Clinical trial NCT03282591: Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Refractory Chronic Cough
Official title: A Randomized, Double-blind, Placebo-controlled Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Refractory Chronic Cough
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Refractory Chronic Cough
Lead sponsor: Vyne Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2017-09-14
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study of the efficacy, safety, and tolerability of serlopitant for the treatment of refractory chronic cough


Eligibility criteria: 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

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

Primary outcomes:
measure: Change in 24-hour Objective Cough Frequency (Log Normalized Percent Change Relative to Placebo)
timeFrame: from Baseline to Day 84
Secondary outcomes:
measure: Change in Awake Objective Cough Frequency
timeFrame: from Baseline to Day 84
measure: Percentage of Participants With ≥ 30% Reduction in 24-hour Objective Cough Frequency
timeFrame: from Baseline to Day 84
measure: Percentage of Participants With ≥30% Reduction in Awake Objective Cough Frequency
timeFrame: from Baseline to Day 84
measure: Change From Baseline in Cough Severity Visual Analog Scale (VAS)
timeFrame: from Baseline to Day 84
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Study Site 130
state: California
city: Mission Viejo
country: United States
facility: Study Site 128
state: California
city: San Diego
country: United States
facility: Study Site 123
state: California
city: San Jose
country: United States
facility: Study Site 127
state: California
city: Stockton
country: United States
facility: Study Site 131
state: California
city: Colorado Springs
country: United States
facility: Study Site 106
state: Colorado
city: Colorado Springs
country: United States
facility: Study Site 113
state: Colorado
city: Denver
country: United States
facility: Study Site 108
state: Colorado
city: Largo
country: United States
facility: Study Site 118
state: Florida
city: Winter Park
country: United States
facility: Study Site 107
state: Florida
city: Plymouth
country: United States
facility: Study Site 115
state: Minnesota
city: Rochester
country: United States
facility: Study Site 110
state: Minnesota
city: Ocean Township
country: United States
facility: Study Site 121
state: New Jersey
city: Rochester
country: United States
facility: Study Site 125
state: New York
city: Charleston
country: United States
facility: Study Site 129
state: North Carolina
city: Charlotte
country: United States
facility: Study Site 103
state: North Carolina
city: Gastonia
country: United States
facility: Study Site 111
state: North Carolina
city: Mooresville
country: United States
facility: Study Site 114
state: North Carolina
city: Cincinnati
country: United States
facility: Study Site 122
state: Ohio
city: Tulsa
country: United States
facility: Study Site 112
state: Oklahoma
city: Eugene
country: United States
facility: Study Site 117
state: Oregon
city: Portland
country: United States
facility: Study Site 116
state: Oregon
city: Rock Hill
country: United States
facility: Study Site 104
state: South Carolina
city: Dallas
country: United States
facility: Study Site 102
state: Texas
city: Dallas
country: United States
facility: Study Site 120
state: Texas
city: San Antonio
country: United States
facility: Study Site 101
state: Texas
city: Waco
country: United States
facility: Study Site 109
state: Texas
city: Bellingham
country: United States
facility: Study Site 126
state: Washington
city: Greenfield
country: United States
facility: Study Site 105
state: Wisconsin
city: Belfast
country: United Kingdom
facility: Study Site 133
city: Birmingham
country: United Kingdom
facility: Study Site 139
city: Cottingham
country: United Kingdom
facility: Study Site 136
city: Llanelli
country: United Kingdom
facility: Study Site 141
city: London
country: United Kingdom
facility: Study Site 138
city: London
country: United Kingdom
facility: Study Site 137
city: Manchester
country: United Kingdom
facility: Study Site 132
city: Oxford
country: United Kingdom
facility: Study Site 135
city: Preston
country: United Kingdom
facility: Study Site 134
city: Taunton
country: United Kingdom
facility: Study Site 140
Study officials:
affiliation: University of Manchester, United Kingdom
name: Jacky Smith
role: PRINCIPAL_INVESTIGATOR
References: