein', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'zip': '15831', 'city': 'Mahlow', 'country': 'Germany', 'facility': 'Michael Sebastian, MD, SCIDerm GmbH', 'geoPoint': {'lat': 52.36017, 'lon': 13.40954}}, {'zip': '55131', 'city': 'Mainz', 'country': 'Germany', 'facility': 'Rudolf Schopf, MD, Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeR', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'city': 'Petach Tikvah', 'country': 'Israel', 'facility': 'Professor Michael David, MD, Beilinson Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vascular Biogenics Ltd. operating as VBL Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}