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

May 18, 2021 updated by: Vyne Therapeutics Inc.

A Randomized, Double-blind, Placebo-controlled Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Refractory Chronic Cough

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
185

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Belfast, United Kingdom, BT9 7AB
        • Study site 133
      • Birmingham, United Kingdom, B9 5SS
        • Study Site 139
      • Cottingham, United Kingdom, HU16 5JQ
        • Study Site 136
      • Llanelli, United Kingdom, SA14 8QF
        • Study Site 141
      • London, United Kingdom, SE5 9RS
        • Study Site 138
      • London, United Kingdom, SW3 6HP
        • Study Site 137
      • Manchester, United Kingdom, M23 9LT
        • Study Site 132
      • Oxford, United Kingdom, OX3 7LE
        • Study Site 135
      • Preston, United Kingdom, PR2 9HT
        • Study Site 134
      • Taunton, United Kingdom, TA2 5DA
        • Study Site 140
  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Study Site 130
      • Mission Viejo, California, United States, 92691
        • Study Site 128
      • San Diego, California, United States, 92108
        • Study site 123
      • San Jose, California, United States, 95117
        • Study Site 127
      • Stockton, California, United States, 95207
        • Study Site 131
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Study Site 106
      • Colorado Springs, Colorado, United States, 80907
        • Study site 113
      • Denver, Colorado, United States, 80230
        • Study Site 108
    • Florida
      • Largo, Florida, United States, 33778
        • Study Site 118
      • Winter Park, Florida, United States, 32789
        • Study Site 107
    • Minnesota
      • Plymouth, Minnesota, United States, 55441
        • Study site 115
      • Rochester, Minnesota, United States, 55905
        • Study site 110
    • New Jersey
      • Ocean Township, New Jersey, United States, 07712
        • Study Site 121
    • New York
      • Rochester, New York, United States, 14618
        • Study site 125
    • North Carolina
      • Charleston, North Carolina, United States, 29420
        • Study site 129
      • Charlotte, North Carolina, United States, 28207
        • Study Site 103
      • Gastonia, North Carolina, United States, 28054
        • Study site 111
      • Mooresville, North Carolina, United States, 28117
        • Study site 114
    • Ohio
      • Cincinnati, Ohio, United States, 45231
        • Study Site 122
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74136
        • Study site 112
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Study site 117
      • Portland, Oregon, United States, 97202
        • Study Site 116
    • South Carolina
      • Rock Hill, South Carolina, United States, 29732
        • Study Site 104
    • Texas
      • Dallas, Texas, United States, 75231
        • Study Site 102
      • Dallas, Texas, United States, 75231
        • Study Site 120
      • San Antonio, Texas, United States, 78229
        • Study Site 101
      • Waco, Texas, United States, 76712
        • Study Site 109
    • Washington
      • Bellingham, Washington, United States, 98225
        • Study site 126
    • Wisconsin
      • Greenfield, Wisconsin, United States, 53228
        • Study Site 105

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 5 mg Serlopitant Tablets
Serlopitant Tablets
Drug: 5 mg Serlopitant Tablets
Serlopitant Tablets
Other Names:
  • VPD-737
Placebo Comparator: Matching Placebo Tablets
Placebo Tablets
Drug: Matching Placebo Tablets
Placebo Tablets

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in 24-hour Objective Cough Frequency (Log Normalized Percent Change Relative to Placebo)
Time Frame: 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).
from Baseline to Day 84

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Awake Objective Cough Frequency
Time Frame: from 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).
from Baseline to Day 84
Percentage of Participants With ≥ 30% Reduction in 24-hour Objective Cough Frequency
Time Frame: from 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).
from Baseline to Day 84
Percentage of Participants With ≥30% Reduction in Awake Objective Cough Frequency
Time Frame: from 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).
from Baseline to Day 84
Change From Baseline in Cough Severity Visual Analog Scale (VAS)
Time Frame: 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.
from Baseline to Day 84

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vyne Therapeutics Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jacky Smith, University of Manchester, United Kingdom

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 3, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 15, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 6, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 11, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 14, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 20, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 18, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MTI-110
  • 2017-003250-16 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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