Clinical trial NCT01497119: A Study of JNJ-39758979 in Adult Japanese Patients With Moderate Atopic Dermatitis
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group Study of JNJ-39758979 in Adult Japanese Subjects With Moderate Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Dermatitis, Atopic
Keywords: Moderate atopic dermatitis
JNJ-39758979
Japanese patients
Lead sponsor: Janssen Pharmaceutical K.K.
Sponsor class: INDUSTRY
First posted: 2011-12-22
Enrollment: 88
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Monitoring of clinical laboratory tests
timeFrame: Up to approximately 14 weeks
measure: The number of adverse events
timeFrame: Up to approximately 14 weeks
measure: Monitoring of electrocardiograms
timeFrame: Up to approximately 14 weeks
measure: Monitoring of vital signs tests
timeFrame: Up to approximately 14 weeks
measure: EASI (Eczema Area and Severity Index) score
timeFrame: Up to approximately 14 weeks
measure: Monitoring of physical examination assessments
timeFrame: Up to 10 weeks
Secondary outcomes:
measure: Investigator's Global Assessment (IGA)
timeFrame: Up to approximately 14 weeks
measure: Pruritus Categorical Response Scale (PCRS)
timeFrame: Up to approximately 14 weeks
measure: Pruritus Numeric Rating Scales (PNRS)
timeFrame: Up to approximately 14 weeks
measure: Pruritus Interference Numeric Rating Scale (PINRS)
timeFrame: Up to approximately 14 weeks
measure: Subject's Global Impressions of Change in Pruritus (SGICP)
timeFrame: Up to 10 weeks
Other outcomes:
Locations:
city: Chitose
country: Japan
city: Dazaifu
country: Japan
city: Ebetsu
country: Japan
city: Eniwa
country: Japan
city: Fukuoka
country: Japan
city: Kasuga
country: Japan
city: Matsudo
country: Japan
city: Saitama
country: Japan
city: Sapporo
country: Japan
city: Setagaya
country: Japan
city: Tokyo
country: Japan
city: Utsunomiya
country: Japan
city: Yokohama
country: Japan
Study officials:
affiliation: Janssen Pharmaceutical K.K.
name: Janssen Pharmaceutical K.K., Japan Clinical Trial
role: STUDY_DIRECTOR
References: