Evaluation of Dupilumab in Chinese Adult Patients With Moderate to Severe Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Dupilumab; Placebo; Emollient (moisturizer)
Intervention description: Pharmaceutical form: solution,
Route of administration: SC; Pharmaceutical form: solution,
Route of administration: SC; Pharmaceutical form: cream,
Route of administration: topical use
Intervention MeSH terms: Emollients
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 165.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Primary Objective:

      To evaluate the efficacy of dupilumab monotherapy compared to placebo treatment in adult
      participants with moderate-to-severe atopic dermatitis (AD).

      Secondary Objectives:

        -  To evaluate the safety of dupilumab monotherapy compared to placebo treatment in adult
           participants with moderate-to-severe AD.

        -  To evaluate the effect of dupilumab on improving patient reported outcomes (PROs).

        -  To evaluate dupilumab immunogenicity.
    

Eligibility criteria:

        Inclusion criteria:

          -  Male or female, 18 years or older.

          -  AD (according to American Academy of Dermatology Consensus Criteria, 2014) that had
             been present for at least 3 years before the screening visit.

          -  Eczema Area and Severity Index (EASI) score greater than or equal to (>=) 16 at the
             screening and baseline visits.

          -  Investigator's Global Assessment (IGA) score >=3 (on the 0 to 4 IGA scale, in which 3
             was moderate and 4 was severe) at the screening and baseline visits.

          -  Participants with >=10 percent (%) body surface area (BSA) of AD involvement at the
             screening and baseline visits.

          -  Baseline Pruritus Numerical Rating Scale (NRS) average score for maximum itch
             intensity >=4.

          -  Documented recent history (within 6 months before the screening visit) of inadequate
             response to treatment with topical medications or for whom topical treatments were
             otherwise medically inadvisable (e.g., because of important side effects or safety
             risks).

        Exclusion criteria:

          -  Had used any of the following treatments within 4 weeks before the baseline visit, or
             any condition that, in the opinion of the investigator, was likely to require such
             treatment(s) during the first 4 weeks of study treatment:

               -  Immunosuppressive/immunomodulating drugs (e.g., systemic corticosteroids,
                  cyclosporine, mycophenolate-mofetil, interferon-gamma [IFN-γ], Janus kinase
                  inhibitors, azathioprine, methotrexate);

               -  Phototherapy for AD.

          -  Treatment with topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI)
             within 1 week before the baseline visit.

          -  Treatment with systemic Traditional Chinese Medicine (TCM) within 4 weeks before the
             baseline visit or treatment with topical TCM within 1 week before the baseline visit.

          -  Treatment with biologics as follows:

               -  Any cell-depleting agents including but not limited to rituximab: within 6 months
                  before the baseline visit, or until lymphocyte count returns to normal, whichever
                  is longer;

               -  Other biologics: within 5 half-lives (if known) or 16 weeks prior to baseline
                  visit, whichever was longer.

          -  Initiation of treatment of AD with prescription moisturizers or moisturizers
             containing additives such as ceramide, hyaluronic acid, urea, or filaggrin degradation
             products during the screening period (participants may continue using stable doses of
             such moisturizers if initiated before the screening visit).

          -  Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks of
             the baseline visit.

          -  Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit.

          -  Active chronic or acute infection requiring treatment with systemic antibiotics,
             antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the
             baseline visit, or superficial skin infections within 1 week before the baseline
             visit. NOTE: participants may be rescreened after infection resolves.

          -  Known or suspected history of immunosuppression, including history of invasive
             opportunistic infections (e.g., tuberculosis [TB], histoplasmosis, listeriosis,
             coccidioidomycosis, pneumocystosis, aspergillosis) despite infection resolution: or
             unusually frequent, recurrent, or prolonged infections, per investigator judgment.

          -  Active TB, latent untreated TB or a history of incompletely treated TB or
             non-tuberculous mycobacterial infection were excluded from the study unless that was
             well documented by a specialist that the participants had adequately treated and could
             then start treatment with a biologic agent, in the medical judgment of the
             Investigator and/or infectious disease specialist. TB testing would be performed
             according to local guidelines if required by regulatory authorities or ethics
             committees.

        The above information was not intended to contain all considerations relevant to a
        participants potential participation in a clinical trial.