Trial · NCT03841331
Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Chronic Pruritus of Unknown Origin
NCT03841331, Phase 2, Completed, Vyne Therapeutics Inc.; results first posted 2020-09-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Chronic Pruritus of Unknown Origin. Trials, record NCT03841331. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03841331
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Chronic Pruritus of Unknown Origin
- NCT number
- NCT03841331
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 233 participants, actual
- Lead sponsor
- Vyne Therapeutics Inc.
- Conditions
- Pruritus
- Interventions
- 5 mg Serlopitant Tablets, Matching Placebo Tablets
- First posted
- 2019-02-15
- Last updated
- 2021-05-20
- Results first posted
- 2020-09-23
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Worst Itch Numeric Rating Scale 4-point Responder Rate at Week 10 | At Week 10 | During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments was reported by the subject via eDiary. The daily NRS results were summarized. The daily results were averaged to create weekly measures. The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable), higher scores indicated greater itch intensity. A subject was a 4-point responder if their change from baseline is ≤ -4 (i.e. a decrease of at least 4). |
| Primary | WI-NRS 4-point Responder Rate at Weeks 2 4, 6, and 8 | At Weeks 2, 4, 6, and 8 | During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments was reported by the subject via eDiary. The daily NRS results were summarized. The daily results were averaged to create weekly measures. The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable), higher scores indicated greater itch intensity. A subject was a 4-point responder if their change from baseline is ≤ -4 (i.e. a decrease of at least 4). |
| Primary | WI-NRS 3-point Responder Rate at Weeks 2, 4, 6, 8, and 10 | At Weeks 2, 4, 6, 8, and 10 | During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments was reported by the subject via eDiary. The daily NRS results were summarized. The daily results were averaged to create weekly measures. The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable), higher scores indicated greater itch intensity. A subject was a 3-point responder if their change from baseline is ≤ -3 (i.e. a decrease of at least 3). Results presented below is of subjects who were a 3-point responder but not a 4-point responder. |
| Primary | Change From Baseline in WI-NRS at Weeks 2, 4, 6, 8, and 10 | At Weeks 2, 4, 6, 8, and 10 | During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments was reported by the subject via eDiary. The daily NRS results were summarized. The daily results were averaged to create weekly measures. The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable), higher scores indicated greater itch intensity. |
| Primary | Change From Baseline in Daily WI-NRS Scores Through Week 2 | Through 2 weeks | During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments was reported by the subject via eDiary. The daily NRS results were summarized. The daily results were averaged to create weekly measures. The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable), higher scores indicated greater itch intensity. |
| Primary | Change From Baseline in Worst-Itch Visual Analog Scale at Weeks 2, 4, 6, and 10 | At Weeks 2, 4, 6, and 10 | The Itch Visual Analog Scale (VAS) is a validated, self-reported instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects to rate the worst intensity of their itch on a 100-mm horizontal line ranging from 0 mm (no itch) to 100 mm (worst itch imaginable). Higher scores indicated greater itch intensity. The VAS measurement were summarized in centimeters. WI-VAS assessments were reported by the subject via a paper form administered at study visits. |
| Secondary | Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | From screening until the Follow-up (F/U) visit which occurred 35 days (+ 7 days) after the Week 10 visit or the last dose of study drug for subjects who discontinued study drug early. | Adverse events (AEs) were recorded to assess the safety and tolerability of repeated oral doses of serlopitant in adult subjects with chronic pruritus of unknown origin. Adverse events (AEs) and SAEs were recorded from the first study drug administration through the follow-up visit. After informed consent was signed, but prior to initiation of study drug, only SAEs considered by the investigator to be caused by a protocol-mandated intervention were collected. |
| Secondary | Plasma Concentrations of Serlopitant and Metabolites | At Week 10 | The plasma concentrations of serlopitant and metabolites were combined with the data from other serlopitant clinical studies for population pharmacokinetic analysis. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Worst Itch Numeric Rating Scale 4-point Responder Rate at Week 10 | At Week 10 | Full Analysis Population: subset of subjects in the randomized population who were dispensed study medication. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | WI-NRS 4-point Responder Rate at Weeks 2 4, 6, and 8 | At Weeks 2, 4, 6, and 8 | Full Analysis Population: subset of subjects in the randomized population who were dispensed study medication. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | WI-NRS 3-point Responder Rate at Weeks 2, 4, 6, 8, and 10 | At Weeks 2, 4, 6, 8, and 10 | Full Analysis Population: subset of subjects in the randomized population who were dispensed study medication. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Change From Baseline in WI-NRS at Weeks 2, 4, 6, 8, and 10 | At Weeks 2, 4, 6, 8, and 10 | Full Analysis Population: subset of subjects in the randomized population who were dispensed study medication. | score on a scale | MEAN |
| PRIMARY | Change From Baseline in Daily WI-NRS Scores Through Week 2 | Through 2 weeks | Full Analysis Population: subset of subjects in the randomized population who were dispensed study medication. | score on a scale | MEAN |
| PRIMARY | Change From Baseline in Worst-Itch Visual Analog Scale at Weeks 2, 4, 6, and 10 | At Weeks 2, 4, 6, and 10 | Full Analysis Population: subset of subjects in the randomized population who were dispensed study medication. | score on a scale | MEAN |
| SECONDARY | Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | From screening until the Follow-up (F/U) visit which occurred 35 days (+ 7 days) after the Week 10 visit or the last dose of study drug for subjects who discontinued study drug early. | Safety Population - Subset of subjects who received at least one dose of study medication | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Plasma Concentrations of Serlopitant and Metabolites | At Week 10 | nmol/L | MEAN |
Source ClinicalTrials.gov
Results by group88
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Worst Itch Numeric Rating Scale 4-point Responder Rate at Week 10 | Placebo | 46 | Participants | ||
| Worst Itch Numeric Rating Scale 4-point Responder Rate at Week 10 | Serlopitant 5 mg | 44 | Participants | ||
| WI-NRS 4-point Responder Rate at Weeks 2 4, 6, and 8 | Placebo | Responders at Week 2 | 19 | Participants | |
| WI-NRS 4-point Responder Rate at Weeks 2 4, 6, and 8 | Serlopitant 5 mg | Responders at Week 2 | 18 | Participants | |
| WI-NRS 4-point Responder Rate at Weeks 2 4, 6, and 8 | Placebo | Responders at Week 4 | 29 | Participants | |
| WI-NRS 4-point Responder Rate at Weeks 2 4, 6, and 8 | Serlopitant 5 mg | Responders at Week 4 | 24 | Participants | |
| WI-NRS 4-point Responder Rate at Weeks 2 4, 6, and 8 | Placebo | Responders at Week 6 | 35 | Participants | |
| WI-NRS 4-point Responder Rate at Weeks 2 4, 6, and 8 | Serlopitant 5 mg | Responders at Week 6 | 38 | Participants | |
| WI-NRS 4-point Responder Rate at Weeks 2 4, 6, and 8 | Placebo | Responders at Week 8 | 40 | Participants | |
| WI-NRS 4-point Responder Rate at Weeks 2 4, 6, and 8 | Serlopitant 5 mg | Responders at Week 8 | 37 | Participants |
1 to 10 of 88Source ClinicalTrials.gov
See all 88 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 117 | |
| Overall Study | STARTED | Serlopitant 5 mg | 116 | |
| Overall Study | COMPLETED | Placebo | 108 | |
| Overall Study | COMPLETED | Serlopitant 5 mg | 106 | |
| Overall Study | NOT COMPLETED | Placebo | 9 | |
| Overall Study | NOT COMPLETED | Serlopitant 5 mg | 10 |
Source ClinicalTrials.gov
Adverse events10
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 0 | 117 | |
| other | Diarrhoea | Gastrointestinal disorders | Serlopitant 5 mg | 8 | 116 | |
| other | Somnolence | Nervous system disorders | Placebo | 1 | 117 | |
| other | Somnolence | Nervous system disorders | Serlopitant 5 mg | 6 | 116 | |
| serious | Intracranial mass | Nervous system disorders | Placebo | 0 | 117 | 0 |
| serious | Intracranial mass | Nervous system disorders | Serlopitant 5 mg | 1 | 116 | 1 |
| serious | Metastasis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Placebo | 0 | 117 | 0 |
| serious | Metastasis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Serlopitant 5 mg | 1 | 116 | 1 |
| serious | Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Placebo | 0 | 117 | 0 |
| serious | Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Serlopitant 5 mg | 1 | 116 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 117 |
| Total, all-cause mortality | Serlopitant 5 mg | 0 | 116 |
| Total, other adverse events | Placebo | 1 | 117 |
| Total, other adverse events | Serlopitant 5 mg | 12 | 116 |
| Total, serious adverse events | Placebo | 0 | 117 |
| Total, serious adverse events | Serlopitant 5 mg | 2 | 116 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Serlopitant 5 mg vs Placebo: Worst Itch Numeric Rating Scale 4-point Responder Rate at Week 10 | Trial comparisons |
| Serlopitant 5 mg vs Placebo: deaths from any cause | Trial comparisons |
| Serlopitant 5 mg vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03841331
GET https://conductscience.org/api/trials/v1/NCT03841331/results?page=2