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An Efficacy and Safety Study of Ustekinumab (CNTO 1275) in Participants With Plaque Psoriasis

Primary Purpose

Psoriasis

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Placebo (CP)
Ustekinumab 45 mg (CP)
Ustekinumab 90 mg (CP)
Placebo A (After CP)
Placebo B (After CP)
Ustekinumab 45 mg (After CP)
Ustekinumab 90 mg (After CP)
Sponsored by
Janssen Pharmaceutical K.K.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring Psoriasis, Ustekinumab, CNTO 1275

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants diagnosed with psoriasis (psoriasis vulgaris and psoriatic arthritis) at least 6 months before registration
  • Participants with plaque type psoriasis covering at least 10 percent of total body surface area at the time of informed consent and at registration
  • Participants with a PASI score of greater than or equal to 12 at the time of informed consent and at registration
  • Female participants of childbearing potential or males, whose partner can be pregnant, must agree that he/she will continuously take an appropriate contraceptive measure for 1 year from the day of informed consent to termination of the final investigational treatment; in the case of childbearing potential females, pregnancy test at screening must be negative
  • Participants must agree not to receive Bacillus Calmette-Guérin (BCG) vaccination and live vaccine inoculation for 1 year after final treatment with the investigational product

Exclusion Criteria:

  • Participants with guttate psoriasis, erythrodermic psoriasis, or pustular psoriasis
  • Participants with a medical history of tuberculosis infection or suspected tuberculosis infection
  • Participants with present or past history of chronic or recurrent infection (e.g., chronic or recurrent urinary tract infection or respiratory infection)
  • Participants with a current serious infection (e.g., sepsis, hepatitis, pneumonia, or pyelonephritis) or those who experienced a serious infection within the 2 month period before registration and including participants who received intravenous administration of antibiotics or antiviral agents within the 2 month period before registration
  • Participants with a current or past history of malignant tumors (except for basal cell carcinoma, intraepidermal squamous cell carcinoma in the skin and uterine cervical squamous cell carcinoma, whose treatment was completed and no sign suggesting a recurrence has been observed, and squamous cell carcinoma in the skin whose treatment was completed and no sign suggesting a recurrence has been observed in the past 5 years)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Placebo Comparator

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Placebo (CP)

Ustekinumab 45 mg (CP)

Ustekinumab 90 mg (CP)

Placebo A (After CP)

Placebo B (After CP)

Ustekinumab 45 mg (After CP)

Ustekinumab 90 mg (After CP)

Arm Description

Placebo 0.5 ml and 1.0 ml will be administered subcutaneously (SC) on Weeks 0 and 4 respectively during the controlled period (Weeks 0-12).

Ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) will be administered SC on Weeks 0 and 4 during controlled period (Weeks 0-12).

Ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) will be administered SC on Weeks 0 and 4 during controlled period (Weeks 0-12).

After the controlled period (that is [i.e.], during the active drug treatment period [Weeks 12-64]), the placebo group will be randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) will be administered SC at Weeks 12, 16, 28, 40, and 52.

After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group will be randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) will be administered SC at Weeks 12, 16, 28, 40, and 52.

After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 45 mg group will receive placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52.

After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 90 mg group will receive placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.

Outcomes

Primary Outcome Measures

Percentage of Participants With Greater Than or Equal to 75 Percent (%) Improvement in Psoriasis Area and Severity Index (PASI) Score
Percentage of participants with >=75% improvement in PASI score at Week 12 from Baseline was reported. PASI is a widely used tool for the measurement of severity of psoriasis. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) to 72 (worst). Baseline visit refers to Week 0.

Secondary Outcome Measures

Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 12
The DLQI is a self-administered 10-item questionnaire that is used to assess 6 different aspects of quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Scores range from 0 (no impairment in quality of life) to 30 (most impairment in quality of life).
Psoriasis Area and Severity Index (PASI) Score
PASI is a widely used tool for the measurement of severity of psoriasis. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) to 72 (worst).
Percentage of Treatment Response Based on Psoriasis Area and Severity Index (PASI) Score
PASI is a widely used tool for the measurement of severity of psoriasis. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) to 72 (worst). Percentage of Treatment Response= (Baseline PASI score-PASI score after treatment)/Baseline PASI score x 100. Baseline visit refers to Week 0.
Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%), 90%, and Equal to 100% of Treatment Response Based on PASI Score
PASI is a widely used tool for the measurement of severity of psoriasis. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) to 72 (worst). Percentage of Treatment Response= (Baseline PASI score-PASI score after treatment)/Baseline PASI score x 100. Baseline visit refers to Week 0.
Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 28, 40, 52 and 64
The DLQI is a self-administered 10-item questionnaire that is used to assess 6 different aspects of quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Scores range from 0 (no impairment in quality of life) to 30 (most impairment in quality of life).
Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Week 12, 28, 40, 52 and 64
The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: (1) physical component summary (PCS)=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary (MCS)=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both sub scores and summary scores. For sub scores and summary scores: 0=worst score and 100=best score.
Change From Baseline in Psoriasis Disability Index (PDI) Score at Week 12, 28, 40, 52 and 64
The PDI questionnaire consists of 15 questions relating to the impact of psoriasis in terms of daily activities, work or school, personal relationships, leisure, and treatment. Each question is scored on a scale of 0 (no impact) to 3 (greatest impact). The PDI is calculated by summing the scores of the questions resulting in a maximum score of 45 (greatest impact) and a minimum score of 0 (no impact).
Treatment Response Based on Nail Psoriasis Severity Index (NAPSI) Score
The NAPSI score is used to evaluate the severity of nail bed psoriasis and nail matrix psoriasis. The nail is divided with into quadrants and given a score for nail bed psoriasis (0-4) and nail matrix psoriasis (0-4) depending on the presence of any of the features of nail psoriasis in that quadrant. Each nail is evaluated, and the sum of all the nails is the total NAPSI score. The sum of the scores from all nails ranges from 0 (no psoriasis) to 80 (psoriasis present in all 4 quadrants of all 10 nails).
Change From Baseline in the Number of Nails With Psoriasis Involvement at Week 12, 28, 40, 52 and 64
The number of nails with psoriasis involvement was assessed by a dermatologist.
Change From Baseline in Joint Symptoms Expressed on a Visual Analogue Scale (VAS) at Week 12, 28, 40, 52 and 64
Each participant will assess his/her pain associated with joint symptoms on each assessment day using a 100 mm VAS ranging from 0 mm (no pain) to 100 mm (the worst pain imaginable).
Percentage of Participants With Cleared (0), Cleared or Minimal (0 or 1) and Mild (Less Than or Equal to 2) Physician's Global Assessment (PGA) Score at Week 12
Percentage of participants with PGA score of cleared (0), cleared or minimal (0 or 1) and mild (less than or equal to 2) was reported. The PGA score is a numeric scale which is completed by the physician and is designed to evaluate the physician's overall assessment of the participant's psoriasis. Overall lesions will be graded for induration (I), erythema (E), and scaling (S) as: 0=cleared, 1=minimal, 2=mild, 3=moderate, 4=marked, and 5=severe. The sum of the 3 scores (I + E + S) will be divided by 3 to obtain a final PGA score ranging from 0 [best] to 5 [worst].
Percentage of Participants With Cleared (0), Cleared or Minimal (0 or 1) and Mild (Less Than or Equal to 2) Physician's Global Assessment (PGA) Score at Week 64
Percentage of participants with PGA score of cleared (0), cleared or minimal (0 or 1) and mild (less than or equal to 2) was reported. The PGA score is a numeric scale which is completed by the physician and is designed to evaluate the physician's overall assessment of the participant's psoriasis. Overall lesions will be graded for induration (I), erythema (E), and scaling (S) as: 0=cleared, 1=minimal, 2=mild, 3=moderate, 4=marked, and 5=severe. The sum of the 3 scores (I + E + S) will be divided by 3 to obtain a final PGA score ranging from 0 [best] to 5 [worst].

Full Information

First Posted
July 24, 2008
Last Updated
April 22, 2014
Sponsor
Janssen Pharmaceutical K.K.
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1. Study Identification

Unique Protocol Identification Number
NCT00723528
Brief Title
An Efficacy and Safety Study of Ustekinumab (CNTO 1275) in Participants With Plaque Psoriasis
Official Title
A Placebo-Controlled Double-Blind Comparative Study of CNTO1275 in Patients With Plaque Type Psoriasis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Pharmaceutical K.K.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the safety and efficacy of ustekinumab (CNTO 1275) compared with placebo in participants with moderate to severe plaque type psoriasis.
Detailed Description
This is a multicenter (involving more than 1 study center), randomized (study medication assigned by chance), double-blind (neither the invesitigator nor the participant knows the identity of the study medication), placebo- controlled (1 of the study medications is inactive), parallel-group comparative study (different groups of participants will receive different treatments at the same time). The total duration of the study will be 78 weeks which will be comprised of: a screening period (6 weeks); an efficacy assessment period (64 weeks [with a total of 7 treatments at Weeks 0, 4, 12, 16, 28, 40, and 52]) and a follow-up assessment period (8 weeks). The efficacy assessment period will further include: a placebo-controlled treatment period (Weeks 0-12) and an active drug treatment period (Weeks 12-64). During the placebo-controlled treatment period, participants will receive ustekinumab (45 mg or 90 mg) subcutaneously (SC-into the muscles) or placebo SC. During the active drug treatment period, participants will continue treatment with 45 mg or 90 mg SC as assigned during the placebo-controlled treatment period; however, participants in the placebo group will be divided into 2 groups and will receive ustekinumab 45 mg (Placebo A) or 90 mg (Placebo B) SC. Efficacy will be evaluated primarily by analysis of psoriasis area and severity index (PASI) score. Participant safety will also be monitored.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
Psoriasis, Ustekinumab, CNTO 1275

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
158 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo (CP)
Arm Type
Placebo Comparator
Arm Description
Placebo 0.5 ml and 1.0 ml will be administered subcutaneously (SC) on Weeks 0 and 4 respectively during the controlled period (Weeks 0-12).
Arm Title
Ustekinumab 45 mg (CP)
Arm Type
Active Comparator
Arm Description
Ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) will be administered SC on Weeks 0 and 4 during controlled period (Weeks 0-12).
Arm Title
Ustekinumab 90 mg (CP)
Arm Type
Active Comparator
Arm Description
Ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) will be administered SC on Weeks 0 and 4 during controlled period (Weeks 0-12).
Arm Title
Placebo A (After CP)
Arm Type
Placebo Comparator
Arm Description
After the controlled period (that is [i.e.], during the active drug treatment period [Weeks 12-64]), the placebo group will be randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) will be administered SC at Weeks 12, 16, 28, 40, and 52.
Arm Title
Placebo B (After CP)
Arm Type
Placebo Comparator
Arm Description
After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group will be randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) will be administered SC at Weeks 12, 16, 28, 40, and 52.
Arm Title
Ustekinumab 45 mg (After CP)
Arm Type
Active Comparator
Arm Description
After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 45 mg group will receive placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52.
Arm Title
Ustekinumab 90 mg (After CP)
Arm Type
Active Comparator
Arm Description
After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 90 mg group will receive placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
Intervention Type
Drug
Intervention Name(s)
Placebo (CP)
Intervention Description
Placebo 0.5 ml and 1.0 ml will be administered subcutaneously (SC) on Weeks 0 and 4 respectively during the controlled period (Weeks 0-12).
Intervention Type
Drug
Intervention Name(s)
Ustekinumab 45 mg (CP)
Intervention Description
Ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) will be administered SC on Weeks 0 and 4 during controlled period (Weeks 0-12).
Intervention Type
Drug
Intervention Name(s)
Ustekinumab 90 mg (CP)
Intervention Description
Ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) will be administered SC on Weeks 0 and 4 during controlled period (Weeks 0-12).
Intervention Type
Drug
Intervention Name(s)
Placebo A (After CP)
Intervention Description
After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group will be randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) will be administered SC at Weeks 12, 16, 28, 40, and 52.
Intervention Type
Drug
Intervention Name(s)
Placebo B (After CP)
Intervention Description
After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group will be randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) will be administered SC at Weeks 12, 16, 28, 40, and 52.
Intervention Type
Drug
Intervention Name(s)
Ustekinumab 45 mg (After CP)
Intervention Description
After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 45 mg group will receive placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52.
Intervention Type
Drug
Intervention Name(s)
Ustekinumab 90 mg (After CP)
Intervention Description
After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 90 mg group will receive placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
Primary Outcome Measure Information:
Title
Percentage of Participants With Greater Than or Equal to 75 Percent (%) Improvement in Psoriasis Area and Severity Index (PASI) Score
Description
Percentage of participants with >=75% improvement in PASI score at Week 12 from Baseline was reported. PASI is a widely used tool for the measurement of severity of psoriasis. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) to 72 (worst). Baseline visit refers to Week 0.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 12
Description
The DLQI is a self-administered 10-item questionnaire that is used to assess 6 different aspects of quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Scores range from 0 (no impairment in quality of life) to 30 (most impairment in quality of life).
Time Frame
Week 12
Title
Psoriasis Area and Severity Index (PASI) Score
Description
PASI is a widely used tool for the measurement of severity of psoriasis. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) to 72 (worst).
Time Frame
Week 64
Title
Percentage of Treatment Response Based on Psoriasis Area and Severity Index (PASI) Score
Description
PASI is a widely used tool for the measurement of severity of psoriasis. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) to 72 (worst). Percentage of Treatment Response= (Baseline PASI score-PASI score after treatment)/Baseline PASI score x 100. Baseline visit refers to Week 0.
Time Frame
Week 64
Title
Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%), 90%, and Equal to 100% of Treatment Response Based on PASI Score
Description
PASI is a widely used tool for the measurement of severity of psoriasis. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) to 72 (worst). Percentage of Treatment Response= (Baseline PASI score-PASI score after treatment)/Baseline PASI score x 100. Baseline visit refers to Week 0.
Time Frame
Week 64
Title
Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 28, 40, 52 and 64
Description
The DLQI is a self-administered 10-item questionnaire that is used to assess 6 different aspects of quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Scores range from 0 (no impairment in quality of life) to 30 (most impairment in quality of life).
Time Frame
Week 28, 40, 52 and 64
Title
Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Week 12, 28, 40, 52 and 64
Description
The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: (1) physical component summary (PCS)=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary (MCS)=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both sub scores and summary scores. For sub scores and summary scores: 0=worst score and 100=best score.
Time Frame
Week 12, 28, 40, 52 and 64
Title
Change From Baseline in Psoriasis Disability Index (PDI) Score at Week 12, 28, 40, 52 and 64
Description
The PDI questionnaire consists of 15 questions relating to the impact of psoriasis in terms of daily activities, work or school, personal relationships, leisure, and treatment. Each question is scored on a scale of 0 (no impact) to 3 (greatest impact). The PDI is calculated by summing the scores of the questions resulting in a maximum score of 45 (greatest impact) and a minimum score of 0 (no impact).
Time Frame
Week 12, 28, 40, 52 and 64
Title
Treatment Response Based on Nail Psoriasis Severity Index (NAPSI) Score
Description
The NAPSI score is used to evaluate the severity of nail bed psoriasis and nail matrix psoriasis. The nail is divided with into quadrants and given a score for nail bed psoriasis (0-4) and nail matrix psoriasis (0-4) depending on the presence of any of the features of nail psoriasis in that quadrant. Each nail is evaluated, and the sum of all the nails is the total NAPSI score. The sum of the scores from all nails ranges from 0 (no psoriasis) to 80 (psoriasis present in all 4 quadrants of all 10 nails).
Time Frame
Week 12, 28, 40,52 and 64
Title
Change From Baseline in the Number of Nails With Psoriasis Involvement at Week 12, 28, 40, 52 and 64
Description
The number of nails with psoriasis involvement was assessed by a dermatologist.
Time Frame
Week 12, 28, 40, 52 and 64
Title
Change From Baseline in Joint Symptoms Expressed on a Visual Analogue Scale (VAS) at Week 12, 28, 40, 52 and 64
Description
Each participant will assess his/her pain associated with joint symptoms on each assessment day using a 100 mm VAS ranging from 0 mm (no pain) to 100 mm (the worst pain imaginable).
Time Frame
Week 12, 28, 40, 52 and 64
Title
Percentage of Participants With Cleared (0), Cleared or Minimal (0 or 1) and Mild (Less Than or Equal to 2) Physician's Global Assessment (PGA) Score at Week 12
Description
Percentage of participants with PGA score of cleared (0), cleared or minimal (0 or 1) and mild (less than or equal to 2) was reported. The PGA score is a numeric scale which is completed by the physician and is designed to evaluate the physician's overall assessment of the participant's psoriasis. Overall lesions will be graded for induration (I), erythema (E), and scaling (S) as: 0=cleared, 1=minimal, 2=mild, 3=moderate, 4=marked, and 5=severe. The sum of the 3 scores (I + E + S) will be divided by 3 to obtain a final PGA score ranging from 0 [best] to 5 [worst].
Time Frame
Week 12
Title
Percentage of Participants With Cleared (0), Cleared or Minimal (0 or 1) and Mild (Less Than or Equal to 2) Physician's Global Assessment (PGA) Score at Week 64
Description
Percentage of participants with PGA score of cleared (0), cleared or minimal (0 or 1) and mild (less than or equal to 2) was reported. The PGA score is a numeric scale which is completed by the physician and is designed to evaluate the physician's overall assessment of the participant's psoriasis. Overall lesions will be graded for induration (I), erythema (E), and scaling (S) as: 0=cleared, 1=minimal, 2=mild, 3=moderate, 4=marked, and 5=severe. The sum of the 3 scores (I + E + S) will be divided by 3 to obtain a final PGA score ranging from 0 [best] to 5 [worst].
Time Frame
Week 64

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants diagnosed with psoriasis (psoriasis vulgaris and psoriatic arthritis) at least 6 months before registration Participants with plaque type psoriasis covering at least 10 percent of total body surface area at the time of informed consent and at registration Participants with a PASI score of greater than or equal to 12 at the time of informed consent and at registration Female participants of childbearing potential or males, whose partner can be pregnant, must agree that he/she will continuously take an appropriate contraceptive measure for 1 year from the day of informed consent to termination of the final investigational treatment; in the case of childbearing potential females, pregnancy test at screening must be negative Participants must agree not to receive Bacillus Calmette-Guérin (BCG) vaccination and live vaccine inoculation for 1 year after final treatment with the investigational product Exclusion Criteria: Participants with guttate psoriasis, erythrodermic psoriasis, or pustular psoriasis Participants with a medical history of tuberculosis infection or suspected tuberculosis infection Participants with present or past history of chronic or recurrent infection (e.g., chronic or recurrent urinary tract infection or respiratory infection) Participants with a current serious infection (e.g., sepsis, hepatitis, pneumonia, or pyelonephritis) or those who experienced a serious infection within the 2 month period before registration and including participants who received intravenous administration of antibiotics or antiviral agents within the 2 month period before registration Participants with a current or past history of malignant tumors (except for basal cell carcinoma, intraepidermal squamous cell carcinoma in the skin and uterine cervical squamous cell carcinoma, whose treatment was completed and no sign suggesting a recurrence has been observed, and squamous cell carcinoma in the skin whose treatment was completed and no sign suggesting a recurrence has been observed in the past 5 years)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Pharmaceutical K.K. Clinical Trial
Organizational Affiliation
Janssen Pharmaceutical K.K.
Official's Role
Study Director
Facility Information:
City
Asahikawa
Country
Japan
City
Chitose
Country
Japan
City
Chuo
Country
Japan
City
Fukuoka
Country
Japan
City
Fushimi
Country
Japan
City
Isehara
Country
Japan
City
Kanazawa
Country
Japan
City
Kurume
Country
Japan
City
Kyoto
Country
Japan
City
Maebashi
Country
Japan
City
Minato
Country
Japan
City
Morioka
Country
Japan
City
Nagasaki
Country
Japan
City
Nagoya
Country
Japan
City
Nankoku
Country
Japan
City
Nishinomiya
Country
Japan
City
Osaka-Sayama
Country
Japan
City
Osaka
Country
Japan
City
Sagamihara
Country
Japan
City
Sapporo
Country
Japan
City
Sendai
Country
Japan
City
Shigenobu N/A
Country
Japan
City
Shimotsuke
Country
Japan
City
Shinjuku
Country
Japan
City
Suita
Country
Japan
City
Tokyo N/A
Country
Japan
City
Tokyo
Country
Japan
City
Tsu
Country
Japan

12. IPD Sharing Statement

Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=425&filename=CR015166_w28CSR.pdf
Description
Week 28 data cut-off Clinical Study Report for a Placebo-Controlled Double-Blind Study of CNTO 1275 in Subjects with Plaque Psoriasis
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=425&filename=CR015166_finalCSR.pdf
Description
|Final Clinical Study Report for A Placebo-Controlled Double-Blind Study of CNTO 1275 in Subjects with Plaque Psoriasi

Learn more about this trial

An Efficacy and Safety Study of Ustekinumab (CNTO 1275) in Participants With Plaque Psoriasis

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