Trial · NCT02654483

Neurokinin-1 Receptor Antagonist for the Treatment of Itch in EB Patients

NCT02654483, Phase 2, Completed, Jean Yuh Tang; results first posted 2019-07-02

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Neurokinin-1 Receptor Antagonist for the Treatment of Itch in EB Patients. Trials, record NCT02654483. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02654483

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Neurokinin-1 Receptor Antagonist for the Treatment of Itch in EB Patients
NCT number: NCT02654483
Status: Completed
Phases: Phase 2
Enrollment: 14 participants, actual
Lead sponsor: Jean Yuh Tang
Conditions: Epidermolysis Bullosa, Pruritus
Interventions: VPD-737, Placebo
First posted: 2016-01-13
Last updated: 2020-03-23
Results first posted: 2019-07-02

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	Comparative Weekly Change in NRS Itch Score Over the 8-week Active Treatment Period	Baseline and 8 weeks	Determine the efficacy of Serlopitant compared with placebo on reducing EB-associated daily itch score as measured by patient self-reports using a numeric rating scale (NRS) for itch severity.The NRS is comprised of one item and represents the numbers 0 ("no itch") to 10 ("worst imaginable itch"). Because itch is subjective and can vary day to day, nightly NRS scores were recorded in patients' Itch Diaries. NRS recorded by subject daily, from screening visit through the end of the study. This study was designed to detect differences between the two treatment groups. The primary endpoint was the comparative weekly change in Numeric Rating Scale (NRS) itch severity score from baseline over 8 weeks; derived from a linear mixed effects model which utilizes observations from both the treatment and placebo groups to generate an interaction term of interest. Itch severity changes from day to day and this model can more appropriately report trends in patients' itch severity with treatment.
Secondary	Wound Healing Determination	Baseline and 8 weeks	Wound dimensions, including length, width, and area (in cm2), will be obtained using the Canfield system. Changes in dimensions between visits as well as changes in dimensions from baseline will be recorded. Overall mean % change from baseline is reported as the secondary endpoint.
Secondary	Change in Mean NRS Itch Score During Bathing/Dressing Changes	Baseline and 8 weeks	Itch is exacerbated by activities such as dressing changes or bathing. NRS itch score during bathing or dressing in the past 24 hours were collected. Numeric rating scale (NRS) for itch severity is comprised of one item and represents the numbers 0 ("no itch") to 10 ("worst imaginable itch"). This study was designed to detect differences between the two treatment groups. This secondary endpoint was the comparative change in Numeric Rating Scale (NRS) itch severity score during bathing/dressing changes from baseline over 8 weeks as determined by application of a linear mixed effects model.

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	Comparative Weekly Change in NRS Itch Score Over the 8-week Active Treatment Period	Baseline and 8 weeks	The relative effect of drug on the mean daily change in NRS itch severity score as compared to baseline is calculated and serves as the primary endpoint. Data is reported as point/week change (delta) in NRS itch score.	score/week comparative change	MEAN
SECONDARY	Wound Healing Determination	Baseline and 8 weeks	Eligible participants were: age 13 and older with a clinical diagnosis of EB and a Numeric Rating Scale (NRS) score for pruritus of ≥4 at baseline on average itch or itch during bathing or dressing in the past 24 hours. Patients were required to have itch symptoms lasting ≥6 weeks that did not respond well to the current standard of care.	percentage change	MEAN
SECONDARY	Change in Mean NRS Itch Score During Bathing/Dressing Changes	Baseline and 8 weeks	The relative effect of drug on the mean change in NRS itch severity score during dressing changes as compared to baseline is calculated and serves as the secondary endpoint.	score on a scale	MEAN

Source ClinicalTrials.gov

Results by group6

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

Outcome	Group	Value	Spread	Units
Comparative Weekly Change in NRS Itch Score Over the 8-week Active Treatment Period	5 mg VPD-737	-2	95% Confidence Interval -5 to 0	score/week comparative change
Comparative Weekly Change in NRS Itch Score Over the 8-week Active Treatment Period	Placebo	-1	95% Confidence Interval -7 to 1	score/week comparative change
Wound Healing Determination	5 mg VPD-737	154.54	Standard Deviation 227	percentage change
Wound Healing Determination	Placebo	38.39	Standard Deviation 180	percentage change
Change in Mean NRS Itch Score During Bathing/Dressing Changes	5 mg VPD-737	-2.5	95% Confidence Interval -4 to 1	score on a scale
Change in Mean NRS Itch Score During Bathing/Dressing Changes	Placebo	-2	95% Confidence Interval -5 to 0	score on a scale

Source ClinicalTrials.gov

Participant flow12

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

Period	Milestone	Group	Participants
Double-blind	STARTED	5 mg VPD-737	7
Double-blind	STARTED	Placebo	7
Double-blind	COMPLETED	5 mg VPD-737	7
Double-blind	COMPLETED	Placebo	7
Double-blind	NOT COMPLETED	5 mg VPD-737	0
Double-blind	NOT COMPLETED	Placebo	0
Open-label	STARTED	5 mg VPD-737	5
Open-label	STARTED	Placebo	3
Open-label	COMPLETED	5 mg VPD-737	5
Open-label	COMPLETED	Placebo	3

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events104

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	nausea	Gastrointestinal disorders	Double-blind, 5 mg VPD-737	2	7
other	nausea	Gastrointestinal disorders	Double-blind, Placebo	1	7
other	nausea	Gastrointestinal disorders	Open-label, 5 mg VPD-737 - 5 mg VPD-737	0	5
other	nausea	Gastrointestinal disorders	Open-label, Placebo - 5 mg VPD-737	0	3
other	diarrhea	Gastrointestinal disorders	Double-blind, 5 mg VPD-737	1	7
other	diarrhea	Gastrointestinal disorders	Double-blind, Placebo	0	7
other	diarrhea	Gastrointestinal disorders	Open-label, 5 mg VPD-737 - 5 mg VPD-737	0	5
other	diarrhea	Gastrointestinal disorders	Open-label, Placebo - 5 mg VPD-737	0	3
other	rash	Skin and subcutaneous tissue disorders	Double-blind, 5 mg VPD-737	0	7
other	rash	Skin and subcutaneous tissue disorders	Double-blind, Placebo	1	7

1 to 10 of 104Source ClinicalTrials.gov

See all 104 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Double-blind, 5 mg VPD-737	0	7
Total, all-cause mortality	Double-blind, Placebo	1	7
Total, all-cause mortality	Open-label, 5 mg VPD-737 - 5 mg VPD-737	0	5
Total, all-cause mortality	Open-label, Placebo - 5 mg VPD-737	0	3
Total, other adverse events	Double-blind, 5 mg VPD-737	6	7
Total, other adverse events	Double-blind, Placebo	7	7
Total, other adverse events	Open-label, 5 mg VPD-737 - 5 mg VPD-737	2	5
Total, other adverse events	Open-label, Placebo - 5 mg VPD-737	3	3
Total, serious adverse events	Double-blind, 5 mg VPD-737	1	7
Total, serious adverse events	Double-blind, Placebo	1	7

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
31541747	RESULT

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 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/NCT02654483

GET https://conductscience.org/api/trials/v1/NCT02654483/events?page=2

API reference For AI assistants