A Study of JNJ-39758979 in Adult Japanese Patients With Moderate Atopic Dermatitis
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|ClinicalTrials.gov Identifier: NCT01497119|
Recruitment Status : Terminated (This study was terminated prematurely due to 2 cases of agranulocytosis.)
First Posted : December 22, 2011
Last Update Posted : December 2, 2015
|Condition or disease||Intervention/treatment||Phase|
|Dermatitis, Atopic||Drug: JNJ-39758979, 300 mg Drug: JNJ-39758979, 100 mg Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||88 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group Study of JNJ-39758979 in Adult Japanese Subjects With Moderate Atopic Dermatitis|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||February 2012|
|Experimental: JNJ-39758979, 300 mg||
Drug: JNJ-39758979, 300 mg
Type=exact number, unit=mg, number=300, form=tablet, route=oral use, once daily for 6 weeks.
|Experimental: JNJ-39758979, 100 mg||
Drug: JNJ-39758979, 100 mg
Type=exact number, unit=mg, number=100, form=tablet, route=oral use, once daily for 6 weeks.
|Placebo Comparator: Placebo||
Form=tablet, route=oral use, once daily for 6 weeks.
- 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
- 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").
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01497119
|Study Director:||Janssen Pharmaceutical K.K., Japan Clinical Trial||Janssen Pharmaceutical K.K.|