Active Plaque PsoriasisPhase 2NCT01001468
Study to Assess VB-201 in Patients With Psoriasis
A Phase 2 study testing VB-201 in people with Active Plaque Psoriasis, run by Vascular Biogenics Ltd. operating as VBL Therapeutics at 18 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Active Plaque Psoriasis
- What is being tested?
- VB-201
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 185 participants
- Where
- 18 sitesin 3 countries
- Study dates
- Dec 2009to Jul 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
18 sites in 3 countries.
18 sites in 3 countries
United States10 sites
Alexa Kimball, MD, Massachusetts General and Brigham and Women's Hospital
Boston, Massachusetts, 02114
Mark Amster, MD, Boston Clinical Trials
Boston, Massachusetts, 02135
David Greenstein, MD, ActivMed Practices and Research
Haverhill (Boston), Massachusetts, 01830
Bruce Strober, MD, New York University Medical Center, Dermatologic Associates
New York, New York, 10016
Gary Goldenberg, MD, Mount Sinai School of Medicine
New York, New York, 10029
Julian MacKay Wiggan, MD, Columbia University Medical Center
New York, New York, 10032
Steven Cohen, MD, Montefiore Medical Center, Dermatology
New York, New York, 10467
Kristina Callis-Duffin, MD, University of Utah
Salt Lake City, Utah, 84132
Craig Leonardi, MD, Central Dermatology
St Louis, Missouri, 63117
Joseph D. Sutton, MD, PC
Suffern, New York, 10901
Germany7 sites
Sandra Philipp, MD, Charité Campus Mitte, Universitaetsmedizin Berlin
Berlin, 10117
Rolf Dominicus, MD, Praxisklinik und Gemeinschaftspraxis
Dülmen, 48249
Bernhard Homey, MD, Universitaetsklinikum Duesseldorf
Düsseldorf, 40225
Diamant Thaci, MD, Klinikum der Johann Wolfgang Goethe-Universität
Frankfurt, 60590
Ulrich Mrowietz, MD, Universitaetsklinikum Schleswig-Holstein
Kiel, 24105
Michael Sebastian, MD, SCIDerm GmbH
Mahlow, 15831
Rudolf Schopf, MD, Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeR
Mainz, 55131
About this study
Official title: 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
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.
- Conditions
- Active Plaque Psoriasis
- Being tested
- VB-201, Placebo
- Keywords
- Psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VB-201Drug
Single daily dose of oral VB-201 20 mg
VB-201Drug
Single daily dose or oral VB-201 80 mg
PlaceboOther
Single daily dose of oral placebo
| Study group | Role | What they receive |
|---|---|---|
| VB-201 20 mg | Experimental | Not described Receives: Drug: VB-201 |
| VB-201 80 mg | Experimental | Not described Receives: Drug: VB-201 |
| Placebo | Placebo comparator | Single daily dose of oral placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in the Psoriasis Area and Severity Index(PASI 75)from baseline at Week 12
Measured: 20 weeks
Secondary outcomes (4)
Change in PGA (Physician Global Assessment) scores from baseline to Week 12
Measured: 20 weeks
Change in Patient Psoriasis Global Assessment scores from baseline to Week 12
Measured: 20 weeks
Change in affected Body Surface Area (BSA) from baseline to Week 12
Measured: 20 weeks
Measurement of improvement in the PASI (50) from baseline at Week 12
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2009 (estimated)
- Study startDec 2009
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Active Plaque PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vascular Biogenics Ltd. operating as VBL Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01001468
- Sponsor's protocol ID
- VB-201-006
- Status last verified
- Nov 2011
- First submitted
- 20 Oct 2009
- Last updated
- 16 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01001468
- Acronym / sponsor ID
- VB-201-006
- Conditions
- Active Plaque Psoriasis
- Keywords
- Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- Vascular Biogenics Ltd. operating as VBL TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 26 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VB-201 20 mg | Experimental | Drug: VB-201 |
| VB-201 80 mg | Experimental | Drug: VB-201 |
| Placebo | Placebo comparator | Other: PlaceboSingle daily dose of oral placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VB-201Single daily dose of oral VB-201 20 mg | Drug | VB-201 20 mg |
| VB-201Single daily dose or oral VB-201 80 mg | Drug | VB-201 80 mg |
| PlaceboSingle daily dose of oral placebo | Other | Placebo |
Primary outcome
Improvement in the Psoriasis Area and Severity Index(PASI 75)from baseline at Week 12
Time frame: 20 weeks
4 secondary outcomes
Change in PGA (Physician Global Assessment) scores from baseline to Week 12
Time frame: 20 weeks
Change in Patient Psoriasis Global Assessment scores from baseline to Week 12
Time frame: 20 weeks
Change in affected Body Surface Area (BSA) from baseline to Week 12
Time frame: 20 weeks
Measurement of improvement in the PASI (50) from baseline at Week 12
Time frame: 20 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VB-201 in people with Active Plaque Psoriasis, run by Vascular Biogenics Ltd. operating as VBL Therapeutics at 18 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Germany, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in the Psoriasis Area and Severity Index(PASI 75)from baseline at Week 12 (time frame: 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2011.