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

Primary Purpose

Psoriasis

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

SB414 6%

Vehicle

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Novella Site# 247
Novella Site# 183
Novella Site# 249
Novella Site# 114

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

SB414 6%

Vehicle Cream

Arm Description

SB414 6% topically twice daily

Vehicle Cream topically twice daily

Outcomes

Primary Outcome Measures

Plasma concentrations of hMAP3

Peak plasma concentrations of hMAP3 after topical application of SB414

Secondary Outcome Measures

Safety Profile (Reported Adverse Events)

Reported Adverse Events

Subject Assessment of Tolerability

Subject-reported from 5-point tolerability scale overall presence and degree of itching and burning/stinging

Efficacy Assessed by Target Plaque Severity Score (TPSS)

Target Plaque Severity Score will be collected

Pharmacodynamics of SB414

Change in relevant Pre and Post-dose tissue cytokine levels (mg/mg tissue)

Efficacy Assessed by Physician's Static Global Assessment

Physician's Static Global Assessment based on overall evaluation of the disease severity

Efficacy as assessed by Itch Numeric Rating Scale (NRS)

Itching due to psoriasis as reported by subject on a 11-point rating scale

Full Information

NCT ID

NCT03445013

First Posted

January 31, 2018

Last Updated

March 26, 2018

Sponsor

Novan, Inc.

Collaborators

Novella Clinical

1. Study Identification

Unique Protocol Identification Number

NCT03445013

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Completed

Study Start Date

October 13, 2017 (Actual)

Primary Completion Date

January 31, 2018 (Actual)

Study Completion Date

February 6, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novan, Inc.

Collaborators

Novella Clinical

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SB414 6%

Arm Type

Experimental

Arm Description

SB414 6% topically twice daily

Arm Title

Vehicle Cream

Arm Type

Placebo Comparator

Arm Description

Vehicle Cream topically twice daily

Intervention Type

Drug

Intervention Name(s)

SB414 6%

Other Intervention Name(s)

NVN1000

Intervention Description

Twice daily

Intervention Type

Drug

Intervention Name(s)

Vehicle

Other Intervention Name(s)

Placebo

Intervention Description

Vehicle Comparator

Primary Outcome Measure Information:

Title

Plasma concentrations of hMAP3

Description

Peak plasma concentrations of hMAP3 after topical application of SB414

Time Frame

Day 29

Secondary Outcome Measure Information:

Title

Safety Profile (Reported Adverse Events)

Description

Reported Adverse Events

Time Frame

Day 29

Title

Subject Assessment of Tolerability

Description

Subject-reported from 5-point tolerability scale overall presence and degree of itching and burning/stinging

Time Frame

Baseline, Week 2 and Week 4

Title

Efficacy Assessed by Target Plaque Severity Score (TPSS)

Description

Target Plaque Severity Score will be collected

Time Frame

Baseline, Week 2 and Week 4

Title

Pharmacodynamics of SB414

Description

Change in relevant Pre and Post-dose tissue cytokine levels (mg/mg tissue)

Time Frame

Day 29

Title

Efficacy Assessed by Physician's Static Global Assessment

Description

Physician's Static Global Assessment based on overall evaluation of the disease severity

Time Frame

Screening, Baseline, Week 2 and Week 4

Title

Efficacy as assessed by Itch Numeric Rating Scale (NRS)

Description

Itching due to psoriasis as reported by subject on a 11-point rating scale

Time Frame

Screening, Baseline, Week 2 and Week 4

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tomoko Maeda-Chubachi, MD

Organizational Affiliation

Novan, Inc.

Official's Role

Study Chair

Facility Information:

Facility Name

Novella Site# 247

City

Boise

State/Province

Idaho

ZIP/Postal Code

83704

Country

United States

Facility Name

Novella Site# 183

City

Austin

State/Province

Texas

ZIP/Postal Code

78759

Country

United States

Facility Name

Novella Site# 249

City

College Station

State/Province

Texas

ZIP/Postal Code

77845

Country

United States

Facility Name

Novella Site# 114

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23502

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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