drugset

drugset / Trial / NCT04930042

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

NCT04930042 ↗

Phase 3 Completed 581 enrolled Alvotech Swiss AG

RandomizedParallel-groupQuadruple-blindTreatment

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

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