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

Atopic Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03431610
• Other study ID #: NI-AD101
• Status: Completed
• Phase: Phase 1
• Start date: November 13, 2017
• Est. completion date: May 11, 2018

Study information

• Verified date: September 2018
• Source: Novan, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: May 11, 2018
• Est. primary completion date: May 11, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• SB414 2%
Twice daily
• SB414 6%
Twice daily
• Vehicle
Placebo comparator

Locations

Country	Name	City	State
United States	Novella Site# 201	Berlin	New Jersey
United States	Novella Site# 247	Boise	Idaho
United States	Novella Site# 242	Coral Gables	Florida
United States	Novella Site# 265	Hazleton	Pennsylvania
United States	Novella Site# 251	Indianapolis	Indiana
United States	Novella Site# 114	Norfolk	Virginia
United States	Novells Site# 263	Pflugerville	Texas
United States	Novella Site# 250	Portland	Oregon
United States	Novella Site# 264	Sweetwater	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Novan, Inc.	Novella Clinical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma concentrations of hMAP3	Peak plasma concentrations of hMAP3 after topical application of SB414	Day 15
Secondary	Pharmacodynamics of SB414	Change in relevant Pre and post dose tissue cytokine levels (mg/mg tissue)	Day 15
Secondary	Safety Profile (Reported Adverse Events)	Reported Adverse Events	Day 15
Secondary	Investigator Assessment of Tolerability	Investigator assessment of overall degree of irritation	Baseline, Week 1 and Week 2
Secondary	Subject Assessment of Tolerability	Subject-reported from 5 point tolerability scale overall presence and degree of itching and burning / stinging	Baseline, Week 1 and Week 2
Secondary	Efficacy as assessed by EASI (Eczema area and severity index) score	EASI Score will be collected	Screening, Baseline and Week 2
Secondary	Efficacy as assessed by Target Lesion Severity Score	Target Lesion Severity Score will be collected	Screening, Baseline, Week 1 and Week 2
Secondary	Efficacy as assessed by Itch NRS	Itching due to AD as reported by subject on an 11 point numerical rating scale	Baseline, Week 1 and Week 2