Open-label Study of Dupilumab in Patients With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Dupilumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2733.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective is to assess the long-term safety of dupilumab administered in adult
      participants with atopic dermatitis (AD).

      The secondary objective of the study is to assess the immunogenicity of dupilumab in adult
      participants with AD, in the context of re-treatment, and to monitor efficacy parameters
      associated with long-term treatment.

      Optional Sub-Study:

      The primary objective of the sub-study is to assess the safety of the new dupilumab drug
      product in adult patients with AD after switching from the current dupilumab drug product.

      The secondary objectives of the sub-study are to evaluate systemic exposure and
      immunogenicity of the new dupilumab drug product in adult patients with AD.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Participation in a prior clinical trial of dupilumab for AD and met one of the
             following:

               1. Received study treatment and adequately completed the assessments required for
                  both the treatment and follow-up periods of the parent studies (except studies
                  listed in b) as defined in the parent protocols

               2. Received study treatment in one the studies that have completed last patient,
                  last visit irrespective of duration of participation, provided that patients
                  completed with the instructions received during the study.

               3. Underwent screening in R668-AD-1334 (Liberty AD SOLO 1) or R668-AD-1416 (Liberty
                  AD SOLO 2) but could not be randomized due to randomization closure.

          2. Willing and able to comply with all clinic visits and study-related procedures

          3. Able to understand and complete study-related questionnaires

          4. Provide signed informed consent

        Optional Sub-Study:

          1. Provide separate informed consent

          2. Continuing in the treatment period of the main OLE study

          3. Demonstrated compliance with dupilumab therapy, as defined in the protocol

        Key Exclusion Criteria:

          1. Patients who, during their participation in a previous dupilumab clinical trial,
             developed a serious adverse event (SAE) deemed related to dupilumab*, which in the
             opinion of the investigator or of the medical monitor could indicate that continued
             treatment with dupilumab may present an unreasonable risk for the patient.

          2. Patients who, during their participation in a previous dupilumab clinical trial,
             developed an AE that was deemed related to dupilumab* and led to study treatment
             discontinuation, which in the opinion of the investigator or of the medical monitor
             could indicate that continued treatment with dupilumab may present an unreasonable
             risk for the patient.

          3. Conditions in the previous dupilumab study consistent with protocol-defined criteria
             for permanent study drug discontinuation, if deemed related to dupilumab* or led to
             investigator - or sponsor-initiated withdrawal of patient from the study (eg,
             non-compliance, inability to complete study assessments, etc.).

             *Note for exclusion criteria # 1, 2, and 3: In studies that are still blinded,
             conditions deemed related to the study treatment will be considered related to
             dupilumab.

          4. Treatment with an investigational drug, other than dupilumab, within 8 weeks or within
             5 half-lives (if known), whichever is longer, before the baseline visit

          5. Pregnant or breastfeeding women, or planning to become pregnant or breastfeed during
             the patient's participation in this study

        Optional Sub-Study:

        1. Patients who have already completed the end of treatment visit (ie, visit 44) for the
        main study R668-AD-1225

        Note: Other Protocol Defined Inclusion / Exclusion Criteria Apply.