A Study of JNJ-39758979 in Adult Japanese Patients With Moderate Atopic Dermatitis

• Monitoring of clinical laboratory tests [ Time Frame: Up to approximately 14 weeks ] [ Designated as safety issue: No ]
  Assessments of blood, serum, and urine as a meaure of safety
  
  
• The number of adverse events [ Time Frame: Up to approximately 14 weeks ] [ Designated as safety issue: No ]
  As a measure of safety
  
  
• Monitoring of electrocardiograms [ Time Frame: Up to approximately 14 weeks ] [ Designated as safety issue: No ]
  As a measure of safety
  
  
• Monitoring of vital signs tests [ Time Frame: Up to approximately 14 weeks ] [ Designated as safety issue: No ]
  Blood pressure and pulse as a measure of safety
  
  
• EASI (Eczema Area and Severity Index) score [ Time Frame: Up to approximately 14 weeks ] [ Designated as safety issue: No ]
  A measure of the severity and extent of atopic dermatitis
  
  
• Monitoring of physical examination assessments [ Time Frame: Up to 10 weeks ] [ Designated as safety issue: No ]
  Including height and body weight, as a measure of safety
  
  

• Investigator's Global Assessment (IGA) [ Time Frame: Up to approximately 14 weeks ] [ Designated as safety issue: No ]
  A 6-point scale that ranges from 0 (clear) to 5 (very severe disease).
  
  
• Pruritus Categorical Response Scale (PCRS) [ Time Frame: Up to approximately 14 weeks ] [ Designated as safety issue: No ]
  A 5-point categorical response scale where the response options range from "no itching" to "extremely severe itching."
  
  
• Pruritus Numeric Rating Scales (PNRS) [ Time Frame: Up to approximately 14 weeks ] [ Designated as safety issue: No ]
  An 11-point (0 to 10) numeric rating scale.
  
  
• Pruritus Interference Numeric Rating Scale (PINRS) [ Time Frame: Up to approximately 14 weeks ] [ Designated as safety issue: No ]
  An 11-point numerical rating scale of 0 to 10, where 0 = "Did Not Interfere" and 10 = "Completely Interfered."
  
  
• Subject's Global Impressions of Change in Pruritus (SGICP) [ Time Frame: Up to 10 weeks ] [ Designated as safety issue: No ]
  A 7-point scale ranging from "a lot more now" to " a lot less now" with a neutral center point ("neither more nor less").
  
  

This is a randomized (treatment assigned by chance), double-blind (patient and investigator will not know what treatment is being given), multicenter, parallel-group, exploratory study in adult Japanese patients with moderate atopic dermatitis. This study will include 3 phases. In the screening phase, patients' eligibility will be determined. During the treatment phase, eligible patients will receive JNJ-39758979, 300 or 100 mg once daily, or placebo (a treatment that looks like JNJ-39758979, but contains no active agent) for up to 6 weeks. Study visits will occur at the end of Weeks 1, 2, 4, and 6. There will be a follow-up visit 4 weeks after dosing is complete. The duration of participation in the study for an individual patient may be up to 14 weeks (including screening). Patient safety will be monitored throughout the study.