Approval Probability
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Ustekinumab- Half-Standard Dosage · 1 trial · 1 indication
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...
Ustekinumab Half-Standard Dosage is used for the treatment of psoriasis in adolescent patients. It is being studied as a half-standard dosage regimen for this dermatological condition. The drug is currently in Phase 3 clinical development for this indication.
Ustekinumab Half-Standard Dosage is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The company is conducting clinical research on this drug for the treatment of psoriasis.
Ustekinumab Half-Standard Dosage is in Phase 3 clinical development for psoriasis. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. One Phase 3 trial has been completed to evaluate its safety and efficacy.
Ustekinumab Half-Standard Dosage has been studied in one completed Phase 3 clinical trial, identified as NCT01090427. This trial, known as CADMUS, evaluated the safety and efficacy of the drug in adolescent patients with psoriasis and enrolled 110 participants.
Ustekinumab Half-Standard Dosage is a specific dosage regimen of ustekinumab, a biologic therapy. The drug name indicates that it is administered at half the standard dose of ustekinumab. It is being studied for the treatment of psoriasis in adolescents.