Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CNTO1959PSO1002 | Other Identifier | Janssen Pharmaceutical K.K., Japan |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to assess the safety and tolerability of CNTO 1959 following a single subcutaneous (SC, under the skin) dose administered to Japanese participants with moderate to severe plaque psoriasis.
This is a randomized (participants are assigned to treatment groups by chance), double-blind (participants and study personnel know what study agents are given), placebo-controlled (a placebo is a treatment identical in appearance to CNTO 1959 but does not contain active drug), single-dose study. The study will include 24 participants: 4 groups of at least 6 participants each. If it is decided that additional data are needed to define the safety and tolerability of CNTO 1959, an additional group may be enrolled. A given dose level may be repeated in newly enrolled participants, or a lower or intermediate dose may be administered based on preliminary data. The total duration of participation will be approximately 30 weeks, which includes a screening period of up to 6 weeks before the administration of study agent. Participant safety will be monitored. Ascending doses of 10, 30, 100, and 300 mg dose of CNTO 1959 and placebo will be administered as single SC injections; however, 2 SC injections may be required for the 300 mg dose level. Dosing will be performed for 24 weeks.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 001 | Experimental |
| |
| 002 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CNTO 1959 | Drug | CNTO 1959: type=range, unit=mg, number=10, 30, 100, 300, form=solution for injection, route=subcutaneous use, ascending dosing for 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| The number and type of adverse events | Up to 24 weeks | |
| Change in clinical laboratory values | Up to 24 weeks | |
| Electrocardiogram | Up to 24 weeks | |
| Changes or abnormalities in body systems | Up to 24 weeks | |
| Axillary temperature | Up to 24 weeks | |
| Pulse rate | Up to 24 weeks | |
| Blood pressure | Up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Blood levels of CNTO 1959 | Up to 24 weeks | |
| Antibodies to CNTO 1959 | Up to 24 weeks | |
| Psoriasis Area and Severity Index (PASI) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Janssen Pharmaceutical K.K., Japan Clinical Trial | Janssen Pharmaceutical K.K. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sapporo | Japan |
Not provided
| Label | URL |
|---|---|
| Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CNTO 1959 following a Single Subcutaneous Administration in Japanese Subjects With Moderate to Severe Plaque Psoriasis | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Placebo: form=solution for injection, route=subcutaneous use, ascending dosing for 24 weeks |
|
The PASI produces a numeric score that can range from 0 (no involvement) to 72 (90% to 100% involvement). |
| Up to 24 weeks |
| Physician's Global Assessment (PGA) | Assessment of the patient's psoriasis status according to the following categories: induration, erythema, and scaling | Up to 24 weeks |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000588857 | guselkumab |
Not provided
Not provided
Not provided