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

Refractory Chronic Cough Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03282591
• Other study ID #: MTI-110
• Secondary ID: 2017-003250-16
• Status: Completed
• Phase: Phase 2
• Start date: October 3, 2017
• Est. completion date: September 6, 2018

Study information

• Verified date: May 2021
• Source: Vyne Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 185
• Est. completion date: September 6, 2018
• Est. primary completion date: August 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cough
• Refractory Chronic Cough

Intervention

Drug:
• 5 mg Serlopitant Tablets
Serlopitant Tablets
• Matching Placebo Tablets
Placebo Tablets

Locations

Country	Name	City	State
United Kingdom	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 137	London
United Kingdom	Study Site 138	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 States	Study Site 126	Bellingham	Washington
United States	Study Site 129	Charleston	North Carolina
United States	Study Site 103	Charlotte	North Carolina
United States	Study Site 122	Cincinnati	Ohio
United States	Study Site 106	Colorado Springs	Colorado
United States	Study Site 113	Colorado Springs	Colorado
United States	Study Site 102	Dallas	Texas
United States	Study Site 120	Dallas	Texas
United States	Study Site 108	Denver	Colorado
United States	Study Site 117	Eugene	Oregon
United States	Study Site 111	Gastonia	North Carolina
United States	Study Site 105	Greenfield	Wisconsin
United States	Study Site 118	Largo	Florida
United States	Study Site 130	Los Angeles	California
United States	Study Site 128	Mission Viejo	California
United States	Study Site 114	Mooresville	North Carolina
United States	Study Site 121	Ocean Township	New Jersey
United States	Study Site 115	Plymouth	Minnesota
United States	Study Site 116	Portland	Oregon
United States	Study Site 110	Rochester	Minnesota
United States	Study Site 125	Rochester	New York
United States	Study Site 104	Rock Hill	South Carolina
United States	Study Site 101	San Antonio	Texas
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 112	Tulsa	Oklahoma
United States	Study Site 109	Waco	Texas
United States	Study Site 107	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Vyne Therapeutics Inc.

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in 24-hour Objective Cough Frequency (Log Normalized Percent Change Relative to Placebo)	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	Change in Awake Objective Cough Frequency	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
Secondary	Percentage of Participants With = 30% Reduction in 24-hour Objective Cough Frequency	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
Secondary	Percentage of Participants With =30% Reduction in Awake Objective Cough Frequency	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
Secondary	Change From Baseline in Cough Severity Visual Analog Scale (VAS)	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