A Study of Ustekinumab (STELARA®) in Adult Japanese Participants With Severe Atopic Dermatitis
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis
Intervention: Ustekinumab; Placebo; Concomitant topical medications for atopic dermatitis
Intervention description: Participants will receive subcutaneous (SC) injections of either ustekinumab 45 mg or ustekinumab 90 mg at Week 0 and Week 4.; Participants will receive SC injections of placebo at Week 0 and Week 4.; Concomitant topical medications (as defined in the protocol) can be used from 4 weeks prior to randomization and throughout the study. However, the dosage cannot be increased and new medications cannot be added until after Week 12.
Intervention MeSH terms: Ustekinumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 79.0
Sex: All
Minimum age: 20 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Dermatitis, Atopic; Eczema; Ustekinumab; CNTO1275; STELARA

Summary:

      The purpose of this study is to assess the safety and effectiveness of 2 doses of ustekinumab
      compared with placebo (inactive medication) in adult Japanese participants with severe atopic
      dermatitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be Japanese

          -  Must have a diagnosis of atopic dermatitis, with childhood onset (under age of 13), in
             accordance with the definition and diagnostic criteria of the Japanese Dermatological
             Association and must have pruritus and eczematous changes; the condition must be
             chronic or chronically relapsing in nature

          -  Inadequate response to, or not willing to use strong treatment with a topical
             corticosteroid and/or a topical calcineurin inhibitor and/or phototherapy

          -  Must meet all the following criteria regarding severity of atopic dermatitis:
             Rajka-Langeland score of 8 to 9; severe or very severe disease as defined in standard
             treatment guidelines; an Eczema Area and Severity Index (EASI) score of >= 12; and an
             Investigator's Global Assessment (IGA) score of severe disease or very severe disease

          -  Must conform to the following tuberculosis (TB) screening criteria: no history of
             latent or active TB prior to screening; no signs or symptoms suggestive of active TB;
             no recent close contact with a person with active TB; and a negative Interferon Gamma
             Release Assay (IGRA) result within 2 months prior to the first administration of study
             drug

        Exclusion Criteria:

          -  History of or current clinically significant medical illness that the investigator
             considers should exclude the participant or that could interfere with the
             interpretation of the study results

          -  Has an indeterminate initial and repeat IGRA result or a newly positive IGRA result
             and is unwilling or unable to undergo TB prophylaxis treatment

          -  Has received any of the following medications or therapies within 4 weeks prior to
             randomization: systemic non-steroid immunosuppressive or immunomodulatory drugs;
             systemic corticosteroids; high daily dose of inhaled corticosteroids; topical
             corticosteroids of strongest potency for atopic dermatitis; topical antihistamines
             (including topical doxepin); topical anesthetics; topical nonsteroidal
             anti-inflammatory drugs; topical counter-irritants (eg, capsaicin, menthol,
             wintergreen oil); antidepressants or antipsychotics; soporifics; phototherapy
             including ultraviolet A , ultraviolet B, and psoralen with ultraviolet A (PUVA);
             hyposensitization (desensitization) therapy

          -  Has changed the dose and dosing regimen within 4 weeks prior to randomization of any
             of the following drugs: topical corticosteroid (excluding the strongest potency) for
             atopic dermatitis; topical calcineurin inhibitor; emollients; anti-leukotriene
             therapies (including therapies for other allergic indications); systemic histamine H1
             blocker (including sleep medications with antihistamine properties); sodium
             cromoglicate; suplatast tosilate; tranilast; thromboxane A2 inhibitors; and topical or
             oral herbal preparations for the treatment of atopic dermatitis

          -  Has received any of the following biologic agents within the following time periods:
             any marketed immunomodulatory biologic within a period of 3 months or 5 half-lives,
             whichever is longer, prior to randomization; a biologic agent targeting IL-12 or
             IL-23, including but not limited to ustekinumab (CNTO 1275), briakinumab (ABT-874),
             guselkumab (CNTO 1959) or MK-3222 at any point in time; or an experimental biologic
             therapy within the previous 6 months