19424A: Lu AG09222 in patients with allergic rhinitis

• Research type

  Research Study

• Full title

  Interventional, randomized, double-blind, placebo-controlled, multiple-dose study investigating the safety, tolerability, and pharmacokinetic properties of Lu AG09222 in patients with allergic rhinitis

• IRAS ID

  1003702

• Contact name

  Lynda Seagrave

• Contact email

  LSEA@lundbeck.com

• Sponsor organisation

  H. Lundbeck A/S

• Eudract number

  2021-001383-20

• Clinicaltrials.gov Identifier

  NCT05126316

• Research summary

  This is an interventional, randomised, double-blind, parallel-group, placebo-controlled, multiple-dose study
  assessing the safety, tolerability, and pharmacokinetics of Lu AG09222 versus placebo in participants with grass pollen-induced allergic rhinitis (hayfever). The study will consist of three treatment groups: placebo (dummy substance with no active ingredient), 100 mg Lu AG09222, and 600 mg Lu AG09222, to which participants will be randomised in a ratio of 1:1:1. 36 male and female participants between 18 and 65 years of age with a body mass index (BMI) between 18 and 30 kg/m2 will be enrolled in this study.

  LuAG09222 or placebo will be administered subcutaneously (under the skin). Participants will receive either placebo or Lu AG09222 at three timepoints (four injections per timepoint), with four weeks between each administration. The total study duration per participant from baseline to the end of follow-up will be approximately 20 weeks.

  The study will include an allergen challenge at baseline and after 8 weeks after first treatment. Other procedures in this study include, but are not limited to physical examination, blood and urine samples, ECGs, vital signs.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  21/NW/0226

• Date of REC Opinion

  20 Sep 2021

• REC opinion

  Further Information Favourable Opinion