Brief Summary

This is a multicenter, open-label Phase 1b study in pediatric patients age 2-11 years old with extensive atopic dermatitis.

Trial Health

At Risk

Trial Health Score

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

Trial has exceeded expected completion date

Enrollment

participants targeted

Target at P25-P50 for phase_1

Timeline

Completed

Started Feb 2018

Shorter than P25 for phase_1

Geographic Reach

1 country

12 active sites

Status

unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

6 months study duration

First Submitted

Initial submission to the registry

January 23, 2018

Completed

7 days until next milestone

First Posted

Study publicly available on registry

January 30, 2018

Completed

6 days until next milestone

Study Start

First participant enrolled

February 5, 2018

Completed

6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 24, 2018

Completed

14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 7, 2018

Completed

Last Updated

May 11, 2018

Status Verified

May 1, 2018

Enrollment Period

6 months

First QC Date

January 23, 2018

Last Update Submit

May 10, 2018

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (5)

Frequency and severity of adverse events (local and systemic)
Adverse events will be coded using the most current release of MedDRA® (Medical Dictionary for Regulatory Activities). The number and proportion of subjects with adverse events will be summarized by treatment, system organ class, and preferred term for all adverse events, all adverse events considered by the investigator to be related to study drug, all serious adverse events, and all adverse events leading to study drug discontinuation
28 days
Laboratory values
Selected laboratory data will be summarized by the observed data and by the change from baseline (as appropriate) across time. Incidence of treatment emergent laboratory values that are considered clinically significantly abnormal will be summarized by treatment group.
28 days
Vital signs
Vital signs will be measured in supine or semi-supine position after a 5 minute rest and will include systolic and diastolic blood pressure and pulse rate. Vital sign data will be listed by subject and summarized by treatment.
28 days
Plasma concentrations of RVT-501
PK samples will be collected at week 1 pre-dose, 2-4 hours post-dose, and 6-8 hours post dose for all subjects. At week PK samples will be collected pre-dose. RVT-501 will be measured in plasma by validated assay in all subjects to confirm exposure. These plasma concentrations will be listed by metabolite, subject, treatment, and time; and will be summarized by analyte and time. If data permit, RVT-501 and M11 concentrations will be summarized descriptively at each collection time point.
28 days
Plasma concentrations of M11 metabolite
PK samples will be collected at week 1 pre-dose, 2-4 hours post-dose, and 6-8 hours post dose for all subjects. At week 4 PK samples will be collected pre-dose. The M11 metabolite will be measured in plasma by validated assay in all subjects to confirm exposure. These plasma concentrations will be listed by metabolite, subject, treatment, and time; and will be summarized by metabolite, treatment and time. If data permit, RVT-501 and M11 concentrations will be summarized descriptively at each collection time point.
28 days

Secondary Outcomes (9)

Efficacy - Investigators Global Assessment (IGA)
28 days
Efficacy - 2-point improvement in IGA
28 days
Efficacy - IGA of 0 or 1 at study end
28 days
Efficacy - Eczema Area and Severity Index (EASI) score
28 days
Efficacy - EASI-50
28 days
+4 more secondary outcomes

Study Arms (1)

Open-label treatment arm

EXPERIMENTAL

Open-label treatment arm - patients will receive RVT-501 0.5% twice daily (BID) for 4 weeks.

Drug: RVT-501 0.5% topical ointment

Interventions

RVT-501 0.5% topical ointmentDRUG

RVT-501 0.5% topical ointment twice daily (BID) for 4 weeks.

Open-label treatment arm

Eligibility Criteria

Age2 Years - 11 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

Male and female pediatric patients aged 2 to 11 with confirmed diagnosis of atopic dermatitis by Hanifin and Rajka criteria.
Patients with atopic dermatitis covering \> 25% of the body surface area and with an Investigator Global Assessment of disease severity of 2 or greater at baseline.
Minimum body weight of 10 kg.
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 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 a \<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.
Nonchildbearing potential is defined as premenarchal or premenopausal 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 drops and nasal preparations are allowed. Inhaled preparations are allowed if used for a stable condition and at 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:
Herbal medicines for atopic dermatitis (topical and oral preparations), unless specifically approved by the Sponsor;
Eucrisa™ (crisaborole) and any other topical phosphodiesterase 4 (PDE4) inhibitor;
+18 more criteria

Contact the study team to confirm eligibility.