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| ID | Type | Description | Link |
|---|---|---|---|
| 39758979ADM2001 | Other Identifier | Janssen Pharmaceutical K.K., Japan |
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This study was terminated prematurely due to 2 cases of agranulocytosis.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JNJ-39758979, 300 mg | Experimental |
| |
| JNJ-39758979, 100 mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-39758979, 300 mg | Drug | Type=exact number, unit=mg, number=300, form=tablet, route=oral use, once daily for 6 weeks. |
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| 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 |
| 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." |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Pharmaceutical K.K., Japan Clinical Trial | Janssen Pharmaceutical K.K. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chitose | Japan | |||||
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| JNJ-39758979, 100 mg | Drug | Type=exact number, unit=mg, number=100, form=tablet, route=oral use, once daily for 6 weeks. |
|
| Placebo | Drug | Form=tablet, route=oral use, once daily for 6 weeks. |
|
| 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 |
| Dazaifu |
| Japan |
| Ebetsu | Japan |
| Eniwa | Japan |
| Fukuoka | Japan |
| Kasuga | Japan |
| Matsudo | Japan |
| Saitama | Japan |
| Sapporo | Japan |
| Setagaya City | Japan |
| Tokyo | Japan |
| Utsunomiya | Japan |
| Yokohama | Japan |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |