NCT03445013

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Novan, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	SB414 6%	Twice daily
DRUG	Vehicle	Vehicle Comparator

Timeline

• Start date: 2017-10-13
• Primary completion: 2018-01-31
• Completion: 2018-02-06
• First posted: 2018-02-26
• Last updated: 2018-03-27

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study