A Phase 1b Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study Assessing the PK, Pharmacodynamics, Safety, and Tolerability of SB414 in Subjects With Psoriasis

Novan, Inc.4 sites in 1 country36 target enrollmentOctober 13, 2017

ConditionsPsoriasis

InterventionsSB414 6%Vehicle

DrugsSB414 6%Vehicle

Overview

Phase: Phase 1
Intervention: SB414 6%
Conditions: Psoriasis
Sponsor: Novan, Inc.
Enrollment: 36
Locations: 4
Primary Endpoint: Plasma concentrations of hMAP3
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 13, 2017

End Date

February 6, 2018

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novan, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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 \>
•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.

Arms & Interventions

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 29

Peak plasma concentrations of hMAP3 after topical application of SB414

Secondary Outcomes

Safety Profile (Reported Adverse Events)(Day 29)
Subject Assessment of Tolerability(Baseline, Week 2 and Week 4)
Efficacy Assessed by Target Plaque Severity Score (TPSS)(Baseline, Week 2 and Week 4)
Pharmacodynamics of SB414(Day 29)
Efficacy Assessed by Physician's Static Global Assessment(Screening, Baseline, Week 2 and Week 4)
Efficacy as assessed by Itch Numeric Rating Scale (NRS)(Screening, Baseline, Week 2 and Week 4)