Trial · NCT02975206

Study of the Efficacy, Safety, and Tolerability of Serlopitant for Pruritus (Itch) in Atopic Dermatitis

NCT02975206, Phase 2, Completed, Vyne Therapeutics Inc.; results first posted 2019-03-05

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of the Efficacy, Safety, and Tolerability of Serlopitant for Pruritus (Itch) in Atopic Dermatitis. Trials, record NCT02975206. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02975206

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 Pruritus (Itch) in Atopic Dermatitis
NCT number: NCT02975206
Status: Completed
Phases: Phase 2
Enrollment: 484 participants, actual
Lead sponsor: Vyne Therapeutics Inc.
Conditions: Pruritus, Atopic Dermatitis
Interventions: Serlopitant High Dose, Placebo Oral Tablet, Serlopitant Low Dose
First posted: 2016-11-29
Last updated: 2021-05-20
Results first posted: 2019-03-05

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in WI-NRS From Baseline to Week 6	Week 6 compared to Baseline	Worst Itch Numeric Rating Scale (WI-NRS). 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. The primary outcome is the change in WI-NRS score between the visit and Baseline.
Secondary	WI-NRS 4-point Responder Rate at Week 6	Week 6 compared to Baseline	Worst Itch Numeric Rating Scale (WI-NRS). 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. A 4-point responder is a subject who had at least a 4-point reduction in score between Week 6 and baseline.
Secondary	Change in Quality of Life (ItchyQoL) From Baseline to Week 6	Week 6 compared to Baseline	ItchyQoL is a 22-item pruritus-specific instrument that measures the degree to which pruritus affects quality-of-life. The responses to the items are Never (1), Rarely (2), Sometimes (3), Often (4) and All the Time (5). A higher score corresponds to a more adverse impact. The overall score is the average of the 22 items ranging from 1 to 5.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in WI-NRS From Baseline to Week 6	Week 6 compared to Baseline	These figures represent full analysis set.	score on a scale	MEAN
SECONDARY	WI-NRS 4-point Responder Rate at Week 6	Week 6 compared to Baseline	These figures represent full analysis set.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change in Quality of Life (ItchyQoL) From Baseline to Week 6	Week 6 compared to Baseline	These figures represent all participants in the full analysis set who completed the ItchyQol assessment at both Baseline and Week 6.	score on a scale	MEAN

Source ClinicalTrials.gov

Results by group9

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change in WI-NRS From Baseline to Week 6	Serlopitant 5 mg	-2.25	Standard Deviation 2.198	score on a scale
Change in WI-NRS From Baseline to Week 6	Serlopitant 1 mg	-2.32	Standard Deviation 2.418	score on a scale
Change in WI-NRS From Baseline to Week 6	Placebo Oral Tablet	-2.01	Standard Deviation 2.212	score on a scale
WI-NRS 4-point Responder Rate at Week 6	Serlopitant 5 mg	33		Participants
WI-NRS 4-point Responder Rate at Week 6	Serlopitant 1 mg	36		Participants
WI-NRS 4-point Responder Rate at Week 6	Placebo Oral Tablet	26		Participants
Change in Quality of Life (ItchyQoL) From Baseline to Week 6	Serlopitant 5 mg	-0.57	Standard Deviation 0.749	score on a scale
Change in Quality of Life (ItchyQoL) From Baseline to Week 6	Serlopitant 1 mg	-0.58	Standard Deviation 0.779	score on a scale
Change in Quality of Life (ItchyQoL) From Baseline to Week 6	Placebo Oral Tablet	-0.53	Standard Deviation 0.683	score on a scale

Source ClinicalTrials.gov

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Serlopitant 5 mg	161
Overall Study	STARTED	Serlopitant 1 mg	161
Overall Study	STARTED	Placebo Oral Tablet	162
Overall Study	COMPLETED	Serlopitant 5 mg	134
Overall Study	COMPLETED	Serlopitant 1 mg	144
Overall Study	COMPLETED	Placebo Oral Tablet	145
Overall Study	NOT COMPLETED	Serlopitant 5 mg	27
Overall Study	NOT COMPLETED	Serlopitant 1 mg	17
Overall Study	NOT COMPLETED	Placebo Oral Tablet	17

Source ClinicalTrials.gov

Adverse events33

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
other	Dermatitis atopic	Skin and subcutaneous tissue disorders	Serlopitant 5 mg	9	161
other	Dermatitis atopic	Skin and subcutaneous tissue disorders	Serlopitant 1 mg	2	160
other	Dermatitis atopic	Skin and subcutaneous tissue disorders	Placebo Oral Tablet	5	158
other	Urinary tract infection	Infections and infestations	Serlopitant 5 mg	5	161
other	Urinary tract infection	Infections and infestations	Serlopitant 1 mg	5	160
other	Urinary tract infection	Infections and infestations	Placebo Oral Tablet	4	158
other	Nasopharyngitis	Infections and infestations	Serlopitant 5 mg	6	161
other	Nasopharyngitis	Infections and infestations	Serlopitant 1 mg	2	160
other	Nasopharyngitis	Infections and infestations	Placebo Oral Tablet	5	158
other	Headache	Nervous system disorders	Serlopitant 5 mg	2	161

1 to 10 of 33Source ClinicalTrials.gov

See all 33 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Serlopitant 5 mg	1	161
Total, all-cause mortality	Serlopitant 1 mg	0	160
Total, all-cause mortality	Placebo Oral Tablet	0	158
Total, other adverse events	Serlopitant 5 mg	27	161
Total, other adverse events	Serlopitant 1 mg	22	160
Total, other adverse events	Placebo Oral Tablet	32	158
Total, serious adverse events	Serlopitant 5 mg	2	161
Total, serious adverse events	Serlopitant 1 mg	1	160
Total, serious adverse events	Placebo Oral Tablet	2	158

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT02975206

GET https://conductscience.org/api/trials/v1/NCT02975206/events?page=2

API reference For AI assistants