Psoriasis
Conditions
Brief summary
This study will examine the safety and efficacy in subjects with moderate to severe psoriasis, as measured by Psoriasis Area and Severity Index(PASI), Body Surface Area (BSA), Dermatology Life Quality Index (DLQI) and other assessments.
Interventions
Sponsors
Vascular Biogenics Ltd. operating as VBL Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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; * Plaque psoriasis covering between 10% to 30 % of body surface area (BSA); * PASI severity moderate to severe, scoring at least 10 but no higher than 20.
Exclusion criteria
* The subject presents with psoriasis that is predominantly guttate, erythrodermic, inverse, pustular or palmo-plantar or an unstable form of psoriasis; * Previously failed (due to lack of efficacy) treatment with at least one systemic biologic agent for psoriasis (e.g. ustekinumab, adalimumab, etanercept, etc); * 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); Biologic psoriasis treatments: 8 weeks or 5 half lives (whichever is longer); Phototherapy: 4 weeks; * The subject anticipates getting enough ultra-violet light during the study (e.g. sunbathing; tanning salon, etc.) to cause psoriasis to improve; * History of cancer, with the exception of skin cancer.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PASI 50 | Week 16 and Week 24 | The proportion of subjects in the VB-201 160 mg (80 mg BID) treatment group who achieve at least 50% improvement from the baseline PASI score at Weeks 16 and 24 (PASI 50) compared to the proportion of PASI 50 responders in the placebo group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PASI 75 | Week 16 and Week 24 | 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 Weeks 16 and 24 compared to the proportion of PASI 75 responders in the placebo group. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Physician Global Assessment | Week 16 and Week 24 | Change in PGA scores from baseline to Weeks 16 and 24 in each of the VB-201 treatment groups and in the combined (both dose groups) VB-201 treatment groups compared to the placebo group. |
| Patient Psoriasis Global Assessment | Week 16 and Week 24 | Change in Patient Psoriasis Global Assessment scores from baseline to Weeks 16 and 24 in each of the VB-201 treatment groups and in the combined (both dose groups) VB-201 treatment groups compared to the placebo group. |
| PASI 50- 80 mg/ day | Week 16 and Week 24 | 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 Weeks 16 and 24 (PASI 50) compared to the proportion of PASI 50 responders in the placebo group. |
| Frequency of Adverse Events | From Baseline through safety follow up at Week 28 | As measured by changes from baseline in physical exam, vital signs, ECG, concomitant medications, laboratory values. |
| Itching Visual Analogue Scale | Week 16 and Week 24 | Change in itching VAS from baseline to weeks 16 and 24 in each of the VB 201 treatment groups and in the combined (both dose groups) VB-201 treatment groups compared to placebo. |
| Pain Visual Analogue Scale | Week 16 and Week 24 | Change in pain VAS from baseline to weeks 16 and 24 in each of the VB 201 treatment groups and in the combined (both dose groups) VB-201 treatment groups compared to placebo. |
| Dermatology Life Quality Index | Week 16 and Week 24 | Change in the DLQI scores from baseline to Weeks 16 and 24 in each of the VB 201 treatment groups and in the combined (both dose groups) VB-201 treatment groups compared to placebo. |
| Change in PASI score | Week 16 and Week 24 | The mean change in the PASI score from baseline to Weeks 16 and 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 change in the placebo group. |
| Body Surface Area | Week 16 and Week 24 | Change in affected Body Surface Area (BSA) from baseline to Week 16 and Week 24 in each of the VB-201 treatment groups and in the combined (both dose groups) VB-201 treatment groups compared to placebo. |
Countries
Germany, Israel, Poland, Spain
Outcome results
None listed