A Study of Intravenous MK-8226 in Participants With Moderate-to-Severe Atopic Dermatitis (MK-8226-003)
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: MK-8226; Placebo
Intervention description: MK-8226 administered IV at a weight-based dose every 2 weeks for 12 weeks.; Placebo administered IV every 2 weeks for a period of 12 weeks.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 65.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a 3-part study to assess the safety, tolerability, efficacy, pharmacokinetics (PK),
      pharmacodynamics (PD), and immunogenicity of MK-8226 in participants with moderate to severe
      atopic dermatitis. Part 1 (multiple rising dose study) objectives were to find the maximum
      tolerated dose (MTD) of MK-8226 and to assess safety and PK. Part 2 objectives were to
      determine safety, PK, and preliminary efficacy. Part 3 objectives were to further define
      safety and PK, and explore MK-8226 PK/PD to model the optimal dose range for future studies.
      The study was terminated early due to business reasons on 08 May 2014; final results from an
      analysis for Part 1 (efficacy, PK, safety, immunogenicity) and Part 2 (safety,
      immunogenicity) are summarized.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body weight >=40 kg

          -  Clinical diagnosis of atopic dermatitis for at least 6 months prior

          -  Candidate for systemic or phototherapy (i.e., failed topical treatment)

          -  Moderate-to-severe disease as defined by Body Surface Area (BSA) ≥10%, EASI ≥12, and
             IGA ≥3

          -  No clinically significant abnormality on electrocardiogram

          -  No history of active or latent tuberculosis (TB) and no signs or symptoms suggestive
             of TB

          -  No history of active or latent TB and no signs or symptoms suggestive of TB

          -  History of inadequate response to a stable (≥ 1 month) regimen of topical
             corticosteroids or calcineurin inhibitors within 3 months before the screening visit

        Exclusion Criteria:

          -  Concurrent significant skin disease

          -  Any significant organ dysfunction within 6 months prior

          -  History of clinically significant heart disease

          -  History of neoplastic disease

          -  Positive for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)

          -  Infection requiring oral antibiotics within 2 weeks prior

          -  Receipt of a live virus vaccine within 4 weeks prior

          -  Inability to refrain from topical or systemic therapy during course of the study

          -  Had major surgery or donated or lost >=1 unit of blood within 4 weeks prior

          -  Participation in another study within 4 weeks prior

          -  Current or regular user of illicit drugs or a history of drug or alcohol abuse within
             1 year prior

          -  Pregnant, breast-feeding, or anticipated to conceive during the course of the study