CTRI/2023/11/060301尚未招募3 期
A Phase 3, 24-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-2) - BUS-P3-02
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Male and female participants are eligible to be included in the study only if all the following criteria apply:
- •1. Between 18 and 80 years of age inclusive, at the time of signing the informed consent
- •2. Capable of understanding the written informed consent, which includes compliance with the requirements and restrictions listed in the Informed Consent Form and in this protocol, provides signed and witnessed written informed consent, and agrees to comply with protocol requirements including being available for the duration of the study
- •3. After investigation into potential underlying causes of chronic cough, have a diagnosis of RCC defined as:
- •a) insufficient improvement in cough after treatment for the underlying condition(s) contributing to their cough
- •b) unexplained cough for which an underlying condition has not been determined despite adequate investigation with diagnostic tests and trials of therapy
- •4. The Eligibility Adjudicator assessment confirms prior to randomization that the participants history meets diagnostic criteria for RCC
- •Persistent cough for = 1 year prior to Screening
- •6. Chest radiograph or computed tomography of the thorax within the last 5 years from Screening and following the onset of chronic cough that does not show any abnormality considered to be significantly contributing to the chronic cough in the opinion of the Investigator.
- •7. Participants must meet the following cough frequency criteria:
- •a) Participants in the Primary Efficacy population must have a 24-hour cough frequency of = 20 coughs/h at both Screening and Cough Frequency Baseline (Day -7) visits. The Primary Efficacy population will be approximately 150 participants per treatment arm
- •b) Participants in the Extended Efficacy population will have a 24-hour cough frequency between = 8 and < 40 coughs/h at Screening and a 24-hour cough frequency between = 8 and < 20 coughs/h at Baseline (Day -7). The Extended Efficacy population will be approximately 50 participants per treatment arm
- •c) Participants in the Exploratory Efficacy population will have a 24-hour cough frequency between > 0 and < 16 coughs/h at Screening and a 24-hour cough frequency between > 0 and < 8 coughs/h at Baseline (Day -7). The exploratory population will enroll up to 25 participants per treatment arm.
- •8. A score of = 40 mm on the Cough Severity Visual Analogue Scale at Screening and Baseline (Day 1)
- •9. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
- •a) Not a woman of childbearing potential (WOCBP)
- •b) A WOCBP who agrees to follow the protocol-specified contraceptive guidance from Screening through the Early Follow-Up Visit.
- •Note: WOCBP must have a negative serum pregnancy test at Screening and negative urine pregnancy test at Baseline and must use a highly effective contraception method from Screening through the Early Follow-up Visit (highly effective methods of birth control in this study include: combined estrogen and
- •progestogen containing or progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, and vasectomized partner)
- •10. Male participants must agree to use protocol-specified contraception from Screening through
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •1. Female participants who are pregnant, trying to become pregnant or lactating
- •2. Current smoker or vaper, or current use of tobacco smoke, cannabis smoke, or nicotine vapors
- •3. Individuals who have given up smoking or vaping within the past 6 months, or those with > 20 pack-year smoking history
- •4. Diagnosis of chronic obstructive pulmonary disease, bronchiectasis, cystic fibrosis, pulmonary sarcoidosis, idiopathic pulmonary fibrosis, or other significant or progressive airway/respiratory disorder that might affect cough based on clinician assessment
- •5. Uncontrolled asthma, defined as one or both of the following:
- •a) = 1 clinically significant exacerbation in the last 6 months or = 2 clinically significant exacerbations in the past 12 months. A clinically significant asthma exacerbation is defined as requiring the use of systemic corticosteroids
- •b) Use of rescue medication = 3 days per week or nighttime awakening > 1 time per week (pre-exercise prophylactic medication use will not be considered rescue medication).
- •6. Pre-bronchodilator forced expiratory in 1 second (FEV1)/forced vital capacity (FVC) < 60% at Screening or on spirometry testing performed within 2 years before Screening and following the onset of chronic cough
- •7. Participants who failed to use the cough monitor or who are confirmed to have incorrectly recorded 24-hour cough frequency at Screening or Cough Frequency Baseline (Day -7) Visits. Retest is allowed once only if insufficient recording time is captured and approved by the Medical Monitor. Incorrectly recorded 24-hour cough frequencies are defined as recordings where less than 20 hours of the recording can be assessed for cough frequency
- •8. History of upper and/or lower respiratory tract infection or significant change in pulmonary status within 28 days of Screening or during Screening or the Single-blind Placebo Run-in
- •9. Current active tuberculosis or nontuberculous mycobacterial infection, a history of latent untreated tuberculosis, or a history of incompletely treated tuberculosis
- •10. Laboratory confirmed severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection at Screening or Day -7
- •11. History of SARS-CoV-2 infection or Coronavirus Disease-2019 (COVID-19) within 3 months of Screening, history of long COVID 19, or known exposure to someone with SARS-CoV-2 infection or COVID-19 within 10 days of Screening. History of fully resolved long COVID may be permitted after
- •discussion with the Medical Monitor
- •12. Requiring concomitant therapy with prohibited medications or non-pharmacological therapy
- •13. Medical history of hypogeusia/dysgeusia/ageusia or known presence of a dysfunction in ability to taste. Participants with a history of taste disturbance that has fully resolved and was due to prior P2X3 antagonist drug exposure or participation in a previous clinical study of P2X3 antagonist or previous SARS-CoV-2 infection will be eligible
- •14. Medical history of malignancy and treatment completed = 5 years prior to Screening except for adequately treated nonmetastatic cutaneous squamous cell or basal cell carcinoma and/or carcinoma in situ of the cervix
- •15. History of a diagnosis of drug or alcohol dependency or abuse within the last 3 years, per Investigator assessment, or a positive urine drug scr
研究者
相似试验
招募中
1 期
A Phase 3, 24-Week, Randomized, Efficacy and Safety Study with Openlabel Extension of BLU-5937 in Adult Participants with Refractory or Unexplained Chronic Cough (CALM-2)Refractory Chronic Cough, Including Unexplained Chronic CoughMedDRA version: 21.0Level: LLTClassification code: 10080782Term: Refractory chronic cough Class: 10038738MedDRA version: 21.1Level: LLTClassification code: 10066656Term: Chronic cough Class: 10038738CTIS2024-513462-19-00Bellus Health Inc.771
尚未招募
3 期
A 24-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough (CALM-2)JPRN-jRCT2031230611Kawamoto Mika825
进行中（未招募）
1 期
A Phase 3, 24-Week, Randomized, Efficacy and Safety Study with Open-label Extension of BLU-5937 in Adult Participants with Refractory or Unexplained Chronic CoughRefractory or Unexplained Chronic CoughMedDRA version: 21.1Level: LLTClassification code 10066656Term: Chronic coughSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2022-000188-38-CZBellus Health, Inc.675
招募中
3 期
A Phase 3 Study with Open-Label Extension of BLU-5937 to determine Efficacy and Safety in Adult Participants with Refractory Chronic Cough, Including Unexplained Chronic Cough (CALM-1)CTRI/2023/06/054278Bellus Health, Inc.
招募中
3 期
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)RCCNL-OMON56306Bellus Health, Inc.24