Psoriasis Clinical Trial

Study to Assess VB-201 in Patients With Psoriasis

Summary

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Male or female Patients, ≥18 to ≤75 years of age, who have a diagnosis of chronic plaque psoriasis for at least 6 months
Non-anorexic subjects with a BMI ≥20
Psoriasis Area and Severity Index (PASI) score of ≥12
Plaque psoriasis covering ≥10% of body surface area (BSA)
Psoriasis severity at least moderate, scoring at least 3 on the 0 to 5 point Physician Global Assessment (PGA) scale

Exclusion Criteria:

The subject presents with the predominant type of psoriasis as guttate, erythrodermic, inverse, pustular or palmo-plantar or an unstable form of psoriasis
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
The subject anticipates getting enough ultra-violet light during the study to cause psoriasis to improve
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
History of cancer, the exception is skin cancer
Has a clinically significant systemic infection within 30 days of Day 0, or a history or presence of recurrent or chronic infection
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
History of clinically significant hypoglycemia
Subjects with currently active peptic ulcer / gastroesophageal reflux disease

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

185

Study ID:

NCT01001468

Recruitment Status:

Completed

Sponsor:

Vascular Biogenics Ltd. operating as VBL Therapeutics

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There are 17 Locations for this study

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Alexa Kimball, MD, Massachusetts General and Brigham and Women's Hospital
Boston Massachusetts, 02114, United States
Mark Amster, MD, Boston Clinical Trials
Boston Massachusetts, 02135, United States
David Greenstein, MD, ActivMed Practices and Research
Haverhill (Boston) Massachusetts, 01830, United States
Craig Leonardi, MD, Central Dermatology
St. Louis Missouri, 63117, United States
Bruce Strober, MD, New York University Medical Center, Dermatologic Associates
New York New York, 10016, United States
Gary Goldenberg, MD, Mount Sinai School of Medicine
New York New York, 10029, United States
Julian MacKay Wiggan, MD, Columbia University Medical Center
New York New York, 10032, United States
Steven Cohen, MD, Montefiore Medical Center, Dermatology
New York New York, 10467, United States
Joseph D. Sutton, MD, PC
Suffern New York, 10901, United States
Kristina Callis-Duffin, MD, University of Utah
Salt Lake City Utah, 84132, United States
Sandra Philipp, MD, Charité Campus Mitte, Universitaetsmedizin Berlin
Berlin , 10117, Germany
Bernhard Homey, MD, Universitaetsklinikum Duesseldorf
Duesseldorf , 40225, Germany
Rolf Dominicus, MD, Praxisklinik und Gemeinschaftspraxis
Dülmen , 48249, Germany
Diamant Thaci, MD, Klinikum der Johann Wolfgang Goethe-Universität
Frankfurt , 60590, Germany
Ulrich Mrowietz, MD, Universitaetsklinikum Schleswig-Holstein
Kiel , 24105, Germany
Michael Sebastian, MD, SCIDerm GmbH
Mahlow , 15831, Germany
Rudolf Schopf, MD, Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeR
Mainz , 55131, Germany
Professor Michael David, MD, Beilinson Hospital
Petach Tikvah , , Israel

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

185

Study ID:

NCT01001468

Recruitment Status:

Completed

Sponsor:


Vascular Biogenics Ltd. operating as VBL Therapeutics

How clear is this clinincal trial information?

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