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

NCT02655679 | Completed Phase 1 Results FDA Drug

• 1 other identifier: VTP-38543-001
• Study Type: interventional
• Target: 104
• Locations: 2 countries
• Sites: 12

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.

Conditions

Dermatitis, Atopic

Keywords

Eczema

Outcome Measures

Primary Outcomes (4)

• 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.

  Baseline (Day 0) to Day 35

• 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.

  Baseline (Day 0) to Day 35

• 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.

  Baseline (Day 0) to Day 35

• 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.

  Baseline (Day 0) to Day 35

Secondary Outcomes (11)

• Maximum Plasma Concentration (Cmax) for VTP-38543-001

  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)

• Time to Maximum Plasma Concentrations (Tmax) for VTP-38543

  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)

• Area Under the Plasma Concentration Versus Time Curve, From Time 0 to the Last Measurable Concentration (AUClast) for VTP-38543

  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)

• Area Under the Plasma Concentration Versus Time Curve, From Time 0 to 12 Hours (AUC0-12hr) for VTP-38543

  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)

• Elimination Half-life (t½) for VTP-38543

  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)

Study Arms (5)

VTP-38543 0.05%

EXPERIMENTAL

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

Drug: VTP-38543

VTP-38543 0.15%

EXPERIMENTAL

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

Drug: VTP-38543

Vehicle without Transcutol®P

PLACEBO COMPARATOR

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

Other: Vehicle without Transcutol®P

VTP-38543 1%

EXPERIMENTAL

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

Drug: VTP-38543

Vehicle with Transcutol®P

PLACEBO COMPARATOR

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

Other: Vehicle with Transcutol®P

Interventions

VTP-38543 DRUG

VTP-38543 topical cream

VTP-38543 0.05%; VTP-38543 0.15%; VTP-38543 1%

Vehicle with Transcutol®P OTHER

Vehicle matching VTP-38543 cream with Transcutol®P

Also known as: Transcutol®P is Diethylene Glycol Monoethyl Ether, NF.

Vehicle with Transcutol®P

Vehicle without Transcutol®P OTHER

Vehicle matching VTP-38543 cream without Transcutol®P

Also known as: Transcutol®P is Diethylene Glycol Monoethyl Ether, NF.

Vehicle without Transcutol®P

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vitae Pharmaceuticals, Inc.: lead

Study Sites (12)

Dundee Dermatology

West Dundee, Illinois, 60118, United States

Location

Hamzavi Dermatology

Fort Gratiot, Michigan, 48059, United States

Location

Skin Specialty Dermatology

New York, New York, 10155, United States

Location

Wake Research Associates, LLC

Raleigh, North Carolina, 27612, United States

Location

Paddington Testing Company, Inc

Philadelphia, Pennsylvania, 19103, United States

Location

Kirk Barber Research

Calgary, Alberta, T2G1B1CA, Canada

Location

Stratica Medical Inc

Edmonton, Alberta, T5K 1X3, Canada

Location

Lynderm Research Inc

Markham, Ontario, L3P 1X2, Canada

Location

The Center for Dermatology / Institution

Richmond Hill, Ontario, L4B 1A5, Canada

Location

Windsor Clinical Research Inc

Windsor, Ontario, N8W 5L7, Canada

Location

Dr Isabelle Delorme Inc

Drummondville, Quebec, J2B 5L4, Canada

Location

Innovaderm Research

Montreal, Quebec, H2K4L5, Canada

Location

Related Publications (1)

• 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.

  PMID: 29567358 DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Therapeutic Area, Head
• Organization: Allergan

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Christy Harutunian

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2016
• First Posted: January 14, 2016
• Study Start: December 15, 2015
• Primary Completion: September 9, 2016
• Study Completion: September 9, 2016
• Last Updated: February 15, 2019
• Results First Posted: February 15, 2019

Record last verified: 2019-01

Locations

CA (7); US (5)