Study of Dupilumab (REGN668/ SAR231893) and Immune Responses in Adults With Atopic Dermatitis (AD)

Key Inclusion Criteria:

1. Male or female adults ages 18 to 64 years with Chronic AD (according to the American
Academy of Dermatology Consensus Criteria, [Eichenfeld 2004])that has been present
for at least 3 years before the screening visit

2. Patients with documented recent history (within 6 months before the screening visit)
of inadequate response to a sufficient course of outpatient treatment with topical AD
medication(s), or for whom topical AD therapies are otherwise inadvisable (e.g.,
because of side effects or safety risks).

3. Eczema Area and Severity Index (EASI) score ≥16 at the screening visit and the
baseline visit

4. Investigator's Global Assessment (IGA) score ≥3 (on the 0-4 IGA scale) at the
screening and baseline visits

5. ≥10% body surface area (BSA) of AD involvement at the screening and baseline visits

Key Exclusion Criteria:

1. Prior treatment with dupilumab (REGN668/ SAR231893)

2. Patients needing >10 mg of daily prednisone (including equivalent doses of other
steroids) or high dose systemic corticosteroids (≥2 mg/kg) for 14 days or longer
during the 16 week treatment period of the study

3. History of Guillain-Barre syndrome

4. History of severe allergic reaction to either vaccine or to vaccine components
including alum, thimerosal, phenol

5. Patients with a severe reaction to natural rubber latex products (some packaging
components of the vaccines contain rubber latex and may cause a reaction in
susceptible individuals)

6. Treatment with biologics within 4 months of baseline visit

7. Chronic or acute infection requiring treatment with antibiotics, antivirals,
antiparasitics, antifungals within 4 weeks before screening visit or superficial skin
infections within 1 week of screening visit

The information listed above is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial and not all inclusion/ exclusion
criteria are listed.