PsoriasisPhase 3NCT00747344
A Phase 3 Trial to Look at the Safety and Effectiveness of Ustekinumab in Korean and Taiwanese Subjects With Moderate to Severe Plaque-type Psoriasis
A Phase 3 study testing Ustekinumab 45 mg - CP and Ustekinumab 45 mg - after CP in people with Psoriasis, run by Centocor, Inc. at 5 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of Ustekinumab in the treatment of patients with moderate to severe psoriasis in South Korea and Taiwan. 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 45 mg - after CP
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 121 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Dec 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
- Must be of Taiwanese or Korean ancestry living in Taiwan or South Korea, respectively
- Have a diagnosis of plaque-type psoriasis at least 6 months prior to first administration of study agent (patients with concurrent psoriatic arthritis may be enrolled)
- Have plaque-type psoriasis covering at least 10% of total body surface area at screening and at the time of first study agent administration
- PASI score of 12 or greater at the time of screening and at time of first study agent administration
- Candidate of phototherapy or systemic treatment of psoriasis (either naïve or history of previous treatment)
- Be able to adhere to the study visit schedule and other protocol requirements
- Capable of giving informed consent prior to any study related procedures.
Who cannot join
- Currently have a non-plaque form of psoriasis
- Have current drug-induced psoriasis
- Are pregnant or nursing or planning pregnancy (both men and women) while enrolled in the study
- Have used any investigational drug within the previous 4 weeks or 5 times the half life of the investigational agent, whichever is longer
- Have used any biologic within the previous 3 months or 5 times the half life of the biologic, whichever is longer
- Have been hospitalized in the past 3 years for asthma, ever required intubation for treatment of asthma, currently require oral corticosteroids for the treatment of asthma, or required more than one short-term course of oral corticosteroids for asthma within the previous year
- Have a history of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis prior to screening.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
About this study
Official title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Ustekinumab in the Treatment of Korean and Taiwanese Subjects With Moderate to Severe Plaque-type Psoriasis
The purpose of this study is to evaluate the efficacy and safety of Ustekinumab in the treatment of patients with moderate to severe psoriasis in South Korea and Taiwan.
Read the detailed description
This is phase 3, multicenter, randomized, placebo-controlled double-blind, parallel study of subcutaneous injection of placebo and ustekinumab 45mg in Taiwanese and Korean patients with moderate to severe plaque psoriasis. Ustekinumab is an experimental medicine that is being tested to see if it may be useful in treating moderate to severe psoriasis. The patients will receive either ustekinumab or placebo at week 0 or week 4, and will be followed up through week 36. Patients who randomized (study drug assigned by chance) to placebo will cross over to ustekinumab 45mg group at week 12 and week 16 .The effectiveness of ustekinumab will be compared with placebo treated patients at week 12. Safety information will be collected through week 36. Patients randomized to ustekinumab will receive placebo at week 12 to maintain the blind and additional dose of 45mg at week 16. This study will be conducted in approximately 13 sites in South Korea and Taiwan and will include approximately 120 patients with approximately 60 patients in each country. This study is "blinded." This means that neither you nor your study doctor will know in which group you are placed. However, in case of medical emergency, your study doctor can quickly find out which treatment group you are in. You may get either ustekinumab or placebo (which looks like the medicine being studied but has no active ingredients) at the start of the study. All patients in the study will eventually receive Ustekinumab after week 12. Patients assigned to the ustekinumab will receive 45 mg subcutaneously at weeks 0, 4 and 16; and placebo at week 12. Patiens assigned to placebo will receive subcutaneous injections of placebo at weeks 0 and 4; then crossover to 45 mg of ustekinumab at weeks 12 and 16. Duration of study participation up to 36 weeks.
- Conditions
- Psoriasis
- Being tested
- Placebo - Controlled Period (CP), Ustekinumab 45 mg - CP, Placebo to ustekinumab 45 mg - after CP, Ustekinumab 45 mg - after CP
- Keywords
- Psoriasis, Psoriatic Arthritis, Ustekinumab, CNTO 1275
- Medical subject headings
- Psoriasis, Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo - Controlled Period (CP)Drug
Placebo, Weeks 0-12
Ustekinumab 45 mg - CPDrug
Ustekinumab 45 mg, Weeks 0-12
Placebo to ustekinumab 45 mg - after CPDrug
Placebo at Weeks 0 and 4, then ustekinumab 45 mg at Week 12 and Week 16
Ustekinumab 45 mg - after CPDrug
Ustekinumab 45 mg at Weeks 0 and 4, then placebo at Week 12 and ustekinumab 45 mg at Week 16
| Study group | Role | What they receive |
|---|---|---|
| Placebo - Controlled Period (CP) | Placebo comparator | Not described Receives: Drug: Placebo - Controlled Period (CP) |
| Ustekinumab 45 mg - CP | Experimental | Not described Receives: Drug: Ustekinumab 45 mg - CP |
| Placebo to ustekinumab 45 mg - after CP | Experimental | Not described Receives: Drug: Placebo to ustekinumab 45 mg - after CP |
| Ustekinumab 45 mg - after CP | Experimental | Not described Receives: Drug: Ustekinumab 45 mg - after CP |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Patients Who Achieved at Least a 75% Improvement in PASI (Psoriasis Area and Severity Index) at Week 12
PASI score can range from 0 (no psoriasis) to 72 (severe psoriasis).
Measured: Week 12
Secondary outcomes (2)
The Number of Patients With a Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12
Measured: Week 12
The Change in Dermatology Life Quality Index (DLQI) From Baseline at Week 12
Scores could range from 0 to 30. A lower DLQI score represents better quality of life.
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2008 (estimated)
- Study startDec 2008
- Primary completionSep 2009
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centocor, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Centocor, Inc. Clinical Trial, Study director, Centocor, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00747344
- Sponsor's protocol ID
- CR015313
- Status last verified
- Mar 2013
- First submitted
- 4 Sep 2008
- Last updated
- 29 Mar 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Ustekinumab in the Treatment of Korean and Taiwanese Subjects With Moderate to Severe Plaque-type Psoriasis
- ClinicalTrials.gov ID
- NCT00747344
- Acronym / sponsor ID
- CR015313
- Conditions
- Psoriasis
- Keywords
- Psoriasis, Psoriatic Arthritis, Ustekinumab, CNTO 1275
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Centocor, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 5 Sep 2008 (estimated)
- Results
- Posted 5 Oct 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy and safety of Ustekinumab in the treatment of patients with moderate to severe psoriasis in South Korea and Taiwan.
Detailed description
This is phase 3, multicenter, randomized, placebo-controlled double-blind, parallel study of subcutaneous injection of placebo and ustekinumab 45mg in Taiwanese and Korean patients with moderate to severe plaque psoriasis. Ustekinumab is an experimental medicine that is being tested to see if it may be useful in treating moderate to severe psoriasis. The patients will receive either ustekinumab or placebo at week 0 or week 4, and will be followed up through week 36. Patients who randomized (study drug assigned by chance) to placebo will cross over to ustekinumab 45mg group at week 12 and week 16 .The effectiveness of ustekinumab will be compared with placebo treated patients at week 12. Safety information will be collected through week 36. Patients randomized to ustekinumab will receive placebo at week 12 to maintain the blind and additional dose of 45mg at week 16. This study will be conducted in approximately 13 sites in South Korea and Taiwan and will include approximately 120 patients with approximately 60 patients in each country. This study is "blinded." This means that neither you nor your study doctor will know in which group you are placed. However, in case of medical emergency, your study doctor can quickly find out which treatment group you are in. You may get either ustekinumab or placebo (which looks like the medicine being studied but has no active ingredients) at the start of the study. All patients in the study will eventually receive Ustekinumab after week 12. Patients assigned to the ustekinumab will receive 45 mg subcutaneously at weeks 0, 4 and 16; and placebo at week 12. Patiens assigned to placebo will receive subcutaneous injections of placebo at weeks 0 and 4; then crossover to 45 mg of ustekinumab at weeks 12 and 16. Duration of study participation up to 36 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo - Controlled Period (CP) | Placebo comparator | Drug: Placebo - Controlled Period (CP) |
| Ustekinumab 45 mg - CP | Experimental | Drug: Ustekinumab 45 mg - CP |
| Placebo to ustekinumab 45 mg - after CP | Experimental | Drug: Placebo to ustekinumab 45 mg - after CP |
| Ustekinumab 45 mg - after CP | Experimental | Drug: Ustekinumab 45 mg - after CP |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Must be of Taiwanese or Korean ancestry living in Taiwan or South Korea, respectively
- Have a diagnosis of plaque-type psoriasis at least 6 months prior to first administration of study agent (patients with concurrent psoriatic arthritis may be enrolled)
- Have plaque-type psoriasis covering at least 10% of total body surface area at screening and at the time of first study agent administration
- PASI score of 12 or greater at the time of screening and at time of first study agent administration
- Candidate of phototherapy or systemic treatment of psoriasis (either naïve or history of previous treatment)
Key exclusion criteria (7 listed)
- Currently have a non-plaque form of psoriasis
- Have current drug-induced psoriasis
- Are pregnant or nursing or planning pregnancy (both men and women) while enrolled in the study
- Have used any investigational drug within the previous 4 weeks or 5 times the half life of the investigational agent, whichever is longer
- Have used any biologic within the previous 3 months or 5 times the half life of the biologic, whichever is longer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo - Controlled Period (CP)Placebo, Weeks 0-12 | Drug | Placebo - Controlled Period (CP) |
| Ustekinumab 45 mg - CPUstekinumab 45 mg, Weeks 0-12 | Drug | Ustekinumab 45 mg - CP |
| Placebo to ustekinumab 45 mg - after CPPlacebo at Weeks 0 and 4, then ustekinumab 45 mg at Week 12 and Week 16 | Drug | Placebo to ustekinumab 45 mg - after CP |
| Ustekinumab 45 mg - after CPUstekinumab 45 mg at Weeks 0 and 4, then placebo at Week 12 and ustekinumab 45 mg at Week 16 | Drug | Ustekinumab 45 mg - after CP |
Primary outcome
The Number of Patients Who Achieved at Least a 75% Improvement in PASI (Psoriasis Area and Severity Index) at Week 12
Time frame: Week 12
PASI score can range from 0 (no psoriasis) to 72 (severe psoriasis).
2 secondary outcomes
The Number of Patients With a Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12
Time frame: Week 12
The Change in Dermatology Life Quality Index (DLQI) From Baseline at Week 12
Time frame: Baseline to Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Centocor, Inc. Clinical Trial study director
Centocor, Inc.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ustekinumab 45 mg - CP and Ustekinumab 45 mg - after CP in people with Psoriasis, run by Centocor, Inc. at 5 sites in 2 countries.
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 7 inclusion and 7 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 29 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Taiwan, South Korea. 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 5 Oct 2012). 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?
The Number of Patients Who Achieved at Least a 75% Improvement in PASI (Psoriasis Area and Severity Index) at Week 12 (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Mar 2013; AzTrials last refreshed its copy on 7 Nov 2026.