Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerabililty of RVT-501 Topical Ointment in Pediatric Patients With Mild to Moderate Atopic Dermatitis
Overview
- Phase
- Phase 2
- Intervention
- RVT-501 0.5% ointment
- Conditions
- Atopic Dermatitis
- Sponsor
- Dermavant Sciences GmbH
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- Efficacy - Investigator Global Assessment (IGA) score
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
This is a multi-center, randomized, vehicle controlled, double-blind Phase 2 study in pediatric patients age 2-17 years old with mild to moderate atopic dermatitis.
Detailed Description
The purpose of this study is to evaluate the safety, efficacy, and tolerability of a 0.5% BID concentration of RVT-501 in pediatric patients 2-17 years of age with mild to moderate atopic dermatitis. The pharmacokinetics of RVT-501 will also be evaluated in patients 2-11 years of age.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male and female pediatric patients ages 2-17 years of age with confirmed diagnosis of atopic dermatitis by Hanifin and Rajka criteria \[Hanifin, 1980\].
- •Patients with atopic dermatitis covering 5% to 40% of the body surface area (BSA) and with an Investigator Global Assessment (IGA) of 2 or 3 (mild or moderate atopic dermatitis) at Baseline. Scalp, palms, and soles should be excluded from the BSA calculation to determine eligibility at Baseline.
- •Note: Patients with mild disease (IGA = 2) will be limited to approximately 25% of total enrollment.
- •Females of childbearing potential and male patients who are engaging in sexual activity that could lead to pregnancy must use the following adequate birth control methods while on study and for 2 weeks after stopping the study drug. Acceptable contraception methods are:
- •Male or male partner with vasectomy, OR
- •Male condom AND partner use of one of the contraceptive options below:
- •Spermicide;
- •Contraceptive subdermal implant that meets effectiveness criteria including a \<1% rate of failure per year, as stated in the product label;
- •Intrauterine device or intrauterine system that meets effectiveness criteria including \<1% rate of failure per year, as stated in the product label;
- •Oral contraceptive, either combined or progestogen alone;
Exclusion Criteria
- •A positive Hepatitis B surface antigen (HBsAg) or positive Hepatitis C antibody result, or positive human immunodeficiency virus (HIV) antibody at Screening.
- •Screening alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 1.5x the upper limit of normal (ULN).
- •Screening total bilirubin \> 1.5x ULN; total bilirubin \> ULN and ≤ 1.5x ULN is acceptable if bilirubin is fractionated and direct bilirubin \< 35%.
- •Patients with a skin condition such as Kaposi's varicelliform eruption, scabies, molluscum contagiosum, impetigo, psoriasis, severe acne, connective tissue disorder, or Netherton's syndrome, or any other disease that could impact study evaluations.
- •Use of any prohibited medication.
- •Prohibited concomitant medications, therapy, etc. during the defined period are as listed in the bullets below. If a patient requires any of these medications throughout the study period, he/she may be excluded from or discontinued from the study, at the discretion of the Investigator and medical monitor.
- •From 6 months prior to the first application of study drugs to the completion of the
- •Follow-up visit or discontinuation:
- •Biological products that might have significantly affected the evaluation of atopic dermatitis condition (e.g., tumor necrosis factor \[TNF\] inhibitors, anti- immunoglobulin \[Ig\]E antibodies, anti-CD20 antibodies, anti-interleukin \[IL\]-4 receptor).
- •From 28 days prior to the first application of study drug until the completion of the Follow- up visit or discontinuation:
Arms & Interventions
RVT-501 0.5% ointment
Subjects will receive RVT-501 0.5% ointment twice daily (BID) for 4 weeks.
Intervention: RVT-501 0.5% ointment
RVT-501 vehicle ointment
Subjects will receive RVT-501 vehicle ointment twice daily (BID) for 4 weeks.
Intervention: Vehicle ointment
Outcomes
Primary Outcomes
Efficacy - Investigator Global Assessment (IGA) score
Time Frame: 28 days
Efficacy will be assessed by determining the proportion of patients who achieve an Investigator Global Assessment (IGA) score of 0 or 1 and at least a 2-point improvement in IGA at Week 4. The IGA will be assessed at every study visit. The IGA is a 5-point morphological assessment of overall disease severity and will be determined according to the following categories: 0-clear; 1-almost clear; 2-mild disease; 3-moderate disease; 4-severe disease.
Efficacy - Eczema Area Severity Index (EASI) score
Time Frame: 28 days
Efficacy will be assessed by determining the proportion of patients who achieve a 50% reduction in Eczema Area Severity Index score (EASI-50) at Week 4.The EASI will be assessed at every study visit. It quantifies the severity of a patient's atopic dermatitis based on both lesion severity and the percent of body surface area affected. The EASI is a composite score ranging from 0-72 that takes into account the degree of erythema, induration/papulation, excoriation, and lichenification (each scored from 0 to 3 separately) for each of four body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region relative to the whole body.
Efficacy - Peak Pruritus Numeric Rating Scale (NRS)
Time Frame: 28 days
Efficacy will be assessed as change from Baseline to Week 4 in peak pruritus as measured with the 24-hour Peak Pruritus Numeric Rating Scale (NRS). Peak Pruitus NRS will be measured at each visit. The assessment consists of a patient-rated scale of 0-10, where 0 is "No itch" and 10 is the "Worst itch possible."
Efficacy - Whole body surface area (BSA) affected
Time Frame: 28 days
This exploratory endpoint will be evaluated as the change in total score from Baseline at all visits in whole body BSA (body surface area) affected. Whole body BSA affected will be assessed at every visit.
Secondary Outcomes
- Frequency and severity of adverse events (local and systemic)(28 days)
- Plasma concentrations of RVT-501(7 days)
- Plasma concentrations of M11 metabolite(7 days)