Efficacy, Safety, and Pharmacokinetic Profiles of REGN3500 Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: REGN3500; REGN3500-Matching Placebo
Intervention description: Administered subcutaneous (SC); Administered subcutaneous (SC)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 129.0
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 assess the efficacy of REGN3500 monotherapy in
      Atopic dermatitis (AD), as well as understand the dose-response relationship, compared with
      placebo treatment, in adult patients with moderate-to-severe AD.

      Secondary objectives are to:

        -  Assess the safety and tolerability of subcutaneous (SC) doses of REGN3500 monotherapy in
           adult patients with moderate-to-severe AD

        -  Assess the Pharmacokinetics (PK) of REGN3500 in adult patients with moderate-to-severe
           AD

        -  Assess the immunogenicity of REGN3500 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. IGA score ≥3 (on the 0 to 4 IGA scale, in which 3 is moderate and 4 is severe) at
             screening and baseline visits

          4. ≥10% Body surface area (BSA) of AD involvement at the screening and baseline visits

          5. 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. Participation in a prior anti-Interleukin (IL)-33 medication clinical study

          2. Treatment with an investigational drug within 8 weeks or within 5 half-lives (if
             known), whichever is longer, before the baseline visit

          3. Having used any of the following treatments within 4 weeks before the baseline visit
             or any condition that, in the opinion of the investigator, is likely to require such
             treatment(s) during the first 4 weeks of study treatment:

               1. Immunosuppressive/immunomodulating drugs (eg, systemic corticosteroids,
                  cyclosporine, mycophenolate-mofetil, Interferon-gamma (IFN-γ), Janus kinase
                  inhibitors, azathioprine, methotrexate, etc)

               2. Phototherapy for AD

          4. Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks of
             the baseline visit

          5. Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit

          6. Active chronic or acute infection requiring treatment with systemic antibiotics,
             antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the
             baseline visit

          7. Known or suspected history of immunosuppression

          8. History of human immunodeficiency virus (HIV) infection or positive HIV serology at
             screening

          9. Positive with hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb),
             or hepatitis C virus antibody (HCV Ab) at the screening visit

         10. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed
             during the study

        Note: Other protocol defined Inclusion/Exclusion Criteria apply