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

Completed · Phase 2 · Has a placebo group

Conditions studied: Refractory Chronic Cough

In brief

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

Key facts

Study ID

NCT03282591

Run by

Vyne Therapeutics Inc.

People needed

185

Starts

2017-10-03

Expected to finish

2018-09-06

Last updated by the study team

2021-05-20

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study Site 130 — Los Angeles, California, United States
• Study Site 128 — Mission Viejo, California, United States
• Study Site 123 — San Diego, California, United States
• Study Site 127 — San Jose, California, United States
• Study Site 131 — Stockton, California, United States
• Study Site 106 — Colorado Springs, Colorado, United States
• Study Site 113 — Colorado Springs, Colorado, United States
• Study Site 108 — Denver, Colorado, United States
• Study Site 118 — Largo, Florida, United States
• Study Site 107 — Winter Park, Florida, United States
• Study Site 115 — Plymouth, Minnesota, United States
• Study Site 110 — Rochester, Minnesota, United States
• Study Site 121 — Ocean Township, New Jersey, United States
• Study Site 125 — Rochester, New York, United States
• Study Site 129 — Charleston, North Carolina, United States
• Study Site 103 — Charlotte, North Carolina, United States
• Study Site 111 — Gastonia, North Carolina, United States
• Study Site 114 — Mooresville, North Carolina, United States
• Study Site 122 — Cincinnati, Ohio, United States
• Study Site 112 — Tulsa, Oklahoma, United States
• Study Site 117 — Eugene, Oregon, United States
• Study Site 116 — Portland, Oregon, United States
• Study Site 104 — Rock Hill, South Carolina, United States
• Study Site 102 — Dallas, Texas, United States
• Study Site 120 — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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