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| ID | Type | Description | Link |
|---|---|---|---|
| CNTO1959PPP2001 | Other Identifier | Janssen Pharmaceutical K.K., Japan |
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The purpose of this study is to assess the efficacy, safety, and tolerability of CNTO 1959 following subcutaneous administration in participants with palmoplantar pustulosis.
This will be a double-blind (participants and study personnel will not know the identity of the treatments given), multicenter study that is placebo-controlled (a placebo is identical to a study treatment, but has no active ingredients). Participants will be randomly assigned to 1 of 2 treatment groups (CNTO 1959 or placebo). The total duration of participation will be approximately 30 weeks, including a screening period of about 6 weeks before dosing. Participant safety will be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| CNTO 1959 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo, as two 1-ml subcutaneous (SC) injections, at Week 0 and Week 4 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in PPSI total score at Week 16. | The Palmoplantar Pustulosis Severity Index (PPSI) assesses the severity of palmoplantar pustulosis lesions and their response to therapy. Scores can range from 0 to 12, with higher scores indicating more severity. | Baseline to Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in PPSI total score over time | The Palmoplantar Pustulosis Severity Index (PPSI) assesses the severity of palmoplantar pustulosis lesions and their response to therapy. Scores can range from 0 to 12, with higher scores indicating more severity. | Baseline up to 24 weeks |
| Change from baseline in PPPASI total score |
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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 |
|---|---|---|---|---|---|---|
| Asahikawa | Japan | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29417135 | Derived | Terui T, Kobayashi S, Okubo Y, Murakami M, Hirose K, Kubo H. Efficacy and Safety of Guselkumab, an Anti-interleukin 23 Monoclonal Antibody, for Palmoplantar Pustulosis: A Randomized Clinical Trial. JAMA Dermatol. 2018 Mar 1;154(3):309-316. doi: 10.1001/jamadermatol.2017.5937. |
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| CNTO 1959 |
| Drug |
CNTO 1959 200 mg, as two 1-ml subcutaneous (SC) injections, at Week 0 and Week 4 |
|
The Palmoplantar Pustulosis Area and Severity Index (PPPASI) assesses the severity of palmoplantar pustulosis lesions and their response to therapy. Scores can range from 0 to 72, with higher scores indicating more severity. |
| Baseline up to 24 weeks |
| Proportion of participants who achieve a PPPASI-50 | PPPASI-50 is at least 50% reduction in the PPPASI score. | Up to 24 weeks |
| Proportion of participants who achieve a PGA score of 1 or less | The Physician's Global Assessment (PGA) is used to determine the participant's overall palmoplantar pustulosis lesions, at a given time point. Scores can range from 0 (clear) to 5 (very severe). | Up to 24 weeks |
| Proportion of participants who achieve a PPPASI-75 | PPPASI-75 is at least 75% reduction in the PPPASI score. | Up to 24 weeks |
| Change from baseline in PA (each score) | The Physician's Assessment (PA) is used to determine the participant's pustule, vesicle, and nail lesions at a given time point. Scores can range from 0 (clear) to 5 (very severe). | Baseline up to 24 weeks |
| Change from baseline in Patient's VAS-PPP severity | The Patient's Visual Analogue Scale (VAS) assessment of palmoplantar pustulosis severity will be recorded on a 10-cm VAS. | Baseline up to 24 weeks |
| Change from baseline in Physician's VAS-PAO activity | Physician's Visual Analogue Scale Assessment of Pustulotic Arthro-Osteitis Activity will be recorded on a 10-cm VAS. | Baseline up to 24 weeks |
| Change from baseline in Patient's VAS-PAO activity and pain | Patient's Visual Analogue Scale Assessment of Pustulotic Arthro-Osteitis Activity and Pain will be recorded on each 10-cm VAS. | Baseline up to 24 weeks |
| Change from baseline in Dermatology Life Quality Index (DLQI) | The DLQI is a 10-item questionnaire that in addition to evaluating overall quality of life (QOL), can be used to assess 6 different aspects that may affect QOL: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. | Baseline up to 24 weeks |
| Change form baseline in SF-36 score | The 36-Item Short Form Health Survey (SF-36) consists of 8 multi-item scales: limitations in physical functioning due to health problems, limitations in usual role activities due to physical health problems, bodily pain, general mental health (psychological distress and well-being), limitations in usual role activities due to personal or emotional problems, limitations in social functioning due to physical or mental health problems, vitality (energy and fatigue), and general health perception. | Baseline up to 24 weeks |
| Fukuoka |
| Japan |
| Fukushima | Japan |
| Matsumoto | Japan |
| Sapporo | Japan |
| Sendai | Japan |
| Tokyo | Japan |
| Touon | Japan |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000588857 | guselkumab |
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