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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group Study of JNJ-39758979 in Adult Japanese Subjects With Moderate Atopic Dermatitis

Brief Summary: The purpose of this study is to evaluate the safety, tolerability, and efficacy of JNJ-39758979 in adult Japanese patients with moderate, active atopic dermatitis.

Detailed Summary: 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.
Sponsor: Janssen Pharmaceutical K.K.

Current Primary Outcome:

• Monitoring of clinical laboratory tests [ Time Frame: Up to approximately 14 weeks ]
  Assessments of blood, serum, and urine as a meaure of safety
• The number of adverse events [ Time Frame: Up to approximately 14 weeks ]
  As a measure of safety
• Monitoring of electrocardiograms [ Time Frame: Up to approximately 14 weeks ]
  As a measure of safety
• Monitoring of vital signs tests [ Time Frame: Up to approximately 14 weeks ]
  Blood pressure and pulse as a measure of safety
• EASI (Eczema Area and Severity Index) score [ Time Frame: Up to approximately 14 weeks ]
  A measure of the severity and extent of atopic dermatitis
• Monitoring of physical examination assessments [ Time Frame: Up to 10 weeks ]
  Including height and body weight, as a measure of safety

Original Primary Outcome:

• Changes in clinical laboratory tests [ Time Frame: Up to approximately 14 weeks ]
  Assessments of blood, serum, and urine
• The number of adverse events [ Time Frame: Up to approximately 14 weeks ]
• Changes in electrocardiograms [ Time Frame: Up to approximately 14 weeks ]
• Changes in vital signs [ Time Frame: Up to approximately 14 weeks ]
  Blood pressure and pulse
• Change in EASI (Eczema Area and Severity Index) score [ Time Frame: Up to approximately 14 weeks ]
  A measure of the severity and extent of atopic dermatitis
• Changes in physical examination evaluations [ Time Frame: Up to 10 weeks ]
  Including height and body weight

Current Secondary Outcome:

• Investigator's Global Assessment (IGA) [ Time Frame: Up to approximately 14 weeks ]
  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 ]
  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 ]
  An 11-point (0 to 10) numeric rating scale.
• Pruritus Interference Numeric Rating Scale (PINRS) [ Time Frame: Up to approximately 14 weeks ]
  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 ]
  A 7-point scale ranging from "a lot more now" to " a lot less now" with a neutral center point ("neither more nor less").

Original Secondary Outcome: Same as current

Information By: Janssen Pharmaceutical K.K.

Dates:
Date Received: December 20, 2011
Date Started: October 2011
Date Completion:
Last Updated: November 30, 2015
Last Verified: November 2015