A Study Assessing the PK, PD, Safety, and Tolerability of SB414 in Psoriasis

Study Overview
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Brief Summary
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The objectives of this study are to assess the pharmacokinetics, pharmacodynamics, safety, and tolerability of SB414 in subjects with mild to moderate plaque psoriasis.

Detailed Description
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This is a phase 1b, multi-center, double-blind, randomized, vehicle-controlled study to be conducted in approximately 36 adult subjects with mild to moderate chronic plaque psoriasis. After obtaining informed consent, subjects will be randomized to active or vehicle treatment arms. Subjects will apply the study product (SB414 6% or Vehicle cream) twice daily to all affected areas of psoriasis on the trunk and/or extremities for 4 weeks.

Official Title
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A Phase 1b Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study Assessing the PK, Pharmacodynamics, Safety, and Tolerability of SB414 in Subjects With Psoriasis

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: SB414 6%
* Drug: Vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be male or female, 18-70 years old, and in good general health; Have a clinical diagnosis of stable chronic plaque psoriasis of mild to moderate severity based on the PSGA, involving 2-15% BSA (excluding the scalp/face), present for > 6 months; Must have at least 2 target plaques on trunk and/or extremities at least 5 cm2 with a TPSS > 5 and thickness sub-score > 2. Target plaques cannot be located on the groin, hands, feet, neck, face, elbows, knees, ankles or scalp; Be willing to not use any other systemic agents used to treat psoriasis or apply any other topical products (medicated or over-the-counter) to the treatment sites on the trunk and/or extremities during the study; Women of childbearing potential (WOCBP) must have a negative UPT prior to randomization and must agree to use an effective method of birth control during the study and for 30 days after their final study visit. Exclusion Criteria: Have inverse (i.e.: axillae, groin) or facial psoriasis only, erythrodermic psoriasis, guttate psoriasis, pustular psoriasis, drug-induced psoriasis, and /or psoriatic arthritis requiring treatment with disease modifying antirheumatic drugs (DMARDs); Concurrent or recent use of topical or systemic medications without a sufficient washout period; Are immunocompromised, including those who are known HIV positive or received immunosuppressive treatment within the past 6 months; Female subjects who are pregnant, nursing mothers, or planning to become pregnant during the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SB414 6%<br>SB414 6% topically twice daily | Drug: SB414 6%<br>* Twice daily<br>* Other names: NVN1000;|
| Placebo Comparator: Vehicle Cream<br>Vehicle Cream topically twice daily | Drug: Vehicle<br>* Vehicle Comparator<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentrations of hMAP3 | Peak plasma concentrations of hMAP3 after topical application of SB414 | Day 29 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Profile (Reported Adverse Events) | Reported Adverse Events | Day 29 | 
| Subject Assessment of Tolerability | Subject-reported from 5-point tolerability scale overall presence and degree of itching and burning/stinging | Baseline, Week 2 and Week 4 | 
| Efficacy Assessed by Target Plaque Severity Score (TPSS) | Target Plaque Severity Score will be collected | Baseline, Week 2 and Week 4 | 
| Pharmacodynamics of SB414 | Change in relevant Pre and Post-dose tissue cytokine levels (mg/mg tissue) | Day 29 | 
| Efficacy Assessed by Physician's Static Global Assessment | Physician's Static Global Assessment based on overall evaluation of the disease severity | Screening, Baseline, Week 2 and Week 4 | 
| Efficacy as assessed by Itch Numeric Rating Scale (NRS) | Itching due to psoriasis as reported by subject on a 11-point rating scale | Screening, Baseline, Week 2 and Week 4 |