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| Name | Class |
|---|---|
| Novella Clinical | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SB414 6% | Experimental | SB414 6% topically twice daily |
|
| Vehicle Cream | Placebo Comparator | Vehicle Cream topically twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SB414 6% | Drug | Twice daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentrations of hMAP3 | Peak plasma concentrations of hMAP3 after topical application of SB414 | Day 29 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tomoko Maeda-Chubachi, MD | Novan, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novella Site# 247 | Boise | Idaho | 83704 | United States | ||
| Novella Site# 183 |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000709171 | berdazimer sodium |
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| Vehicle |
| Drug |
Vehicle Comparator |
|
|
| 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 |
| Austin |
| Texas |
| 78759 |
| United States |
| Novella Site# 249 | College Station | Texas | 77845 | United States |
| Novella Site# 114 | Norfolk | Virginia | 23502 | United States |