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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04761627 | A Study to Investigate Interchangeability of ABP 654 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis | PHASE3 | COMPLETED | 494 | — | — | Mar 24, 2021 | Feb 28, 2023 | Jan 11, 2024 | 88 | United States, Canada +6 |
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...