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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

110

participants targeted

Target at P50-P75 for phase_2

Timeline

Completed

Started Jan 2018

Shorter than P25 for phase_2

Geographic Reach

2 countries

7 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

5 months study duration

First Submitted

Initial submission to the registry

December 21, 2017

Completed

19 days until next milestone

First Posted

Study publicly available on registry

January 9, 2018

Completed

16 days until next milestone

Study Start

First participant enrolled

January 25, 2018

Completed

5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2018

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2018

Completed

Last Updated

July 19, 2018

Status Verified

July 1, 2018

Enrollment Period

5 months

First QC Date

December 21, 2017

Last Update Submit

July 18, 2018

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (4)

Efficacy - Investigator Global Assessment (IGA) score
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.
28 days
Efficacy - Eczema Area Severity Index (EASI) score
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.
28 days
Efficacy - Peak Pruritus Numeric Rating Scale (NRS)
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."
28 days
Efficacy - Whole body surface area (BSA) affected
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.
28 days

Secondary Outcomes (3)

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

Study Arms (2)

RVT-501 0.5% ointment

EXPERIMENTAL

Subjects will receive RVT-501 0.5% ointment twice daily (BID) for 4 weeks.

Drug: RVT-501 0.5% ointment

RVT-501 vehicle ointment

PLACEBO COMPARATOR

Subjects will receive RVT-501 vehicle ointment twice daily (BID) for 4 weeks.

Drug: Vehicle ointment

Interventions

RVT-501 0.5% ointmentDRUG

Patients will receive RVT-501 0.5% ointment twice daily (BID) for 4 weeks.

RVT-501 0.5% ointment

Vehicle ointmentDRUG

Placebo comparator - ointment twice daily (BID) for 4 weeks.

RVT-501 vehicle ointment

Eligibility Criteria

Age2 Years - 17 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

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;
Injectable progestogen;
Contraceptive vaginal ring;
Percutaneous contraceptive patches.
These allowed methods of contraception are only effective when used consistently, correctly, and in accordance with the product label. The Investigator is responsible for ensuring that patients understand how to properly use these methods of contraception.
Non-child-bearing potential is defined as pre-menarchal or pre-menopausal females with a documented bilateral tubal ligation, bilateral oophorectomy (removal of the ovaries) or hysterectomy, or hysteroscopic sterilization. Documented verbal history from the patient is acceptable.
+4 more criteria

You may not qualify if:

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:
Corticosteroid preparations (oral, injection, and suppository preparations) and topical corticosteroids that were classified as super-high potency (clobetasol propionate). Eye drop and nasal preparations are allowed. Inhaled preparations are allowed if used for a stable condition and at a stable dose for \> 28 days before Screening, and are continued at the same dose throughout the study.
Oral preparations and injections of immunosuppressants (cyclosporine, methotrexate, azathioprine, tacrolimus, etc.);
Excessive sun exposure, tanning booth, other ultraviolet (UV) light source and phototherapy including psoralen and ultraviolet A (PUVA) therapy.
From 14 days prior to the first application of the study drug to the completion of the
Follow-up visit or discontinuation:
+24 more criteria

Contact the study team to confirm eligibility.