Open-Label Study of RVT-501 Topical Ointment in Pediatric Patients With Atopic Dermatitis

Status unconfirmed · Phase 1

Conditions studied: Atopic Dermatitis

In brief

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

Key facts

Study ID: NCT03415282
Run by: Dermavant Sciences GmbH
People needed: 24
Starts: 2018-02-05
Expected to finish: 2018-08-07
Last updated by the study team: 2018-05-11

Who can join

Age: 2 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

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.
Patients who are abstinent are eligible, but they must use one of the birth control methods listed above if they start engaging in sexual activity that could lead to pregnancy during the study.
Female patients of childbearing potential must have a negative pregnancy test at screening and Baseline (Day 0).
History of atopic dermatitis and stable disease for at least 1 month according to the patient or caregiver.
Patient or patient's parent(s)/legal representative must be capable of giving written informed consent or verbal assent, as applicable, which includes compliance with the requirements and restrictions listed in the consent/assent form; written informed consent must be obtained prior to any study related procedures.

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;
Tacrolimus and pimecrolimus cream and/or ointment;
Topical corticosteroids that were classified as low, medium, or high potency (e.g., fluocinonide, triamcinolone acetonide, desonide, hydrocortisone). Eye drops and nasal preparations are allowed.
From 7 days prior to the first application of the study drug to the completion of the Follow- up visit or discontinuation:
Oral or intravenous antibiotics, antifungal or antivirus medications
Antihistamines/anti-allergics (oral, topical and injections): diphenhydramine, chlorpheniramine maleate, hydroxyzine).
NOTE: The following antihistamines are allowed:
Loratadine, fexofenadine hydrochloride, cetirizine hydrochloride
Pregnant or lactating females.
History of sensitivity to the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the Investigator or medical monitor, contraindicates their participation.
The patient has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives, or twice the duration of the biological effect of the investigational product (whichever is longer).

Where it is running

Dermavant Investigational Site — Anniston, Alabama, United States
Dermavant Investigational Site — Irvine, California, United States
Dermavant Investigational Site — Jacksonville, Florida, United States
Dermavant Investigational Site — Miami, Florida, United States
Dermavant Investigational Site — Miami, Florida, United States
Dermavant Investigational Site — Stockbridge, Georgia, United States
Dermavant Investigational Site — Indianapolis, Indiana, United States
Dermavant Investigational Site — Raleigh, North Carolina, United States
Dermavant Investigational Site — Arlington, Texas, United States
Dermavant Investigational Site — San Antonio, Texas, United States
Dermavant Investigational Site — San Antonio, Texas, United States
Dermavant Investigational Site — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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