Trial · NCT02196324
A Randomized Placebo-Controlled Study of the Neurokinin-1 (NK1) Receptor Antagonist Serlopitant Prurigo Nodularis (PN)
NCT02196324, Phase 2, Completed, Vyne Therapeutics Inc.; results first posted 2021-02-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Randomized Placebo-Controlled Study of the Neurokinin-1 (NK1) Receptor Antagonist Serlopitant Prurigo Nodularis (PN). Trials, record NCT02196324. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02196324
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Randomized Placebo-Controlled Study of the Neurokinin-1 (NK1) Receptor Antagonist Serlopitant Prurigo Nodularis (PN)
- NCT number
- NCT02196324
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 128 participants, actual
- Lead sponsor
- Vyne Therapeutics Inc.
- Conditions
- Prurigo Nodularis
- Interventions
- serlopitant, Placebo
- First posted
- 2014-07-22
- Last updated
- 2021-05-20
- Results first posted
- 2021-02-02
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Average Visual Analog Scale at Baseline | At Baseline | At study visits, participants recorded a mark for pruritus severity on a 10-cm horizontal line. This thermometer-type scale was marked with ratings of "no itch" (0 cm) and worst imaginable itch" (10 cm). Average Visual Analog Scale (VAS) (average itch over the past 24 hours) was recorded. Higher scores indicated worse outcome. |
| Primary | Average Visual Analog Scale at Week 2 | At Week 2 | At study visits, participants recorded a mark for pruritus severity on a 10-cm horizontal line. This thermometer-type scale was marked with ratings of "no itch" (0 cm) and worst imaginable itch" (10 cm). Average VAS (average itch over the past 24 hours) was recorded. Higher scores indicated worse outcome. |
| Primary | Average Visual Analog Scale at Week 4 | At Week 4 | At study visits, participants recorded a mark for pruritus severity on a 10-cm horizontal line. This thermometer-type scale was marked with ratings of "no itch" (0 cm) and worst imaginable itch" (10 cm). Average VAS (average itch over the past 24 hours) was recorded. Higher scores indicated worse outcome. |
| Primary | Average Visual Analog Scale at Week 8 | At Week 8 | At study visits, participants recorded a mark for pruritus severity on a 10-cm horizontal line. This thermometer-type scale was marked with ratings of "no itch" (0 cm) and worst imaginable itch" (10 cm). Average VAS (average itch over the past 24 hours) was recorded. Higher scores indicated worse outcome. |
| Secondary | Number of Participants With Improvement in Pruritus as Reported on Verbal Rating Scale (VRS) - Pruritus | At Baseline and Week 8 | At study visits, participants used the VRS to rate their skin sensations (pruritus, burning, and stinging) using a 5-point scale (0 = not present; 1 = mild present; 2 = moderately present; 3 = severely present; and 4 = very severely present). Higher scores indicated worse outcome. |
| Secondary | Number of Participants With Improvement in Burning as Reported on Verbal Rating Scale (VRS) - Burning | At Baseline and Week 8 | At study visits, participants used the VRS to rate their skin sensations (pruritus, burning, and stinging) using a 5-point scale (0 = not present; 1 = mild present; 2 = moderately present; 3 = severely present; and 4 = very severely present). Higher scores indicated worse outcome. |
| Secondary | Number of Participants With Improvement in Stinging as Reported on Verbal Rating Scale (VRS) - Stinging | At Baseline and Week 8 | At study visits, participants used the VRS to rate their skin sensations (pruritus, burning, and stinging) using a 5-point scale (0 = not present; 1 = mild present; 2 = moderately present; 3 = severely present; and 4 = very severely present). Higher scores indicated worse outcome. |
| Secondary | Worst Visual Analog Scale (VAS) | At Baseline, Weeks 2, 4, and 8 | At study visits, participants recorded a mark for pruritus severity on a 10-cm horizontal line. This thermometer-type scale was marked with ratings of "no itch" (0 cm) and worst imaginable itch" (10 cm). Worst VAS (worst itch over the past 24 hours) was recorded. Higher scores indicated worse outcome. |
| Secondary | Number of Participants With Improvement in Pruritus as Reported on Patient Global Assessment (PGA) | At Weeks 2, 4, and 8 | The PGA included a question: Did the pruritus improve during the treatment period (yes/no). |
| Secondary | Numeric Rating Scale (NRS) | At Baseline, Weeks 2, 4, and 8 | Numeric Rating Scale: Using the patient diary, participants rated the following using an 11-point NRS (0 = no itching; to 10 = worst itch imaginable): average itching over the past 24 hours (Average NRS). Higher scores indicated worse outcome. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Average Visual Analog Scale at Baseline | At Baseline | The Intent-to-treat (ITT) population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized. | Units on a scale | MEAN |
| PRIMARY | Average Visual Analog Scale at Week 2 | At Week 2 | The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.~Here, overall number of participants analyzed signifies only the participants with available data that were analyzed for the outcome measure. | Units on a scale | MEAN |
| PRIMARY | Average Visual Analog Scale at Week 4 | At Week 4 | The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.~Here, overall number of participants analyzed signifies only the participants with available data that were analyzed for the outcome measure. | Units on a scale | MEAN |
| PRIMARY | Average Visual Analog Scale at Week 8 | At Week 8 | Intent-to-treat (ITT) population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.~Here, overall number of participants analyzed signifies only the participants with available data that were analyzed for the outcome measure. | Units on a scale | MEAN |
| SECONDARY | Number of Participants With Improvement in Pruritus as Reported on Verbal Rating Scale (VRS) - Pruritus | At Baseline and Week 8 | The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.~Here, number analyzed in each row signifies only the participants with available data that were analyzed for each parameter. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Improvement in Burning as Reported on Verbal Rating Scale (VRS) - Burning | At Baseline and Week 8 | The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.~Here, number analyzed in each row signifies only the participants with available data that were analyzed for each parameter. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Improvement in Stinging as Reported on Verbal Rating Scale (VRS) - Stinging | At Baseline and Week 8 | The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.~Here, number analyzed in each row signifies only the participants with available data that were analyzed for each parameter. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Worst Visual Analog Scale (VAS) | At Baseline, Weeks 2, 4, and 8 | The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.~Here, number analyzed in each row signifies only the participants with available data that were analyzed for each parameter. | Units on a scale | MEAN |
| SECONDARY | Number of Participants With Improvement in Pruritus as Reported on Patient Global Assessment (PGA) | At Weeks 2, 4, and 8 | The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.~Here, number analyzed in each row signifies only the participants with available data that were analyzed for each parameter. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Numeric Rating Scale (NRS) | At Baseline, Weeks 2, 4, and 8 | The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized. | Units on a scale | MEAN |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group164
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Average Visual Analog Scale at Baseline | Placebo | 7.92 | Standard Deviation 1.630 | Units on a scale | |
| Average Visual Analog Scale at Baseline | Serlopitant | 7.88 | Standard Deviation 1.311 | Units on a scale | |
| Average Visual Analog Scale at Week 2 | Placebo | 7.01 | Standard Deviation 2.187 | Units on a scale | |
| Average Visual Analog Scale at Week 2 | Serlopitant | 6.06 | Standard Deviation 2.236 | Units on a scale | |
| Average Visual Analog Scale at Week 4 | Placebo | 6.32 | Standard Deviation 2.403 | Units on a scale | |
| Average Visual Analog Scale at Week 4 | Serlopitant | 5.41 | Standard Deviation 2.719 | Units on a scale | |
| Average Visual Analog Scale at Week 8 | Placebo | 5.56 | Standard Deviation 2.630 | Units on a scale | |
| Average Visual Analog Scale at Week 8 | Serlopitant | 4.21 | Standard Deviation 2.746 | Units on a scale | |
| Number of Participants With Improvement in Pruritus as Reported on Verbal Rating Scale (VRS) - Pruritus | Placebo | Baseline, Mild Present | 2 | Participants | |
| Number of Participants With Improvement in Pruritus as Reported on Verbal Rating Scale (VRS) - Pruritus | Serlopitant | Baseline, Mild Present | 0 | Participants |
1 to 10 of 164Source ClinicalTrials.gov
See all 164 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 | 63 | |
| Overall Study | STARTED | Serlopitant | 65 | |
| Overall Study | COMPLETED | Placebo | 48 | |
| Overall Study | COMPLETED | Serlopitant | 57 | |
| Overall Study | NOT COMPLETED | Placebo | 15 | |
| Overall Study | NOT COMPLETED | Serlopitant | 8 |
Source ClinicalTrials.gov
Adverse events32
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 | 3 | 63 | |
| other | Diarrhoea | Gastrointestinal disorders | Serlopitant | 7 | 64 | |
| other | Fatigue | General disorders | Placebo | 4 | 63 | |
| other | Fatigue | General disorders | Serlopitant | 6 | 64 | |
| other | Oedema peripheral | General disorders | Placebo | 0 | 63 | |
| other | Oedema peripheral | General disorders | Serlopitant | 4 | 64 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 2 | 63 | |
| other | Nasopharyngitis | Infections and infestations | Serlopitant | 11 | 64 | |
| other | Urinary tract infection | Infections and infestations | Placebo | 4 | 63 | |
| other | Urinary tract infection | Infections and infestations | Serlopitant | 0 | 64 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 63 |
| Total, all-cause mortality | Serlopitant | 0 | 64 |
| Total, other adverse events | Placebo | 20 | 63 |
| Total, other adverse events | Serlopitant | 31 | 64 |
| Total, serious adverse events | Placebo | 2 | 63 |
| Total, serious adverse events | Serlopitant | 3 | 64 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32936233 | DERIVED |
Source PubMed
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 vs Placebo: deaths from any cause | Trial comparisons |
| Serlopitant 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/NCT02196324
GET https://conductscience.org/api/trials/v1/NCT02196324/results?page=2