The VOLTAIRE-X Trial Looks at the Effect of Switching Between Humira® and BI 695501 in Patients With Plaque Psoriasis

Summary

The primary objective of the trial is to assess the PK similarity between patients receiving Humira® continuously vs those who alternate between BI 695501 and Humira®, in patients with moderate-to-severe chronic plaque psoriasis. The secondary objectives of this trial are to descriptively compare the safety, immunogenicity and efficacy profiles between patients receiving Humira® continuously vs those who alternate between BI 695501 and Humira®.

Timeline

Start

2017-07-10

Primary completion

2019-04-16

Completion

2019-04-16

Outcome

Met primary endpoint

paper Both CIs were within a predefined bioequivalence range of 80.0-125.0%. PMID 35934770 ↗

registry Least squares means ratio 105.19 (90.2% CI 96.58 to 114.64) NCT03210259 ↗

registry Least squares means ratio 101.14 (90.2% CI 93.26 to 109.70) NCT03210259 ↗

Publications

• Menter A, Cohen S, Kay J, Strand V, Gottlieb A, Hanauer S, Eduru SK, Buschke S, Lang B, Liesenfeld KH, Schaible J, McCabe D. Switching Between Adalimumab Reference Product and BI 695501 in Patients with Chronic Plaque Psoriasis (VOLTAIRE-X): A Randomized Controlled Trial. Am J Clin Dermatol. 2022 Sep;23(5):719-728. doi: 10.1007/s40257-022-00708-w. Epub 2022 Aug 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Adalimumab	Monoclonal antibody	40 mg	Subcutaneous
Subject	BI 695501	Monoclonal antibody	40 mg	Subcutaneous

Indications