Study of Dupilumab and Immune Responses in Adults With Atopic Dermatitis (AD)
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Dupilumab; Placebo
Intervention description: Administered via subcutaneous injection.; An inactive substance containing no medicine administered via subcutaneous injection.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 194.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No

Summary:

      This was a 32-week, randomized, double-blind, placebo-controlled, parallel-group study
      assessing immunization responses to vaccination in adults with moderate to severe atopic
      dermatitis who are treated with subcutaneous dupilumab.
    

Eligibility criteria:

        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. Participants 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.