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

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03445013
• Other study ID #: NI-PS101
• Status: Completed
• Phase: Phase 1
• First received: January 31, 2018
• Last updated: March 26, 2018
• Start date: October 13, 2017
• Est. completion date: February 6, 2018

Study information

• Verified date: March 2018
• Source: Novan, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: February 6, 2018
• Est. primary completion date: January 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• SB414 6%
Twice daily
• Vehicle
Vehicle Comparator

Locations

Country	Name	City	State
United States	Novella Site# 183	Austin	Texas
United States	Novella Site# 247	Boise	Idaho
United States	Novella Site# 249	College Station	Texas
United States	Novella Site# 114	Norfolk	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Novan, Inc.	Novella Clinical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma concentrations of hMAP3	Peak plasma concentrations of hMAP3 after topical application of SB414	Day 29
Secondary	Safety Profile (Reported Adverse Events)	Reported Adverse Events	Day 29
Secondary	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
Secondary	Efficacy Assessed by Target Plaque Severity Score (TPSS)	Target Plaque Severity Score will be collected	Baseline, Week 2 and Week 4
Secondary	Pharmacodynamics of SB414	Change in relevant Pre and Post-dose tissue cytokine levels (mg/mg tissue)	Day 29
Secondary	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
Secondary	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