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

Completed · Phase 2 · Has a placebo group

Conditions studied: Atopic Dermatitis

In brief

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.

Key facts

Study ID

NCT03394677

Run by

Dermavant Sciences GmbH

People needed

110

Starts

2018-01-25

Expected to finish

2018-07-02

Last updated by the study team

2018-07-19

Who can join

Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

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.
• Patients who are abstinent are eligible, but they must agree to use of one of the birth control methods listed above if they start engaging in sexual activity that could lead to pregnancy during the study.
• Female subjects 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/caregiver.
• Patient, patient's parent(s), or 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 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:
• 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 (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

Where it is running

• Dermavant Investigational Site — Los Angeles, California, United States
• Dermavant Investigational Site — Oklahoma City, Oklahoma, United States
• Dermavant Investigational Site — Portland, Oregon, United States
• Dermavant Investigational Site — Dallas, Texas, United States
• Dermavant Investigational Site — San Antonio, Texas, United States
• Dermavant Investigational Site — Surrey, British Columbia, Canada
• Dermavant Investigational Site — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.