Back to resultsA Study of the Safety, Tolerability, Pharmacokinetics (What the Body Does to the Drug), and Pharmacodynamics (What the Drug Does to the Body) of CNTO 1959 Following a Single Subcutaneous (Under the Skin) Administration in Japanese Participants With Moderate to Severe Plaque Psoriasis
Primary Purpose
Psoriasis
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
CNTO 1959
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis focused on measuring Moderate to Severe Plaque-Type Psoriasis, Psoriasis, Plaque-type psoriasis, CNTO 1959, Japanese participants
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of plaque-type psoriasis at least 6 months prior to screening (participants with concurrent psoriatic arthritis may be enrolled)
- Having plaque-type psoriasis covering at least 10% of total body surface area (BSA) at baseline
- Has a Psoriasis Area and Severity Index (PASI) score of 12 or greater at baseline
- Is a candidate for systemic phototherapy or systemic treatment of psoriasis (either new to treatment or having had previous treatment)
- Has at least 2 plaques suitable for repeat biopsy (Only participants who consent separately to participate in this assessment. Refusal to give consent for this component does not exclude an individual from participation in the clinical study).
Exclusion Criteria:
- Currently has non-plaque forms of psoriasis (eg, erythrodermic, guttate, or pustular)
- Has current drug-induced psoriasis (e.g., a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
- Has a history of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection (e.g., secondary infection occurred on bronchiectasis), recurrent urinary tract infection (recurrent pyelonephritis or chronic nonremitting cystitis), or open, draining, or infected skin wounds or ulcers
- Has a history of latent, or active or opportunistic systemic infection with pathogens including, but not limited to, Klebsiella pneumoniae, Cryptococcus neoformans, Candida albicans, Toxoplasma gondii, and Pneumocystis jiroveci prior to screening
- Has or has had a serious infection (e.g., sepsis, pneumonia or pyelonephritis), or have been hospitalized or received intravenous antibiotics for an infection during the 2 months prior to screening
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
001
002
Arm Description
Outcomes
Primary Outcome Measures
The number and type of adverse events
Change in clinical laboratory values
Electrocardiogram
Changes or abnormalities in body systems
Axillary temperature
Pulse rate
Blood pressure
Secondary Outcome Measures
Blood levels of CNTO 1959
Antibodies to CNTO 1959
Psoriasis Area and Severity Index (PASI)
The PASI produces a numeric score that can range from 0 (no involvement) to 72 (90% to 100% involvement).
Physician's Global Assessment (PGA)
Assessment of the patient's psoriasis status according to the following categories: induration, erythema, and scaling
Full Information
NCT ID
NCT01484587
First Posted
September 2, 2011
Last Updated
September 1, 2017
Sponsor
Janssen Pharmaceutical K.K.
1. Study Identification
Unique Protocol Identification Number
NCT01484587
Brief Title
A Study of the Safety, Tolerability, Pharmacokinetics (What the Body Does to the Drug), and Pharmacodynamics (What the Drug Does to the Body) of CNTO 1959 Following a Single Subcutaneous (Under the Skin) Administration in Japanese Participants With Moderate to Severe Plaque Psoriasis
Official Title
A Randomized, Double-blind, Placebo-controlled, Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CNTO 1959 Following a Single Subcutaneous Administration in Japanese Subjects With Moderate to Severe Plaque Psoriasis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
August 22, 2011 (Actual)
Primary Completion Date
April 11, 2013 (Actual)
Study Completion Date
April 11, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Pharmaceutical K.K.
4. Oversight
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to assess the safety and tolerability of CNTO 1959 following a single subcutaneous (SC, under the skin) dose administered to Japanese participants with moderate to severe plaque psoriasis.
Detailed Description
This is a randomized (participants are assigned to treatment groups by chance), double-blind (participants and study personnel know what study agents are given), placebo-controlled (a placebo is a treatment identical in appearance to CNTO 1959 but does not contain active drug), single-dose study. The study will include 24 participants: 4 groups of at least 6 participants each. If it is decided that additional data are needed to define the safety and tolerability of CNTO 1959, an additional group may be enrolled. A given dose level may be repeated in newly enrolled participants, or a lower or intermediate dose may be administered based on preliminary data. The total duration of participation will be approximately 30 weeks, which includes a screening period of up to 6 weeks before the administration of study agent. Participant safety will be monitored. Ascending doses of 10, 30, 100, and 300 mg dose of CNTO 1959 and placebo will be administered as single SC injections; however, 2 SC injections may be required for the 300 mg dose level. Dosing will be performed for 24 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
Moderate to Severe Plaque-Type Psoriasis, Psoriasis, Plaque-type psoriasis, CNTO 1959, Japanese participants
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
001
Arm Type
Experimental
Arm Title
002
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
CNTO 1959
Intervention Description
CNTO 1959: type=range, unit=mg, number=10, 30, 100, 300, form=solution for injection, route=subcutaneous use, ascending dosing for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo: form=solution for injection, route=subcutaneous use, ascending dosing for 24 weeks
Primary Outcome Measure Information:
Title
The number and type of adverse events
Time Frame
Up to 24 weeks
Title
Change in clinical laboratory values
Time Frame
Up to 24 weeks
Title
Electrocardiogram
Time Frame
Up to 24 weeks
Title
Changes or abnormalities in body systems
Time Frame
Up to 24 weeks
Title
Axillary temperature
Time Frame
Up to 24 weeks
Title
Pulse rate
Time Frame
Up to 24 weeks
Title
Blood pressure
Time Frame
Up to 24 weeks
Secondary Outcome Measure Information:
Title
Blood levels of CNTO 1959
Time Frame
Up to 24 weeks
Title
Antibodies to CNTO 1959
Time Frame
Up to 24 weeks
Title
Psoriasis Area and Severity Index (PASI)
Description
The PASI produces a numeric score that can range from 0 (no involvement) to 72 (90% to 100% involvement).
Time Frame
Up to 24 weeks
Title
Physician's Global Assessment (PGA)
Description
Assessment of the patient's psoriasis status according to the following categories: induration, erythema, and scaling
Time Frame
Up to 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of plaque-type psoriasis at least 6 months prior to screening (participants with concurrent psoriatic arthritis may be enrolled)
Having plaque-type psoriasis covering at least 10% of total body surface area (BSA) at baseline
Has a Psoriasis Area and Severity Index (PASI) score of 12 or greater at baseline
Is a candidate for systemic phototherapy or systemic treatment of psoriasis (either new to treatment or having had previous treatment)
Has at least 2 plaques suitable for repeat biopsy (Only participants who consent separately to participate in this assessment. Refusal to give consent for this component does not exclude an individual from participation in the clinical study).
Exclusion Criteria:
Currently has non-plaque forms of psoriasis (eg, erythrodermic, guttate, or pustular)
Has current drug-induced psoriasis (e.g., a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
Has a history of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection (e.g., secondary infection occurred on bronchiectasis), recurrent urinary tract infection (recurrent pyelonephritis or chronic nonremitting cystitis), or open, draining, or infected skin wounds or ulcers
Has a history of latent, or active or opportunistic systemic infection with pathogens including, but not limited to, Klebsiella pneumoniae, Cryptococcus neoformans, Candida albicans, Toxoplasma gondii, and Pneumocystis jiroveci prior to screening
Has or has had a serious infection (e.g., sepsis, pneumonia or pyelonephritis), or have been hospitalized or received intravenous antibiotics for an infection during the 2 months prior to screening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Pharmaceutical K.K., Japan Clinical Trial
Organizational Affiliation
Janssen Pharmaceutical K.K.
Official's Role
Study Director
Facility Information:
City
Sapporo
Country
Japan
12. IPD Sharing Statement
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_7051&studyid=3368&filename=CR108646_CSR.pdf
Description
Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CNTO 1959 following a Single Subcutaneous Administration in Japanese Subjects With Moderate to Severe Plaque Psoriasis
Learn more about this trial
A Study of the Safety, Tolerability, Pharmacokinetics (What the Body Does to the Drug), and Pharmacodynamics (What the Drug Does to the Body) of CNTO 1959 Following a Single Subcutaneous (Under the Skin) Administration in Japanese Participants With Moderate to Severe Plaque Psoriasis
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