Clinical trial NCT03445013: A Study Assessing the PK, PD, Safety, and Tolerability of SB414 in Psoriasis
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 Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Psoriasis
Lead sponsor: Novan, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Novella Clinical
First posted: 2018-02-26
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objectives of this study are to assess the pharmacokinetics, pharmacodynamics, safety, and tolerability of SB414 in subjects with mild to moderate plaque psoriasis.

Detailed description: This is a phase 1b, multi-center, double-blind, randomized, vehicle-controlled study to be conducted in approximately 36 adult subjects with mild to moderate chronic plaque psoriasis. After obtaining informed consent, subjects will be randomized to active or vehicle treatment arms. Subjects will apply the study product (SB414 6% or Vehicle cream) twice daily to all affected areas of psoriasis on the trunk and/or extremities for 4 weeks.

Eligibility criteria: Inclusion Criteria:

* Be male or female, 18-70 years old, and in good general health;
* Have a clinical diagnosis of stable chronic plaque psoriasis of mild to moderate severity based on the PSGA, involving 2-15% BSA (excluding the scalp/face), present for \> 6 months;
* Must have at least 2 target plaques on trunk and/or extremities at least 5 cm2 with a TPSS \> 5 and thickness sub-score \> 2. Target plaques cannot be located on the groin, hands, feet, neck, face, elbows, knees, ankles or scalp;
* Be willing to not use any other systemic agents used to treat psoriasis or apply any other topical products (medicated or over-the-counter) to the treatment sites on the trunk and/or extremities during the study;
* Women of childbearing potential (WOCBP) must have a negative 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:

* Have inverse (i.e.: axillae, groin) or facial psoriasis only, erythrodermic psoriasis, guttate psoriasis, pustular psoriasis, drug-induced psoriasis, and /or psoriatic arthritis requiring treatment with disease modifying antirheumatic drugs (DMARDs);
* Concurrent or recent use of topical or systemic medications without a sufficient washout period;
* Are immunocompromised, including those who are known HIV positive or received immunosuppressive treatment within the past 6 months;
* Female subjects who are pregnant, nursing mothers, or planning to become pregnant during the study.

Primary outcomes:
measure: Plasma concentrations of hMAP3
timeFrame: Day 29
Secondary outcomes:
measure: Safety Profile (Reported Adverse Events)
timeFrame: Day 29
measure: Subject Assessment of Tolerability
timeFrame: Baseline, Week 2 and Week 4
measure: Efficacy Assessed by Target Plaque Severity Score (TPSS)
timeFrame: Baseline, Week 2 and Week 4
measure: Pharmacodynamics of SB414
timeFrame: Day 29
measure: Efficacy Assessed by Physician's Static Global Assessment
timeFrame: Screening, Baseline, Week 2 and Week 4
measure: Efficacy as assessed by Itch Numeric Rating Scale (NRS)
timeFrame: Screening, Baseline, Week 2 and Week 4
Other outcomes:
Locations:
city: Boise
country: United States
facility: Novella Site# 247
state: Idaho
city: Austin
country: United States
facility: Novella Site# 183
state: Texas
city: College Station
country: United States
facility: Novella Site# 249
state: Texas
city: Norfolk
country: United States
facility: Novella Site# 114
state: Virginia
Study officials:
affiliation: Novan, Inc.
name: Tomoko Maeda-Chubachi, MD
role: STUDY_CHAIR
References: