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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...
Ustekinumab is used for the treatment of moderate to severe plaque psoriasis. It is being studied in a Phase 3 clinical trial for this condition. The drug is administered to adult participants aged 18 years and older. The trial is active-controlled and double-blinded, with 494 participants enrolled.
Ustekinumab is developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker AMGN. The company is conducting a Phase 3 clinical trial to evaluate the drug for the treatment of moderate to severe plaque psoriasis.
Ustekinumab is in Phase 3 clinical development. It is an investigational drug being studied for the treatment of moderate to severe plaque psoriasis. The Phase 3 trial has been completed, with 494 participants enrolled across multiple countries including the United States, Canada, and several European nations.
Ustekinumab is associated with one completed Phase 3 clinical trial, identified as NCT04761627. The trial, titled 'A Study to Investigate Interchangeability of ABP 654 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis,' enrolled 494 participants. It was a randomized, double-blind, active-controlled study conducted in the United States, Canada, Estonia, Georgia, Germany, Hungary, Latvia, and Poland.
Ustekinumab is the drug being studied in the clinical trial, and ABP 654 is the name used in the trial title. The trial investigates the interchangeability of ABP 654 for the treatment of moderate to severe plaque psoriasis. This suggests ABP 654 may be a formulation or version of Ustekinumab, though the relationship is not explicitly defined in the available information.