* CQGE031E12301

• Research type

  Research Study

• Full title

  A multi-center, randomized, double-blind, placebo controlled study to investigate the efficacy and safety of ligelizumab (QGE031) in the treatment of Chronic Inducible Urticaria (CINDU) in adolescents and adults inadequately controlled with H1-antihistamines

• IRAS ID

  1004157

• Contact name

  Claus-Peter Danzer

• Contact email

  claus-peter.danzer@novartis.com

• Sponsor organisation

  Novartis Pharma AG

• Eudract number

  2020-003018-11

• Clinicaltrials.gov Identifier

  NCT05024058

• Research summary

  The study is designed to look at the safety and efficacy of ligelizumab in patients with Chronic Inducible Urticaria (CINDU) inadequately controlled by H1-antihistamines. The Sponsor (funder) for the study is Novartis. There will be 428 participants from 37 countries in the study, split into 3 parallel cohorts depending on how their disease symptoms are provoked. 168 participants with symptomatic dermographism, 102 participants with cold urticaria and 158 participants with cholinergic urticaria. Participants will sign an informed consent form and then will enter a screening phase lasting up to 4 weeks where they will have blood and urine samples taken, a physical examination and be asked to complete an eDiary to record their CINDU symptoms.
  Those that are eligible to enter the study will receive either the study drug or a placebo followed by the study drug.
  Patients with symptomatic dermographism or cold urticaria will have a one in three chance of receiving ligelizumab 120mg or 72 mg or placebo followed by ligelzumab at one of the 2 doses mentioned.
  Cholinergic urticaria patients will have a 1 in 2 chance of receiving either ligelizumab (120mg) or placebo followed by ligelizumab (120 mg). Patients on the placebo arm will receive 12 weeks of placebo followed by 12 weeks of ligelizumab. The study will be blinded so neither the study doctor nor the participant will know which treatment they are receiving. Participants will be in the study for about 40 weeks and will have 11 study visits lasting between 2 to 5 hours each. At each visit blood and urine samples will be collected, patients will be asked to complete patient reported outcome (PROs) questionnaires, have a physical examination, stool samples if necessary and provocation tests to provoke CINDU symptoms. The type of provocation test depends on which cohort the patient is in. At each visit the study drug or placebo will be administered sub cutaneously (an injection into the skin) by the study team.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  21/FT/0137

• Date of REC Opinion

  9 Nov 2021

• REC opinion

  Further Information Favourable Opinion