NL-OMON56306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) - BUS-P3-01 (CALM-1)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 24
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
- 年龄范围
- 18 至 99（—）
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 as
- •described in Appendix 1, Section 10.1.5, 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 24hour 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
- •cough frequency between >0 and <16 coughs/h at Screening and a
- •24hour 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) as defined in Appendix 5. OR ii) A
- •WOCBP who agrees to follow the contraceptive guidance in Appendix 5 from
- •Screening through the Follow-Up Visit (2 weeks after the last dose of study
- •drug). 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, b
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. 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 HIV,
- •hepatitis B, or hepatitis C at
- •Note: 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.
研究者
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