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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
88
Type=exact number, unit=mg, number=300, form=tablet, route=oral use, once daily for 6 weeks.
Type=exact number, unit=mg, number=100, form=tablet, route=oral use, once daily for 6 weeks.
Form=tablet, route=oral use, once daily for 6 weeks.
Unnamed facility
Chitose, Japan
Unnamed facility
Dazaifu, Japan
Unnamed facility
Ebetsu, Japan
Unnamed facility
Eniwa, Japan
Monitoring of clinical laboratory tests
Assessments of blood, serum, and urine as a meaure of safety
Time frame: Up to approximately 14 weeks
The number of adverse events
As a measure of safety
Time frame: Up to approximately 14 weeks
Monitoring of electrocardiograms
As a measure of safety
Time frame: Up to approximately 14 weeks
Monitoring of vital signs tests
Blood pressure and pulse as a measure of safety
Time frame: Up to approximately 14 weeks
EASI (Eczema Area and Severity Index) score
A measure of the severity and extent of atopic dermatitis
Time frame: Up to approximately 14 weeks
Monitoring of physical examination assessments
Including height and body weight, as a measure of safety
Time frame: Up to 10 weeks
Investigator's Global Assessment (IGA)
A 6-point scale that ranges from 0 (clear) to 5 (very severe disease).
Time frame: 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."
Time frame: Up to approximately 14 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Fukuoka, Japan
Unnamed facility
Kasuga, Japan
Unnamed facility
Matsudo, Japan
Unnamed facility
Saitama, Japan
Unnamed facility
Sapporo, Japan
Unnamed facility
Setagaya City, Japan
...and 3 more locations
Pruritus Numeric Rating Scales (PNRS)
An 11-point (0 to 10) numeric rating scale.
Time frame: 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."
Time frame: 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").
Time frame: Up to 10 weeks