A Study to Determine the Safety and Tolerability of Dupilumab (REGN668/SAR231893) in Patients Aged ≥6 to <18 Years With Atopic Dermatitis (Eczema)
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Dupilumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 78.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Eczema

Summary:

      The primary objective of the study is to characterize the safety and pharmacokinetics (PK) of
      dupilumab in pediatric patients with moderate-to-severe atopic dermatitis (AD) (for
      adolescents ≥12 to <18 years of age) or severe AD (for children ≥6 to <12 years of age).

      The secondary objective of the study is to explore the immunogenicity and efficacy of
      dupilumab in pediatric patients with moderate-to-severe AD (for adolescents ≥12 to <18 years
      of age) or severe AD (for children ≥6 to <12 years of age).
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Male or female patients ≥6 to <18 years of age with a diagnosis of 1. Atopic
             Dermatitis whose disease cannot be adequately controlled with topical medications

          2. Minimum disease severity, as defined by Investigator's Global Assessment (IGA)

               1. IGA = 3 or 4 in adolescents ≥12 to <18 year of age

               2. IGA = 4 in children ≥6 to <12 years of age

        Key Exclusion Criteria:

          1. Recent treatment (within specific time windows before the baseline visit) with
             systemic immunosuppressive agents for eg. Systemic corticosteroids, live (attenuated)
             vaccines and other investigational drugs including biologics

          2. History of any of the following infections:

               1. Any systemic infection requiring treatment within 4 weeks before the baseline
                  visit

               2. Superficial skin infections within 1 week before the baseline visit

               3. Known history of HIV infection

               4. History of seropositivity to hepatitis B or C screening tests

               5. History of clinical endoparasitosis (ie, helminthic infection) within 12 months
                  before the baseline visit, or high risk of helminthic infection, unless
                  subsequent medical assessments (e.g. stool exam, blood tests, etc.) have ruled
                  out the possibility of parasite infection/infestation

          3. History of malignancy within 5 years before the baseline visit

          4. Persistent (confirmed by repeated tests ≥2 weeks apart) elevated transaminases
             (alanine aminotransferase [ALT] and/or aspartate aminotransferase [AST]) more than 3
             times the upper limit of normal (ULN) during the screening period

          5. Presence of any severe concomitant illness(es) that, in the investigator's judgment,
             would adversely affect the patient's participation in the study

          6. Presence of skin comorbidities that may interfere with study assessments

          7. Females patients who are pregnant or breastfeeding

          8. Female patients who are of reproductive potential and are sexually active, who are
             unwilling to use adequate methods of contraception