A Study Assessing the PK, PD, Safety, and Tolerability of SB414 in Psoriasis

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

The objectives of this study are to assess the pharmacokinetics, pharmacodynamics, safety, and tolerability of SB414 in subjects with mild to moderate plaque psoriasis.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: SB414 6%; Drug: Vehicle

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Idaho
    • Boise, Idaho, United States, 83704
      • Novella Site# 247
  • Texas
    • Austin, Texas, United States, 78759
      • Novella Site# 183
    • College Station, Texas, United States, 77845
      • Novella Site# 249
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Novella Site# 114

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: SB414 6%; SB414 6% topically twice daily	Drug: SB414 6%; Twice daily; Other Names: NVN1000
PLACEBO_COMPARATOR: Vehicle Cream; Vehicle Cream topically twice daily	Drug: Vehicle; Vehicle Comparator; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma concentrations of hMAP3	Peak plasma concentrations of hMAP3 after topical application of SB414	Day 29

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Profile (Reported Adverse Events)	Reported Adverse Events	Day 29
Subject Assessment of Tolerability	Subject-reported from 5-point tolerability scale overall presence and degree of itching and burning/stinging	Baseline, Week 2 and Week 4
Efficacy Assessed by Target Plaque Severity Score (TPSS)	Target Plaque Severity Score will be collected	Baseline, Week 2 and Week 4
Pharmacodynamics of SB414	Change in relevant Pre and Post-dose tissue cytokine levels (mg/mg tissue)	Day 29
Efficacy Assessed by Physician's Static Global Assessment	Physician's Static Global Assessment based on overall evaluation of the disease severity	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	Screening, Baseline, Week 2 and Week 4

Collaborators and Investigators

• Sponsor: Novan, Inc.
• Collaborators: Novella Clinical

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 13, 2017
• Primary Completion (ACTUAL): January 31, 2018
• Study Completion (ACTUAL): February 6, 2018

Study Registration Dates

• First Submitted: January 31, 2018
• First Submitted That Met QC Criteria: February 19, 2018
• First Posted (ACTUAL): February 26, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 27, 2018
• Last Update Submitted That Met QC Criteria: March 26, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: NI-PS101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No