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PsoriasisPhase 3NCT00723528

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

A Phase 3 study testing Ustekinumab 45 mg (CP) and Ustekinumab 90 mg (CP) in people with Psoriasis, run by Janssen Pharmaceutical K.K. at 27 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Psoriasis
What is being tested?
Ustekinumab 45 mg (CP) and Ustekinumab 90 mg (CP)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
158 participants
Where
27 sitesJapan
Study dates
Mar 2008to Mar 2010
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

27 sites in 1 country.

27 sites in 1 country

Japan27 sites

  • Study site

    Asahikawa

  • Study site

    Chitose

  • Study site

    Chūō

  • Study site

    Fukuoka

  • Study site

    Fushimi

  • Study site

    Isehara

  • Study site

    Kanazawa

  • Study site

    Kurume

  • Study site

    Kyoto

  • Study site

    Maebashi

  • Study site

    Minato

  • Study site

    Morioka

  • Study site

    Nagasaki

  • Study site

    Nagoya

  • Study site

    Nankoku

  • Study site

    Nishinomiya

  • Study site

    Osaka

  • Study site

    Ōsaka-sayama

  • Study site

    Sagamihara

  • Study site

    Sapporo

  • Study site

    Sendai

  • Study site

    Shigenobu N/A

  • Study site

    Shimotsuke

  • Study site

    Shinjuku

  • Study site

    Suita

  • Study site

    Tokyo

  • Study site

    Tsu

Other trials in Japan

About this study

Official title: A Placebo-Controlled Double-Blind Comparative Study of CNTO1275 in Patients With Plaque Type Psoriasis

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.

Read the 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.

Conditions
Psoriasis
Being tested
Placebo (CP), Ustekinumab 45 mg (CP), Ustekinumab 90 mg (CP), Placebo A (After CP), Placebo B (After CP)
Keywords
Psoriasis, Ustekinumab, CNTO 1275
Medical subject headings
Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Placebo (CP)Drug

    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 (CP)Drug

    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 (CP)Drug

    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).

  • Placebo A (After CP)Drug

    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.

  • Placebo B (After CP)Drug

    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.

  • Ustekinumab 45 mg (After CP)Drug

    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.

  • Ustekinumab 90 mg (After CP)Drug

    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.

Study groups in NCT00723528
Study groupRoleWhat they receive
Placebo (CP)Placebo comparatorPlacebo 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).
Receives: Drug: Placebo (CP)
Ustekinumab 45 mg (CP)Active comparatorUstekinumab 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).
Receives: Drug: Ustekinumab 45 mg (CP)
Ustekinumab 90 mg (CP)Active comparatorUstekinumab 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).
Receives: Drug: Ustekinumab 90 mg (CP)
Placebo A (After CP)Placebo comparatorAfter 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.
Receives: Drug: Placebo A (After CP)
Placebo B (After CP)Placebo comparatorAfter 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.
Receives: Drug: Placebo B (After CP)
Ustekinumab 45 mg (After CP)Active comparatorAfter 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.
Receives: Drug: Ustekinumab 45 mg (After CP)
Ustekinumab 90 mg (After CP)Active comparatorAfter 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.
Receives: Drug: Ustekinumab 90 mg (After CP)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Week 12

Secondary outcomes (12)

  1. 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).

    Measured: Week 12

  2. 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).

    Measured: Week 64

  3. 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.

    Measured: Week 64

  4. 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.

    Measured: Week 64

  5. 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).

    Measured: Week 28, 40, 52 and 64

  6. 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.

    Measured: Week 12, 28, 40, 52 and 64

  7. 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).

    Measured: Week 12, 28, 40, 52 and 64

  8. 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).

    Measured: Week 12, 28, 40,52 and 64

  9. 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.

    Measured: Week 12, 28, 40, 52 and 64

  10. 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).

    Measured: Week 12, 28, 40, 52 and 64

  11. 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].

    Measured: Week 12

  12. 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].

    Measured: Week 64

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2008 (estimated)
  2. Study startMar 2008
  3. Primary completionJan 2009
  4. Study completionMar 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
158 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00723528
Sponsor's protocol ID
CR015166
Other IDs
JNS009-JPN-02
Status last verified
Apr 2014
First submitted
24 Jul 2008
Last updated
20 May 2014
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ustekinumab 45 mg (CP) and Ustekinumab 90 mg (CP) in people with Psoriasis, run by Janssen Pharmaceutical K.K. at 27 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Greater Than or Equal to 75 Percent (%) Improvement in Psoriasis Area and Severity Index (PASI) Score (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00723528.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2014.

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