A Study to Investigate ABP 654 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis

Phase 3 Completed 563 enrolled Amgen

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of the study is to evaluate the efficacy, safety, and immunogenicity of ABP 654 compared with ustekinumab in participants with moderate to severe plaque psoriasis.

Timeline

Start: 2020-11-11
Primary completion: 2022-01-13
Completion: 2022-06-03

Outcome

Met primary endpoint

paper was 0.14 with a two-sided 90% confidence interval (CI) of (-2.6 to 2.9), well within the prespecified similarity margin of (-10 to 10). PMID 39442018 ↗

Publications

Blauvelt A, Papp K, Trivedi M, Barragan C, Chow V, Mytych DT, Yamauchi P, Crowley J, Franklin J. Efficacy and safety of the ustekinumab biosimilar ABP 654 in patients with moderate-to-severe plaque psoriasis: a randomized double-blinded active-controlled comparative clinical study over 52 weeks. Br J Dermatol. 2025 Apr 28;192(5):826-836. doi: 10.1093/bjd/ljae402.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ABP 654	Protein / enzyme biologic	45 mg	Subcutaneous
Subject	ABP 654	Protein / enzyme biologic	90 mg	Subcutaneous
Subject	Ustekinumab	Monoclonal antibody	45 mg	Subcutaneous
Subject	Ustekinumab	Monoclonal antibody	90 mg	Subcutaneous