PRC Bradford recruit world's first patients in TITANIA study
World’s first participants to take part in TITANIA were recently recruited at NIHR National Patient Recruitment Centre (PRC) based in Bradford.
UK based firm AstraZeneca AB, launched the phase 3 clinical trial of Tozorakimab , in the UK in January this year, with the first participants enrolled at the NIHR PRC in Bradford on 7th February 2022.
The study will investigate the efficacy and safety of a new treatment called Tozorakimab (MEDI3506) administered subcutaneously via two dose regimens in adult participants with moderate to severe symptomatic COPD.
The study is looking to recruit participants aged over 40 who suffer with COPD with a history of two or more moderate or one or more severe exacerbation of COPD in the previous 12 months. Participants should be receiving optimised treatment with maintenance inhaled therapy (ICS/LABA/LAMA triple therapy, or dual therapy if triple is not indicated or contraindicated) at a stable dose for at least 3 months prior to enrolment.
Professor Dinesh Saralaya, Consultant Respiratory Physician & Director of the NIHR PRC Bradford and Principal Investigator on the TITANIA clinical trial, said:
“Bradford has recruited a Global-first, adding to our extensive track record of recruitment successes including previous Global first and European first recruits. It is further evidence of our expertise and capabilities here in Bradford and we look forward to continuing this success with our extensive portfolio of commercial studies. It's also a testament to the hard work of our team and the commitment of our patients to research and improving care ”
The study will take place at the PRC: Bradford’s state-of-the-art facilities based at Bradford Teaching Hospitals NHS Foundation Trust. The National Patient Recruitment Centres (PRCs) are the first family of NIHR-funded research facilities that are 100% dedicated to delivering commercial research. They are purpose-designed to increase the UK’s capacity to deliver large scale, late-phase commercial clinical trials and to make it easier and quicker to deliver commercial research in our NHS and wider care settings.
This Global-first patient is further evidence to the service the PRCs are providing commercial partners and patients. Being the first country to recruit a patient in a global trial is a key performance indicator for the life sciences industry as it shows that the UK can support the rapid set-up and recruitment of studies.
About the TITANIA study
The purpose of this Phase III study is to evaluate the efficacy and safety of Tozorakimab (MEDI3506) Dose 1 and Dose 2 administered subcutaneously (SC) in adult participants with symptomatic COPD and history of ≥ 2 moderate or ≥ 1 severe exacerbation of COPD in the previous 12 months. Participants should be receiving optimised treatment with maintenance inhaled therapy (ICS/LABA/LAMA triple therapy, or dual therapy if triple is not indicated or contraindicated) at a stable dose for at least 3 months prior to enrolment.
This is a phase III, multicentre, randomised, double-blind, chronic-dosing, parallel-group, placebo-controlled study to evaluate the efficacy and safety of two dose regimens of MEDI3506 in participants with moderate to very severe Chronic Obstructive Pulmonary Disease (COPD) with a history of COPD exacerbations.