1109 Amgen lupus trial
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Product Development

Amgen’s adaptive solution to lupus

Amgen tackles clinical development challenges in lupus with an adaptive trial design

Through an FDA pilot, Amgen tackles clinical development challenges in lupus with an adaptive trial design other companies can replicate.

Nov 7, 2020 | 2:12 AM GMT

The latest study selected for FDA’s Complex Innovative Trial Designs pilot program aims to address one of the biggest problems in clinical development for systemic lupus erythematosus: translating Phase II signals to positive registrational data. 

Last week, Amgen Inc. (NASDAQ:AMGN) announced its adaptive Phase II trial of systemic lupus erythematosus therapy efavaleukin alfa (AMG 592) was accepted into the CID program — an FDA initiative designed to improve the efficiency of late-stage clinical development while promoting innovation with novel trial structures and statistical modeling. 

The study, which is slated to begin next half, uses adaptive randomization to assign more patients

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