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A Phase 1b Study Assessing the PK, PD, Safety & Tolerability of SB414 in Atopic Dermatitis

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SB414 2%
SB414 6%
Vehicle
Sponsored by
Novan, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

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

Inclusion Criteria:

  • Male or female, 18 years of age and older, and in good general health;
  • EASI score >1 and ≤21, involving ≥5% body surface area (BSA).
  • Two target lesions at least 5 cm2 with a TLSS ≥5. Target lesions can not be located on the groin, hands, elbows, feet, ankles, knees, face or scalp.
  • Willing to not use any other products for AD during the study;
  • Women of childbearing potential (WOCBP) must have a negative urine pregnancy test (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:

  • Concurrent or recent use of topical or systemic medications without a sufficient washout period;
  • Immunocompromised subjects including those who are known HIV positive or receiving current immunosuppressive treatment,
  • Female subjects who are pregnant, nursing mothers, or planning to become pregnant during the study;
  • Active acute bacterial, fungal, or viral skin infection within 1 week before the baseline visit.

Sites / Locations

  • Novella Site# 242
  • Novella Site# 264
  • Novella Site# 247
  • Novella Site# 251
  • Novella Site# 201
  • Novella Site# 250
  • Novella Site# 265
  • Novells Site# 263
  • Novella Site# 114

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

SB414 2%

SB414 6%

Vehicle Cream

Arm Description

SB414 2% topically twice daily

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

Pharmacodynamics of SB414
Change in relevant Pre and post dose tissue cytokine levels (mg/mg tissue)
Safety Profile (Reported Adverse Events)
Reported Adverse Events
Investigator Assessment of Tolerability
Investigator assessment of overall degree of irritation
Subject Assessment of Tolerability
Subject-reported from 5 point tolerability scale overall presence and degree of itching and burning / stinging
Efficacy as assessed by EASI (Eczema area and severity index) score
EASI Score will be collected
Efficacy as assessed by Target Lesion Severity Score
Target Lesion Severity Score will be collected
Efficacy as assessed by Itch NRS
Itching due to AD as reported by subject on an 11 point numerical rating scale

Full Information

First Posted
January 31, 2018
Last Updated
September 6, 2018
Sponsor
Novan, Inc.
Collaborators
Novella Clinical
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1. Study Identification

Unique Protocol Identification Number
NCT03431610
Brief Title
A Phase 1b Study Assessing the PK, PD, Safety & Tolerability of SB414 in Atopic Dermatitis
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 Atopic Dermatitis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
November 13, 2017 (Actual)
Primary Completion Date
May 11, 2018 (Actual)
Study Completion Date
May 11, 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
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a Phase 1b, 2-week study assessing the pharmacokinetics, pharmacodynamics, safety and tolerability of SB414 in subjects with mild to moderate AD.
Detailed Description
This is a phase 1b, multi-center, randomized, double-blind, vehicle-controlled study to be conducted in approximately 48 non-immunocompromised adult subjects with mild to moderate AD. Subjects will be randomized to 2 active and 1 vehicle treatment arms. Subjects will apply the study drug (SB414 or Vehicle) to affected areas twice daily for 2 weeks (14 days).

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SB414 2%
Arm Type
Experimental
Arm Description
SB414 2% topically twice daily
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 2%
Other Intervention Name(s)
NVN1000
Intervention Description
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
Placebo comparator
Primary Outcome Measure Information:
Title
Plasma concentrations of hMAP3
Description
Peak plasma concentrations of hMAP3 after topical application of SB414
Time Frame
Day 15
Secondary Outcome Measure Information:
Title
Pharmacodynamics of SB414
Description
Change in relevant Pre and post dose tissue cytokine levels (mg/mg tissue)
Time Frame
Day 15
Title
Safety Profile (Reported Adverse Events)
Description
Reported Adverse Events
Time Frame
Day 15
Title
Investigator Assessment of Tolerability
Description
Investigator assessment of overall degree of irritation
Time Frame
Baseline, Week 1 and Week 2
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 1 and Week 2
Title
Efficacy as assessed by EASI (Eczema area and severity index) score
Description
EASI Score will be collected
Time Frame
Screening, Baseline and Week 2
Title
Efficacy as assessed by Target Lesion Severity Score
Description
Target Lesion Severity Score will be collected
Time Frame
Screening, Baseline, Week 1 and Week 2
Title
Efficacy as assessed by Itch NRS
Description
Itching due to AD as reported by subject on an 11 point numerical rating scale
Time Frame
Baseline, Week 1 and Week 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male or female, 18 years of age and older, and in good general health; EASI score >1 and ≤21, involving ≥5% body surface area (BSA). Two target lesions at least 5 cm2 with a TLSS ≥5. Target lesions can not be located on the groin, hands, elbows, feet, ankles, knees, face or scalp. Willing to not use any other products for AD during the study; Women of childbearing potential (WOCBP) must have a negative urine pregnancy test (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: Concurrent or recent use of topical or systemic medications without a sufficient washout period; Immunocompromised subjects including those who are known HIV positive or receiving current immunosuppressive treatment, Female subjects who are pregnant, nursing mothers, or planning to become pregnant during the study; Active acute bacterial, fungal, or viral skin infection within 1 week before the baseline visit.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomoko Maeda-Chubachi
Organizational Affiliation
Novan, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Novella Site# 242
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Novella Site# 264
City
Sweetwater
State/Province
Florida
ZIP/Postal Code
33172
Country
United States
Facility Name
Novella Site# 247
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Facility Name
Novella Site# 251
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
Novella Site# 201
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Novella Site# 250
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Novella Site# 265
City
Hazleton
State/Province
Pennsylvania
ZIP/Postal Code
18201
Country
United States
Facility Name
Novells Site# 263
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Facility Name
Novella Site# 114
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32428543
Citation
Guttman-Yassky E, Gallo RL, Pavel AB, Nakatsuji T, Li R, Zhang N, Messersmith E, Maeda-Chubachi T. A Nitric Oxide-Releasing Topical Medication as a Potential Treatment Option for Atopic Dermatitis through Antimicrobial and Anti-Inflammatory Activity. J Invest Dermatol. 2020 Dec;140(12):2531-2535.e2. doi: 10.1016/j.jid.2020.04.013. Epub 2020 May 16. No abstract available.
Results Reference
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A Phase 1b Study Assessing the PK, PD, Safety & Tolerability of SB414 in Atopic Dermatitis

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