Pharmacokinetic, Efficacy, Safety, and Immunogenicity of AVT02 With Moderate to Severe Chronic Plaque Psoriasis

Summary

Pharmacokinetic, Efficacy, Safety, and Immunogenicity Between Patients with Moderate to Severe Chronic Plaque Psoriasis Receiving Humira® and Patients with Moderate to Severe Chronic Plaque Psoriasis

Timeline

Start

2020-06-30

Primary completion

2021-05-31

Completion

2021-11-16

Outcome

Met primary endpoint

paper The 90% CIs for the switching versus non-switching arithmetic means ratio for primary endpoints AUCtau, W26-28 and Cmax, W26-28 were within the prespecified limits of 80-125% PMID 37204631 ↗

Publications

• Feldman SR, Kay R, Reznichenko N, Sobierska J, Dias R, Otto H, Haliduola HN, Sattar A, Ruffieux R, Stroissnig H, Berti F. Assessing the Interchangeability of AVT02 and Humira(R) in Participants with Moderate-to-Severe Chronic Plaque Psoriasis: Pharmacokinetics, Efficacy, Safety, and Immunogenicity Results from a Multicenter, Double-Blind, Randomized, Parallel-Group Study. BioDrugs. 2023 Jul;37(4):551-567. doi: 10.1007/s40259-023-00600-x. Epub 2023 May 19.

Drugs

Indications