Efficacy and Safety of REGN3500 Monotherapy and Combination of REGN3500 Plus Dupilumab in Adult Patients With Moderate-to-Severe Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: REGN3500; Dupilumab; REGN3500 + Dupilumab Combo; Placebo
Intervention description: Administered subcutaneous (SC) every 2 weeks (q2w); Administered SC q2w; Administered SC q2w; Administered SC q2w
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 206.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Moderate; Severe

Summary:

      The primary objective of the study is to evaluate the efficacy of REGN3500 monotherapy
      compared with placebo treatment in adult patients with moderate-to-severe Atopic dermatitis
      (AD).

      Secondary Objectives are to:

        -  Evaluate the efficacy of REGN3500 in combination with dupilumab compared with placebo
           treatment in adult patients with moderate-to-severe AD

        -  Assess the safety, tolerability, and immunogenicity of subcutaneous (SC) doses of
           REGN3500 monotherapy and REGN3500 in combination with dupilumab in adult patients with
           moderate-to-severe AD

        -  Evaluate the Pharmacokinetic (PK) of REGN3500 monotherapy and REGN3500 in combination
           with dupilumab in adult patients with moderate-to-severe AD
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Chronic AD, according to American Academy of Dermatology Consensus Criteria
             (Eichenfield, 2014), that has been present for at least 3 years before the screening
             visit

          2. Eczema Area and Severity Index (EASI) score ≥16 at the screening and baseline visits

          3. ≥10% Body surface area (BSA) of AD involvement at the screening and baseline visits

          4. Documented recent history (within 6 months before the screening visit) of inadequate
             response to topical AD medication(s) or for whom topical treatments are medically
             inadvisable

        Key Exclusion Criteria:

          1. Prior participation in an anti-Interleukin (IL)-33 class antibody (including but not
             limited to REGN3500) or anti-IL-4Rα class antibody (including but not limited to
             dupilumab) clinical study; past treatment with or current treatment with dupilumab or
             another anti-IL-4Rα treatment

          2. Active chronic or acute infection requiring treatment with systemic antibiotics,
             antivirals, antiparasitics, antiprotozoals, or antifungals 2 weeks before the baseline
             visit, or superficial skin infections within 1 week before the baseline visit

          3. Known or suspected history of immunosuppression, including history of invasive
             opportunistic infections (eg, tuberculosis (TB), histoplasmosis, listeriosis,
             coccidioidomycosis, pneumocystosis, aspergillosis) despite infection resolution: or
             unusually frequent, recurrent, or prolonged infections, per investigator judgment

          4. History of human immunodeficiency virus (HIV) infection or positive HIV serology at
             screening

          5. Positive with hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb),
             or hepatitis C virus antibody (HCV Ab) at the screening visit

          6. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed
             during the study

        Note: Other protocol defined Inclusion/Exclusion Criteria apply