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

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ClinicalTrials.gov Identifier: NCT02655679
Recruitment Status : Completed
First Posted : January 14, 2016
Results First Posted : February 15, 2019
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Vitae Pharmaceuticals, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Dermatitis, Atopic Drug: VTP-38543 Other: Vehicle with Transcutol®P Other: Vehicle without Transcutol®P Phase 1 Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : December 15, 2015
Actual Primary Completion Date : September 9, 2016
Actual Study Completion Date : September 9, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arms and Interventions
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Arm Intervention/treatment
Experimental: VTP-38543 0.05%
VTP-38543 0.05% administered topically every 12 hours for 28 days.
 Drug: VTP-38543
VTP-38543 topical cream
Experimental: VTP-38543 0.15%
VTP-38543 0.15% administered topically every 12 hours for 28 days.
 Drug: VTP-38543
VTP-38543 topical cream
Placebo Comparator: Vehicle without Transcutol®P
Vehicle without Transcutol®P administered topically every 12 hours for 28 days.
 Other: Vehicle without Transcutol®P
Vehicle matching VTP-38543 cream without Transcutol®P
Other Name: Transcutol®P is Diethylene Glycol Monoethyl Ether, NF.
Experimental: VTP-38543 1%
VTP-38543 1% administered topically every 12 hours for 28 days.
 Drug: VTP-38543
VTP-38543 topical cream
Placebo Comparator: Vehicle with Transcutol®P
Vehicle with Transcutol®P administered topically every 12 hours for 28 days.
 Other: Vehicle with Transcutol®P
Vehicle matching VTP-38543 cream with Transcutol®P
Other Name: Transcutol®P is Diethylene Glycol Monoethyl Ether, NF.


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Treatment-related Adverse Events (AEs) [ Time Frame: Baseline (Day 0) to Day 35 ]
    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.

  2. Number of Participants With Clinically Significant Changes in Clinical Laboratory Values [ Time Frame: Baseline (Day 0) to Day 35 ]
    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.

  3. Number of Participants With Clinically Significant Changes in Vital Signs [ Time Frame: Baseline (Day 0) to Day 35 ]
    Vital signs included blood pressure, pulse, respiration rate and body temperature. The investigator determined if the changes in vital sign results were clinically significant.

  4. Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values [ Time Frame: Baseline (Day 0) to Day 35 ]
    A standard 12-lead ECG was performed. The investigator determined if the changes in ECG results were clinically significant.


Secondary Outcome Measures :
  1. 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) ]
  2. 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) ]
  3. 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) ]
  4. 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) ]
  5. 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) ]
  6. Percentage Change From Baseline in Total Body Surface Area (BSA) [ Time Frame: Baseline (Day 0) to Day 28 ]
    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.

  7. Percentage Change From Baseline in Investigator Global Assessments (IGA) Score [ Time Frame: Baseline (Day 0) to Day 28 ]
    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.

  8. Percentage Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score [ Time Frame: Baseline (Day 0) to Day 28 ]
    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.

  9. Percentage Change From Baseline Eczema Area and Severity Index (EASI) [ Time Frame: Baseline (Day 0) to Day 28 ]
    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.

  10. Percentage Change From Baseline in Pruritus VAS Score [ Time Frame: Baseline (Day 0) to Day 28 ]
    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.

  11. Percentage Change From Baseline in VAS Sleep Score [ Time Frame: Baseline (Day 0) to Day 28 ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02655679


Locations
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United States, Illinois
Dundee Dermatology
West Dundee, Illinois, United States, 60118
United States, Michigan
Hamzavi Dermatology
Fort Gratiot, Michigan, United States, 48059
United States, New York
Skin Specialty Dermatology
New York, New York, United States, 10155
United States, North Carolina
Wake Research Associates, LLC
Raleigh, North Carolina, United States, 27612
United States, Pennsylvania
Paddington Testing Company, Inc
Philadelphia, Pennsylvania, United States, 19103
Canada, Alberta
Kirk Barber Research
Calgary, Alberta, Canada, T2G1B1CA
Stratica Medical Inc
Edmonton, Alberta, Canada, T5K 1X3
Canada, Ontario
Lynderm Research Inc
Markham, Ontario, Canada, L3P 1X2
The Center for Dermatology / Institution
Richmond Hill, Ontario, Canada, L4B 1A5
Windsor Clinical Research Inc
Windsor, Ontario, Canada, N8W 5L7
Canada, Quebec
Dr Isabelle Delorme Inc
Drummondville, Quebec, Canada, J2B 5L4
Innovaderm Research
Montreal, Quebec, Canada, H2K4L5
Sponsors and Collaborators
Vitae Pharmaceuticals, Inc.
Investigators
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Study Director: Christy Harutunian Allergan
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Vitae Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02655679    
Other Study ID Numbers: VTP-38543-001
First Posted: January 14, 2016    Key Record Dates
Results First Posted: February 15, 2019
Last Update Posted: February 15, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vitae Pharmaceuticals, Inc.:
Eczema
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
 Immune System Diseases
Ether
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs