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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00747344
Recruitment Status : Completed
First Posted : September 5, 2008
Results First Posted : October 5, 2012
Last Update Posted : March 29, 2013
Information provided by (Responsible Party):
Centocor, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: Placebo - Controlled Period (CP) Drug: Ustekinumab 45 mg - CP Drug: Placebo to ustekinumab 45 mg - after CP Drug: Ustekinumab 45 mg - after CP Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : December 2008
Actual Primary Completion Date : September 2009
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Ustekinumab

Arm Intervention/treatment
Placebo Comparator: Placebo - Controlled Period (CP) Drug: Placebo - Controlled Period (CP)
Placebo, Weeks 0-12

Experimental: Ustekinumab 45 mg - CP Drug: Ustekinumab 45 mg - CP
Ustekinumab 45 mg, Weeks 0-12

Experimental: Placebo to ustekinumab 45 mg - after CP Drug: Placebo to ustekinumab 45 mg - after CP
Placebo at Weeks 0 and 4, then ustekinumab 45 mg at Week 12 and Week 16

Experimental: Ustekinumab 45 mg - after CP Drug: Ustekinumab 45 mg - after CP
Ustekinumab 45 mg at Weeks 0 and 4, then placebo at Week 12 and ustekinumab 45 mg at Week 16

Primary Outcome Measures :
  1. 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).

Secondary Outcome Measures :
  1. 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 ]
  2. The Change in Dermatology Life Quality Index (DLQI) From Baseline at Week 12 [ Time Frame: Baseline to Week 12 ]
    Scores could range from 0 to 30. A lower DLQI score represents better quality of life.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00747344

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Korea, Republic of
Anyang, Korea, Republic of
Seoul, Korea, Republic of
Changhua, Taiwan
Kaohsiung County, Taiwan
Taipei, Taiwan
Sponsors and Collaborators
Centocor, Inc.
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Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
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Responsible Party: Centocor, Inc. Identifier: NCT00747344    
Other Study ID Numbers: CR015313
First Posted: September 5, 2008    Key Record Dates
Results First Posted: October 5, 2012
Last Update Posted: March 29, 2013
Last Verified: March 2013
Keywords provided by Centocor, Inc.:
Psoriatic Arthritis
CNTO 1275
Additional relevant MeSH terms:
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Skin Diseases, Papulosquamous
Skin Diseases
Dermatologic Agents