Almirall initiates experimental phase of Lebrikizumab trial in AD patients that have failed or are unsuitable to oral Cyclosporine
The ADvantage study, whose principal investigator and coordinator is Professor Richard Warren of the University of Manchester, began in July 2021 after being submitted to the ethics committees of 80 centres in 9 European countries and their respective regulatory agencies
Almirall has recently started the experimental phase of the Phase III clinical trial (ADvantage) with lebrikizumab in patients with moderate to severe atopic dermatitis (AD) who have failed treatment with oral Cyclosporine. This study is a requirement for the Market Access Price and Reimbursement dossier in Europe.
The ADvantage study, whose principal investigator and coordinator is Professor Richard Warren of the University of Manchester, began in July 2021 after being submitted to the ethics committees of 80 centres in 9 European countries and their respective regulatory agencies. The 80 centres are located across the following countries: Spain, UK, France, Germany, the Netherlands, Belgium, Italy, Austria, and Poland.
The first centres to be initiated was in Spain on 15 December 2021, after obtaining all the necessary approvals and the relevant contract with the centre, and therefore the patient recruitment process for the ADvantage study has already started. The principal investigator is Dr Servando Marrón from the Miguel Servet Hospital in Zaragoza.
"We are very proud that Spain, in multicentre studies in the EU, once again contributes with centres of excellence in drug development, in our case specifically in Dermatology. We demonstrate a very efficient evaluation with very competitive timelines not only by the Spanish Medicines Agency, but also by the Ethics Committees," said Estrella Garcia, PhD, director of Global Clinical Operations. "These organizations already demonstrated great efficiency in approving clinical trials during the first phase of the Covid 19 pandemic, and we can confirm that they are continuing with the same dynamic," she added.
About Almirall
Almirall is a global biopharmaceutical company focused on skin health. We collaborate with scientists and healthcare professionals to address patient’s needs through science to improve their lives. Our Noble Purpose is at the core of our work: “Transform the patients' world by helping them realize their hopes and dreams for a healthy life”. We invest in differentiated and ground-breaking medical dermatology products to bring our innovative solutions to patients in need.
The company, founded in 1943 and headquartered in Barcelona, is publicly traded on the Spanish Stock Exchange and is a member of the IBEX35 (ticker: ALM). Throughout its 78-year history, Almirall has retained a strong focus on the needs of patients. Currently, Almirall has a direct presence in 21 countries and strategic agreements in over 70, through 13 subsidiaries, with about 1,800 employees. Total revenues in 2020 were 814.5 million euros.