- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01845987
A Study of the Efficacy, Safety and Tolerability of CNTO 1959, a Human Anti-IL 23 Monoclonal Antibody in Participants With Palmoplantar Pustulosis
October 26, 2015 updated by: Janssen Pharmaceutical K.K.
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of CNTO 1959, a Human Anti-IL 23 Monoclonal Antibody, Following Subcutaneous Administration in Subjects With Palmoplantar Pustulosis
The purpose of this study is to assess the efficacy, safety, and tolerability of CNTO 1959 following subcutaneous administration in participants with palmoplantar pustulosis.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
49
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Asahikawa, Japan
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Fukuoka, Japan
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Fukushima, Japan
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Matsumoto, Japan
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Sapporo, Japan
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Sendai, Japan
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Tokyo, Japan
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Touon, Japan
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Participant has a diagnosis of palmoplantar pustulosis at screening (participants with concurrent extra-palmoplantar lesions [includes plaque-type psoriasis lesions] and/or pustulotic arthro-osteitis [PAO] can also be included)
- Participant has active lesions on the palms or soles at screening and baseline
- Participant has inadequate response to treatment with topical steroid and/or topical vitamin D3 derivative preparations and/or phototherapy and/or systemic etretinate prior to or at screening
- Participant has a Palmoplantar Pustulosis Severity Index (PPSI) score of 7 or greater at screening and baseline
- At screening, the results of laboratory blood tests must be within protocol-specified limits
Exclusion Criteria:
- History of or current signs of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurologic, cerebral, or psychiatric disease
- Participant has unstable cardiovascular disease, defined as a recent clinical deterioration in the last 3 months or a cardiac hospitalization within the last 3 months prior to screening
- History of chronic or recurrent infectious disease, including, but not limited to, chronic renal infection, chronic chest infection (eg, bronchiectasis), recurrent urinary tract infection (eg, recurrent pyelonephritis), fungal infection (eg, mucocutaneous candidiasis), or open, draining, or infected skin wounds or ulcers
- Participant has or has had a serious infection (eg, sepsis, pneumonia or pyelonephritis), or has been hospitalized or received intravenous (IV) antibiotics for an infection during the 2 months prior to screening
- Participant has or has had herpes zoster within the 2 months prior to screening
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
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Placebo, as two 1-ml subcutaneous (SC) injections, at Week 0 and Week 4
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Experimental: CNTO 1959
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CNTO 1959 200 mg, as two 1-ml subcutaneous (SC) injections, at Week 0 and Week 4
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in PPSI total score at Week 16.
Time Frame: Baseline to Week 16
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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.
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Baseline to Week 16
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in PPSI total score over time
Time Frame: Baseline up to 24 weeks
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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.
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Baseline up to 24 weeks
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Change from baseline in PPPASI total score
Time Frame: Baseline up to 24 weeks
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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.
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Baseline up to 24 weeks
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Proportion of participants who achieve a PPPASI-50
Time Frame: Up to 24 weeks
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PPPASI-50 is at least 50% reduction in the PPPASI score.
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Up to 24 weeks
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Proportion of participants who achieve a PGA score of 1 or less
Time Frame: Up to 24 weeks
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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).
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Up to 24 weeks
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Proportion of participants who achieve a PPPASI-75
Time Frame: Up to 24 weeks
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PPPASI-75 is at least 75% reduction in the PPPASI score.
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Up to 24 weeks
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Change from baseline in PA (each score)
Time Frame: Baseline up to 24 weeks
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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).
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Baseline up to 24 weeks
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Change from baseline in Patient's VAS-PPP severity
Time Frame: Baseline up to 24 weeks
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The Patient's Visual Analogue Scale (VAS) assessment of palmoplantar pustulosis severity will be recorded on a 10-cm VAS.
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Baseline up to 24 weeks
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Change from baseline in Physician's VAS-PAO activity
Time Frame: Baseline up to 24 weeks
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Physician's Visual Analogue Scale Assessment of Pustulotic Arthro-Osteitis Activity will be recorded on a 10-cm VAS.
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Baseline up to 24 weeks
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Change from baseline in Patient's VAS-PAO activity and pain
Time Frame: Baseline up to 24 weeks
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Patient's Visual Analogue Scale Assessment of Pustulotic Arthro-Osteitis Activity and Pain will be recorded on each 10-cm VAS.
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Baseline up to 24 weeks
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Change from baseline in Dermatology Life Quality Index (DLQI)
Time Frame: Baseline up to 24 weeks
|
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.
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Baseline up to 24 weeks
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Change form baseline in SF-36 score
Time Frame: Baseline up to 24 weeks
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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.
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Baseline up to 24 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2013
Primary Completion (Actual)
September 1, 2014
Study Completion (Actual)
September 1, 2014
Study Registration Dates
First Submitted
April 30, 2013
First Submitted That Met QC Criteria
April 30, 2013
First Posted (Estimate)
May 3, 2013
Study Record Updates
Last Update Posted (Estimate)
November 20, 2015
Last Update Submitted That Met QC Criteria
October 26, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR100950
- CNTO1959PPP2001 (Other Identifier: Janssen Pharmaceutical K.K., Japan)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Palmoplantaris Pustulosis
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The Guenther Dermatology Research CentreBiogenCompletedPsoriasis | Palmoplantaris Pustulosis | Pustulosis of Palms and Soles | Pustular Psoriasis of Palms and Soles | Pustulosis Palmaris et PlantarisCanada
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