CALM-1

• Research type

  Research Study

• Full title

  A Phase 3, 52-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm Efficacy and Safety Study with Open-Label Extension of BLU-5937 in Adult Participants with Refractory Chronic Cough, Including Unexplained Chronic Cough (CALM-1)

• IRAS ID

  1006707

• Contact name

  Catherine Bonuccelli

• Contact email

  CALM@bellushealth.com

• Sponsor organisation

  Bellus Health, Inc.

• Eudract number

  2022-000223-20

• Research summary

  Refractory chronic cough (RCC) is defined as chronic cough after the patient is treated for all identified underlying medical conditions, as well as chronic cough for which an underlying medical condition has not been identified despite appropriate patient evaluation. In people with RCC, it is thought that the nerves controlling the muscles in the throat and chest are easily activated, causing frequent coughing. Although RCC is common, currently there are no medicines approved for the treatment of RCC.

  The study drug BLU-5937 is being developed to reduce activation of the nerves that trigger cough in the airways.

  This Phase 3 protocol is designed to evaluate the efficacy and safety of 2 doses of BLU-5937 in participants with RCC over a 52-week course of treatment. The study is made up of 3 periods: Screening period (4 weeks), Study treatment period (79 weeks) and Follow-up period (2 weeks).

  Adult participants (18 to 80 years of age) will be randomly assigned (by a computer, by chance) to one of the following groups:

  • Group 1: 25 milligrams (mg) of BLU-5937 + 50 mg placebo
  • Group 2: 50 mg of BLU-5937 + 25 mg placebo
  • Group 3: 50 mg placebo + 25 mg placebo

  All participants in the study will receive BLU-5937 only for at least part of the study drug treatment period. Additionally, all participants in the study will receive placebo only at some point during the study drug treatment period:

  For every 3 participants:
  • 2 participants will receive 76 weeks of BLU-5937 and 3 weeks of placebo
  • 1 participant will receive 24 weeks of BLU-5937 and 55 weeks of placebo

  Approximately 2000 participants will be screened to achieve up to 675 participants randomly assigned to study treatment.

• REC name

  East of England - Cambridge Central Research Ethics Committee

• REC reference

  22/EE/0290

• Date of REC Opinion

  16 Aug 2023

• REC opinion

  Further Information Favourable Opinion