Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Refractory Chronic Cough
- Conditions
- Refractory Chronic Cough
- Interventions
- Drug: 5 mg Serlopitant TabletsDrug: Matching Placebo Tablets
- Registration Number
- NCT03282591
- Lead Sponsor
- Vyne Therapeutics Inc.
- Brief Summary
Study of the efficacy, safety, and tolerability of serlopitant for the treatment of refractory chronic cough
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 185
- Female and males between 18 and 80 years of age
- Have a diagnosis of treatment refractory chronic cough or unexplained cough for at least one year
- Chest radiograph or computed tomography (CT) Thorax within the last 5 years not demonstrating any abnormality considered to be significantly contributing to the chronic cough
- At Screening have a score of ≥ 40mm on the Cough Severity VAS
- At Baseline (Day 0) have a score of ≥ 40mm on the Cough Severity VAS
- All female subjects who are of childbearing potential must practice highly effective contraception (i.e., pregnancy prevention method with a failure rate of < 1% per year) from the time of the initial screening visit until 4 weeks after last dose of study drug. Please refer to the protocol for acceptable methods of contraception
- Prior treatment with serlopitant or other NK1-R antagonist
- Presence of any medical condition or disability that could interfere with study
- History of hypersensitivity to serlopitant or any of its components
- Currently pregnant or male partner of pregnant female
- Females of childbearing potential who are unable or unwilling to use adequate contraception or who are breast feeding
- Current smoker or individuals who have given up smoking within the past 12 months
- FEV1/FVC < 60%
- Body mass index (BMI) <18 kg/m2 or ≥ 40 kg/m2 at Screening
- History of upper or lower respiratory tract infection or recent significant change in pulmonary status within 4 weeks of the Baseline Visit (Day 0)
- History of cystic fibrosis
- History of opioid use within 1 week of the Baseline Visit (Day 0)
- Requiring concomitant therapy with prohibited medications
- Treatment with biologic therapies within 8 weeks or 5 half-lives prior to the Baseline Visit (Day 0), whichever is longer
- Treatment with strong CYP3A4 inhibitors within 4 weeks prior to the Baseline Visit (Day 0)
- Treatment with any investigational therapy within 4 weeks (investigational biologic therapies within 8 weeks) prior to the Baseline Visit (Day 0)
- Serum creatinine, total bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2x the upper limit of normal (ULN) during screening
- Positive test for any drug of abuse
- History of malignancy within 5 years prior to the Baseline Visit (Day 0), with the exception of completely treated and non-metastatic basal cell carcinoma or squamous cell carcinoma of the skin
- Any known psychiatric diagnosis meeting DSM-5 criteria which may confound the assessment of serlopitant safety or efficacy, or interfere with the subject's ability to comply with protocol-mandated activities, within 3 years prior to randomization. Examples of such DSM-5 diagnoses include but are not limited to major depressive disorder, bipolar disorder, schizophrenia, psychotic disorder, intellectual disability, severe alcohol use disorder.
- Known active hepatitis infection
- Known history of human immunodeficiency virus (HIV) infection
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 5 mg Serlopitant Tablets 5 mg Serlopitant Tablets Serlopitant Tablets Matching Placebo Tablets Matching Placebo Tablets Placebo Tablets
- Primary Outcome Measures
Name Time Method Change in 24-hour Objective Cough Frequency (Log Normalized Percent Change Relative to Placebo) from Baseline to Day 84 Change in 24-hour objective cough frequency is total number of cough events during the monitoring period (24-hour interval)/24 (Total duration (in hours) for the monitoring period) which is captured through sound recordings by a custom-built digital recording device (VitaloJAK, Vitalograph, Ltd).
- Secondary Outcome Measures
Name Time Method Change From Baseline in Cough Severity Visual Analog Scale (VAS) from Baseline to Day 84 Visual Analog Scale (VAS) 101-point scale ranging from 0 (no cough) to 100 (worst cough). A higher score corresponds to higher cough severity.
Change in Awake Objective Cough Frequency from Baseline to Day 84 Awake cough frequency = (total number of cough events during the monitoring period (24-hour interval) the subject is awake)/(Total duration (in hours) for the monitoring period the subject is awake) which is captured by a custom-built digital recording device (VitaloJAK, Vitalograph, Ltd).
Percentage of Participants With ≥ 30% Reduction in 24-hour Objective Cough Frequency from Baseline to Day 84 The percentage of participants with ≥ 30% of reduction from baseline in 24-hour cough frequency is the number of participants with ≤-30% change in 24-hour cough frequency divided by the total number of participants with available data. This data is captured by a custom-built digital recording device (VitaloJAK, Vitalograph, Ltd).
Percentage of Participants With ≥30% Reduction in Awake Objective Cough Frequency from Baseline to Day 84 The percentage of participants with ≥ 30% of reduction from baseline in the awake cough frequency is the number of participants with ≤30% change in awake cough frequency divided by the total number of participants with available data. This data is captured by a custom-built digital recording device (VitaloJAK, Vitalograph, Ltd).
Trial Locations
- Locations (39)
Study Site 122
🇺🇸Cincinnati, Ohio, United States
Study Site 141
🇬🇧Llanelli, United Kingdom
Study Site 123
🇺🇸San Diego, California, United States
Study Site 105
🇺🇸Greenfield, Wisconsin, United States
Study Site 118
🇺🇸Largo, Florida, United States
Study Site 121
🇺🇸Ocean Township, New Jersey, United States
Study Site 120
🇺🇸Dallas, Texas, United States
Study Site 128
🇺🇸Mission Viejo, California, United States
Study Site 101
🇺🇸San Antonio, Texas, United States
Study Site 133
🇬🇧Belfast, United Kingdom
Study Site 136
🇬🇧Cottingham, United Kingdom
Study Site 135
🇬🇧Oxford, United Kingdom
Study Site 137
🇬🇧London, United Kingdom
Study Site 126
🇺🇸Bellingham, Washington, United States
Study Site 117
🇺🇸Eugene, Oregon, United States
Study Site 127
🇺🇸San Jose, California, United States
Study Site 138
🇬🇧London, United Kingdom
Study Site 110
🇺🇸Rochester, Minnesota, United States
Study Site 109
🇺🇸Waco, Texas, United States
Study Site 132
🇬🇧Manchester, United Kingdom
Study Site 129
🇺🇸Charleston, North Carolina, United States
Study Site 102
🇺🇸Dallas, Texas, United States
Study Site 140
🇬🇧Taunton, United Kingdom
Study Site 104
🇺🇸Rock Hill, South Carolina, United States
Study Site 112
🇺🇸Tulsa, Oklahoma, United States
Study Site 103
🇺🇸Charlotte, North Carolina, United States
Study Site 111
🇺🇸Gastonia, North Carolina, United States
Study Site 134
🇬🇧Preston, United Kingdom
Study Site 108
🇺🇸Denver, Colorado, United States
Study Site 106
🇺🇸Colorado Springs, Colorado, United States
Study Site 113
🇺🇸Colorado Springs, Colorado, United States
Study Site 130
🇺🇸Los Angeles, California, United States
Study Site 107
🇺🇸Winter Park, Florida, United States
Study Site 114
🇺🇸Mooresville, North Carolina, United States
Study Site 139
🇬🇧Birmingham, United Kingdom
Study Site 116
🇺🇸Portland, Oregon, United States
Study Site 131
🇺🇸Stockton, California, United States
Study Site 115
🇺🇸Plymouth, Minnesota, United States
Study Site 125
🇺🇸Rochester, New York, United States