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

Study Overview
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Brief Summary
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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 Description
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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.

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

Conditions
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Dermatitis, Atopic

Intervention / Treatment
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* Drug: JNJ-39758979, 300 mg
* Drug: JNJ-39758979, 100 mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of atopic dermatitis based on the criteria of the Japanese Dermatological Association and have: pruritus (itching); eczema-like changes in a typical pattern, and a chronic or chronically relapsing course. Childhood onset (under age of 13) of atopic dermatitis. Diagnosis of moderate atopic dermatitis based on the Rajka Langeland score between 4.5 and 7.5, inclusive. Have at least 3 ratings of Moderate itching, Severe itching, or Extremely severe itching either at night or during the day based on the Pruritus Categorical Response Scale (PCRS) in the 7 days prior to randomization. Atopic dermatitis with 10% to 50% (inclusive) Body Surface Area (BSA) involvement. Exclusion Criteria: Have current signs or symptoms of liver or renal insufficiency or cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, psychiatric, or metabolic disturbances that are severe, progressive or uncontrolled in the Investigator's opinion. Patients with well controlled asthma, allergic rhinitis, or allergic conjunctivitis are allowed to participate. Atopic dermatitis patients with other chronic conditions will not be excluded if the Investigator has determined that the condition is not severe or progressive and is being controlled with stable therapy. Have any known malignancy or have a history of malignancy (with the exception of basal cell carcinoma, squamous cell carcinoma in situ of the skin, or squamous cell carcinoma of the skin that has been treated with no evidence of recurrence within 5 years prior to the first administration of study agent). Evidence of any other skin condition that, in the opinion of the Investigator, would interfere with the assessment of atopic dermatitis. Use of non-steroid immunosuppressive or immunomodulatory agents within 4 weeks of randomization, including cyclosporine A, azathioprine, mycophenolate mofetil, and interferon gamma. Use of systemic corticosteroids within 4 weeks of randomization.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: JNJ-39758979, 300 mg<br> | Drug: JNJ-39758979, 300 mg<br>* Type=exact number, unit=mg, number=300, form=tablet, route=oral use, once daily for 6 weeks.<br>|
| Experimental: JNJ-39758979, 100 mg<br> | Drug: JNJ-39758979, 100 mg<br>* Type=exact number, unit=mg, number=100, form=tablet, route=oral use, once daily for 6 weeks.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Form=tablet, route=oral use, once daily for 6 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Moderate atopic dermatitis, JNJ-39758979, Japanese patients