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

September 6, 2018 updated by: Novan, Inc.

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

This is a Phase 1b, 2-week study assessing the pharmacokinetics, pharmacodynamics, safety and tolerability of SB414 in subjects with mild to moderate AD.

Study Overview

Status

Completed

Conditions

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).

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Florida
      • Coral Gables, Florida, United States, 33134
        • Novella Site# 242
      • Sweetwater, Florida, United States, 33172
        • Novella Site# 264
    • Idaho
      • Boise, Idaho, United States, 83704
        • Novella Site# 247
    • Indiana
      • Indianapolis, Indiana, United States, 46256
        • Novella Site# 251
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Novella Site# 201
    • Oregon
      • Portland, Oregon, United States, 97210
        • Novella Site# 250
    • Pennsylvania
      • Hazleton, Pennsylvania, United States, 18201
        • Novella Site# 265
    • Texas
      • Pflugerville, Texas, United States, 78660
        • Novells Site# 263
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Novella Site# 114

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SB414 2%
SB414 2% topically twice daily
Twice daily
Other Names:
  • NVN1000
Experimental: SB414 6%
SB414 6% topically twice daily
Twice daily
Other Names:
  • NVN1000
Placebo Comparator: Vehicle Cream
Vehicle Cream topically twice daily
Placebo comparator
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma concentrations of hMAP3
Time Frame: Day 15
Peak plasma concentrations of hMAP3 after topical application of SB414
Day 15

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacodynamics of SB414
Time Frame: Day 15
Change in relevant Pre and post dose tissue cytokine levels (mg/mg tissue)
Day 15
Safety Profile (Reported Adverse Events)
Time Frame: Day 15
Reported Adverse Events
Day 15
Investigator Assessment of Tolerability
Time Frame: Baseline, Week 1 and Week 2
Investigator assessment of overall degree of irritation
Baseline, Week 1 and Week 2
Subject Assessment of Tolerability
Time Frame: Baseline, Week 1 and Week 2
Subject-reported from 5 point tolerability scale overall presence and degree of itching and burning / stinging
Baseline, Week 1 and Week 2
Efficacy as assessed by EASI (Eczema area and severity index) score
Time Frame: Screening, Baseline and Week 2
EASI Score will be collected
Screening, Baseline and Week 2
Efficacy as assessed by Target Lesion Severity Score
Time Frame: Screening, Baseline, Week 1 and Week 2
Target Lesion Severity Score will be collected
Screening, Baseline, Week 1 and Week 2
Efficacy as assessed by Itch NRS
Time Frame: Baseline, Week 1 and Week 2
Itching due to AD as reported by subject on an 11 point numerical rating scale
Baseline, Week 1 and Week 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Investigators

  • Study Chair: Tomoko Maeda-Chubachi, Novan, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 13, 2017

Primary Completion (Actual)

May 11, 2018

Study Completion (Actual)

May 11, 2018

Study Registration Dates

First Submitted

January 31, 2018

First Submitted That Met QC Criteria

February 6, 2018

First Posted (Actual)

February 13, 2018

Study Record Updates

Last Update Posted (Actual)

September 7, 2018

Last Update Submitted That Met QC Criteria

September 6, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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