Trial · NCT03677401
Study of the Efficacy, Safety and Tolerability of Serlopitant for the Treatment of Pruritus (Itch) With Prurigo Nodularis
NCT03677401, Phase 3, Completed, Vyne Therapeutics Inc.; results first posted 2020-10-28
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 NCT03677401. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03677401
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
- NCT03677401
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 295 participants, actual
- Lead sponsor
- Vyne Therapeutics Inc.
- Conditions
- Pruritus, Prurigo Nodularis
- Interventions
- 5mg Serlopitant Tablets, Placebo Tablets
- First posted
- 2018-09-19
- Last updated
- 2021-05-20
- Other registries' IDs
- eudract:2017-004210-25
- Results first posted
- 2020-10-28
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 Participants With Worst Itch Numeric Rating Scale (WI-NRS) 4-point Responder Rate at Week 10 | At Week 10 | During the study, WI-NRS assessments were reported by the participant 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 participants 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. A participant was a 4-point responder if their change from baseline is ≤ -4 (i.e. a decrease of at least 4). |
| Secondary | Percent of Participants With WI-NRS 4-point Responder Rate at Week 4 | At Week 4 | During the study, WI-NRS assessments were reported by the participant 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 participants 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. A participant was a 4-point responder if their change from baseline is ≤ -4 (i.e. a decrease of at least 4). |
| Secondary | Percent of Participants With WI-NRS 4-point Responder Rate at Week 2 | At Week 2 | During the study, WI-NRS assessments were reported by the participant 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 participants 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. A participant was a 4-point responder if their change from baseline is ≤ -4 (i.e. a decrease of at least 4). |
| 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 participant 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 participants 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 Participants 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 participant 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 participants 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. A participant was a 3-point responder if their change from baseline is ≤ -3 (i.e. a decrease of at least 3). |
| 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 participant'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 participant 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 | 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 participant'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 participant 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 Investigator's Global Assessment of Prurigo Nodularis 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 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 | Number of Participants With Treatment-emergent Adverse Events 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 participants who discontinued study drug early | 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 Participants With Worst Itch Numeric Rating Scale (WI-NRS) 4-point Responder Rate at Week 10 | At Week 10 | Intent-to-Treat Population: included all randomized participants who were dispensed study drug. | Percentage of participants | NUMBER |
| SECONDARY | Percent of Participants With WI-NRS 4-point Responder Rate at Week 4 | At Week 4 | Intent-to-Treat Population: included all randomized participants who were dispensed study drug. | percentage of participants | NUMBER |
| SECONDARY | Percent of Participants With WI-NRS 4-point Responder Rate at Week 2 | At Week 2 | Intent-to-Treat Population: included all randomized participants who were dispensed study drug. | percentage of participants | 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 participants who were dispensed study drug. | Score on a scale | MEAN |
| SECONDARY | Percent of Participants 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 participants who were dispensed study drug. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 10 | At Week 10 | Intent-to-Treat Population: included all randomized participants 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 participants who were dispensed study drug. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline in Investigator's Global Assessment of Prurigo Nodularis Stage (IGA PN-S) to Weeks 2, 4, and 10 | At Weeks 2, 4 and 10 | Intent-to-Treat Population: included all randomized participants who were dispensed study drug. | Score on a scale | MEAN |
| 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 participants who were dispensed study drug. | Score on a scale | MEAN |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events 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 participants who discontinued study drug early | Safety population: included all treated participants with at least one post-baseline assessment or a reported TEAE. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group54
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent of Participants With Worst Itch Numeric Rating Scale (WI-NRS) 4-point Responder Rate at Week 10 | Placebo | Success | 18.95 | Percentage of participants | |
| Percent of Participants With Worst Itch Numeric Rating Scale (WI-NRS) 4-point Responder Rate at Week 10 | Serlopitant 5 mg | Success | 25.90 | Percentage of participants | |
| Percent of Participants With Worst Itch Numeric Rating Scale (WI-NRS) 4-point Responder Rate at Week 10 | Placebo | Failure | 81.05 | Percentage of participants | |
| Percent of Participants With Worst Itch Numeric Rating Scale (WI-NRS) 4-point Responder Rate at Week 10 | Serlopitant 5 mg | Failure | 74.10 | Percentage of participants | |
| Percent of Participants With WI-NRS 4-point Responder Rate at Week 4 | Placebo | Success | 11.49 | percentage of participants | |
| Percent of Participants With WI-NRS 4-point Responder Rate at Week 4 | Serlopitant 5 mg | Success | 12.63 | percentage of participants | |
| Percent of Participants With WI-NRS 4-point Responder Rate at Week 4 | Placebo | Failure | 88.51 | percentage of participants | |
| Percent of Participants With WI-NRS 4-point Responder Rate at Week 4 | Serlopitant 5 mg | Failure | 87.37 | percentage of participants | |
| Percent of Participants With WI-NRS 4-point Responder Rate at Week 2 | Placebo | Success | 6.76 | percentage of participants | |
| Percent of Participants With WI-NRS 4-point Responder Rate at Week 2 | Serlopitant 5 mg | Success | 5.55 | percentage of participants |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 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 | 148 | |
| Overall Study | STARTED | Serlopitant 5 mg | 147 | |
| Overall Study | COMPLETED | Placebo | 138 | |
| Overall Study | COMPLETED | Serlopitant 5 mg | 129 | |
| Overall Study | NOT COMPLETED | Placebo | 10 | |
| Overall Study | NOT COMPLETED | Serlopitant 5 mg | 18 |
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 | Fatigue | General disorders | Placebo | 6 | 148 | |
| other | Fatigue | General disorders | Serlopitant 5 mg | 7 | 147 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 22 | 148 | |
| other | Nasopharyngitis | Infections and infestations | Serlopitant 5 mg | 15 | 147 | |
| other | Headache | Nervous system disorders | Placebo | 5 | 148 | |
| other | Headache | Nervous system disorders | Serlopitant 5 mg | 9 | 147 | |
| serious | Coronary artery disease | Cardiac disorders | Placebo | 0 | 148 | |
| serious | Coronary artery disease | Cardiac disorders | Serlopitant 5 mg | 1 | 147 | |
| serious | Wound | Injury, poisoning and procedural complications | Placebo | 0 | 148 | |
| serious | Wound | Injury, poisoning and procedural complications | Serlopitant 5 mg | 1 | 147 |
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 | Placebo | 0 | 148 |
| Total, all-cause mortality | Serlopitant 5 mg | 1 | 147 |
| Total, other adverse events | Placebo | 33 | 148 |
| Total, other adverse events | Serlopitant 5 mg | 31 | 147 |
| Total, serious adverse events | Placebo | 2 | 148 |
| Total, serious adverse events | Serlopitant 5 mg | 5 | 147 |
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/NCT03677401
GET https://conductscience.org/api/trials/v1/NCT03677401/results?page=2