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

NCT ID: NCT03445013

Last Updated: 2018-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-13
• Study Completion Date: 2018-02-06

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.

Conditions

Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

SB414 6%

SB414 6% topically twice daily

Group Type: EXPERIMENTAL

SB414 6%

Intervention Type: DRUG

Twice daily

Vehicle Cream

Vehicle Cream topically twice daily

Group Type: PLACEBO_COMPARATOR

Vehicle

Intervention Type: DRUG

Vehicle Comparator

Interventions

SB414 6%

Twice daily

Intervention Type: DRUG

Vehicle

Vehicle Comparator

Intervention Type: DRUG

Other Intervention Names

NVN1000; Placebo

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 > 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novella Clinical

OTHER

Sponsor Role: collaborator

Novan, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tomoko Maeda-Chubachi, MD

Role: STUDY_CHAIR

Novan, Inc.

Locations

Novella Site# 247

Boise, Idaho, United States

Novella Site# 183

Austin, Texas, United States

Novella Site# 249

College Station, Texas, United States

Novella Site# 114

Norfolk, Virginia, United States

Countries

United States

Other Identifiers

NI-PS101

Identifier Type: -

Identifier Source: org_study_id