drugset / Trial / NCT02647086
Open Label, Drug-Drug Interaction (DDI) Study of Dupilumab (REGN668/SAR231893) in Patients With Moderate to Severe Atopic Dermatitis (AD)
Non-randomizedSingle-groupOpen-labelBasic science
Summary
This is an open-label, single-sequence DDI study designed to examine the effects of dupilumab on the pharmacokinetics of selected cytochrome P450 substrates in adult patients with moderate to severe AD. The study consists of a screening period (day -35 to -2), study period 1 (day -1 to 7), study period 2 (day 8 to 50), and a follow-up period (day 51 to 135 \[end of study\]). Following completion of study period 2 (Day 50), patients will be given the option to enroll into the Open-Label Extension (OLE) study R668-AD-1225. Patients who decline will be followed for the next 12 weeks (Day 135).
Timeline
- Start
- 2015-12
- Primary completion
- 2016-07
- Completion
- 2016-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Caffeine | Small molecule | — | Oral |
| Subject | Dupilumab | Monoclonal antibody | 300 mg | Subcutaneous |
| Subject | Metoprolol | Other / unclassified | — | Oral |
| Subject | Midazolam | Small molecule | — | Oral |
| Subject | Omeprazole | Other / unclassified | — | Oral |
| Subject | Warfarin | Small molecule | — | Oral |