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

Completed · Phase 1

Conditions studied: Atopic Dermatitis

In brief

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 facts

Study ID

NCT02647086

Run by

Regeneron Pharmaceuticals

People needed

14

Starts

2015-12-01

Expected to finish

2016-07-01

Last updated by the study team

2016-08-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female patient, aged 18 years or older
• Diagnosis of Chronic AD, defined as diagnosis of AD for at least 3 years before the screening visit
• Eczema Area Severity Index (EASI) score ≥16 at the screening and baseline visits
• Investigator's Global Assessment (IGA) score ≥3 (on the 0 to 4 IGA scale) at the screening and baseline visits
• ≥10% Body Surface Area (BSA) of AD involvement at the screening and baseline visits
• Patients with documented recent history (within 6 months before the screening visit) of inadequate response to outpatient treatment with topical medications, or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks)
• Provide signed informed consent

You may not qualify if…

• Prior participation in a dupilumab clinical trial
• The use of any of the following treatments within 4 weeks before the baseline visit:
• Systemic corticosteroids
• Immunosuppressive/immunomodulating drugs
• Phototherapy for AD
• Administration, within 14 days before baseline or within a period of 5 times the elimination half-life of the medication before baseline, whichever is longer, of any medication that is a known inducer or inhibitor of either one or more of the following CYP enzymes: CYP3A, CYP2C19, CYP2C9, CYD2D6, and CYP1A2. Patients who are on any of these medications at the time of screening and cannot be safely taken off these medications will be excluded from the study.
• Any contraindication to one or more of the following drugs, according to the applicable labeling:
• Midazolam
• Omeprazole
• Warfarin
• Caffeine
• Metoprolol
• Consumption of any 1 or more of the following food items and/ or beverages within 1 week prior to baseline:
• Grapefruit or grapefruit juice, apple or apple juice, orange or orange juice, lemons or lemon juice, limes or lime juice
• Vegetables from the mustard green family (eg, broccoli)
• Charbroiled meats
• Caffeinated beverages, foods or drugs containing caffeine Patients who are not willing to abstain from the consumption of these food items and/or beverages for certain periods during the study will also be excluded
• History of excessive consumption of beverages containing caffeine (more than 4 cups or glasses per day). Patients who are not willing to abstain from the consumption of caffeine during certain periods of the study will also be excluded
• History or presence of alcohol or drug abuse within last 2 years
• History of smoking within last 2 years
• Poor metabolizers for CYP2C9, CYP2C19, or CYP2D6 based on genotyping
• Presence of any one or more of the following lab abnormalities at screening:
• Platelet count ≤100 x 10\^3/µL
• Neutrophils ≤1 x 10\^3/µL
• Creatinine phosphokinase (CPK) >10 x upper limit of normal (ULN)

Where it is running

• Regeneron Study Site — Little Rock, Arkansas, United States
• Regeneron Study Site — Centennial, Colorado, United States
• Regeneron Study Site — Minneapolis, Minnesota, United States
• Regeneron Study Site — Berlin, New Jersey, United States
• Regeneron Study Site — Raleigh, North Carolina, United States

Full record on ClinicalTrials.gov

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