PruritusPhase 2NCT03841331

Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Chronic Pruritus of Unknown Origin

A Phase 2 study testing 5 mg Serlopitant Tablets in people with Pruritus, run by Vyne Therapeutics Inc. at 41 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Chronic Pruritus of Unknown Origin Read more about this study

Who is it for?: Ages 18 to 120 years
Conditions the study is for: Pruritus
What is being tested?: 5 mg Serlopitant Tablets
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 233 participants
Where: 41 sitesUnited States
Study dates: 22 Jan 2019to 21 Jan 2020
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 120 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female, age 18 years or older at consent.
The subject must have ongoing chronic pruritus
The subject's pruritus is assessed by the investigator to be of unknown origin at baseline.
Worst-Itch Numeric Rating Scale (WI-NRS) score in the 24-hour period prior to the Screening visit, and average weekly WI-NRS score in each of the 2 weeks prior to Baseline visit indicating an appropriate pruritus level for the study.
The pruritus must have been unresponsive to prior treatment with emollients.
The subject's pruritus must be present on multiple segments of the body

Show all 10Show fewer

Willing and able to complete daily eDiary entries within a consistent timeframe for the duration of the study
All females who are of childbearing potential must be willing to practice highly effective contraception and not be pregnant or nursing
Willing to comply with study visits and study related requirements including providing written informed consent.
Adequate cognitive and physical ability, in the investigator's opinion, to comply with study visits and study related requirements including providing written informed consent

Who cannot join

Prior treatment with any NK1-receptor antagonists
Known dermatologic or systemic condition(s), other than dry skin, that is considered by the investigator to be the primary cause of current pruritus.
Untreated or inadequately treated thyroid, adrenal, or pituitary disease or nodules, or history of thyroid malignancy.
Use of an excluded therapy within 3 weeks prior to randomization
Treatment with any investigational therapy within 3 weeks prior to randomization.
Serum creatinine, total bilirubin, alanine aminotransferase or aspartate aminotransferase > 2.5 times the upper limit of normal during screening.

Show all 14Show fewer

History of malignancy within 3 years prior to randomization, with the (actinic keratosis, non-metastatic cutaneous squamous cell carcinoma, basal cell carcinoma of skin).
Any known major psychiatric diagnosis that would impact the subject's ability to complete the study
Suicidal ideation within 3 years prior to randomization, or any history of suicide attempt.
Known use of recreational drugs.
Documented history of parasitic infection, including skin parasites such as scabies, within 12 weeks prior to randomization.
Presence of clinically significant dementia, intellectual impairment, or any medical condition or disability that, in the investigator's opinion, could interfere with the assessment of safety or efficacy in this trial or compromise the safety of the subject.
History of hypersensitivity to serlopitant or any of its components.
Planned or anticipated major surgical procedure or other activity that would interfere with the subject's ability to comply with protocol-mandated assessments (e.g. extended international travel) during the subject's participation in the study.

Trial locations and contacts

41 sites in 1 country.

City, postcode or hospital

41 sites in 1 country

United States41 sites

Study Site 365
Austin, Texas, 78745
Study Site 811
Aventura, Florida, 33180
Study Site 823
Bakersfield, California, 93301
Study Site 821
Bellevue, Nebraska, 68123
Study Site 808
Brighton, Massachusetts, 02135
Study Site 507
Brooklyn, New York, 11203
Study Site 820
Centennial, Colorado, 80112
Study Site 120
Dallas, Texas, 75231
Study Site 804
Denver, Colorado, 80210
Study Site 524
Dublin, Ohio, 43016
Study Site 819
Fort Worth, Texas, 76244
Study Site 204
Fremont, California, 94538
Study Site 341
High Point, North Carolina, 27262
Study Site 221
Hot Springs, Arkansas, 72022
Study Site 814
Indianapolis, Indiana, 46250
Study Site 801
Jacksonville, Florida, 32256
Study Site 345
Johnston, Rhode Island, 02919
Study Site 813
Las Vegas, Nevada, 89128
Study Site 387
Las Vegas, Nevada, 89148
Study Site 803
Los Angeles, California, 90045
Study Site 807
Miami, Florida, 33137
Study Site 331
Miami, Florida, 33144
Study Site 816
Morristown, New Jersey, 07960
Study Site 805
Nashville, Tennessee, 37215
Study Site 217
Norfolk, Virginia, 23502
Study Site 121
Ocean Township, New Jersey, 07712
Study Site 359
Pflugerville, Texas, 78660
Study Site 522
Pittsburgh, Pennsylvania, 15213
Study Site 116
Portland, Oregon, 97202
Study Site 810
Raleigh, North Carolina, 27612
Study Site 822
Rolla, Missouri, 65401
Study Site 371
Saint Joseph, Missouri, 64506
Study Site 809
San Antonio, Texas, 78229
Study Site 824
Sarasota, Florida, 34239
Study Site 349
Savannah, Georgia, 31406
Study Site 806
Spokane, Washington, 99202
Study Site 817
St Louis, Missouri, 63110
Study Site 802
The Bronx, New York, 10458
Study Site 812
Walla Walla, Washington, 09362
Study Site 815
Warwick, Rhode Island, 02886
Study Site 818
West Palm Beach, Florida, 33406

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Chronic Pruritus of Unknown Origin

A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Chronic Pruritus of Unknown Origin

Conditions: Pruritus
Being tested: 5 mg Serlopitant Tablets, Matching Placebo Tablets
Keywords: Pruritus
Medical subject headings: Pruritus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

5 mg Serlopitant TabletsDrug
Also called VPD-737
Serlopitant Tablets
Matching Placebo TabletsDrug
Placebo Tablets

Study groups in NCT03841331
Study group	Role	What they receive
5 mg Serlopitant Tablets	Experimental	Serlopitant Tablets Receives: Drug: 5 mg Serlopitant Tablets
5 mg Placebo Tablets	Placebo comparator	Placebo Tablets Receives: Drug: Matching Placebo Tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

Worst Itch Numeric Rating Scale 4-point Responder Rate at Week 10
During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments was reported by the subject via eDiary. The daily NRS results were summarized. The daily results were averaged to create weekly measures.
The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects 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 subject was a 4-point responder if their change from baseline is ≤ -4 (i.e. a decrease of at least 4).
Measured: At Week 10
WI-NRS 4-point Responder Rate at Weeks 2 4, 6, and 8
During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments was reported by the subject via eDiary. The daily NRS results were summarized. The daily results were averaged to create weekly measures.
The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects 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 subject was a 4-point responder if their change from baseline is ≤ -4 (i.e. a decrease of at least 4).
Measured: At Weeks 2, 4, 6, and 8
WI-NRS 3-point Responder Rate at Weeks 2, 4, 6, 8, and 10
During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments was reported by the subject via eDiary. The daily NRS results were summarized. The daily results were averaged to create weekly measures.
The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects 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 subject was a 3-point responder if their change from baseline is ≤ -3 (i.e. a decrease of at least 3). Results presented below is of subjects who were a 3-point responder but not a 4-point responder.
Measured: At Weeks 2, 4, 6, 8, and 10
Change From Baseline in WI-NRS at Weeks 2, 4, 6, 8, and 10
During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments was reported by the subject via eDiary. The daily NRS results were summarized. The daily results were averaged to create weekly measures.
The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects 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.
Measured: At Weeks 2, 4, 6, 8, and 10
Change From Baseline in Daily WI-NRS Scores Through Week 2
During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments was reported by the subject via eDiary. The daily NRS results were summarized. The daily results were averaged to create weekly measures.
The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects 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.
Measured: Through 2 weeks
Change From Baseline in Worst-Itch Visual Analog Scale at Weeks 2, 4, 6, and 10
The Itch Visual Analog Scale (VAS) is a validated, self-reported instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects to rate the worst intensity of their itch on a 100-mm horizontal line ranging from 0 mm (no itch) to 100 mm (worst itch imaginable). Higher scores indicated greater itch intensity. The VAS measurement were summarized in centimeters. WI-VAS assessments were reported by the subject via a paper form administered at study visits.
Measured: At Weeks 2, 4, 6, and 10

Secondary outcomes (2)

Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Adverse events (AEs) were recorded to assess the safety and tolerability of repeated oral doses of serlopitant in adult subjects with chronic pruritus of unknown origin. Adverse events (AEs) and SAEs were recorded from the first study drug administration through the follow-up visit. After informed consent was signed, but prior to initiation of study drug, only SAEs considered by the investigator to be caused by a protocol-mandated intervention were collected.
Measured: 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 subjects who discontinued study drug early.
Plasma Concentrations of Serlopitant and Metabolites
The plasma concentrations of serlopitant and metabolites were combined with the data from other serlopitant clinical studies for population pharmacokinetic analysis.
Measured: At Week 10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Jan 201921 Jan 2020

First posted15 Feb 2019
Study start22 Jan 2019
Primary completion10 Dec 2019
Study completion21 Jan 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PruritusStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 233 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03841331
Sponsor's protocol ID: MTI-117
Status last verified: May 2021
First submitted: 12 Feb 2019
Last updated: 20 May 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pruritus trials

Study at a glance

From the registry record, last updated by the sponsor on 20 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Chronic Pruritus of Unknown Origin
ClinicalTrials.gov ID: NCT03841331
Acronym / sponsor ID: MTI-117
Conditions: Pruritus
Keywords: Pruritus
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 233 participants (actual)
Lead sponsor: Vyne Therapeutics Inc.Industry (pharma, biotech, devices)
Study start: 22 Jan 2019 (actual)
Primary completion: 10 Dec 2019 (actual)
Study completion: 21 Jan 2020 (actual)
First posted: 15 Feb 2019 (actual)
Results: Posted 23 Sep 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Chronic Pruritus of Unknown Origin

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
5 mg Serlopitant Tablets	Experimental	Drug: 5 mg Serlopitant TabletsSerlopitant Tablets
5 mg Placebo Tablets	Placebo comparator	Drug: Matching Placebo TabletsPlacebo Tablets

Who may qualify

Ages: 18 to 120 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Male or female, age 18 years or older at consent.
The subject must have ongoing chronic pruritus
The subject's pruritus is assessed by the investigator to be of unknown origin at baseline.
Worst-Itch Numeric Rating Scale (WI-NRS) score in the 24-hour period prior to the Screening visit, and average weekly WI-NRS score in each of the 2 weeks prior to Baseline visit indicating an appropriate pruritus level for the study.
The pruritus must have been unresponsive to prior treatment with emollients.

Key exclusion criteria (14 listed)

Prior treatment with any NK1-receptor antagonists
Known dermatologic or systemic condition(s), other than dry skin, that is considered by the investigator to be the primary cause of current pruritus.
Untreated or inadequately treated thyroid, adrenal, or pituitary disease or nodules, or history of thyroid malignancy.
Use of an excluded therapy within 3 weeks prior to randomization
Treatment with any investigational therapy within 3 weeks prior to randomization.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
5 mg Serlopitant TabletsAlso: VPD-737Serlopitant Tablets	Drug	5 mg Serlopitant Tablets
Matching Placebo TabletsPlacebo Tablets	Drug	5 mg Placebo Tablets

Primary outcome

Worst Itch Numeric Rating Scale 4-point Responder Rate at Week 10
Time frame: At Week 10
During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments was reported by the subject via eDiary. The daily NRS results were summarized. The daily results were averaged to create weekly measures. The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects 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 subject was a 4-point responder if their change from baseline is ≤ -4 (i.e. a decrease of at least 4).
WI-NRS 4-point Responder Rate at Weeks 2 4, 6, and 8
Time frame: At Weeks 2, 4, 6, and 8
During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments was reported by the subject via eDiary. The daily NRS results were summarized. The daily results were averaged to create weekly measures. The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects 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 subject was a 4-point responder if their change from baseline is ≤ -4 (i.e. a decrease of at least 4).
WI-NRS 3-point Responder Rate at Weeks 2, 4, 6, 8, and 10
Time frame: At Weeks 2, 4, 6, 8, and 10
During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments was reported by the subject via eDiary. The daily NRS results were summarized. The daily results were averaged to create weekly measures. The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects 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 subject was a 3-point responder if their change from baseline is ≤ -3 (i.e. a decrease of at least 3). Results presented below is of subjects who were a 3-point responder but not a 4-point responder.
Change From Baseline in WI-NRS at Weeks 2, 4, 6, 8, and 10
Time frame: At Weeks 2, 4, 6, 8, and 10
During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments was reported by the subject via eDiary. The daily NRS results were summarized. The daily results were averaged to create weekly measures. The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects 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.
Change From Baseline in Daily WI-NRS Scores Through Week 2
Time frame: Through 2 weeks
During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments was reported by the subject via eDiary. The daily NRS results were summarized. The daily results were averaged to create weekly measures. The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects 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.
Change From Baseline in Worst-Itch Visual Analog Scale at Weeks 2, 4, 6, and 10
Time frame: At Weeks 2, 4, 6, and 10
The Itch Visual Analog Scale (VAS) is a validated, self-reported instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects to rate the worst intensity of their itch on a 100-mm horizontal line ranging from 0 mm (no itch) to 100 mm (worst itch imaginable). Higher scores indicated greater itch intensity. The VAS measurement were summarized in centimeters. WI-VAS assessments were reported by the subject via a paper form administered at study visits.

2 secondary outcomes

Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: 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 subjects who discontinued study drug early.
Plasma Concentrations of Serlopitant and Metabolites
Time frame: At Week 10

Results and safety

Results posted to the registry on 23 Sep 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	117	108
Serlopitant 5 mg	116	106

Primary outcome: Worst Itch Numeric Rating Scale 4-point Responder Rate at Week 10

Time frame: At Week 10. Count of participants. Unit: Participants

Measure	Placebo n = 117	Serlopitant 5 mg n = 116
Value	46	44

Placebo vs Serlopitant 5 mg: Treatment Effect: -1.4 (95% CI -13.9 to 11.1), p = 0.5861, Cochran-Mantel-Haenszel

Population analysed: Full Analysis Population: subset of subjects in the randomized population who were dispensed study medication.

Primary outcome: WI-NRS 4-point Responder Rate at Weeks 2 4, 6, and 8

Time frame: At Weeks 2, 4, 6, and 8. Count of participants. Unit: Participants

Measure	Placebo n = 117	Serlopitant 5 mg n = 116
Responders at Week 2	19	18
Responders at Week 4	29	24
Responders at Week 6	35	38
Responders at Week 8	40	37

Placebo vs Serlopitant 5 mg: Treatment Effect: -0.7 (95% CI -10.1 to 8.7), p = 0.5651, Cochran-Mantel-Haenszel
Placebo vs Serlopitant 5 mg: Treatment Effect: -4.1 (95% CI -14.8 to 6.7), p = 0.7769, Cochran-Mantel-Haenszel
Placebo vs Serlopitant 5 mg: Treatment Effect: 2.8 (95% CI -9.1 to 14.8), p = 0.3285, Cochran-Mantel-Haenszel

Population analysed: Full Analysis Population: subset of subjects in the randomized population who were dispensed study medication.

Primary outcome: WI-NRS 3-point Responder Rate at Weeks 2, 4, 6, 8, and 10

Time frame: At Weeks 2, 4, 6, 8, and 10. Count of participants. Unit: Participants

Measure	Placebo n = 117	Serlopitant 5 mg n = 116
Responders at Week 2	6	6
Responders at Week 4	8	14
Responders at Week 6	15	10
Responders at Week 8	14	15
Responders at Week 10	13	16

Placebo vs Serlopitant 5 mg: Treatment effect: 0.0 (95% CI -5.6 to 5.7), p = 0.4952, Cochran-Mantel-Haenszel
Placebo vs Serlopitant 5 mg: Treatment effect: 5.2 (95% CI -2.3 to 12.7), p = 0.0891, Cochran-Mantel-Haenszel
Placebo vs Serlopitant 5 mg: Treatment effect: -4.2 (95% CI -12.1 to 3.7), p = 0.8447, Cochran-Mantel-Haenszel

Population analysed: Full Analysis Population: subset of subjects in the randomized population who were dispensed study medication.

Primary outcome: Change From Baseline in WI-NRS at Weeks 2, 4, 6, 8, and 10

Time frame: At Weeks 2, 4, 6, 8, and 10. Mean (Standard Deviation). Unit: score on a scale

Measure	Placebo n = 117	Serlopitant 5 mg n = 116
Baseline (Observed value)	8.37 (0.929)	8.44 (0.855)
Change from Baseline at Week 2	-1.65 (2.115)	-1.61 (1.961)
Change from Baseline at Week 4	-2.41 (2.382)	-2.46 (2.349)
Change from Baseline at Week 6	-2.83 (2.624)	-2.94 (2.495)
Change from Basline at Week 8	-2.99 (2.647)	-2.97 (2.562)
Change from Baseline at Week 10	-3.34 (2.787)	-3.25 (2.545)

Placebo vs Serlopitant 5 mg: Mean Difference (Final Values): 0.04 (95% CI -0.49 to 0.57), p = 0.4409, ANOVA
Placebo vs Serlopitant 5 mg: Mean Difference (Final Values): -0.04 (95% CI -0.65 to 0.57), p = 0.5496, ANOVA
Placebo vs Serlopitant 5 mg: Mean Difference (Final Values): -0.11 (95% CI -0.78 to 0.55), p = 0.6311, ANOVA

Population analysed: Full Analysis Population: subset of subjects in the randomized population who were dispensed study medication.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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 subjects who discontinued study drug early.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 117 (0%)	1 of 117 (0.9%)	0 of 117
Serlopitant 5 mg	2 of 116 (1.7%)	12 of 116 (10.3%)	0 of 116

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

41 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 5 mg Serlopitant Tablets in people with Pruritus, run by Vyne Therapeutics Inc. at 41 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Worst Itch Numeric Rating Scale 4-point Responder Rate at Week 10 (time frame: At Week 10). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03841331.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2021.