Trial · NCT03546816
Study of the Efficacy, Safety and Tolerability of Serlopitant for the Treatment of Pruritus (Itch) With Prurigo Nodularis
NCT03546816, Phase 3, Completed, Vyne Therapeutics Inc.; results first posted 2020-09-07
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Study of the Efficacy, Safety and Tolerability of Serlopitant for the Treatment of Pruritus (Itch) With Prurigo Nodularis. Trials, record NCT03546816. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03546816
On this page
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 Pruritus (Itch) With Prurigo Nodularis
- NCT number
- NCT03546816
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 285 participants, actual
- Lead sponsor
- Vyne Therapeutics Inc.
- Conditions
- Pruritus, Prurigo Nodularis
- Interventions
- 5mg Serlopitant Tablets, Placebo Tablets
- First posted
- 2018-06-06
- Last updated
- 2021-05-20
- Results first posted
- 2020-09-07
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent of Subjects With Worst-Itch Numeric Rating Scale 4-point Responder at Week 10 | At Week 10 | During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments were reported by the subject via eDiary once daily from screening/mid-screening visit through the follow-up visit. The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity and subjects were asked 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. Subjects were considered responders if they had at least a 4-point reduction from baseline in weekly average WI-NRS at Week 10. |
| Secondary | Percent of Subjects With WI-NRS 4-point Responder at Week 4 | At Week 4 | During the study, WI-NRS assessments were reported by the subject via eDiary once daily from screening/mid-screening visit through the follow-up visit. The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity and subjects were asked 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. |
| Secondary | Percent of Subjects With WI-NRS 4-point Responder at Week 2 | At Week 2 | During the study, WI-NRS assessments were reported by the subject via eDiary once daily from screening/mid-screening visit through the follow-up visit. The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity and subjects were asked 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. |
| Secondary | Change From Baseline in WI-NRS at Weeks 2, 4, 6, and 10 | At Weeks 2, 4, 6, and 10 | During the study, WI-NRS assessments were reported by the subject via eDiary once daily from screening/mid-screening visit through the follow-up visit. The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity and subjects were asked 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. |
| Secondary | Percent of Subjects With WI-NRS 3-point Responder at Weeks 2, 4, and 10 | At Weeks 2, 4, and 10 | During the study, WI-NRS assessments were reported by the subject via eDiary once daily from screening/mid-screening visit through the follow-up visit. The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity and subjects were asked 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. For the 3-point responder rate, subjects were considered responders if they had at least a 3-point reduction between baseline and the corresponding week. |
| Secondary | Change From Baseline in Investigator's Global Assessment of Prurigo Nodularis Activity (IGA PN-A) to Weeks 2, 4, and 10 | At Weeks 2, 4, and 10 | The IGA PN-A is an instrument used to assess the overall activity of PN lesions at a given time point, as determined by the investigator. It consists of a 5-point scale ranging from 0 (clear) to 4 (severe). Higher scores indicate severe prurigo nodularis. |
| Secondary | Change From Baseline in Investigator's Global Assessment of PN Stage (IGA PN-S) to Weeks 2, 4, and 10 | At Weeks 2, 4, and 10 | The IGA PN-S is an instrument used to assess the overall number and thickness of PN lesions at a given time point, as determined by the investigator. It consists of a 5-point scale ranging from 0 (clear) to 4 (severe). Higher scores indicate severe prurigo nodularis. |
| Secondary | Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 10 | At Week 10 | Dermatology Life Quality Index (DLQI) is a dermatology specific quality of life (QoL) instrument designed to assess the impact of the skin disease on a subject's QoL over the prior week. It is a ten item questionnaire that assesses overall QoL and six aspects that may affect QoL (symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment). The DLQI questions are rated by the subject as 0 (not at all) to 3 (very much). Scores range from 0 to 30 with higher scores indicating poor QoL. |
| Secondary | Change From Baseline in DLQI Question 1 to Week 10 | At Week 10 | DLQI is a dermatology specific QoL instrument designed to assess the impact of the skin disease on a subject's QoL over the prior week. It is a ten item questionnaire that assesses overall QoL and six aspects that may affect QoL (symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment) The DLQI question 1 is to measure how itchy, sore, painful or stinging the subject's skin had been. It is rated by the subject as 0 (not at all) to 3 (very much). Scores range from 0 to 30 with higher scores indicating poor QoL. |
| Secondary | Number of Subjects With Treatment-emergent Adverse Events and Serious Adverse Events (SAEs) | 35 days (+3 days) after Week 10 or Early Treatment Discontinuation | Adverse events (AEs) and serious adverse events (SAEs) were recorded from the first study drug administration through the follow-up visit. Severity of all AEs were graded using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.03. During the period between informed consent and first study drug dose, only SAEs caused by a protocol-mandated intervention were collected. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent of Subjects With Worst-Itch Numeric Rating Scale 4-point Responder at Week 10 | At Week 10 | Intent-to-Treat Population: included all randomized subjects who were dispensed study drug. | Percentage of subjects | NUMBER |
| SECONDARY | Percent of Subjects With WI-NRS 4-point Responder at Week 4 | At Week 4 | Intent-to-Treat Population: included all randomized subjects who were dispensed study drug. | Percentage of subjects | NUMBER |
| SECONDARY | Percent of Subjects With WI-NRS 4-point Responder at Week 2 | At Week 2 | Intent-to-Treat Population: included all randomized subjects who were dispensed study drug. | Percentage of subjects | NUMBER |
| SECONDARY | Change From Baseline in WI-NRS at Weeks 2, 4, 6, and 10 | At Weeks 2, 4, 6, and 10 | Intent-to-Treat Population: included all randomized subjects who were dispensed study drug. | Score on a scale | MEAN |
| SECONDARY | Percent of Subjects With WI-NRS 3-point Responder at Weeks 2, 4, and 10 | At Weeks 2, 4, and 10 | Intent-to-Treat Population: included all randomized subjects who were dispensed study drug. | Percentage of subjects | NUMBER |
| SECONDARY | Change From Baseline in Investigator's Global Assessment of Prurigo Nodularis Activity (IGA PN-A) to Weeks 2, 4, and 10 | At Weeks 2, 4, and 10 | Intent-to-Treat Population: included all randomized subjects who were dispensed study drug. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline in Investigator's Global Assessment of PN Stage (IGA PN-S) to Weeks 2, 4, and 10 | At Weeks 2, 4, and 10 | Intent-to-Treat Population: included all randomized subjects who were dispensed study drug. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 10 | At Week 10 | Intent-to-Treat Population: included all randomized subjects who were dispensed study drug. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline in DLQI Question 1 to Week 10 | At Week 10 | Intent-to-Treat Population: included all randomized subjects who were dispensed study drug. | Score on a scale | MEAN |
| SECONDARY | Number of Subjects With Treatment-emergent Adverse Events and Serious Adverse Events (SAEs) | 35 days (+3 days) after Week 10 or Early Treatment Discontinuation | Safety population: included all treated subjects with at least one post-baseline assessment or a reported TEAE. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group48
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent of Subjects With Worst-Itch Numeric Rating Scale 4-point Responder at Week 10 | Serlopitant 5 mg | 26.45 | Percentage of subjects | ||
| Percent of Subjects With Worst-Itch Numeric Rating Scale 4-point Responder at Week 10 | Placebo | 20.31 | Percentage of subjects | ||
| Percent of Subjects With WI-NRS 4-point Responder at Week 4 | Serlopitant 5 mg | 17.66 | Percentage of subjects | ||
| Percent of Subjects With WI-NRS 4-point Responder at Week 4 | Placebo | 7.80 | Percentage of subjects | ||
| Percent of Subjects With WI-NRS 4-point Responder at Week 2 | Serlopitant 5 mg | 8.45 | Percentage of subjects | ||
| Percent of Subjects With WI-NRS 4-point Responder at Week 2 | Placebo | 4.93 | Percentage of subjects | ||
| Change From Baseline in WI-NRS at Weeks 2, 4, 6, and 10 | Serlopitant 5 mg | Change from Baseline at Week 2 | -1.30 | Standard Deviation 1.725 | Score on a scale |
| Change From Baseline in WI-NRS at Weeks 2, 4, 6, and 10 | Placebo | Change from Baseline at Week 2 | -0.96 | Standard Deviation 1.740 | Score on a scale |
| Change From Baseline in WI-NRS at Weeks 2, 4, 6, and 10 | Serlopitant 5 mg | Change from Baseline at Week 4 | -1.82 | Standard Deviation 2.226 | Score on a scale |
| Change From Baseline in WI-NRS at Weeks 2, 4, 6, and 10 | Placebo | Change from Baseline at Week 4 | -1.32 | Standard Deviation 2.248 | Score on a scale |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Serlopitant 5 mg | 142 | |
| Overall Study | STARTED | Placebo | 143 | |
| Overall Study | COMPLETED | Serlopitant 5 mg | 121 | |
| Overall Study | COMPLETED | Placebo | 124 | |
| Overall Study | NOT COMPLETED | Serlopitant 5 mg | 21 | |
| Overall Study | NOT COMPLETED | Placebo | 19 |
Source ClinicalTrials.gov
Adverse events24
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 | Upper respiratory tract infection | Infections and infestations | Serlopitant 5 mg | 10 | 141 | |
| other | Upper respiratory tract infection | Infections and infestations | Placebo | 3 | 139 | |
| other | Pruritus | Skin and subcutaneous tissue disorders | Serlopitant 5 mg | 9 | 141 | |
| other | Pruritus | Skin and subcutaneous tissue disorders | Placebo | 2 | 139 | |
| serious | Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | Serlopitant 5 mg | 1 | 139 | |
| serious | Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | Placebo | 0 | 141 | |
| serious | Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Serlopitant 5 mg | 1 | 139 | |
| serious | Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Placebo | 0 | 141 | |
| serious | Schizoaffective disorder | Psychiatric disorders | Serlopitant 5 mg | 1 | 139 | |
| serious | Schizoaffective disorder | Psychiatric disorders | Placebo | 0 | 141 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Serlopitant 5 mg | 0 | 139 |
| Total, all-cause mortality | Placebo | 0 | 141 |
| Total, other adverse events | Serlopitant 5 mg | 18 | 141 |
| Total, other adverse events | Placebo | 5 | 139 |
| Total, serious adverse events | Serlopitant 5 mg | 6 | 139 |
| Total, serious adverse events | Placebo | 3 | 141 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| 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/NCT03546816
GET https://conductscience.org/api/trials/v1/NCT03546816/results?page=2