A Study of Ustekinumab (STELARA®) in Adult Japanese Participants With Severe Atopic Dermatitis
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      This is a randomized (the study medication is assigned by chance), double-blind (neither
      physician nor participant knows the identity of the assigned treatment), placebo-controlled
      (one of the study medications is inactive), multicenter, parallel group study (each
      participant group receives different treatments simultaneously). Participants will be
      randomly assigned in a 1:1:1 ratio to receive either ustekinumab 45 mg, ustekinumab 90 mg, or
      placebo. The study will consist of a screening period, a 12-week double-blind treatment
      period, and a 12-week follow-up period. During the double-blind treatment period,
      participants will receive one subcutaneous injection of study medication at Week 0 and Week
      4. Participants will return to the study center for 7 evaluation visits on Weeks 2, 4, 8, 12,
      16, 20, and 24. Clinical response will be evaluated by Eczema Area and Severity Index (EASI),
      Investigator's Global Assessment (IGA), photography, and Dermatology Life Quality Index
      (DLQI). Participants will record their itch condition twice daily using the participant daily
      diary from 2 weeks prior to randomization until Week 12. Blood samples will be drawn at time
      periods during the screening, double-blind treatment, and follow-up periods. Participant
      safety will be monitored throughout the study. Participants are permitted to use concomitant
      topical medications, as defined in the protocol and without any increase in dose, from 4
      weeks prior to randomization through to the end of the treatment period. After Week 12,
      additional treatment can be started or the dose of concomitant medications can be increased,
      if no improvement in clinical response is observed; in these cases EASI, IGA, and photography
      evaluations will be stopped. The study duration for each participant is expected to be
      approximately 30 weeks. Ustekinumab (also known as STELARA) is an antibody medication that
      inhibits the inflammatory proteins IL-12 and IL-23 and is approved as a treatment for
      moderate to severe plaque-type psoriasis; this study will examine whether ustekinumab can
      provide benefit in atopic dermatitis and assess for any risks or side effects.
    

Intervention name(s): Ustekinumab; Placebo; Concomitant topical medications for atopic dermatitis
Intervention type(s): Drug; Drug; Other
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dermatitis, Atopic; Eczema; Ustekinumab; CNTO1275; STELARA