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

Novan, Inc.9 sites in 1 country48 target enrollmentNovember 13, 2017

ConditionsAtopic Dermatitis

InterventionsSB414 2%SB414 6%Vehicle

DrugsSB414 2%SB414 6%Vehicle

Overview

Phase: Phase 1
Intervention: SB414 2%
Conditions: Atopic Dermatitis
Sponsor: Novan, Inc.
Enrollment: 48
Locations: 9
Primary Endpoint: Plasma concentrations of hMAP3
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

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).

Registry

clinicaltrials.gov

Start Date

November 13, 2017

End Date

May 11, 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novan, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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%

SB414 6%

SB414 6% topically twice daily

Intervention: SB414 6%

Vehicle Cream

Vehicle Cream topically twice daily

Intervention: Vehicle

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)