Phase 2
N=185
Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Refractory Chronic Cough
Refractory Chronic Cough
Bottom Line
View on ClinicalTrials.gov: NCT03282591 ↗Enrolled (actual)
185
Serious AEs
3.3%
Results posted
Oct 2019
Primary outcome: Primary: Change in 24-hour Objective Cough Frequency (Log Normalized Percent Change Relative to Placebo) — -0.18; -0.45 coughs/hr — p=0.9942
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 5 mg Serlopitant Tablets (Drug); Matching Placebo Tablets (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vyne Therapeutics Inc.
- Primary completion
- Aug 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in 24-hour Objective Cough Frequency (Log Normalized Percent Change Relative to Placebo) |
-0.18; -0.45 | 0.9942 |
| SECONDARY Change in Awake Objective Cough Frequency |
-0.12; -0.30; -0.25; -0.32; -0.19; -0.46 | — |
| SECONDARY Percentage of Participants With ≥ 30% Reduction in 24-hour Objective Cough Frequency |
71.4; 90.2 | — |
| SECONDARY Percentage of Participants With ≥30% Reduction in Awake Objective Cough Frequency |
32.6; 37.0 | — |
| SECONDARY Change From Baseline in Cough Severity Visual Analog Scale (VAS) |
-10.2; -9.9; -14.6; -7.4; -14.2; -9.9 | — |
Summary
Study of the efficacy, safety, and tolerability of serlopitant for the treatment of refractory chronic cough
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 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
Data sourced from ClinicalTrials.gov (NCT03282591). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.