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Study of RVT-501 in Adult and Adolescent Subjects With Atopic Dermatitis
This is a multi-center, randomized, vehicle-controlled, double-blind Phase 2 study in adults and adolescent subjects with mild to moderate atopic dermatitis.
Details
| Lead sponsor | Dermavant Sciences GmbH |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 157 |
| Start date | 2016-11 |
| Completion | 2017-07-03 |
Conditions
- Atopic Dermatitis
Interventions
- RVT-501 0.2% ointment
- RVT-501 0.5% ointment
- Vehicle ointment
Primary outcomes
- Frequency and severity of adverse events (local and systemic) — 28 days
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 - Laboratory values — 28 days
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. - Vital signs — 28 days
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. - ECGs — 28 Days
Single 12-lead ECGs will be obtained at Screening, Day 0, Day 7, Day 28 and during follow up 7-10 days-post-dose using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals. ECG data will be listed by subject and summarized by treatment. - Plasma concentrations of RVT-501 — 28 Days
PK samples will be collected pre-dose at week 1 for all subjects. At week 4, PK samples will be collected pre-dose and within 2-4 hours post-dose. RVT-501 will be measured in plasma by validated assay in all subjects to confirm exposure. These plasma concentrations will be listed separately for adults and adolescents by metabolite, subject, treatment, and time; and will be summarized by metabolite, treatment and time. The number of percent of subjects with measurable concentration at each time point and any time during the study will be provided. - Plasma concentrations of M11 metabolite — 28 Days
PK samples will be collected pre-dose at week 1 for all subjects. At week 4, PK samples will be collected pre-dose and within 2-4 hours post-dose. The M11 metabolite will be measured in plasma by validated assay in all subjects to confirm exposure. These plasma concentrations will be listed separately for adults and adolescents by metabolite, subject, treatment, and time; and will be summarized by metabolite, treatment and time. The number of percent of subjects with measurable concentration at each time point and any time during the study will be provided.
Countries
United States, Canada