PruritusPhase 2NCT03343639

Study of the Efficacy, Safety and Tolerability of Serlopitant for the Treatment of Pruritus (Itch) With Plaque Psoriasis

A Phase 2 study testing 5 mg Serlopitant Tablets in people with Pruritus and Psoriasis, run by Vyne Therapeutics Inc. at 39 sites in United States.

Completed

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

Official record

Search all trials

Trial summary

Study of the efficacy, safety, and tolerability of serlopitant for the treatment of pruritus in adults with plaque psoriasis Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Pruritus, Psoriasis
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: 204 participants
Where: 39 sitesUnited States
Study dates: 1 Nov 2017to 12 Nov 2018
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 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female, age 18-80 years at consent.
Diagnosis of plaque psoriasis for at least 6 months prior to randomization.
Presence of plaque psoriasis in any anatomic location, covering ≤ 10% BSA in total, at the Screening and Baseline visits.
Pruritus of at least 4 weeks' duration prior to the initial Screening visit, and throughout the screening period prior to randomization.
Subjects must be willing to discontinue use of all psoriasis therapies other than the following, for the duration of the study: bland emollients (e.g., Cetaphil, Eucerin, Aquaphor) on any anatomic location; coal tar shampoos, limited to use on scalp.
WI-NRS initial screening score consistent with severe pruritus.

Show all 11Show fewer

WI-NRS scores during the 2 weeks of screening consistent with sever pruritus.
All female subjects who are of childbearing potential must be willing to practice highly effective contraception (i.e., pregnancy prevention method with a failure rate of < 1% per year) from the time of the initial Screening visit until 2 weeks after last dose of study drug.
Weight ≥ 32 kg at the Screening and Baseline visits.
Willing and able to complete daily eDiary entries within a consistent timeframe for the duration of the study.
Subjects must have ≥ 80% eDiary completion rate during the two weeks of the screening period immediately prior to randomization.

Who cannot join

Prior treatment with serlopitant.
Prior treatment with other neurokinin-1 receptor (NK1-R) antagonists (e.g., aprepitant, fosaprepitant, rolapitant) is not allowed within 1 year prior to randomization.
Clinical worsening of psoriasis in the opinion of the investigator (e.g., increase in affected BSA or severity requiring use of systemic psoriasis therapies) within 12 weeks prior to randomization.
Predominance of non-plaque forms of psoriasis (e.g., guttate, drug-induced, pustular, erythrodermic).
Presence of any concurrent medical condition that provides a clearly defined etiology for pruritus other than psoriasis. These include but are not limited to urticaria, atopic dermatitis or other dermatologic conditions, hepatic or renal disease, psychogenic pruritus, drug reaction, untreated hyperthyroidism, and infection.
Treatment with systemic biologic therapies including but not limited to etanercept, infliximab, adalimumab, ustekinumab, secukinumab, or ixekizumab, within 6 months or 5 half-lives (whichever is longer) prior to randomization.

Show all 27Show fewer

Treatment with systemic non-biologic psoriasis therapies, including but not limited to systemic corticosteroids, phosphodiesterase-4 inhibitors, Janus kinase inhibitors, cyclosporine, methotrexate, retinoids, hydroxyurea, mycophenolate mofetil, thioguanine, sirolimus, azathioprine, or fumaric acid derivatives, within 12 weeks prior to randomization.
Treatment with any of the following therapies within 4 weeks prior to randomization:
Any topical/local psoriasis therapies other than those permitted per inclusion #4, including but not limited to topical corticosteroids, vitamin D analogues, calcineurin inhibitors, phosphodiesterase-4 inhibitors, Janus kinase inhibitors, non-shampoo forms of coal tar, salicylates, retinoids, anthralin, or excimer laser.
Non-systemic corticosteroids that do not involve skin application (e.g., inhaled, intranasal, or intra-articular corticosteroids) will be permitted.
Phototherapy, with or without psoralen. c. Use of an indoor tanning facility, or sun exposure likely to result in sunburn.
Systemic therapies with recognized anti-pruritic properties including but not limited to H1 antihistamines, doxepin, mirtazapine, gabapentin, pregabalin, cannabinoids, and kappa opioid receptor agonists.
Any topical anti-pruritic therapies, including but not limited to H1 antihistamines, doxepin, capsaicin, or medicated emollients (e.g., menthol or pramoxine).
Strong CYP3A4 inhibitors.
Treatment with any investigational therapy within 4 weeks or 5 half-lives (whichever is longer) prior to randomization.
Serum creatinine, total bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2x the upper limit of normal (ULN) during screening.
History of malignancy within 5 years prior to randomization, with the exception of completely treated and non-metastatic basal cell carcinoma or squamous cell carcinoma of the skin.
Presence of any of the following conditions meeting DSM-5 diagnostic criteria within 3 years prior to randomization: major depressive disorder, bipolar disorder, schizophrenia, psychotic disorder, intellectual disability, severe alcohol use disorder, or other known psychiatric condition meeting DSM-5 diagnostic criteria which may confound the assessment of serlopitant safety or efficacy, compromise the safety of the subject, or interfere with the subject's ability to comply with protocol-mandated activities.
Suicidal ideation within 3 years prior to randomization, or history of suicide attempt at any time.
Known active hepatitis infection.
Known history of human immunodeficiency virus (HIV) infection.
Documented history of parasitic infection, including skin parasites such as scabies, within 12 months prior to randomization.
History of hypersensitivity to serlopitant or any of its components.
Currently pregnant or breastfeeding female subject.
Presence of any medical condition or disability that, in the investigator's opinion, could interfere with the assessment of serlopitant safety or efficacy, compromise the safety of the subject, or interfere with the subject's ability to comply with protocol-mandated activities; this includes any clinically significant screening ECG abnormalities any may include some clinically significant screening laboratory abnormalities.
Unless specifically excluded per exclusion #9, clinically significant laboratory abnormalities at screening which are unlikely to interfere with the assessment of safety or efficacy in this trial, compromise the safety of the subject, or interfere with the subject's ability to comply with protocol mandated activities are permitted.
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

39 sites in 1 country.

City, postcode or hospital

39 sites in 1 country

United States39 sites

Study Site 506
Ann Arbor, Michigan, 48103
Study Site 220
Beverly Hills, California, 90212
Study Site 516
Bexley, Ohio, 43209
Study Site 213
Boise, Idaho, 83704
Study Site 211
Broomall, Pennsylvania, 19008
Study Site 221
Bryant, Arkansas, 72022
Study Site 212
Clearwater, Florida, 33761
Study Site 219
Clinton Township, Michigan, 48038
Study Site 182
College Station, Texas, 77845
Study Site 210
Coral Gables, Florida, 33134
Study Site 201
East Windsor, New Jersey, 08520
Study Site 375
Forest Hills, New York, 11375
Study Site 204
Fremont, California, 94538
Study Site 209
Fridley, Minnesota, 55432
Study Site 224
Houston, Texas, 77004
Study Site 345
Johnston, Rhode Island, 02919
Study Site 228
Louisville, Kentucky, 40202
Study Site 216
Louisville, Kentucky, 40241
Study Site 331
Miami, Florida, 33144
Study Site 348
Miami, Florida, 33165
Study Site 205
Murfreesboro, Tennessee, 37130
Study Site 360
New Albany, Indiana, 47150
Study Site 500
New York, New York, 10023
Study Site 217
Norfolk, Virginia, 23502
Study Site 222
North Miami Beach, Florida, 33162
Study Site 227
Omaha, Nebraska, 68144
Study Site 359
Pflugerville, Texas, 78660
Study Site 339
Plano, Texas, 75024
Study Site 336
Richmond, Virginia, 23220
Study Site 371
Saint Joseph, Missouri, 64506
Study Site 203
San Antonio, Texas, 78218
Study Site 356
San Diego, California, 92108
Study Site 202
San Diego, California, 92123
Study Site 215
San Diego, California, 92123
Study Site 206
Sanford, Florida, 32771
Study Site 376
Santa Monica, California, 90404
Study Site 207
South Bend, Indiana, 46617
Study Site 223
Sugar Land, Texas, 77479
Study Site 226
Webster, Texas, 77598

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 Pruritus in Adults With Plaque Psoriasis

Study of the efficacy, safety, and tolerability of serlopitant for the treatment of pruritus in adults with plaque psoriasis

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

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 NCT03343639
Study group	Role	What they receive
5 mg Serlopitant Tablets	Experimental	Serlopitant Tablets Receives: Drug: 5 mg Serlopitant Tablets
Matching 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.

WI-NRS 4-point Responder Rate at Week 8
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 Baseline and Week 8.
Measured: 8 weeks

Secondary outcomes (3)

WI-NRS 4-point Responder Rate at Week 4
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 Baseline and Week 4.
Measured: 4 weeks
Change in WI-NRS From Baseline to Day 7
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 secondary outcome is the change in WI-NRS score at 7 days compared with Baseline.
Measured: Change from baseline to day 7
Change in WI-NRS From Baseline to Day 3
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 secondary outcome is the change in WI-NRS score at 3 days compared with Baseline.
Measured: 3 days

Timeline

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

1 Nov 201712 Nov 2018

First posted17 Nov 2017
Study start1 Nov 2017
Primary completion23 Oct 2018
Study completion12 Nov 2018

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.
Publications (1)Papers the sponsor has linked to this study.
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: 204 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03343639
Sponsor's protocol ID: MTI-109
Status last verified: May 2021
First submitted: 10 Nov 2017
Last updated: 20 May 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Pariser DM, Bagel J, Lebwohl M, Yosipovitch G, Chien E, Spellman MC. Serlopitant for psoriatic pruritus: A phase 2 randomized, double-blind, placebo-controlled clinical trial. J Am Acad Dermatol. 2020 Jun;82(6):1314-1320. doi: 10.1016/j.jaad.2020.01.056. Epub 2020 Jan 30.
PubMed 32007513

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

Recruiting
Investigation of the Effects of Sleep Deprivation on Itch and Pain Sensitivity
Histamine, Cowhage
Active, not recruiting
Identification of the Mechanism of Non-histaminergic Itch Inducing Epigenetic Changes
Itch
Recruiting
Investigate the Relationship Between Catastrophizing and the Perception of Itch Intensity in Healthy Individuals
Histamine, Cowhage
RecruitingPhase 3
Roflumilast Cream 0.3% for Moderate to Severe Atopic Dermatitis
Atopic Dermatitis, Atopic Dermatitis (AD)
Recruiting
Topographical Distribution of Itch and Pain Receptors
Pain, Itch

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 Pruritus in Adults With Plaque Psoriasis
ClinicalTrials.gov ID: NCT03343639
Acronym / sponsor ID: MTI-109
Conditions: Pruritus, Psoriasis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 204 participants (actual)
Lead sponsor: Vyne Therapeutics Inc.Industry (pharma, biotech, devices)
Study start: 1 Nov 2017 (actual)
Primary completion: 23 Oct 2018 (actual)
Study completion: 12 Nov 2018 (actual)
First posted: 17 Nov 2017 (actual)
Results: Posted 12 Jun 2019

Clinical summary

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

Study of the efficacy, safety, and tolerability of serlopitant for the treatment of pruritus in adults with plaque psoriasis

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
Matching Placebo Tablets	Placebo comparator	Drug: Matching Placebo TabletsPlacebo Tablets

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Male or female, age 18-80 years at consent.
Diagnosis of plaque psoriasis for at least 6 months prior to randomization.
Pruritus of at least 4 weeks' duration prior to the initial Screening visit, and throughout the screening period prior to randomization.
Subjects must be willing to discontinue use of all psoriasis therapies other than the following, for the duration of the study: bland emollients (e.g., Cetaphil, Eucerin, Aquaphor) on any anatomic location; coal tar shampoos, limited to use on scalp.
WI-NRS initial screening score consistent with severe pruritus.

Key exclusion criteria (27 listed)

Prior treatment with serlopitant.
Clinical worsening of psoriasis in the opinion of the investigator (e.g., increase in affected BSA or severity requiring use of systemic psoriasis therapies) within 12 weeks prior to randomization.
Predominance of non-plaque forms of psoriasis (e.g., guttate, drug-induced, pustular, erythrodermic).
Presence of any concurrent medical condition that provides a clearly defined etiology for pruritus other than psoriasis. These include but are not limited to urticaria, atopic dermatitis or other dermatologic conditions, hepatic or renal disease, psychogenic pruritus, drug reaction, untreated hyperthyroidism, and infection.
Treatment with systemic biologic therapies including but not limited to etanercept, infliximab, adalimumab, ustekinumab, secukinumab, or ixekizumab, within 6 months or 5 half-lives (whichever is longer) 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	Matching Placebo Tablets

Primary outcome

WI-NRS 4-point Responder Rate at Week 8
Time frame: 8 weeks
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 Baseline and Week 8.

3 secondary outcomes

WI-NRS 4-point Responder Rate at Week 4
Time frame: 4 weeks
Change in WI-NRS From Baseline to Day 7
Time frame: Change from baseline to day 7
Change in WI-NRS From Baseline to Day 3
Time frame: 3 days

Results and safety

Results posted to the registry on 12 Jun 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Serlopitant 5 mg	102	88
Placebo	102	90

Primary outcome: WI-NRS 4-point Responder Rate at Week 8

Time frame: 8 weeks. Number. Unit: % of subjects (incl. imputed data)

Measure	Serlopitant 5 mg n = 102	Placebo n = 101
Value	33.29	21.07

Population analysed: These figures represent full analysis set.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the Follow-up visit, for a total of approximately 10 weeks.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Serlopitant 5 mg	0 of 102 (0%)	9 of 102 (8.8%)	0 of 102
Placebo	2 of 100 (2%)	17 of 100 (17%)	1 of 100

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.
Derived from this study: PubMed 32007513Pariser DM, Bagel J, Lebwohl M, Yosipovitch G, Chien E, Spellman MC. Serlopitant for psoriatic pruritus: A phase 2 randomized, double-blind, placebo-controlled clinical trial. J Am Acad Dermatol. 2020 Jun;82(6):1314-1320. doi: 10.1016/j.jaad.2020.01.056. Epub 2020 Jan 30.

Related trials for Pruritus

Recruiting
Investigation of the Effects of Sleep Deprivation on Itch and Pain Sensitivity
Histamine, Cowhage
Active, not recruiting
Identification of the Mechanism of Non-histaminergic Itch Inducing Epigenetic Changes
Itch
Recruiting
Investigate the Relationship Between Catastrophizing and the Perception of Itch Intensity in Healthy Individuals
Histamine, Cowhage
RecruitingPhase 3
Roflumilast Cream 0.3% for Moderate to Severe Atopic Dermatitis
Atopic Dermatitis, Atopic Dermatitis (AD)
Recruiting
Topographical Distribution of Itch and Pain Receptors
Pain, Itch

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.

39 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 and Psoriasis, run by Vyne Therapeutics Inc. at 39 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 11 inclusion and 27 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 39 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 12 Jun 2019). 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?

WI-NRS 4-point Responder Rate at Week 8 (time frame: 8 weeks). 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 NCT03343639, which also lists 1 linked publication.

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.