Extension study of long-term efficacy, safety and tolerability of remibrutinib in CSU patients

• Research type

  Research Study

• Full title

  A multicenter, double-blind, placebo-controlled, randomized withdrawal and open-label extension study followed by long-term open-label treatment cycles to assess the efficacy, safety and tolerability of remibrutinib (LOU064) in adult chronic spontaneous urticaria patients who completed the preceding remibrutinib Phase 3 studies

• IRAS ID

  1007711

• Contact name

  Stanislav Chevernozhenko

• Contact email

  stanislav.chevernozhenko@novartis.com

• Sponsor organisation

  Novartis Pharma AG

• Eudract number

  2022-001034-11

• Clinicaltrials.gov Identifier

  NCT05513001

• Research summary

  This is an extension study is to see if Remibrutinib is safe and can help patients with Chronic Spontaneous Urticaria (CSU). The study will also evaluate if treatment with remibrutinib for a longer time results in improvement or recovery of the disease.
  About 1021 participants with CSU, who previously completed the treatment phase of remibrutinib preceding studies, will be in this study.
  Upon consenting to the study, patients will enter the 1st period (Epoch 1) for 6 months. Depending on the patients disease severity they will either receive
  Mild to moderate disease - Remibrutinib 25mg twice per day or Placebo (patients have 50% chance of getting either Remibrutinib or placebo, the patient or doctor will not know)
  Moderate to severe disease - open label Remibrutinib 25mg twice per day
  In addition, all patients will be asked to take H1-antihistamines.
  After completing Epoch 1, if continued treatment with Remibrutinib is considered beneficial they will enter Epoch 2; which are 24 week cycles of either Remibutinib or observation. There are a total of 5 (Re-) treatment and observation periods. Which period the patient enters will depend on their disease severity; both the patient and doctor will know what the patient is receiving. If at any time during the observation periods symptoms become moderate to severe they will start re-treatment with Remibrutnib. For patients completing the observation period with no symptoms/ disease well controlled they will exit the study. In case of flare ups there will be rescue medication provided. The maximum duration for which patients may be in the study is approximately 160 weeks with 17 study visits .
  At study visits patients will complete safety assessments including physical exam, blood/ urine samples, ECG. Patients will complete questionnaires and be given an eDiary device to record information about CSU symptoms and rescue medication use.
  Novartis Pharma AG is funding the study being run at participating Hospitals

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  23/LO/0352

• Date of REC Opinion

  26 Apr 2023

• REC opinion

  Favourable Opinion