222926 - MODIFY

• Research type

  Research Study

• Full title

  The MODIFY Study: A Phase 3b/4 randomized, double-blind, placebo-controlled, multicentre study evaluating the impact of early intervention with depemokimab on exacerbation rate, clinical remission, lung function decline, and safety in adults and adolescents with at risk Type 2 asthma, conducted up to 156 weeks.

• IRAS ID

  1013624

• Contact name

  Sarah Douglas

• Contact email

  sarah.a.douglas@gsk.com

• Sponsor organisation

  GlaxoSmithKline Research & Development Limited

• Clinicaltrials.gov Identifier

  NCT07456033

• Research summary

  The purpose of this clinical research study is to look at whether a medication called Depemokimab (Exdensur), known as the ‘study drug’ works to reduce asthma attacks and is safe in adult and adolescent participants. This study is a Phase 3b/4 study, which includes large-scale testing in hundreds to thousands of participants. It’s goal is to expand on the information already obtained from previous studies and provide an understanding of whether or not the study drug works, the benefits from it and its safety. Asthma is a long-term illness that sometimes makes the airways inflamed and narrow, making it harder to breathe. Some people have a distinct type of asthma, where the body makes more of certain white blood cells (called eosinophils) that can cause swelling and damage in the airways, and this makes them more likely to have asthma attacks. The study drug being researched, is meant to stop the signal that tells the body to make these cells. The study drug targets the inflammation pathway by binding and inhibiting an inflammation mediator called interleukin-5. By doing this, it may help reduce inflammation and swelling in the airways and lower the chance of having asthma attacks. The study drug is a type of medicine that is given as an injection under the skin about every 6 months.
  Depemokimab (Exdensur) was approved by the UK health authorities for use in severe asthma.
  Participants will be in this study for a minimum of 2 years and maximum of 3 years depending on when they were recruited. Participants will be randomly assigned to receive either the study drug or a placebo every 26 weeks. A placebo looks like the study drug but does not contain any active ingredients.
  Approximately 456 people will take part in this study worldwide

• REC name

  East of England - Cambridge South Research Ethics Committee

• REC reference

  26/EE/0081

• Date of REC Opinion

  29 Apr 2026

• REC opinion

  Further Information Favourable Opinion