Clinical trial NCT03431610: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Atopic Dermatitis
Lead sponsor: Novan, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Novella Clinical
First posted: 2018-02-13
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Plasma concentrations of hMAP3
timeFrame: Day 15
Secondary outcomes:
measure: Pharmacodynamics of SB414
timeFrame: Day 15
measure: Safety Profile (Reported Adverse Events)
timeFrame: Day 15
measure: Investigator Assessment of Tolerability
timeFrame: Baseline, Week 1 and Week 2
measure: Subject Assessment of Tolerability
timeFrame: Baseline, Week 1 and Week 2
measure: Efficacy as assessed by EASI (Eczema area and severity index) score
timeFrame: Screening, Baseline and Week 2
measure: Efficacy as assessed by Target Lesion Severity Score
timeFrame: Screening, Baseline, Week 1 and Week 2
measure: Efficacy as assessed by Itch NRS
timeFrame: Baseline, Week 1 and Week 2
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: Novella Site# 242
state: Florida
city: Sweetwater
country: United States
facility: Novella Site# 264
state: Florida
city: Boise
country: United States
facility: Novella Site# 247
state: Idaho
city: Indianapolis
country: United States
facility: Novella Site# 251
state: Indiana
city: Berlin
country: United States
facility: Novella Site# 201
state: New Jersey
city: Portland
country: United States
facility: Novella Site# 250
state: Oregon
city: Hazleton
country: United States
facility: Novella Site# 265
state: Pennsylvania
city: Pflugerville
country: United States
facility: Novells Site# 263
state: Texas
city: Norfolk
country: United States
facility: Novella Site# 114
state: Virginia
Study officials:
affiliation: Novan, Inc.
name: Tomoko Maeda-Chubachi
role: STUDY_CHAIR
References:
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.