Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01090427 | A Study of the Safety and Efficacy of Ustekinumab in Adolescent Patients With Psoriasis (CADMUS) | PHASE3 | COMPLETED | 110 | — | — | May 1, 2010 | Jan 1, 2014 | Jan 29, 2015 | 50 | Belgium, Canada +8 |
The PGA documents the physician's assessment of the participant's psoriasis status according to the following categories: induration, scaling, and erythema. The participant's psoriasis is assessed as 5-point scale as follows: cleared (0), minimal (1), mild (2), moderate (3), or severe (4); higher score indicates worse disease. The table below shows the percentage of participants who achieved a PGA score of 0 or 1 at Week 12 in each treatment group.
| Arm | Type | Description |
|---|---|---|
| Ustekinumab Half-standard Dosage | EXPERIMENTAL | Participants will receive ustekinumab at half the standard dosage at Weeks 0, 4, 16, 28, and 40. In addition, all participants will receive a single SC dose of placebo at Week 12. |
| Ustekinumab Standard Dosage | EXPERIMENTAL | Participants will receive ustekinumab at the standard dosage at Weeks 0, 4, 16, 28, and 40. In addition, all participants will receive a single SC dose of placebo at Week 12. |
| Placebo | EXPERIMENTAL | Participants will receive matching placebo at Week 0 and 4, followed by ustekinumab at half-standard or standard dosage at Weeks 12, 16, 28, and 40. |
| Name | Type | Description |
|---|---|---|
| Ustekinumab - Half-Standard Dosage | DRUG | Ustekinumab 0.375 mg/kg, 22.5 mg, or 45 mg based on body weight, administered subcutaneously (under the skin) at Weeks 0, 4, 16, 28, and 40. |
| Ustekinumab - Standard Dosage | DRUG | Ustekinumab 0.75 mg/kg, 45 mg, or 90 mg based on body weight administered subcutaneously at Weeks 0, 4, 16, 28, and 40. |
| Placebo | OTHER | Placebo administered subcutaneously at Weeks 0 and 4 or at Week 12. |
Inclusion Criteria: * Have a diagnosis of plaque-type psoriasis with or without psoriatic arthritis (PsA) for at least 6 months * Are candidates for phototherapy or systemic treatment of psoriasis * Have screening laboratory test results within the study parameters Exclusion Criteria: * Currently...