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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04607980 | A Study to Investigate ABP 654 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis | PHASE3 | COMPLETED | 563 | — | — | Nov 11, 2020 | Jun 3, 2022 | Dec 12, 2024 | 84 | United States, Canada +6 |
The PASI is a measure of the average redness (erythema), thickness (induration), and scaliness (scaling; each graded on a 0-4 scale \[0 = clear; 1-4 = increasing severity\]) of the lesions, weighted by the area of involvement in the four main body areas (i.e., head, arms, trunk to groin, and legs to top of buttocks). The PASI score ranges from 0 to 72. Higher scores represent worse symptom severity.
| Arm | Type | Description |
|---|---|---|
| Treatment Group A (ABP 654) | EXPERIMENTAL | Participants will receive subcutaneous (SC) injection of ABP 654, 45 mg (baseline BW less than equal to \[\<=\] 100 kg) or 90 mg (baseline BW greater than \[\>\] 100 kg) at weeks 0, 4, and 16. Further from week 28 participants will receive ABP 654 (same dose) every 12 weeks (Q12W) at weeks 28 and 40 or may receive dose intensification Q8W at weeks 28, 36, and 44, depending on PASI score. |
| Treatment Group B (Ustekinumab - ABP 654) | EXPERIMENTAL | Participants will receive SC injection of ustekinumab,45 mg (baseline BW \<= 100 kg) or 90 mg (baseline BW \> 100 kg) at weeks 0, 4, and 16. At week 28, participants will be re-randomized to continue on ustekinumab (Treatment group B1), or to receive ABP 654 (Treatment group B2) on weeks 28 and 40. Depending on PASI score, some participants may not be re-randomized and may receive dose intensification with ustekinumab Q8W at weeks 28, 36, and 44. |
| Name | Type | Description |
|---|---|---|
| ABP 654 | DRUG | Participants will receive SC injection of ABP 654. |
| Ustekinumab | DRUG | Participants will receive SC injection of ustekinumab. |
Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: * Stable moderate to severe plaque psoriasis for at least 6 months * Baseline score of PASI \>= 12, involvement of \>= 10% BSA, and sPGA \>= 3 at screening and at baseline * Candi...