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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
36
Novella Site# 247
Boise, Idaho, United States
Novella Site# 183
Austin, Texas, United States
Novella Site# 249
College Station, Texas, United States
Novella Site# 114
Norfolk, Virginia, United States
Plasma concentrations of hMAP3
Peak plasma concentrations of hMAP3 after topical application of SB414
Time frame: Day 29
Safety Profile (Reported Adverse Events)
Reported Adverse Events
Time frame: Day 29
Subject Assessment of Tolerability
Subject-reported from 5-point tolerability scale overall presence and degree of itching and burning/stinging
Time frame: Baseline, Week 2 and Week 4
Efficacy Assessed by Target Plaque Severity Score (TPSS)
Target Plaque Severity Score will be collected
Time frame: Baseline, Week 2 and Week 4
Pharmacodynamics of SB414
Change in relevant Pre and Post-dose tissue cytokine levels (mg/mg tissue)
Time frame: Day 29
Efficacy Assessed by Physician's Static Global Assessment
Physician's Static Global Assessment based on overall evaluation of the disease severity
Time frame: 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
Time frame: Screening, Baseline, Week 2 and Week 4
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.