Efficacy, Safety, and Immunogenicity of AVT04 With Moderate-to-Severe Chronic Plaque Psoriasis

Summary

Safety and Efficacy study of AVT04 (Alvotech Biosimilar to Ustekinumab), in patients with moderate to severe plaque psoriasis

Timeline

Start

2021-06-03

Primary completion

2021-12-28

Completion

2022-10-11

Outcome

Met primary endpoint

paper The percent PASI improvement for AVT04 vs RP was 87.3% vs 86.8% (CI: -2.14%, 3.01%); study met its primary endpoint. PMID 37435850 ↗

release “The confirmatory clinical, safety and efficacy study for AVT04, biosimilar candidate to Stelara® (ustekinumab) met its primary endpoint.” alvotech.com ↗

release “data from the AVT04-GL-301 confirmatory clinical, safety and efficacy study that met its primary endpoint” alvotech.com ↗

Publications

• Feldman SR, Reznichenko N, Berti F, Duijzings P, Ruffieux R, Otto H, Haliduola HN, Leutz S, Stroissnig H. Randomized, double-blind, multicenter study to evaluate efficacy, safety, tolerability, and immunogenicity between AVT04 and the reference product ustekinumab in patients with moderate-to-severe chronic plaque psoriasis. Expert Opin Biol Ther. 2023 Jul-Dec;23(8):759-771. doi: 10.1080/14712598.2023.2235263. Epub 2023 Jul 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	AVT04	Monoclonal antibody	45 mg	Subcutaneous
Comparator	Ustekinumab	Monoclonal antibody	45 mg	Subcutaneous

Indications