PruritusPhase 3NCT03540160

Study of the Long Term Safety of Serlopitant for the Treatment of Pruritus (Itch)

A Phase 3 study testing 5 mg Serlopitant Tablets in people with Pruritus and Prurigo Nodularis, run by Vyne Therapeutics Inc. at 85 sites in 4 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Study of the long term safety of serlopitant for the treatment of pruritus in adults. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Pruritus, Prurigo Nodularis, Atopic Dermatitis
What is being tested?: 5 mg Serlopitant Tablets
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 558 participants
Where: 85 sitesin 4 countries
Study dates: 15 Mar 2018to 17 Jun 2020
Phase: Phase 3
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female, age 18 years or older at consent.
Pruritus associated with prurigo nodularis, atopic dermatitis, or psoriasis.
Female subjects of childbearing potential must be willing to practice highly effective contraception until 5 weeks after last dose of study drug.
Willing and able to comply with study visits and study related requirements including providing written informed consent.

Who cannot join

Malignancy within 5 years prior to enrollment (exception for non-melanoma cutaneous malignancies).
Any known major psychiatric diagnosis, such as major depressive disorder, bipolar disorder, schizophrenia, psychotic disorder, intellectual disability, severe alcohol use disorder, which may confound the assessment of serlopitant safety or efficacy, or interfere with the subject's ability to comply with protocol-mandated activities, within 3 years prior to enrollment.
Untreated or inadequately treated thyroid, adrenal, or pituitary nodules or disease, or history of thyroid malignancy; or the prescense of any medical condition or disability, that could interfere with the assessment of safety in this study or compromise the safety of the subject.
Investigational therapy within 4 weeks or 5-half-lives prior to enrollment (whichever is longer) or expected participation in another clinical study involving an investigational product or device during the subject's participation in this study.
Treatment with other neurokinin-1 receptor (NK1-R) antagonists (e.g., aprepitant, fosaprepitant, rolapitant) within 4 weeks.
Treatment with strong cytochrome P450 3A4 inhibitors within 4 weeks.
Currently pregnant or breastfeeding or planning to become pregnant during the study.

Trial locations and contacts

85 sites in 4 countries.

Country

City, postcode or hospital

85 sites in 4 countries

United States46 sites

Study Site 506
Ann Arbor, Michigan, 48103
Study Site 365
Austin, Texas, 78745
Study Site 501
Aventura, Florida, 33180
Study Site 520
Bellaire, Texas, 77401
Study Site 516
Bexley, Ohio, 43209
Study Site 504
Birmingham, Alabama, 35233
Study Site 507
Brooklyn, New York, 11203
Study Site 508
Buffalo, New York, 14221
Study Site 509
Cleveland, Ohio, 44106
Study Site 210
Coral Gables, Florida, 33134
Study Site 502
Dallas, Texas, 75231
Study Site 515
Detroit, Michigan, 48202
Study Site 524
Dublin, Ohio, 43016
Study Site 201
East Windsor, New Jersey, 08520
Study Site 534
Fort Lauderdale, Florida, 33316
Study Site 204
Fremont, California, 94538
Study Site 525
Glenn Dale, Maryland, 20769
Study Site 526
Henderson, Nevada, 89052
Study Site 341
High Point, North Carolina, 27262
Study Site 224
Houston, Texas, 77004
Study Site 345
Johnston, Rhode Island, 02919
Study Site 511
Knoxville, Tennessee, 37317
Study Site 228
Louisville, Kentucky, 40202
Study Site 531
Miami, Florida, 33155
Study Site 532
Morgantown, West Virginia, 26505
Study Site 527
New Orleans, Louisiana, 70115
Study Site 500
New York, New York, 10025
Study Site 517
New York, New York, 10075
Study Site 510
Newnan, Georgia, 30263
Study Site 383
North Hollywood, California, 91606
Study Site 222
North Miami Beach, Florida, 33162
Study Site 227
Omaha, Nebraska, 68144
Study Site 359
Pflugerville, Texas, 78660
Study Site 523
Philadelphia, Pennsylvania, 19104
Study Site 522
Pittsburgh, Pennsylvania, 15213
Study Site 336
Richmond, Virginia, 23220
Study Site 371
Saint Joseph, Missouri, 64506
Study Site 356
San Diego, California, 92108
Study Site 514
Santa Ana, California, 92701
Study Site 388
Skokie, Illinois, 60077
Study Site 343
Spartanburg, South Carolina, 29303
Study Site 806
Spokane, Washington, 99202
Study Site 528
St Louis, Missouri, 63110
Study Site 112
Tulsa, Oklahoma, 74136
Study Site 529
Verona, New Jersey, 07044-2946
Study Site 226
Webster, Texas, 77598

Other trials in United States

Germany19 sites

Study Site 623
Bad Bentheim, 48455
Study Site 607
Berlin, 10117
Study Site 641
Berlin, 10783
Study Site 600
Bielefeld, 33647
Study Site 617
Bochum, 44793
Study Site 608
Bonn, 53127
Study Site 642
Buxtehude, 21614
Study Site 606
Dresden, 01307
Study Site 621
Erlangen, 91054
Study Site 602
Frankfurt am Main, 60590
Study Site 639
Hamburg, 22391
Study Site 605
Heidelberg, 69115
Study Site 611
Leipzig, 04103
Study Site 620
Mahlow, 15831
Study Site 614
Mainz, 55131
Study Site 601
Münster, 48149
Study Site 618
Osnabrück, 49074
Study Site 615
Selters, 56242
Study Site 643
Stuttgart, 70178

Other trials in Germany

Poland17 sites

Study Site 636
Bydgoszcz, 85-065
Study Site 628
Iwonicz-Zdrój, 38-440
Study Site 633
Krakow, 30-033
Study Site 624
Krakow, 31-070
Study Site 635
Krakow, 31-209
Study Site 629
Lodz, 90-436
Study Site 631
Olsztyn, 10-900
Study Site 625
Osielsko, 86-031
Study Site 645
Poznan, 60-214
Study Site 644
Poznan, 60-848
Study Site 634
Rzeszów, 35-055
Study Site 638
Szczecin, 70-332
Study Site 632
Torun, 87-100
Study Site 627
Warsaw, 02-758
Study Site 637
Wroclaw, 50-566
Study Site 630
Wroclaw, 53-301
Study Site 647
Wroclaw, 53-658

Other trials in Poland

Austria3 sites

Study Site 649
Graz, 8036
Study Site 648
Linz, 4020
Study Site 650
Vienna, 1130

Other trials in Austria

About this study

Official title: An Open-Label Long-Term Safety Study of Serlopitant for the Treatment of Pruritus

Study of the long term safety of serlopitant for the treatment of pruritus in adults.

Conditions: Pruritus, Prurigo Nodularis, Atopic Dermatitis, Psoriasis
Being tested: 5 mg Serlopitant Tablets
Medical subject headings: Pruritus, Dermatitis, Atopic, 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

Study groups in NCT03540160
Study group	Role	What they receive
Experimental: 5 mg Serlopitant Tablets	Experimental	Serlopitant Tablets Receives: Drug: 5 mg Serlopitant Tablets

What is being measured

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

Number of Subjects With Treatment-emergent Adverse Events
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.
Measured: 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.

Timeline

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

15 Mar 201817 Jun 2020

First posted30 May 2018
Study start15 Mar 2018
Primary completion8 Apr 2020
Study completion17 Jun 2020

Why it stopped: No longer pursuing development of serlopitant

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 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 558 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03540160
Sponsor's protocol ID: MTI-107
Other IDs: 2017-004211-40, 2017
Status last verified: May 2021
First submitted: 5 Apr 2018
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

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: An Open-Label Long-Term Safety Study of Serlopitant for the Treatment of Pruritus
ClinicalTrials.gov ID: NCT03540160
Acronym / sponsor ID: MTI-107
Conditions: Pruritus, Prurigo Nodularis, Atopic Dermatitis, Psoriasis
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: No longer pursuing development of serlopitant
Enrolment: 558 participants (actual)
Lead sponsor: Vyne Therapeutics Inc.Industry (pharma, biotech, devices)
Study start: 15 Mar 2018 (actual)
Primary completion: 8 Apr 2020 (actual)
Study completion: 17 Jun 2020 (actual)
First posted: 30 May 2018 (actual)
Results: Posted 30 Nov 2020

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 long term safety of serlopitant for the treatment of pruritus in adults.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Experimental: 5 mg Serlopitant Tablets	Experimental	Drug: 5 mg Serlopitant TabletsSerlopitant Tablets

Who may qualify

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

Key inclusion criteria (4 listed)

Male or female, age 18 years or older at consent.
Pruritus associated with prurigo nodularis, atopic dermatitis, or psoriasis.
Female subjects of childbearing potential must be willing to practice highly effective contraception until 5 weeks after last dose of study drug.
Willing and able to comply with study visits and study related requirements including providing written informed consent.

Key exclusion criteria (7 listed)

Malignancy within 5 years prior to enrollment (exception for non-melanoma cutaneous malignancies).
Any known major psychiatric diagnosis, such as major depressive disorder, bipolar disorder, schizophrenia, psychotic disorder, intellectual disability, severe alcohol use disorder, which may confound the assessment of serlopitant safety or efficacy, or interfere with the subject's ability to comply with protocol-mandated activities, within 3 years prior to enrollment.
Untreated or inadequately treated thyroid, adrenal, or pituitary nodules or disease, or history of thyroid malignancy; or the prescense of any medical condition or disability, that could interfere with the assessment of safety in this study or compromise the safety of the subject.
Investigational therapy within 4 weeks or 5-half-lives prior to enrollment (whichever is longer) or expected participation in another clinical study involving an investigational product or device during the subject's participation in this study.
Treatment with other neurokinin-1 receptor (NK1-R) antagonists (e.g., aprepitant, fosaprepitant, rolapitant) within 4 weeks.

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	Experimental: 5 mg Serlopitant Tablets

Primary outcome

Number of Subjects With Treatment-emergent Adverse Events
Time frame: 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.

Results and safety

Results posted to the registry on 30 Nov 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
Serlopitant 5 mg	558	179

Primary outcome: Number of Subjects With Treatment-emergent Adverse Events

Time frame: 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.. Count of participants. Unit: Participants

Measure	Serlopitant 5 mg n = 549
Subjects with any TEAE	325
Subjects with any related TEAE	55
Subjects with any SAE	45
Subjects with any related SAE	1
Subjects who died	0
Subjects who discontinued study drug due to TEAE	28

Population analysed: 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

Adverse events

Time frame: From baseline until the 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. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Serlopitant 5 mg	45 of 549 (8.2%)	36 of 549 (6.6%)	0 of 549

Limitations and caveats (from the sponsor): 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.

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.

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.

85 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 5 mg Serlopitant Tablets in people with Pruritus and Prurigo Nodularis, run by Vyne Therapeutics Inc. at 85 sites in 4 countries.

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 4 inclusion and 7 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: stopped early, 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 85 sites in United States, Germany, Poland, Austria. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 30 Nov 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?

Number of Subjects With Treatment-emergent Adverse Events (time frame: 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.). 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 NCT03540160.

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.