- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03431610
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
Intervention / Treatment
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:
|
Experimental: SB414 6%
SB414 6% topically twice daily
|
Twice daily
Other Names:
|
Placebo Comparator: Vehicle Cream
Vehicle Cream topically twice daily
|
Placebo comparator
Other Names:
|
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- NI-AD101
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.
Clinical Trials on Atopic Dermatitis
-
Jacob Pontoppidan ThyssenThe Novo Nordic FoundationRecruitingAtopic Dermatitis | Atopic Dermatitis Eczema | Atopic Dermatitis FlareDenmark
-
ShaperonNot yet recruitingAtopic Dermatitis | Atopic Dermatitis Eczema | Atopic Dermatitis of Scalp
-
University of California, San FranciscoSanofi; Regeneron PharmaceuticalsRecruitingEczema | Atopic Dermatitis | Atopic Dermatitis Eczema | Atopic Dermatitis and Related ConditionsUnited States
-
PfizerRecruitingEczema | Atopic Dermatitis | Eczema, Atopic | Atopic Dermatitis, UnspecifiedUnited States, Czechia, Canada, Poland
-
AmgenCompletedDermatitis, Atopic DermatitisCanada, United States, Japan
-
Hadassah Medical OrganizationUnknownATOPIC DERMATITIS
-
SanofiCompletedAtopic Dermatitis | Dermatitis AtopicChina
-
SanofiCompletedDermatitis AtopicSaudi Arabia, Kuwait, United Arab Emirates
-
National Institute of Allergy and Infectious Diseases...Atopic Dermatitis Research NetworkCompletedAtopic Dermatitis (AD) | Non-atopic Healthy ControlsUnited States
-
AbbVieRecruiting
Clinical Trials on SB414 6%
-
Novan, Inc.Novella ClinicalCompletedPsoriasisUnited States
-
B. Braun Melsungen AGCompleted
-
Cuneyt M. AlperNational Institute on Deafness and Other Communication Disorders (NIDCD)CompletedMiddle Ear Gas ExchangeUnited States
-
B. Braun Melsungen AGCompletedSurgeryGermany, Austria, Czech Republic, Italy, Netherlands
-
Universitat Internacional de CatalunyaRecruitingCovid19 | Pulmonary Disease | Physical DisabilitySpain
-
ART Fertility Clinics LLCRecruitingInfertility | ImplantationUnited Arab Emirates
-
Celularity IncorporatedCompletedDiabetic Foot | Peripheral Arterial DiseaseUnited States
-
University of California, San FranciscoTobacco Related Disease Research ProgramCompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Disorder | Tobacco Use Cessation | Tobacco Dependence | Smoking, Tobacco | Smoking, CigaretteUnited States
-
The Netherlands Cancer InstituteTerminatedHead and Neck NeoplasmsNetherlands
-
Adynxx, Inc.National Institute on Drug Abuse (NIDA)Withdrawn