A Phase 2 interventional study of Placebo and CNTO 1959 in Palmoplantaris Pustulosis, sponsored by Janssen Pharmaceutical K.K.. Completed at 8 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2015-11-20.
Sponsored by Janssen Pharmaceutical K.K. · Phase 2, Interventional, and Treatment
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.
1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.
This study's enrollment of 49 is below the median of 70 across 1,447 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →Janssen Pharmaceutical K.K. is the lead sponsor of 122 studies on the registry; none are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 6 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Placebo
Drug: CNTO 1959
Placebo, as two 1-ml subcutaneous (SC) injections, at Week 0 and Week 4
CNTO 1959 200 mg, as two 1-ml subcutaneous (SC) injections, at Week 0 and Week 4
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.
Time frame: Baseline to Week 16
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.
Time frame: Baseline up to 24 weeks
Change from baseline in PPPASI total score
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.
Time frame: Baseline up to 24 weeks
Proportion of participants who achieve a PPPASI-50
PPPASI-50 is at least 50% reduction in the PPPASI score.
Time frame: 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).
Time frame: Up to 24 weeks
Proportion of participants who achieve a PPPASI-75
PPPASI-75 is at least 75% reduction in the PPPASI score.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline up to 24 weeks
This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
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Janssen Pharmaceutical K.K.