A Phase 1b Multi-Center, Double-Blind, Randomized Vehicle-Controlled Study Assessing the PK , Pharmacodynamics, Safety and Tolerability of SB414 in Subjects With Atopic Dermatitis
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Novan, Inc.
- Enrollment
- 48
- Locations
- 9
- Primary Endpoint
- Plasma concentrations of hMAP3
Study Overview
Brief Summary
This is a Phase 1b, 2-week study assessing the pharmacokinetics, pharmacodynamics, safety and tolerability of SB414 in subjects with mild to moderate AD.
Detailed Description
This is a phase 1b, multi-center, randomized, double-blind, vehicle-controlled study to be conducted in approximately 48 non-immunocompromised adult subjects with mild to moderate AD. Subjects will be randomized to 2 active and 1 vehicle treatment arms. Subjects will apply the study drug (SB414 or Vehicle) to affected areas twice daily for 2 weeks (14 days).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Male or female, 18 years of age and older, and in good general health;
- •EASI score >1 and ≤21, involving ≥5% body surface area (BSA).
- •Two target lesions at least 5 cm2 with a TLSS ≥
- •Target lesions can not be located on the groin, hands, elbows, feet, ankles, knees, face or scalp.
- •Willing to not use any other products for AD during the study;
- •Women of childbearing potential (WOCBP) must have a negative urine pregnancy test (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
- •Concurrent or recent use of topical or systemic medications without a sufficient washout period;
- •Immunocompromised subjects including those who are known HIV positive or receiving current immunosuppressive treatment,
- •Female subjects who are pregnant, nursing mothers, or planning to become pregnant during the study;
- •Active acute bacterial, fungal, or viral skin infection within 1 week before the baseline visit.
Arms & Interventions
SB414 2%
SB414 2% topically twice daily
Intervention: SB414 2% (Drug)
SB414 6%
SB414 6% topically twice daily
Intervention: SB414 6% (Drug)
Vehicle Cream
Vehicle Cream topically twice daily
Intervention: Vehicle (Drug)
Outcomes
Primary Outcomes
Plasma concentrations of hMAP3
Time Frame: Day 15
Peak plasma concentrations of hMAP3 after topical application of SB414
Secondary Outcomes
- Pharmacodynamics of SB414(Day 15)
- Safety Profile (Reported Adverse Events)(Day 15)
- Efficacy as assessed by EASI (Eczema area and severity index) score(Screening, Baseline and Week 2)
- Investigator Assessment of Tolerability(Baseline, Week 1 and Week 2)
- Efficacy as assessed by Itch NRS(Baseline, Week 1 and Week 2)
- Subject Assessment of Tolerability(Baseline, Week 1 and Week 2)
- Efficacy as assessed by Target Lesion Severity Score(Screening, Baseline, Week 1 and Week 2)