MedPath

Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Refractory Chronic Cough

Phase 2
Completed
Conditions
Refractory Chronic Cough
Interventions
Drug: 5 mg Serlopitant Tablets
Drug: 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
Inclusion Criteria
  • 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
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Exclusion Criteria
  • 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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
5 mg Serlopitant Tablets5 mg Serlopitant TabletsSerlopitant Tablets
Matching Placebo TabletsMatching Placebo TabletsPlacebo Tablets
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
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 Frequencyfrom 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 Frequencyfrom 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 Frequencyfrom 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

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Cincinnati, Ohio, United States

Study Site 141

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Llanelli, United Kingdom

Study Site 123

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San Diego, California, United States

Study Site 105

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Greenfield, Wisconsin, United States

Study Site 118

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Largo, Florida, United States

Study Site 121

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Ocean Township, New Jersey, United States

Study Site 120

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Dallas, Texas, United States

Study Site 128

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Mission Viejo, California, United States

Study Site 101

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San Antonio, Texas, United States

Study Site 133

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Belfast, United Kingdom

Study Site 136

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Cottingham, United Kingdom

Study Site 135

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Oxford, United Kingdom

Study Site 137

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London, United Kingdom

Study Site 126

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Bellingham, Washington, United States

Study Site 117

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Eugene, Oregon, United States

Study Site 127

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San Jose, California, United States

Study Site 138

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London, United Kingdom

Study Site 110

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Rochester, Minnesota, United States

Study Site 109

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Waco, Texas, United States

Study Site 132

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Manchester, United Kingdom

Study Site 129

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Charleston, North Carolina, United States

Study Site 102

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Dallas, Texas, United States

Study Site 140

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Taunton, United Kingdom

Study Site 104

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Rock Hill, South Carolina, United States

Study Site 112

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Tulsa, Oklahoma, United States

Study Site 103

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Charlotte, North Carolina, United States

Study Site 111

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Gastonia, North Carolina, United States

Study Site 134

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Preston, United Kingdom

Study Site 108

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Denver, Colorado, United States

Study Site 106

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Colorado Springs, Colorado, United States

Study Site 113

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Colorado Springs, Colorado, United States

Study Site 130

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Los Angeles, California, United States

Study Site 107

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Winter Park, Florida, United States

Study Site 114

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Mooresville, North Carolina, United States

Study Site 139

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Birmingham, United Kingdom

Study Site 116

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Portland, Oregon, United States

Study Site 131

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Stockton, California, United States

Study Site 115

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Plymouth, Minnesota, United States

Study Site 125

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Rochester, New York, United States

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