Clinical trial NCT02655679: An Ascending Multiple Dose Study of VTP-38543 in Adult Participants With Mild to Moderate Atopic Dermatitis
Official title: A Randomized, Double-Blind, Vehicle-Controlled Ascending Multiple Dose and Clinical Proof-Of-Concept Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VTP-38543 in Adult Patients With Mild to Moderate Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Dermatitis, Atopic
Keywords: Eczema
Lead sponsor: Vitae Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2016-01-14
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary clinical efficacy of VTP-38543 administered as a cream, twice-daily, for 28 days in otherwise healthy adult male and female participants with mild to moderate atopic dermatitis.

Detailed description: This is a randomized, double-blind, vehicle-controlled study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary clinical efficacy of VTP-38543 following twice-daily, every twelve hours (Q12h) administration for 28 days in otherwise healthy adult male and female participants with mild to moderate atopic dermatitis.

Evaluation of three ascending doses in three dose panels is planned for this trial. Dose Panel 1 (VTP-38543 0.05%) and Panel 2 (VTP-38543 0.15%) will each enroll 30 participants and randomize 20 to VTP-38543 and 10 to matching vehicle control (Vehicle without Transcutol®P). Dose Panel 3 (VTP-38543 1%) will enroll 40 participants and randomize 20 to VTP-38543 and 20 to matching vehicle control (Vehicle with Transcutol®P). A total of approximately 100 participants will participate in the trial.

Eligibility criteria: Inclusion Criteria:

* Mild to moderate atopic dermatitis with a minimum of 3 to a maximum of 15% body surface area (BSA) involvement
* Investigator Global Assessments (IGA) score of 2 or 3
* Body Mass Index (BMI) = 18 - 35 kg/m\^2
* Negative Pregnancy test for females

Exclusion Criteria:

* Treatment for atopic dermatitis with systemic medications, topical agents, and parenteral biological/monoclonal antibody agents, within specific time period prior to dosing.
* Organ dysfunction or any clinically significant deviation from normal in vital signs, physical examinations, labs, and Electrocardiogram (ECG) findings
* Major surgery within 3 months of Screening
* Use of prescription drugs, sedative antihistamine, medical devices for treatment of atopic dermatitis (AD), and topical products containing urea and/or ceramides within 14 prior to dosing
* Excessive sun exposures, use of tanning booths or other ultraviolet (UV) light sources 4 weeks prior to dosing

Primary outcomes:
measure: Number of Participants With Treatment-related Adverse Events (AEs)
timeFrame: Baseline (Day 0) to Day 35
measure: Number of Participants With Clinically Significant Changes in Clinical Laboratory Values
timeFrame: Baseline (Day 0) to Day 35
measure: Number of Participants With Clinically Significant Changes in Vital Signs
timeFrame: Baseline (Day 0) to Day 35
measure: Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values
timeFrame: Baseline (Day 0) to Day 35
Secondary outcomes:
measure: Maximum Plasma Concentration (Cmax) for VTP-38543-001
timeFrame: Day 0 (pre-dose, 1, 2, 4, 6, 9, and 12 hours post first dose), and Day 27 (pre-dose, 1, 2, 4, 6, 9, 12, 24, 48, and 72 hours post last dose)
measure: Time to Maximum Plasma Concentrations (Tmax) for VTP-38543
timeFrame: Day 0 (pre-dose, 1, 2, 4, 6, 9, and 12 hours post first dose), and Day 27 (pre-dose, 1, 2, 4, 6, 9, 12, 24, 48, and 72 hours post last dose)
measure: Area Under the Plasma Concentration Versus Time Curve, From Time 0 to the Last Measurable Concentration (AUClast) for VTP-38543
timeFrame: Day 0 (pre-dose, 1, 2, 4, 6, 9, and 12 hours post first dose), and Day 27 (pre-dose, 1, 2, 4, 6, 9, 12, 24, 48, and 72 hours post last dose)
measure: Area Under the Plasma Concentration Versus Time Curve, From Time 0 to 12 Hours (AUC0-12hr) for VTP-38543
timeFrame: Day 0 (pre-dose, 1, 2, 4, 6, 9, and 12 hours post first dose), and Day 27 (pre-dose, 1, 2, 4, 6, 9, 12, 24, 48, and 72 hours post last dose)
measure: Elimination Half-life (t½) for VTP-38543
timeFrame: Day 0 (pre-dose, 1, 2, 4, 6, 9, and 12 hours post first dose), and Day 27 (pre-dose, 1, 2, 4, 6, 9, 12, 24, 48, and 72 hours post last dose)
measure: Percentage Change From Baseline in Total Body Surface Area (BSA)
timeFrame: Baseline (Day 0) to Day 28
measure: Percentage Change From Baseline in Investigator Global Assessments (IGA) Score
timeFrame: Baseline (Day 0) to Day 28
measure: Percentage Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score
timeFrame: Baseline (Day 0) to Day 28
measure: Percentage Change From Baseline Eczema Area and Severity Index (EASI)
timeFrame: Baseline (Day 0) to Day 28
measure: Percentage Change From Baseline in Pruritus VAS Score
timeFrame: Baseline (Day 0) to Day 28
measure: Percentage Change From Baseline in VAS Sleep Score
timeFrame: Baseline (Day 0) to Day 28
Other outcomes:
Locations:
city: West Dundee
country: United States
facility: Dundee Dermatology
state: Illinois
city: Fort Gratiot
country: United States
facility: Hamzavi Dermatology
state: Michigan
city: New York
country: United States
facility: Skin Specialty Dermatology
state: New York
city: Raleigh
country: United States
facility: Wake Research Associates, LLC
state: North Carolina
city: Philadelphia
country: United States
facility: Paddington Testing Company, Inc
state: Pennsylvania
city: Calgary
country: Canada
facility: Kirk Barber Research
state: Alberta
city: Edmonton
country: Canada
facility: Stratica Medical Inc
state: Alberta
city: Markham
country: Canada
facility: Lynderm Research Inc
state: Ontario
city: Richmond Hill
country: Canada
facility: The Center for Dermatology / Institution
state: Ontario
city: Windsor
country: Canada
facility: Windsor Clinical Research Inc
state: Ontario
city: Drummondville
country: Canada
facility: Dr Isabelle Delorme Inc
state: Quebec
city: Montreal
country: Canada
facility: Innovaderm Research
state: Quebec
Study officials:
affiliation: Allergan
name: Christy Harutunian
role: STUDY_DIRECTOR
References:
citation: Czarnowicki T, Dohlman AB, Malik K, Antonini D, Bissonnette R, Chan TC, Zhou L, Wen HC, Estrada Y, Xu H, Bryson C, Shen J, Lala D, Ma'ayan A, McGeehan G, Gregg R, Guttman-Yassky E. Effect of short-term liver X receptor activation on epidermal barrier features in mild to moderate atopic dermatitis: A randomized controlled trial. Ann Allergy Asthma Immunol. 2018 Jun;120(6):631-640.e11. doi: 10.1016/j.anai.2018.03.013. Epub 2018 Mar 19.