search
Back to results

An Ascending Multiple Dose Study of VTP-38543 in Adult Participants With Mild to Moderate Atopic Dermatitis

Primary Purpose

Dermatitis, Atopic

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
VTP-38543
Vehicle with Transcutol®P
Vehicle without Transcutol®P
Sponsored by
Vitae Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dermatitis, Atopic focused on measuring Eczema

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dundee Dermatology
  • Hamzavi Dermatology
  • Skin Specialty Dermatology
  • Wake Research Associates, LLC
  • Paddington Testing Company, Inc
  • Kirk Barber Research
  • Stratica Medical Inc
  • Lynderm Research Inc
  • The Center for Dermatology / Institution
  • Windsor Clinical Research Inc
  • Dr Isabelle Delorme Inc
  • Innovaderm Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

VTP-38543 0.05%

VTP-38543 0.15%

Vehicle without Transcutol®P

VTP-38543 1%

Vehicle with Transcutol®P

Arm Description

VTP-38543 0.05% administered topically every 12 hours for 28 days.

VTP-38543 0.15% administered topically every 12 hours for 28 days.

Vehicle without Transcutol®P administered topically every 12 hours for 28 days.

VTP-38543 1% administered topically every 12 hours for 28 days.

Vehicle with Transcutol®P administered topically every 12 hours for 28 days.

Outcomes

Primary Outcome Measures

Number of Participants With Treatment-related Adverse Events (AEs)
An Adverse Event is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The number of participants with AEs related to treatment are reported.
Number of Participants With Clinically Significant Changes in Clinical Laboratory Values
Clinical Laboratory tests included chemistry, hematology and urinalysis tests collected during the study. The investigator determined if the changes in laboratory results were clinically significant.
Number of Participants With Clinically Significant Changes in Vital Signs
Vital signs included blood pressure, pulse, respiration rate and body temperature. The investigator determined if the changes in vital sign results were clinically significant.
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values
A standard 12-lead ECG was performed. The investigator determined if the changes in ECG results were clinically significant.

Secondary Outcome Measures

Maximum Plasma Concentration (Cmax) for VTP-38543-001
Time to Maximum Plasma Concentrations (Tmax) for VTP-38543
Area Under the Plasma Concentration Versus Time Curve, From Time 0 to the Last Measurable Concentration (AUClast) for VTP-38543
Area Under the Plasma Concentration Versus Time Curve, From Time 0 to 12 Hours (AUC0-12hr) for VTP-38543
Elimination Half-life (t½) for VTP-38543
Percentage Change From Baseline in Total Body Surface Area (BSA)
Percent BSA was estimated using the palmar surface of the participant's hand up to the proximal interphalangeal joint, including the thumb, to approximate 1% of the participant's BSA. The overall BSA affected by atopic dermatitis was evaluated from 0 to 100% and divided by 5 for a maximum of 20. A negative percentage change indicates improvement.
Percentage Change From Baseline in Investigator Global Assessments (IGA) Score
The investigator assessed the participant's atopic dermatitis using the 5-point IGA where 0=clear (Minor, residual discoloration, no erythema or induration/papulation, no oozing/crusting) to 4=Severe disease (Deep/bright red erythema with severe induration/papulation with oozing/crusting). A negative percentage change indicates improvement.
Percentage Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score
The investigator assessed severity of atopic dermatitis (AD) using scoring atopic dermatitis (SCORAD) score obtained from different individual scales. 6-items: erythema, edema/papulation, oozing/crusts, excoriation, lichenification, and dryness were graded on a 4-point scale where 0=Absent to 3=Severe. The individual scores were added together to get a score of 0 to 18 that was multiplied by 3.5 for a score of 0 to 63. The overall BSA affected by AD (0 to 100 %) was divided by 5 for a score 0 to 20. The participant used a 10-point Visual Analog Scale (VAS) to evaluate loss of sleep and the occurrence of pruritus averaged over the last 3 days where 0=None to Worst Imaginable. The sum of the 2 VAS scores was 0 to 20. The above measures were added together for a total possible SCORAD score of 0 (best) to 103 (worst). A negative percentage change indicates improvement.
Percentage Change From Baseline Eczema Area and Severity Index (EASI)
The investigator assessed four body regions: Head and neck, Upper extremities, Trunk including axillae and groin, and Lower extremities including buttocks. Each body region was scored based on BSA where 0=No involvement to 6=90-100%. Each body region was assessed for erythema, infiltration/papulation, excoriation and lichenification using a 4-point scale where 0=None to 3=Severe. EASI total score was determined by combining the individual scores for each of the 4 body regions. The total for each region was calculated by [erythema + infiltration+ excoriation + lichenification * area involvement * a constant (constants Head and Neck=0.1, Upper Limbs=0.2, Trunk=0.3, Lower Limbs=0.4)]. The EASI total score was determined by combining the individual scores for each of the 4 body regions for a total possible score of 0 (best) to 72 (worst). A negative percentage change indicates improvement.
Percentage Change From Baseline in Pruritus VAS Score
The participant used a 10-point VAS to assess the occurrence of pruritus (itchy skin) over the last 3 days where 0= None to 10=Worst Imaginable for a total possible score of 0 to 10. A negative percentage change indicates improvement.
Percentage Change From Baseline in VAS Sleep Score
The participant used a 10-point VAS to evaluate loss of sleep averaged over the last 3 days where 0= None to 10=Worst imaginable for a total possible score of 0 to 10. A negative percentage change indicates improvement.

Full Information

First Posted
January 11, 2016
Last Updated
January 18, 2019
Sponsor
Vitae Pharmaceuticals, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT02655679
Brief Title
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

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
December 15, 2015 (Actual)
Primary Completion Date
September 9, 2016 (Actual)
Study Completion Date
September 9, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vitae Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatitis, Atopic
Keywords
Eczema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VTP-38543 0.05%
Arm Type
Experimental
Arm Description
VTP-38543 0.05% administered topically every 12 hours for 28 days.
Arm Title
VTP-38543 0.15%
Arm Type
Experimental
Arm Description
VTP-38543 0.15% administered topically every 12 hours for 28 days.
Arm Title
Vehicle without Transcutol®P
Arm Type
Placebo Comparator
Arm Description
Vehicle without Transcutol®P administered topically every 12 hours for 28 days.
Arm Title
VTP-38543 1%
Arm Type
Experimental
Arm Description
VTP-38543 1% administered topically every 12 hours for 28 days.
Arm Title
Vehicle with Transcutol®P
Arm Type
Placebo Comparator
Arm Description
Vehicle with Transcutol®P administered topically every 12 hours for 28 days.
Intervention Type
Drug
Intervention Name(s)
VTP-38543
Intervention Description
VTP-38543 topical cream
Intervention Type
Other
Intervention Name(s)
Vehicle with Transcutol®P
Other Intervention Name(s)
Transcutol®P is Diethylene Glycol Monoethyl Ether, NF.
Intervention Description
Vehicle matching VTP-38543 cream with Transcutol®P
Intervention Type
Other
Intervention Name(s)
Vehicle without Transcutol®P
Other Intervention Name(s)
Transcutol®P is Diethylene Glycol Monoethyl Ether, NF.
Intervention Description
Vehicle matching VTP-38543 cream without Transcutol®P
Primary Outcome Measure Information:
Title
Number of Participants With Treatment-related Adverse Events (AEs)
Description
An Adverse Event is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The number of participants with AEs related to treatment are reported.
Time Frame
Baseline (Day 0) to Day 35
Title
Number of Participants With Clinically Significant Changes in Clinical Laboratory Values
Description
Clinical Laboratory tests included chemistry, hematology and urinalysis tests collected during the study. The investigator determined if the changes in laboratory results were clinically significant.
Time Frame
Baseline (Day 0) to Day 35
Title
Number of Participants With Clinically Significant Changes in Vital Signs
Description
Vital signs included blood pressure, pulse, respiration rate and body temperature. The investigator determined if the changes in vital sign results were clinically significant.
Time Frame
Baseline (Day 0) to Day 35
Title
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values
Description
A standard 12-lead ECG was performed. The investigator determined if the changes in ECG results were clinically significant.
Time Frame
Baseline (Day 0) to Day 35
Secondary Outcome Measure Information:
Title
Maximum Plasma Concentration (Cmax) for VTP-38543-001
Time Frame
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)
Title
Time to Maximum Plasma Concentrations (Tmax) for VTP-38543
Time Frame
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)
Title
Area Under the Plasma Concentration Versus Time Curve, From Time 0 to the Last Measurable Concentration (AUClast) for VTP-38543
Time Frame
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)
Title
Area Under the Plasma Concentration Versus Time Curve, From Time 0 to 12 Hours (AUC0-12hr) for VTP-38543
Time Frame
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)
Title
Elimination Half-life (t½) for VTP-38543
Time Frame
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)
Title
Percentage Change From Baseline in Total Body Surface Area (BSA)
Description
Percent BSA was estimated using the palmar surface of the participant's hand up to the proximal interphalangeal joint, including the thumb, to approximate 1% of the participant's BSA. The overall BSA affected by atopic dermatitis was evaluated from 0 to 100% and divided by 5 for a maximum of 20. A negative percentage change indicates improvement.
Time Frame
Baseline (Day 0) to Day 28
Title
Percentage Change From Baseline in Investigator Global Assessments (IGA) Score
Description
The investigator assessed the participant's atopic dermatitis using the 5-point IGA where 0=clear (Minor, residual discoloration, no erythema or induration/papulation, no oozing/crusting) to 4=Severe disease (Deep/bright red erythema with severe induration/papulation with oozing/crusting). A negative percentage change indicates improvement.
Time Frame
Baseline (Day 0) to Day 28
Title
Percentage Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score
Description
The investigator assessed severity of atopic dermatitis (AD) using scoring atopic dermatitis (SCORAD) score obtained from different individual scales. 6-items: erythema, edema/papulation, oozing/crusts, excoriation, lichenification, and dryness were graded on a 4-point scale where 0=Absent to 3=Severe. The individual scores were added together to get a score of 0 to 18 that was multiplied by 3.5 for a score of 0 to 63. The overall BSA affected by AD (0 to 100 %) was divided by 5 for a score 0 to 20. The participant used a 10-point Visual Analog Scale (VAS) to evaluate loss of sleep and the occurrence of pruritus averaged over the last 3 days where 0=None to Worst Imaginable. The sum of the 2 VAS scores was 0 to 20. The above measures were added together for a total possible SCORAD score of 0 (best) to 103 (worst). A negative percentage change indicates improvement.
Time Frame
Baseline (Day 0) to Day 28
Title
Percentage Change From Baseline Eczema Area and Severity Index (EASI)
Description
The investigator assessed four body regions: Head and neck, Upper extremities, Trunk including axillae and groin, and Lower extremities including buttocks. Each body region was scored based on BSA where 0=No involvement to 6=90-100%. Each body region was assessed for erythema, infiltration/papulation, excoriation and lichenification using a 4-point scale where 0=None to 3=Severe. EASI total score was determined by combining the individual scores for each of the 4 body regions. The total for each region was calculated by [erythema + infiltration+ excoriation + lichenification * area involvement * a constant (constants Head and Neck=0.1, Upper Limbs=0.2, Trunk=0.3, Lower Limbs=0.4)]. The EASI total score was determined by combining the individual scores for each of the 4 body regions for a total possible score of 0 (best) to 72 (worst). A negative percentage change indicates improvement.
Time Frame
Baseline (Day 0) to Day 28
Title
Percentage Change From Baseline in Pruritus VAS Score
Description
The participant used a 10-point VAS to assess the occurrence of pruritus (itchy skin) over the last 3 days where 0= None to 10=Worst Imaginable for a total possible score of 0 to 10. A negative percentage change indicates improvement.
Time Frame
Baseline (Day 0) to Day 28
Title
Percentage Change From Baseline in VAS Sleep Score
Description
The participant used a 10-point VAS to evaluate loss of sleep averaged over the last 3 days where 0= None to 10=Worst imaginable for a total possible score of 0 to 10. A negative percentage change indicates improvement.
Time Frame
Baseline (Day 0) to Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christy Harutunian
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Dundee Dermatology
City
West Dundee
State/Province
Illinois
ZIP/Postal Code
60118
Country
United States
Facility Name
Hamzavi Dermatology
City
Fort Gratiot
State/Province
Michigan
ZIP/Postal Code
48059
Country
United States
Facility Name
Skin Specialty Dermatology
City
New York
State/Province
New York
ZIP/Postal Code
10155
Country
United States
Facility Name
Wake Research Associates, LLC
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Paddington Testing Company, Inc
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States
Facility Name
Kirk Barber Research
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2G1B1CA
Country
Canada
Facility Name
Stratica Medical Inc
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5K 1X3
Country
Canada
Facility Name
Lynderm Research Inc
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 1X2
Country
Canada
Facility Name
The Center for Dermatology / Institution
City
Richmond Hill
State/Province
Ontario
ZIP/Postal Code
L4B 1A5
Country
Canada
Facility Name
Windsor Clinical Research Inc
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 5L7
Country
Canada
Facility Name
Dr Isabelle Delorme Inc
City
Drummondville
State/Province
Quebec
ZIP/Postal Code
J2B 5L4
Country
Canada
Facility Name
Innovaderm Research
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2K4L5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
29567358
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.
Results Reference
derived

Learn more about this trial

An Ascending Multiple Dose Study of VTP-38543 in Adult Participants With Mild to Moderate Atopic Dermatitis

We'll reach out to this number within 24 hrs