A Phase 2 interventional study of 5 mg Serlopitant Tablets and Matching Placebo Tablets in Refractory Chronic Cough, sponsored by Vyne Therapeutics Inc.. Completed at 39 sites in 2 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-05-20.
Sponsored by Vyne Therapeutics Inc. · Phase 2, Interventional, and Treatment
Among 44 studies in Chronic Cough with a site in United States — 9 open to participants now, 11 under way, 1 of them phase 3. Chronic Cough · United States.
Among the 44 studies in Chronic Cough with a site in United States, this one is the 11th largest by enrollment of the 37 interventional ones that give a count, is the only one that started in 2017, is one of 16 in phase 2, and was the 11th registered.
142 studies on the registry are indexed under Chronic Cough; 39 are open to participants now.
Browse Chronic Cough studies →9 of the 44 studies in Chronic Cough with a site in United States are open now. Recruiting first, the newest first:
University of North Carolina, Chapel Hill · Sites in United States
University of Montana · Sites in United States
Hyfe Inc · Sites in United States
Medical University of South Carolina · Sites in United States
University of Montana · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 30 Chronic Cough studies recruiting now, 10 (33%) set no upper age limit and 11 (37%) stop at 75 or younger; 3 take children under 18; 5 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
44 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 1 started in 2017.
This study's enrollment of 185 is above the median of 60 across 104 interventional studies indexed under Chronic Cough.
Median enrollment 50 across the 37 interventional studies, 35 across the 7 observational. Of the 32 that completed or were terminated, 16 (50%) have results posted.
This tab as a report to print or save as PDF → With an account.
21 of 44 have an industry lead sponsor. The 10 most frequent:
Vyne Therapeutics Inc. is the lead sponsor of 32 studies on the registry; none are open to participants now.
Of its 22 completed or terminated interventional studies of FDA-regulated products, 13 (59%) have results posted.
Vyne Therapeutics Inc. has 1 study filed under Chronic Cough — fewer than ten, so there is no comparison to draw.
3 of the studies in Chronic Cough with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05110144Mayo ClinicEfficacy of Two Doses of Duloxetine and Amitriptyline in Subjects With Refractory Chronic Cough | 2026-12 |
| NCT05273190University of MinnesotaStimulation of the Larynx to Treat Unexplained Chronic Cough | 2027-06-01 |
| NCT06634823Medical University of South CarolinaEfficacy of Intramuscular Steroid Injection for Chronic Cough. | 2027-06-30 |
Among the 44 studies in Chronic Cough with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Study of the efficacy, safety, and tolerability of serlopitant for the treatment of refractory chronic cough
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Serlopitant Tablets
Drug: 5 mg Serlopitant Tablets
Placebo Tablets
Drug: Matching Placebo Tablets
Serlopitant Tablets
Also known as: VPD-737
Placebo Tablets
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).
Time frame: from Baseline to Day 84
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).
Time frame: from Baseline to Day 84
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).
Time frame: from Baseline to Day 84
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).
Time frame: from Baseline to Day 84
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.
Time frame: from Baseline to Day 84
| Milestone | Serlopitant 5 mg | Placebo |
|---|---|---|
| Started | 92 | 93 |
| Completed | 88 | 89 |
| Not completed | 4 | 4 |
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).
| coughs/hr | Serlopitant 5 mg | Placebo |
|---|---|---|
| Change in 24-hour Objective Cough Frequency (Log Normalized Percent Change Relative to Placebo) | -0.18 ± 0.09 | -0.45 ± 0.08 |
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).
| coughs/hr | Serlopitant 5 mg | Placebo |
|---|---|---|
| Day 28 (Week 4) | -0.12 (-0.26 to 0.01) | -0.30 (-0.43 to -0.17) |
| Day 56 (Week 8) | -0.25 (-0.39 to -0.10) | -0.32 (-0.47 to -0.18) |
| Day 84 (Week 12) | -0.19 (-0.34 to -0.04) | -0.46 (-0.60 to -0.31) |
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).
| Percentage of participants | Serlopitant 5 mg | Placebo |
|---|---|---|
| Percentage of Participants With ≥ 30% Reduction in 24-hour Objective Cough Frequency | 71.4 | 90.2 |
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).
| percentage of participants | Serlopitant 5 mg | Placebo |
|---|---|---|
| Percentage of Participants With ≥30% Reduction in Awake Objective Cough Frequency | 32.6 | 37.0 |
Visual Analog Scale (VAS) 101-point scale ranging from 0 (no cough) to 100 (worst cough). A higher score corresponds to higher cough severity.
| units on a scale | Serlopitant 5 mg | Placebo |
|---|---|---|
| Day 28 (Week 4) | -10.2 (-14.6 to -5.8) | -9.9 (-14.4 to -5.5) |
| Day 56 (Week 8) | -14.6 (-19.4 to -9.8) | -7.4 (-12.3 to -2.5) |
| Day 84 (Week 12) | -14.2 (-19.2 to -9.3) | -9.9 (-15.0 to -4.9) |
Collected over Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at approximately Day 112 (± 3 days). After the Follow-Up visit, only SAEs that are believed to be drug related will be reported, without a specific end time.. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Serlopitant 5 mg | 1/92 (1.1%) | 3/92 (3.3%) | 43/92 (46.7%) |
| Placebo | 0/92 (0%) | 3/92 (3.3%) | 28/92 (30.4%) |
| Event | Serlopitant 5 mg | Placebo |
|---|---|---|
| UrosepsisInfections and infestations | 0/92 | 1/92 |
| NephrolithiasisRenal and urinary disorders | 0/92 | 1/92 |
| AppendicitisInfections and infestations | 0/92 | 1/92 |
| Post procedural infectionInfections and infestations | 0/92 | 1/92 |
| Metastatic malignant melanomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/92 | 1/92 |
| Pelvic painReproductive system and breast disorders | 1/92 | 0/92 |
| ConstipationGastrointestinal disorders | 1/92 | 0/92 |
| SepsisInfections and infestations | 1/92 | 0/92 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 1/92 | 0/92 |
| Event | Serlopitant 5 mg | Placebo |
|---|---|---|
| HeadacheNervous system disorders | 6/92 | 8/92 |
| Upper Respiratory Tract InfectionInfections and infestations | 7/92 | 6/92 |
| Urinary tract infectionInfections and infestations | 6/92 | 3/92 |
| FatigueGeneral disorders | 5/92 | 6/92 |
| CoughRespiratory, thoracic and mediastinal disorders | 3/92 | 6/92 |
| BronchitisInfections and infestations | 5/92 | 1/92 |
| DiarrhoeaGastrointestinal disorders | 5/92 | 3/92 |
| DizzinessNervous system disorders | 4/92 | 1/92 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 4/92 | 0/92 |
| SinusitisInfections and infestations | 4/92 | 4/92 |
These figures represent the Full Analysis set (FAS) and is defined as all randomized subjects who received any amount of study treatment and had Baseline and at least one post baseline observation of the primary endpoint during the treatment period.
| Age, Continuous(years) | Serlopitant 5 mg | Placebo | Total |
|---|---|---|---|
| Mean | 62.7 ± 11.21 | 62.6 ± 10.09 | 62.6 ± 10.63 |
| Age, Continuous(years) | Serlopitant 5 mg | Placebo | Total |
|---|---|---|---|
| Median | 65.5 (28 to 79) | 64.5 (26 to 80) | 65 (26 to 80) |
| Sex: Female, Male(Participants) | Serlopitant 5 mg | Placebo | Total |
|---|---|---|---|
| Female | 68 | 67 | 135 |
| Male | 20 | 21 | 41 |
| Ethnicity (NIH/OMB)(Participants) | Serlopitant 5 mg | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 5 | 1 | 6 |
| Not Hispanic or Latino | 83 | 87 | 170 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Serlopitant 5 mg | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 4 | 7 |
| White | 83 | 83 | 166 |
| More than one race | NA | NA | NA |
| Unknown or Not Reported | 1 | 0 | 1 |
| Region of Enrollment(participants) | Serlopitant 5 mg | Placebo | Total |
|---|---|---|---|
| United States | 69 | 68 | 137 |
| United Kingdom | 19 | 20 | 39 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Oct 2017 to primary completion in Aug 2018, 10 months.
Results were first posted in Oct 2019, 1 year 2 months after primary completion.
Of 25 phase 2 interventional studies under Chronic Cough, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 21. This study's 10 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Serlopitant