CLOU064A2201 - dose-finding study in Chronic Spontaneous Urticaria

• Research type

  Research Study

• Full title

  A multicenter, randomized, double-blind, placebo controlled Phase 2b dose-finding study to investigate the efficacy, safety and tolerability of LOU064 in adult chronic spontaneous urticaria patients inadequately controlled by H1-antihistamines

• IRAS ID

  254033

• Contact name

  Clive Grattan

• Contact email

  Clive.E.Grattan@gstt.nhs.uk

• Sponsor organisation

  Novartis Pharma AG

• Eudract number

  2018-000993-31

• Duration of Study in the UK

  1 years, 3 months, 5 days

• Research summary

  This is a Phase 2b dose-finding study to investigate the efficacy, safety and tolerability of LOU064 in adult chronic spontaneous urticaria (CSU) patients.\n\nTreatment of CSU is a challenge and H1 antihistamines (H1AH)are the recommended first line treatment of CSU. While H1AH at approved doses provide relief for some patients, less than 40% of patients respond to H1AH at regular doses. Omalizumab is the only other licensed treatment for CSU. Omalizumab is a highly effective third line therapy for CSU subjects, however, less than 50% of subjects treated with Omalizumab reach a complete control of signs and symptoms of CSU. Therefore, there is high medical need for new treatment options for patients with CSU.\n\nThe purpose of this study is to evaluate the efficacy and safety of LOU064 in subjects suffering from CSU inadequately controlled by H1-antihistamines and to select a LOU064 dosing regimen for the subsequent Phase 3 study program.\n\nStudy duration is 18 weeks (2 weeks screening period; 12 weeks treatment period; 4 weeks follow-up period).\nThe study comprises the 7 following treatment arms:\n10 mg LOU064 once daily\n35 mg LOU064 once daily\n100 mg LOU064 once daily\n10 mg LOU064 twice a day\n25 mg LOU064 twice a day\n100 mg LOU064 twice a day\nPlacebo\n\nEligible subjects will be randomly assigned to the treatment arms in a 1:1:1:1:1:1:1 ratio.\n\nApproximately 308 patients who have been diagnosed with CSU will be enrolled worldwide and it is anticipated that\nthe UK will enrol 10 of these patients.

• REC name

  South West - Central Bristol Research Ethics Committee

• REC reference

  19/SW/0046

• Date of REC Opinion

  30 May 2019

• REC opinion

  Further Information Favourable Opinion