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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo - Controlled Period (CP) | Placebo Comparator |
| |
| Ustekinumab 45 mg - CP | Experimental |
| |
| Placebo to ustekinumab 45 mg - after CP | Experimental |
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| Ustekinumab 45 mg - after CP | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo - Controlled Period (CP) | Drug | Placebo, Weeks 0-12 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Patients With a Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Centocor, Inc. Clinical Trial | Centocor, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anyang | South Korea | |||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo (CP) | Controlled period (Week 0-12) - Placebo Group |
| FG001 | Ustekinumab 45 mg (CP) | Controlled period (Week 0-12) - Ustekinumab 45 mg Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Controlled Period |
|
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| Ustekinumab 45 mg - CP |
| Drug |
Ustekinumab 45 mg, Weeks 0-12 |
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| Placebo to ustekinumab 45 mg - after CP | Drug | Placebo at Weeks 0 and 4, then ustekinumab 45 mg at Week 12 and Week 16 |
|
| Ustekinumab 45 mg - after CP | Drug | Ustekinumab 45 mg at Weeks 0 and 4, then placebo at Week 12 and ustekinumab 45 mg at Week 16 |
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| Baseline to Week 12 |
| Seoul |
| South Korea |
| Changhua | Taiwan |
| Kaohsiung County | Taiwan |
| Taipei | Taiwan |
| FG002 | Placebo -> Ustekinumab 45 mg (After CP) | After controlled period (Week 12-36) - receiving Placebo at Weeks 0 and 4 -> receiving ustekinumab 45 mg at Week 12 and Week 16 |
| FG003 | Ustekinumab 45 mg (After CP) | After controlled period (Week 12-36) - receiving ustekinumab 45 mg at Weeks 0 and 4 -> receiving placebo at Week 12 and ustekinumab 45 mg at Week 16 |
| COMPLETED |
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| NOT COMPLETED |
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| After Controlled Period |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo (CP) | Controlled period (Week 0-12) - Placebo Group |
| BG001 | Ustekinumab 45 mg (CP) | Controlled period (Week 0-12) - Ustekinumab 45 mg Group |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Participants were analyzed according to the treatment group to which they were randomized, regardless of the treatment they received. | Posted | Number | Participants | Week 12 |
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| Secondary | The Number of Patients With a Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12 | Participants were analyzed according to the treatment group to which they were randomized, regardless of the treatment they received. | Posted | Number | Participants | Week 12 |
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| Secondary | 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. | Participants were analyzed according to the treatment group to which they were randomized, regardless of the treatment they received. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline to Week 12 |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo (CP) | Controlled period (Week 0-12) - Placebo Group | 2 | 60 | 30 | 60 | ||
| EG001 | Ustekinumab 45 mg (CP) | Controlled period (Week 0-12) - Ustekinumab 45 mg Group | 0 | 61 | 25 | 61 | ||
| EG002 | Placebo -> Ustekinumab 45 mg (After CP) | After controlled period (Week 12-36) - receiving Placebo at Weeks 0 and 4 -> receiving ustekinumab 45 mg at Week 12 and Week 16 | 5 | 55 | 18 | 55 | ||
| EG003 | Ustekinumab 45 mg (After CP) | After controlled period (Week 12-36) - receiving ustekinumab 45 mg at Weeks 0 and 4 -> receiving placebo at Week 12 and ustekinumab 45 mg at Week 16 | 2 | 59 | 28 | 59 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anal abscess | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
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| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA 12.1 | Non-systematic Assessment |
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| Muscle injury | Injury, poisoning and procedural complications | MedDRA 12.1 | Non-systematic Assessment |
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| Parathyroid tumour benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Non-systematic Assessment |
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| Henoch-Schonlein purpura | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Eosinophilia | Blood and lymphatic system disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Injection site erythema | General disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Psoriatic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Research | Janssen Research & Development, LLC | 215-793-7646 |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
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| ID | Term |
|---|---|
| D000069549 | Ustekinumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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| Male |
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| Taiwan |
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| Superiority or Other |
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