A Study to Confirm the Efficacy and Safety of Different Dupilumab Dose Regimens in Adults With Atopic Dermatitis (AD)
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Dupilumab; Placebo
Intervention description: Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) was administered.; Subcutaneous injection of Placebo (for Dupilumab) was administered once weekly (QW).
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 422.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Eczema

Summary:

      The primary objective of the study was to assess the ability of different Dupilumab dose
      regimens, administered as monotherapy, to maintain the treatment response achieved after 16
      weeks of initial treatment with Dupilumab monotherapy compared to placebo.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Must have completed the treatment phase in 1 of the two 16-week initial treatment
             studies (R668-AD-1334 or R668-AD-1416).

          2. Must have achieved at least 1 of the following 2 treatment success criteria:

             Investigator Global Assessment (IGA) = 0 or 1 (clear or almost clear) at week 16 OR
             Eczema Area and Severity Index >= 75% (EASI-75) (at least 75% reduction in EASI score
             from baseline to week 16)

          3. Must be willing and able to comply with clinic visits and study-related procedures

          4. Must provide signed informed consent

          5. Must be able to understand and complete study-related questionnaires

        Key Exclusion Criteria:

          1. Receipt of rescue medication for AD in the initial treatment study

          2. Any conditions that require permanent discontinuation of study treatment in either
             initial treatment study

          3. Planned or anticipated major surgical procedure during the participants's
             participation in this study

          4. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed
             during this study

          5. Women unwilling to use adequate birth control, if of reproductive potential* and
             sexually active. Adequate birth control is defined as agreement to consistently
             practice an effective and accepted method of contraception, whenever engaging in
             heterosexual intercourse, throughout the duration of the study and for 120 days after
             last dose of study drug. These include hormonal contraceptives, intrauterine device,
             or double barrier contraception (e.g, condom + diaphragm), or a male partner with
             documented vasectomy. Additional requirements for acceptable contraception may apply
             in certain countries, based on local regulations. Investigators in these countries
             will be notified accordingly in a protocol clarification letter.

        (*For females, menopause is defined as at least 12 consecutive months without menses; if in
        question, a follicle stimulating hormone level of >= 25 milli units per milliliter (mU/mL)
        must be documented. Hysterectomy, bilateral oophorectomy, or bilateral tubal ligation must
        be documented, as applicable; if documented, women with these conditions are not required
        to use additional contraception).