EUCTR2022-000188-38-CZ进行中（未招募）1 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) - CALM-2
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 675
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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 (ICF) 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, OR
- •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 participant’s history meets diagnostic criteria for RCC
- •5. 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/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 CS-VAS 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:
- •i) Not a woman of childbearing potential (WOCBP).
- •ii) A WOCBP who agrees to follow the contraceptive guidance from Screening through the 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 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 contraception from Screening through the Follow-Up Visit and make no donation of sperm from Screening until 3 months after the last dose of study treatment.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 412
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for t
排除标准
- •1. Current smoker or vaper or current use of tobacco smoke, cannabis smoke, or nicotine vapors
- •2. Individuals who have given up smoking or vaping within the past 6 months, or those with > 20 pack-year smoking history
- •3. 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
- •4. 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
- •5. Laboratory confirmed severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection at Screening or Day -7
- •6. 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
- •7. History of a diagnosis of drug or alcohol dependency or abuse within the last 3 years, per Investigator assessment, or a positive urine opioid
- •drug screen result at Screening. Stable opioid treatment for non-cough indication is permitted (refer to Appendix 4 of the study protocol)
- •8. Positive serological test for human immunodeficiency virus, hepatitis B, or hepatitis C. Note: Participants with positive hepatitis B or C
- •serology will have confirmatory testing
- •9. Previous participation in an investigational study of BLU-5937
- •For the full list of exclusion criteria please refer to the study protocol.
研究者
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