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

NCT03282591 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: MTI-1102017-003250-16
• Study Type: interventional
• Target: 185
• Locations: 2 countries
• Sites: 39

Brief Summary

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

Conditions

Refractory Chronic Cough

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in Awake Objective Cough Frequency

  from Baseline to Day 84

• Percentage of Participants With ≥ 30% Reduction in 24-hour Objective Cough Frequency

  from Baseline to Day 84

• Percentage of Participants With ≥30% Reduction in Awake Objective Cough Frequency

  from Baseline to Day 84

• Change From Baseline in Cough Severity Visual Analog Scale (VAS)

  from Baseline to Day 84

Study Arms (2)

5 mg Serlopitant Tablets

EXPERIMENTAL

Serlopitant Tablets

Drug: 5 mg Serlopitant Tablets

Matching Placebo Tablets

PLACEBO COMPARATOR

Placebo Tablets

Drug: Matching Placebo Tablets

Interventions

5 mg Serlopitant Tablets DRUG

Serlopitant Tablets

Also known as: VPD-737

5 mg Serlopitant Tablets

Matching Placebo Tablets DRUG

Placebo Tablets

Matching Placebo Tablets

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• Vyne Therapeutics Inc.: lead

Study Sites (39)

Study Site 130

Los Angeles, California, 90048, United States

Location

Study Site 128

Mission Viejo, California, 92691, United States

Location

Study Site 123

San Diego, California, 92108, United States

Location

Study Site 127

San Jose, California, 95117, United States

Location

Study Site 131

Stockton, California, 95207, United States

Location

Study Site 106

Colorado Springs, Colorado, 80907, United States

Location

Study Site 113

Colorado Springs, Colorado, 80907, United States

Location

Study Site 108

Denver, Colorado, 80230, United States

Location

Study Site 118

Largo, Florida, 33778, United States

Location

Study Site 107

Winter Park, Florida, 32789, United States

Location

Study Site 115

Plymouth, Minnesota, 55441, United States

Location

Study Site 110

Rochester, Minnesota, 55905, United States

Location

Study Site 121

Ocean Township, New Jersey, 07712, United States

Location

Study Site 125

Rochester, New York, 14618, United States

Location

Study Site 129

Charleston, North Carolina, 29420, United States

Location

Study Site 103

Charlotte, North Carolina, 28207, United States

Location

Study Site 111

Gastonia, North Carolina, 28054, United States

Location

Study Site 114

Mooresville, North Carolina, 28117, United States

Location

Study Site 122

Cincinnati, Ohio, 45231, United States

Location

Study Site 112

Tulsa, Oklahoma, 74136, United States

Location

Study Site 117

Eugene, Oregon, 97401, United States

Location

Study Site 116

Portland, Oregon, 97202, United States

Location

Study Site 104

Rock Hill, South Carolina, 29732, United States

Location

Study Site 102

Dallas, Texas, 75231, United States

Location

Study Site 120

Dallas, Texas, 75231, United States

Location

Study Site 101

San Antonio, Texas, 78229, United States

Location

Study Site 109

Waco, Texas, 76712, United States

Location

Study Site 126

Bellingham, Washington, 98225, United States

Location

Study Site 105

Greenfield, Wisconsin, 53228, United States

Location

Study Site 133

Belfast, BT9 7AB, United Kingdom

Location

Study Site 139

Birmingham, B9 5SS, United Kingdom

Location

Study Site 136

Cottingham, HU16 5JQ, United Kingdom

Location

Study Site 141

Llanelli, SA14 8QF, United Kingdom

Location

Study Site 138

London, SE5 9RS, United Kingdom

Location

Study Site 137

London, SW3 6HP, United Kingdom

Location

Study Site 132

Manchester, M23 9LT, United Kingdom

Location

Study Site 135

Oxford, OX3 7LE, United Kingdom

Location

Study Site 134

Preston, PR2 9HT, United Kingdom

Location

Study Site 140

Taunton, TA2 5DA, United Kingdom

Location

MeSH Terms

Conditions

Chronic Cough

Interventions

serlopitant

Condition Hierarchy (Ancestors)

Cough; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Anna Gururajan
• Organization: Menlo Therapeutics Inc.

agururajan@menlotx.com

(650) 486-1416

Study Officials

• Jacky Smith

  University of Manchester, United Kingdom

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2017
• First Posted: September 14, 2017
• Study Start: October 3, 2017
• Primary Completion: August 15, 2018
• Study Completion: September 6, 2018
• Last Updated: May 20, 2021
• Results First Posted: October 22, 2019

Record last verified: 2021-05

Locations

GB (10); US (29)