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

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT02647086
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dupilumab — DRUG
  • Midazolam — DRUG
    Cytochrome P450 substrate
  • Omeprazole — DRUG
    Cytochrome P450 substrate
  • Warfarin — DRUG
    Cytochrome P450 substrate
  • Caffeine — DRUG
    Cytochrome P450 substrate
  • Metoprolol — DRUG
    Cytochrome P450 substrate

Study Details

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).

Key Dates

Start date
Dec 31, 2015
Status verified
Aug 2016
Primary completion
Jul 31, 2016
Completion
Jul 31, 2016

Study Design

Enrollment
14 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Period 1
    Patients will receive selected Cytochrome P450 substrates (Midazolam, Omeprazole, Warfarin, Caffeine, Metoprololin) in period 1 (day 1)
  • Experimental: Period 2
    Patients will receive dupilumab starting in Period 2 (day 8) and continue weekly through day 50; Patients will receive selected Cytochrome P450 substrates (Midazolam, Omeprazole, Warfarin, Caffeine, Metoprolol) in period 2 (at day 36).

Primary Outcome Measure

Ratio of Area Under Curve last (AUClast) and maximum concentration (Cmax) for Cytochrome P450 substrates from pre-dupilumab administration at baseline (period 1, day 1) [ Time Frame: At Baseline (day 1) ]

Locations (5)

FacilityCityStateZIPSite coordinators
Regeneron Study SiteLittle RockArkansas--
Regeneron Study SiteCentennialColorado--
Regeneron Study SiteMinneapolisMinnesota--
Regeneron Study SiteBerlinNew Jersey--
Regeneron Study SiteRaleighNorth Carolina--

Find similar trials in Little Rock, AR

By condition
Atopic dermatitis / eczema
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
Regeneron Study Site· Little Rock, ARRegeneron Study Site· Centennial, CORegeneron Study Site· Minneapolis, MNRegeneron Study Site· Berlin, NJRegeneron Study Site· Raleigh, NC

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