*ANCHOR-1: depemokimab in patients with chronic rhinosinusitis with nasal polyps

• Research type

  Research Study

• Full title

  A randomised, double-blind, parallel group Phase III study to assess the efficacy and safety of 100 mg SC depemokimab in patients with chronic rhinosinusitis with nasal polyps (CRSwNP) – ANCHOR-1 (depemokimAb iN CHrOnic Rhinosinusitis)

• IRAS ID

  1004771

• Contact name

  Markas Marriott

• Contact email

  markas.j.marriott@gsk.com

• Sponsor organisation

  Glaxosmithkline Research & Development Limited

• Eudract number

  2021-005037-16

• Clinicaltrials.gov Identifier

  NCT05274750

• Research summary

  Nasal polyposis (NP) is a chronic inflammatory disease of the lining of inside of the nose. It causes soft tissue overgrowth in the nose cavity; causing symptoms including pain, smell disturbance and congestion. Although prescription medicines may successfully treat NPs, in more serious cases an operation may be needed.

  GSK is conducting a study to test how safe and effective a medicine called depemokimab is at treating nasal polyps. Depemokimab is a type of medicine called a monoclonal antibody, that works by reducing the number of eosinophils (a type of white blood cell) in the body. It is already known that eosinophils are involved in nasal polyp creation and that NP sufferers have comparatively higher levels of eosinophils in their blood versus the general population.

  In this study, patients with NPs on both sides will be randomised into one of two treatment groups; either 100mg depemokimab or placebo (a dummy drug), both given by an injection under the skin. Participants will receive two doses of depemokimab or placebo, each one given 6 months apart, plus their usual standard of care medications. This study is ‘double blind’ meaning that neither the participant nor the study team will know which treatment the participant is receiving.

  Globally, approximately 250 participants will be involved, with about 10 participants in the UK.

  Study participants will spend approximately 60 weeks in the study; comprising of a 4-week screening period, followed by a 52-week treatment period and then a 4-week follow-up period.

  Study assessments include:
  - Physical examination
  - Assessment of nasal polpys
  - Blood and urine tests
  - Electronic diary to record symptoms
  - Questionnaires
  - ECG and Vital signs
  - Computed tomography (CT) scan: Images of your sinuses to help assess the severity of your nasal polyps.

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  22/SC/0290

• Date of REC Opinion

  4 Apr 2022

• REC opinion

  Further Information Favourable Opinion