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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...
Top 12 of 13 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Johnson & Johnson | JNJ | 11 | PHASE3 | JNJ-77242113, Ustekinumab, Guselkumab |
| Bristol-Myers Squibb Company | BMY | 14 | PHASE3 | Deucravacitinib |
| AbbVie, Inc. | ABBV | 5 | PHASE3 | Risankizumab |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 3 | PHASE3 | Zasocitinib |
| Alumis Inc. | ALMS | 2 | PHASE3 | Envudeucitinib |
| Oruka Therapeutics, Inc. | ORKA | 4 | PHASE2 | ORKA-002, ORKA-001 |
| Can-Fite Biopharma Ltd | CANF | 1 | PHASE3 | Piclidenoson |
| Organon & Co. | OGN | 1 | PHASE3 | Tapinarof |
| Vanda Pharmaceuticals Inc. | VNDA | 1 | PHASE3 | Ponesimod |
| Novartis AG Sponsored ADR | NVS | 4 | - | Secukinumab |
| Bausch Health Companies Inc. | BHC | 2 | - | Brodalumab |
| Merck & Co., Inc. | MRK | 1 | PHASE1 | MK-8644 |
Ustekinumab half-standard dosage refers to a reduced-dose regimen of ustekinumab studied for the treatment of psoriasis, including adolescent patients with plaque psoriasis. It is a monoclonal antibody therapy in the dermatology therapeutic area. The half-standard dosage describes a lower exposure level than the standard ustekinumab dosing used in clinical practice.
Ustekinumab half-standard dosage targets IL12B, IL12A, and IL23A. It is an inhibitor of these interleukin subunits, which are components of the IL-12 and IL-23 cytokine pathways involved in inflammatory signaling. By binding these targets, the antibody interferes with the inflammatory cascade implicated in psoriasis.
Johnson & Johnson, which trades under the ticker JNJ, is the developer associated with ustekinumab half-standard dosage. The company is the sponsor behind the clinical development of this reduced-dose ustekinumab regimen for psoriasis.
Ustekinumab half-standard dosage has been studied in Phase 3 clinical development. It is an investigational reduced-dose regimen and is not described as an approved product. The Phase 3 program has been completed, with no active trials currently listed for this specific half-standard dosage regimen.
Ustekinumab half-standard dosage was evaluated in the Phase 3 CADMUS study, registered as NCT01090427, titled A Study of the Safety and Efficacy of Ustekinumab in Adolescent Patients With Psoriasis. The trial enrolled 110 adolescent patients with psoriasis across Belgium, Canada, France, Germany, Hungary, Portugal, Russia, Sweden, Ukraine, and the United Kingdom, and it is completed.
Ustekinumab half-standard dosage is an alternative name for a reduced-dose ustekinumab regimen, so it refers to the same monoclonal antibody given at a lower dose level rather than a different molecule. It is distinct from standard-dose ustekinumab in terms of the amount administered, not in its molecular target or modality.