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

Vitae Pharmaceuticals

Status and phase: Completed; Phase 2; Phase 1

Conditions: Dermatitis, Atopic

Treatments: Drug: VTP-38543; Other: Vehicle with Transcutol®P; Other: Vehicle without Transcutol®P

Study type: Interventional

Funder types: Industry

Identifiers

NCT02655679

VTP-38543-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 104 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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104 participants in 5 patient groups, including a placebo group

VTP-38543 0.05%

Experimental group

Description:

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

Treatment:

Drug: VTP-38543

VTP-38543 0.15%

Experimental group

Description:

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

Treatment:

Drug: VTP-38543

Vehicle without Transcutol®P

Placebo Comparator group

Description:

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

Treatment:

Other: Vehicle without Transcutol®P

VTP-38543 1%

Experimental group

Description:

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

Treatment:

Drug: VTP-38543

Vehicle with Transcutol®P

Placebo Comparator group

Description:

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

Treatment:

Other: Vehicle with Transcutol®P