Trial · NCT03540160
Study of the Long Term Safety of Serlopitant for the Treatment of Pruritus (Itch)
NCT03540160, Phase 3, Terminated, Vyne Therapeutics Inc.; results first posted 2020-11-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of the Long Term Safety of Serlopitant for the Treatment of Pruritus (Itch). Trials, record NCT03540160. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03540160
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of the Long Term Safety of Serlopitant for the Treatment of Pruritus (Itch)
- NCT number
- NCT03540160
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 558 participants, actual
- Lead sponsor
- Vyne Therapeutics Inc.
- Conditions
- Pruritus, Prurigo Nodularis, Atopic Dermatitis, Psoriasis
- Interventions
- 5 mg Serlopitant Tablets
- First posted
- 2018-05-30
- Last updated
- 2021-05-20
- Other registries' IDs
- eudract:2017-004211-40
- Results first posted
- 2020-11-30
- Limitations and caveats
- Due to a corporate decision to no longer pursue an indication of treatment for pruritus, and further to terminate the development program for serlopitant, the study was terminated prematurely.
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects With Treatment-emergent Adverse Events | From baseline until the Follow-up (F/U) visit which occurred 35 days (+ 7 days) after the Week 52 visit or the last dose of study drug for subjects who discontinued study drug early. | Treatments emergent adverse events (TEAEs) 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
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects With Treatment-emergent Adverse Events | From baseline until the Follow-up (F/U) visit which occurred 35 days (+ 7 days) after the Week 52 visit or the last dose of study drug for subjects who discontinued study drug early. | Safety population: included all treated participants with at least one postbaseline assessment or a reported TEAE.~No statistical analyses were performed for this end point | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects With Treatment-emergent Adverse Events | Serlopitant 5 mg | Subjects with any TEAE | 325 | Participants | |
| Number of Subjects With Treatment-emergent Adverse Events | Serlopitant 5 mg | Subjects with any related TEAE | 55 | Participants | |
| Number of Subjects With Treatment-emergent Adverse Events | Serlopitant 5 mg | Subjects with any SAE | 45 | Participants | |
| Number of Subjects With Treatment-emergent Adverse Events | Serlopitant 5 mg | Subjects with any related SAE | 1 | Participants | |
| Number of Subjects With Treatment-emergent Adverse Events | Serlopitant 5 mg | Subjects who died | 0 | Participants | |
| Number of Subjects With Treatment-emergent Adverse Events | Serlopitant 5 mg | Subjects who discontinued study drug due to TEAE | 28 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Serlopitant 5 mg | 558 | |
| Overall Study | COMPLETED | Serlopitant 5 mg | 179 | |
| Overall Study | NOT COMPLETED | Serlopitant 5 mg | 379 |
Source ClinicalTrials.gov
Adverse events53
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 | Nasopharyngitis | Infections and infestations | Serlopitant 5 mg | 36 | 549 | |
| serious | Arterial occlusive disease | Vascular disorders | Serlopitant 5 mg | 1 | 549 | |
| serious | Hypertension | Vascular disorders | Serlopitant 5 mg | 1 | 549 | |
| serious | Peripheral arterial occlusive disease | Vascular disorders | Serlopitant 5 mg | 2 | 549 | |
| serious | Hernia hiatus repair | Surgical and medical procedures | Serlopitant 5 mg | 1 | 549 | |
| serious | Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Serlopitant 5 mg | 1 | 549 | |
| serious | Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | Serlopitant 5 mg | 1 | 549 | |
| serious | Adjustment disorder with anxiety | Psychiatric disorders | Serlopitant 5 mg | 1 | 549 | |
| serious | Clavicle fracture | Injury, poisoning and procedural complications | Serlopitant 5 mg | 1 | 549 | |
| serious | Craniofacial fracture | Injury, poisoning and procedural complications | Serlopitant 5 mg | 1 | 549 |
1 to 10 of 53Source ClinicalTrials.gov
See all 53 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Serlopitant 5 mg | 0 | 549 |
| Total, other adverse events | Serlopitant 5 mg | 36 | 549 |
| Total, serious adverse events | Serlopitant 5 mg | 45 | 549 |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT03540160
GET https://conductscience.org/api/trials/v1/NCT03540160/events?page=2