Status:
COMPLETED
Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Refractory Chronic Cough
Lead Sponsor:
Vyne Therapeutics Inc.
Conditions:
Refractory Chronic Cough
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
Study of the efficacy, safety, and tolerability of serlopitant for the treatment of refractory chronic cough
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 3 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 6 2018
Estimated Enrollment :
185 Patients enrolled
Trial Details
Trial ID
NCT03282591
Start Date
October 3 2017
End Date
September 6 2018
Last Update
May 20 2021
Active Locations (39)
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1
Study Site 130
Los Angeles, California, United States, 90048
2
Study Site 128
Mission Viejo, California, United States, 92691
3
Study Site 123
San Diego, California, United States, 92108
4
Study Site 127
San Jose, California, United States, 95117