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

NCT03445013 | Completed Phase 1 FDA Drug

• 1 other identifier: NI-PS101
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 4

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.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• Plasma concentrations of hMAP3

  Peak plasma concentrations of hMAP3 after topical application of SB414

  Day 29

Secondary Outcomes (6)

• 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

Study Arms (2)

SB414 6%

EXPERIMENTAL

SB414 6% topically twice daily

Drug: SB414 6%

Vehicle Cream

PLACEBO COMPARATOR

Vehicle Cream topically twice daily

Drug: Vehicle

Interventions

SB414 6% DRUG

Twice daily

Also known as: NVN1000

SB414 6%

Vehicle DRUG

Vehicle Comparator

Also known as: Placebo

Vehicle Cream

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novan, Inc.: lead
• Novella Clinical: collaborator

Study Sites (4)

Novella Site# 247

Boise, Idaho, 83704, United States

Location

Novella Site# 183

Austin, Texas, 78759, United States

Location

Novella Site# 249

College Station, Texas, 77845, United States

Location

Novella Site# 114

Norfolk, Virginia, 23502, United States

Location

MeSH Terms

Conditions

Psoriasis

Interventions

berdazimer sodium

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Tomoko Maeda-Chubachi, MD

  Novan, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2018
• First Posted: February 26, 2018
• Study Start: October 13, 2017
• Primary Completion: January 31, 2018
• Study Completion: February 6, 2018
• Last Updated: March 27, 2018

Record last verified: 2018-03

Locations

US (4)