TITANIA

• Research type

  Research Study

• Full title

  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 Symptomatic Chronic Obstructive Pulmonary Disease (COPD) with a History of COPD Exacerbations (TITANIA)

• IRAS ID

  1004258

• Contact name

  Krishna Varsani

• Contact email

  krishna.varsani@astrazeneca.com

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2021-003771-34

• Clinicaltrials.gov Identifier

  NCT05158387

• Research summary

  This is a randomised, double-blind, chronic dosing, parallel-group, placebo-controlled study with 3 treatment arms. This study is looking to find out if the experimental drug called MEDI3506 will work and be safe for the treatment of Symptomatic Chronic Obstructive Pulmonary Disease (COPD) patients with a history of exacerbations (also called flare-ups, which is when COPD gets worse) . This study will also help to better understand the studied disease and associated health problems.
  A total of 1272 participants are expected to be randomised in the study that will be conducted in 19 countries.
  This study has 3 consecutive periods (screening, treatment, and follow-up), described below:
  The screening period will last a minimum of 2 weeks and can be extended up to 12 weeks.
  If patients meet the screening criteria, they will enter a 52 weeks treatment period. They will be randomly assigned to receive one of the following treatment options:
  • MEDI3506 300 mg every 4 weeks
  • MEDI3506 300 mg every 8 weeks alternating with placebo (i.e. week 0 = MEDI3506, week 4 = placebo, week 8 = MEDI3506, and so on)
  • Placebo every 4 weeks
  Patients will receive 13 injections in total, once every 4 weeks, with the last dose given at week 48, and the last visit of treatment period at week 52 (14 visits in total).
  Once patients complete 52 weeks of treatment in this study, they will be given the opportunity to participate in a separate extension study. If they do not participate in an extension study, they will attend a follow-up visit 8 weeks after completion of the treatment period (at week 60).

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  21/LO/0848

• Date of REC Opinion

  5 Jan 2022

• REC opinion

  Further Information Favourable Opinion