Patients with Moderate to Severe Plaque Psoriasis MedDRA version: 17.0 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris System Organ Class: 100000004858
Conditions
Interventions
Product Name: VB-201
Product Code: VB-201, formerly CI-201
Pharmaceutical Form: Capsule
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Sponsors
Vascular Biogenics Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Fully understand all elements of and have signed and dated the written Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approved informed consent before initiation of protocol-specified procedures; 2. Male or female subjects, =18 to =75 years of age, who have a diagnosis of chronic plaque psoriasis for at least 6 months prior to screening; 3. Plaque psoriasis covering between 10% to 30 % of body surface area (BSA); 4. PASI severity moderate to severe, scoring at least 10 but no higher than 20; 5. For a female subject; either: - subject is of non-childbearing potential, defined as: menopause with amenorrhea >2 years, hysterectomy, or bilateral oopherectomy or - agrees to continue to use adequate contraception (implants, injectables, combined oral contraceptives, intrauterine devices [IUDs], sexual abstinence or vasectomised partner) throughout the study and for at least one month following termination and have a negative pregnancy test at screening and before the first dose of study drug; Males must use at least one method of contraception (e.g., condom) throughout the study; 6. In the opinion of the investigator, the subject will be compliant and have a high probability of completing the study and all required procedures. 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 170 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1. The subject presents with psoriasis that is predominantly guttate, erythrodermic, inverse, pustular or palmo-plantar or an unstable form of psoriasis; 2. Received any investigational drug within 30 days of screening; 3. Previous participation in a VB-201 study; 4. Previously received or is currently receiving systemic biologic treatment for psoriasis (e.g. ustekinumab, adalimumab, etanercept, etc); 5. The subject has not undergone wash-out periods of sufficient duration for the following treatments at Baseline: Topical psoriasis treatments: 2 weeks; Systemic (non-biologic) psoriasis treatments: 4 weeks or 5 half-lives (whichever is longer); Phototherapy: 4 weeks 6. The subject anticipates getting enough ultra-violet light during the study (e.g. sunbathing; tanning salon, etc.) to cause psoriasis to improve; 7. 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 (see list of ingredients in the Investigator’s Brochure); 8. Any other acute or chronic medical condition that, in the opinion of the investigator, increases the risk to the subject or the likelihood that the subject will be unable to complete the study; 9. Subjects with any laboratory test at screening that common medical practice would deem as significantly abnormal. The following will be deemed as significantly abnormal: Alanine transaminase (ALT), aspartate transaminase (AST), or alkaline phosphatase 2.0-times the upper limit of normal (ULN) or Cytopenia (to include any of the following: WBC 3 previous squamous cell skin cancer lesions are excluded; Subjects who had histologically controlled excision of basal cell and/or squamous cell carcinoma of the skin and have been declared to have no evidence of tumor can be enrolled; Subjects who had basal cell and/or squamous cell carcinoma of the skin removed and have not met these criteria can be enrolled if the skin cancer was removed >3 years prior to study participation and there is no evidence of recurrence; 11. Has a clinically significant systemic infection (e.g., chronic or acute infection, UTI, URI) within 30 days of baseline, or a history or presence of recurrent or chronic infection [e.g. viral infections, (including hepatitis B or C, HIV), bacterial infections, systemic fungal infections, or syphilis]; 12. Evidence of tuberculosis as indicated by a positive Quantiferon test at screening or within 30 days prior to screening; 13. Chest X-ray within 3 months of screening visit suggestive of tuberculosis or active fungal infection; 14. History of substance abuse, including alcohol abuse, within the past year; 15. Has a history of or has a current, clinically significant major psychiatric disorder (e.g., major depressive disorder, psychosis, schizophrenia) according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV-TR). [Exception: Subjects with depression that has been adequately controlled for at least 6 months may enroll in the study]; 16. Female subject with a posi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Safety Objective To examine the safety and tolerability of up to 24 weeks’ treatment with VB-201 or placebo in patients with psoriasis. Efficacy Objective Stage 1: To examine the effect of treatment with two different doses of VB-201 compared to placebo (initial 16 weeks) on measures of disease activity in patients with psoriasis. Stage 2: To examine the effect of treatment with two different doses of VB-201 compared to placebo (24 weeks) on measures of disease activity in patients with psoriasis. Exploratory Biomarker To examine the effect of up to 24 weeks treatment with two different doses of VB-201 as compared with placebo on inflammatory related biomarkers.;Secondary Objective: not applicable;Primary end point(s): Stage 1 Primary Efficacy Endpoints The primary efficacy analysis for Stage 1 will include the MITT Population and compare the proportions (%) of Patients achieving a PASI 50 response in the VB-201 160 mg (80 mg BID) group to the placebo group at Week 16 This analysis will be performed using the Chi-square test. The null hypothesis of equality of PASI 50 response rates will be assessed using a two-sided test at the 5% level of significance. The primary efficacy analyses will also be completed in a Per-Protocol population. Stage 2 Primary Efficacy Endpoints The primary efficacy analysis for Stage 2 will include the MITT Population and compare the proportions (%) of Patients achieving a PASI 50 response in the VB-201 160 mg (80 mg BID) group to the placebo group at Week 24. For week 24 placebo group efficacy responses, modeling of the trajectory of response for the placebo group during weeks 0-16 is to be used to determine the placebo week 24 values for all endpoints. This analysis will be performed using the Chi-square test. The null hypothesis of equality of PASI 50 response rates will be assessed using a two-sided test at the 5% level of significance. The primary efficacy analyses will also be completed in a Per-Protocol population. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Stage 1 Secondary Efficacy Endpoints 1. Proportion of subjects in each of the VB-201 treatment groups and in the combined (both dose groups) VB-201 treatment groups who achieve at least 75% improvement from the baseline PASI score (PASI 75) at Week 16 compared to the proportion of PASI 75 responders in the placebo group; 2. The mean change in the PASI score from baseline to Week 16 in each of the two VB-201 treatment groups and in the combined (both dose groups) VB-201 treatment groups compared to the mean change in the placebo group. 3. Change in affected Body Surface Area (BSA) from baseline to Week 16 in each of the VB-201 treatment groups and in the combined (both dose groups) VB-201 treatment groups compared to placebo; 4. Change in PGA scores from baseline to Week 16 in each of the VB-201 treatment groups and in the combined (both dose groups) VB-201 treatment groups compared to the placebo group, to include analyses of: (a) proportion with PGA score of 0-1, and (b) proportion with PGA score of 4-5; 5. Change in Patient Psoriasis Global Assessment scores from baseline to Week 16 in each of the VB-201 treatment groups and in the combined (both dose groups) VB-201 treatment groups compared to the placebo group; 6. The proportion of subjects in the VB-201 80 mg/day treatment group who achieve at least 50% improvement from the baseline PASI score at Week 16 (PASI 50) compared to the proportion of PASI 50 responders in the placebo group. Stage 2 Secondary Efficacy Endpoints 1. Proportion of subjects in each of the VB-201 treatment groups and in the combined (both dose groups) VB-201 treatment groups who achieve at least 75% improvement from the baseline PASI score (PASI 75) at Week 24 compared to the proportion of PASI 75 responders in the placebo group; 2. The mean change in the PASI score from baseline to Week 24 in each of the two VB-201 treatment groups and in the combined (both dose groups) VB-201 treatment groups compared to the mean | — |
Countries
Germany, Israel, Poland, Spain
Contacts
Public ContactProject Manager
SCIderm GmbH
Outcome results
None listed