NCT02647086

Open Label, Drug-Drug Interaction (DDI) Study of Dupilumab (REGN668/SAR231893) in Patients With Moderate to Severe Atopic Dermatitis (AD)

An Open-Label, Drug-Drug Interaction Study to Examine the Effects of Dupilumab on the Pharmacokinetics of Selected Cytochrome P450 Substrates in Adult Patients With Moderate to Severe Atopic Dermatitis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	Dupilumab
DRUG	Midazolam	Cytochrome P450 substrate
DRUG	Omeprazole	Cytochrome P450 substrate
DRUG	Warfarin	Cytochrome P450 substrate
DRUG	Caffeine	Cytochrome P450 substrate
DRUG	Metoprolol	Cytochrome P450 substrate

Timeline

• Start date: 2015-12-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2016-01-06
• Last updated: 2016-08-22

Locations

5 sites across 1 country: United States