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

NCT ID: NCT03282591

Last Updated: 2021-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 185 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-03
• Study Completion Date: 2018-09-06

Brief Summary

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

Conditions

Refractory Chronic Cough

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

5 mg Serlopitant Tablets

Serlopitant Tablets

Group Type: EXPERIMENTAL

5 mg Serlopitant Tablets

Intervention Type: DRUG

Serlopitant Tablets

Matching Placebo Tablets

Placebo Tablets

Group Type: PLACEBO_COMPARATOR

Matching Placebo Tablets

Intervention Type: DRUG

Placebo Tablets

Interventions

5 mg Serlopitant Tablets

Serlopitant Tablets

Intervention Type: DRUG

Matching Placebo Tablets

Placebo Tablets

Intervention Type: DRUG

Other Intervention Names

VPD-737

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vyne Therapeutics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacky Smith

Role: PRINCIPAL_INVESTIGATOR

University of Manchester, United Kingdom

Locations

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

Study Site 101

San Antonio, Texas, United States

Study Site 109

Waco, Texas, United States

Study Site 126

Bellingham, Washington, United States

Study Site 105

Greenfield, Wisconsin, United States

Study Site 133

Belfast, , United Kingdom

Study Site 139

Birmingham, , United Kingdom

Study Site 136

Cottingham, , United Kingdom

Study Site 141

Llanelli, , United Kingdom

Study Site 138

London, , United Kingdom

Study Site 137

London, , United Kingdom

Study Site 132

Manchester, , United Kingdom

Study Site 135

Oxford, , United Kingdom

Study Site 134

Preston, , United Kingdom

Study Site 140

Taunton, , United Kingdom

Countries

United States; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2017-003250-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MTI-110

Identifier Type: -

Identifier Source: org_study_id