Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABP 654 · 1 trial · 1 indication
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...
ABP 654 is an investigational small molecule being developed for the treatment of moderate to severe plaque psoriasis, a chronic skin condition characterized by red, scaly patches. It is currently in Phase 3 clinical development and has not yet been approved by regulatory authorities.
ABP 654 is being developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMGN. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational therapy for plaque psoriasis.
ABP 654 is in Phase 3 clinical development. A Phase 3 trial has been completed, involving 563 participants with moderate to severe plaque psoriasis. The drug remains investigational and is not yet approved for commercial use.
ABP 654 has one completed Phase 3 clinical trial, registered as NCT04607980. This randomized, double-blind, controlled study enrolled 563 participants with moderate to severe plaque psoriasis across multiple countries, including the United States, Canada, and several European nations.
ABP 654 is not FDA approved. It is an investigational drug currently in Phase 3 clinical development for plaque psoriasis. The completed Phase 3 trial (NCT04607980) provides data that may support a future regulatory submission, but approval has not been granted.