Clinical trial NCT00723528: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Keywords: Psoriasis
Ustekinumab
CNTO 1275
Lead sponsor: Janssen Pharmaceutical K.K.
Sponsor class: INDUSTRY
First posted: 2008-07-28
Enrollment: 158
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Percentage of Participants With Greater Than or Equal to 75 Percent (%) Improvement in Psoriasis Area and Severity Index (PASI) Score
timeFrame: Week 12
Secondary outcomes:
measure: Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 12
timeFrame: Week 12
measure: Psoriasis Area and Severity Index (PASI) Score
timeFrame: Week 64
measure: Percentage of Treatment Response Based on Psoriasis Area and Severity Index (PASI) Score
timeFrame: Week 64
measure: Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%), 90%, and Equal to 100% of Treatment Response Based on PASI Score
timeFrame: Week 64
measure: Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 28, 40, 52 and 64
timeFrame: Week 28, 40, 52 and 64
measure: Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Week 12, 28, 40, 52 and 64
timeFrame: Week 12, 28, 40, 52 and 64
measure: Change From Baseline in Psoriasis Disability Index (PDI) Score at Week 12, 28, 40, 52 and 64
timeFrame: Week 12, 28, 40, 52 and 64
measure: Treatment Response Based on Nail Psoriasis Severity Index (NAPSI) Score
timeFrame: Week 12, 28, 40,52 and 64
measure: Change From Baseline in the Number of Nails With Psoriasis Involvement at Week 12, 28, 40, 52 and 64
timeFrame: Week 12, 28, 40, 52 and 64
measure: Change From Baseline in Joint Symptoms Expressed on a Visual Analogue Scale (VAS) at Week 12, 28, 40, 52 and 64
timeFrame: Week 12, 28, 40, 52 and 64
measure: 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
timeFrame: Week 12
measure: 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
timeFrame: Week 64
Other outcomes:
Locations:
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
Study officials:
affiliation: Janssen Pharmaceutical K.K.
name: Janssen Pharmaceutical K.K. Clinical Trial
role: STUDY_DIRECTOR
References: