Psoriasis
Conditions
Brief summary
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
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.
Interventions
DRUGSB414 6%
Twice daily
DRUGVehicle
Vehicle Comparator
Sponsors
Novella Clinical
Novan, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma concentrations of hMAP3 | Day 29 | Peak plasma concentrations of hMAP3 after topical application of SB414 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety Profile (Reported Adverse Events) | Day 29 | Reported Adverse Events |
| Subject Assessment of Tolerability | Baseline, Week 2 and Week 4 | Subject-reported from 5-point tolerability scale overall presence and degree of itching and burning/stinging |
| Efficacy Assessed by Target Plaque Severity Score (TPSS) | Baseline, Week 2 and Week 4 | Target Plaque Severity Score will be collected |
| Pharmacodynamics of SB414 | Day 29 | Change in relevant Pre and Post-dose tissue cytokine levels (mg/mg tissue) |
| Efficacy Assessed by Physician's Static Global Assessment | Screening, Baseline, Week 2 and Week 4 | Physician's Static Global Assessment based on overall evaluation of the disease severity |
| Efficacy as assessed by Itch Numeric Rating Scale (NRS) | Screening, Baseline, Week 2 and Week 4 | Itching due to psoriasis as reported by subject on a 11-point rating scale |
Countries
United States
Outcome results
None listed