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Label indication Ustekinumab is a human interleukin-12 and -23 antagonist indicated for the treatment of: Moderate to severe plaque psoriasis in adult and pediatric patients 6 years of age and older who are candidates for phototherapy or systemic therapy. ( 1.1 ) Active psoriatic arthritis in adults and pediatric patients 6 years of age and older. FDA label
Also known as Stelara®
Ustekinumab · 1 trial · 1 indication
AUCtau from time 0 (week 52) over the dosing interval up to week 64 is presented. Pharmacokinetic (PK) parameters are based on ABP 654 in the switching group and on ustekinumab in the continued-use group.
Cmax between week 52 and week 64 is presented. PK parameters are based on ABP 654 in the switching group and on ustekinumab in the continued-use group.
| Arm | Type | Description |
|---|---|---|
| Continued-use Group (Ustekinumab) | ACTIVE_COMPARATOR | Participants will receive subcutaneous injection of ustekinumab up to Week 52. |
| Switching Group (Ustekinumab - ABP 654) | EXPERIMENTAL | Participants will initially receive injection of ustekinumab up to Week 16. Thereafter, starting from Week 28, participants will switch between ABP 654 and ustekinumab every 12 weeks up to Week 52. |
| Name | Type | Description |
|---|---|---|
| Ustekinumab | DRUG | Participants will receive subcutaneous (SC) injection of ustekinumab. |
| ABP 654 | DRUG | Participants will receive SC injection of ABP 654. |
Inclusion Criteria: * Participant has stable moderate to severe plaque psoriasis for at least 6 months * Participant has a score of PASI ≥ 12, involvement of ≥ 10% body surface area and static Physician Global Assessment ≥ 3 at screening and at baseline * Participant is a candidate for phototherapy...
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 is used for the treatment of psoriasis, a chronic inflammatory skin condition. It is a monoclonal antibody developed by Amgen Inc. (ticker: AMGN) and is currently in Phase 3 clinical development for moderate to severe plaque psoriasis.
Ustekinumab targets the p40 subunit shared by the cytokines interleukin-12 (IL-12) and interleukin-23 (IL-23), specifically binding to the IL12B, IL12A, and IL23A subunits. It acts as an inhibitor of these pathways, which are involved in inflammatory responses associated with psoriasis.
Ustekinumab is being developed by Amgen Inc., a biotechnology company traded under the ticker symbol AMGN. Amgen is responsible for the clinical development of this monoclonal antibody for psoriasis.
Ustekinumab is in Phase 3 clinical development for psoriasis. It is an investigational therapy and has not been approved by the FDA for this indication. The Phase 3 trial has been completed.
Ustekinumab has been evaluated in a Phase 3 clinical trial, NCT04761627, titled "A Study to Investigate Interchangeability of ABP 654 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis." This completed trial enrolled 494 participants across multiple countries, including the United States, Canada, and several European nations.