EUCTR2022-000188-38-SK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
- 825
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 Overall Efficacy population must have a 24-hour cough frequency of =16 coughs/h at Screening and =20 coughs/h at Baseline (Day -7), or between =8 and <40 coughs/h at Screening and between =8 and <20 coughs/h at Baseline (Day -7).
- •Approximately 25% of participants with a 24-hour cough frequency between =8 and <40 coughs/h at Screening and between =8 and <20 coughs/h at Baseline will be enrolled (approximately 63 participants per treatment arm). When this 25% threshold has been reached, only participants with a 24-hour cough frequency of =16 coughs/h at Screening and =20 coughs/h at Baseline will be enrolled (approximately 187 participants per treatment arm).
- •b) 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 participants until up to 25 per treatment arm has been reached.
- •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, vasectomized partner or same sex partner) or agrees to total abstinence, defined as refraining from heterosexual intercourse, as the preferred and usual lifestyle.
- •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
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, chronic bronchitis, 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 during Single-blind Placebo Run-in
- •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(HIV), hepatitis B, or hepatitis C at Screening
- •Participants with positive hepatitis B or C serology will have confirmatory testing.
- •Participants with HIV on stable treatment with undetectable viral load are acceptable if the participant otherwise meets entry criteria
- •Participants with positive hepatitis C antibody test due to prior resolved disease who have successfully completed a course of antiviral therapy can be enrolled, only if a confirmatory negative hepatitis C RNA test is obtained and if the participant otherwise meets entry criteria
- •9. Previous participation in an investigational study of BLU-5937
- •For the full list of exclusion criteria please refer to the study protocol.
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