PruritusPhase 3NCT03546816
Study of the Efficacy, Safety and Tolerability of Serlopitant for the Treatment of Pruritus (Itch) With Prurigo Nodularis
A Phase 3 study testing 5mg Serlopitant Tablets in people with Pruritus and Prurigo Nodularis, run by Vyne Therapeutics Inc. at 49 sites in United States.
Trial summary
Study of the efficacy, safety, and tolerability of serlopitant for the treatment of pruritus in adults with prurigo nodularis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pruritus, Prurigo Nodularis
- What is being tested?
- 5mg Serlopitant Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 285 participants
- Where
- 49 sitesUnited States
- Study dates
- 2 May 2018to 14 Feb 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
Inclusion Criteria (Subjects must meet the following criteria to be randomized into the study:
- Male or female, age 18 years or older at consent.
- Prurigo nodularis (PN), with at least ten nodules on at least two different body surface areas.
- Idiopathic PN, or an identified pruritic condition associated with the PN with persistent pruritus despite at least 6 weeks of optimized and stable treatment of the underlying condition.
- The worst pruritus is identified as within the areas of the PN lesions, with a 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.
- 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 complete daily eDiary entries within a consistent timeframe for the duration of the study.
- Willing and able to comply with study visits and study related requirements including providing written informed consent.
Exclusion Criteria (Subjects who meet any of the following criteria are not eligible for participation in the study):
- Prior treatment with serlopitant.
- Active pruritic skin disease, other than PN, within 6 months (with the exception of acute dermatoses such as contact dermatitis, sunburn, viral exanthem, which have been resolved for longer than 4 weeks).
- Treatment with any of the following therapies within 4 weeks.
- Other neurokinin-1 receptor antagonists (e.g., aprepitant, fosaprepitant, rolapitant).
- Systemic or topical immunosuppressive/immunomodulatory therapies.
- Systemic therapies with recognized anti-pruritic properties.
- Strong cytochrome-P 3A4 inhibitors.
- Use of an indoor tanning facility, or natural sun exposure resulting in significant tanning or sunburn.
- Treatment with topical anti-pruritic therapies within 2 weeks.
- Treatment with biologic therapies within 8 weeks or 5 half-lives, whichever is longer.
- Treatment with any investigational therapy within 4 weeks (8 weeks for investigational biologic therapies) or 5 half-lives, whichever is longer.
- Serum creatinine, total bilirubin, alanine aminotransferase or aspartate aminotransferase > 2.5 times the upper limit of normal during screening.
- Untreated or inadequately treated thyroid adrenal, or pituitary nodules or disease, or history of thyroid malignancy.
- Malignancy within 5 years prior to enrollment (exception for non-melanoma cutaneous malignancies).
- Relevant major psychiatric diagnosis in the past 3 years, such as major depressive disorder, bipolar disorder, schizophrenia, psychotic disorder, intellectual disability, severe alcohol use disorder.
- Documented history of parasitic infection, including skin parasites such as scabies, within 8 weeks.
- Any medical condition or disability that could interfere with the assessment of safety or efficacy in this study or compromise the safety of the subject.
- History of hypersensitivity to serlopitant or any of its components.
- Currently pregnant or breastfeeding or planning to become pregnant during the study.
- Planned or anticipated major surgical procedure or other activity that would interfere with the subject's ability to comply with protocol-mandated assessments during participation in the study.
Trial locations and contacts
49 sites in 1 country.
49 sites in 1 country
United States49 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 379
Boston, Massachusetts, 02114
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 530
Miami, Florida, 33165
Study Site 532
Morgantown, West Virginia, 26505
Study Site 805
Nashville, Tennessee, 37215
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 533
Rogers, Arkansas, 72758
Study Site 371
Saint Joseph, Missouri, 64506
Study Site 361
San Antonio, Texas, 78213
Study Site 356
San Diego, California, 92108
Study Site 514
Santa Ana, California, 92701
Study Site 388
Skokie, Illinois, 60077
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
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 Prurigo Nodularis
Study of the efficacy, safety, and tolerability of serlopitant for the treatment of pruritus in adults with prurigo nodularis
- Conditions
- Pruritus, Prurigo Nodularis
- Being tested
- 5mg Serlopitant Tablets, Placebo Tablets
- Medical subject headings
- Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5mg Serlopitant TabletsDrug
Also called VPD-737
Serlopitant Tablets
Placebo TabletsDrug
Placebo Tablets
| Study group | Role | What they receive |
|---|---|---|
| 5 mg Serlopitant Tablets | Experimental | Not described Receives: Drug: 5mg Serlopitant Tablets |
| Matching Placebo Tablets | Placebo comparator | Not described Receives: Drug: Placebo Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Subjects With Worst-Itch Numeric Rating Scale 4-point Responder at Week 10
During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments were reported by the subject via eDiary once daily from screening/mid-screening visit through the follow-up visit. The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity and subjects were asked 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. Subjects were considered responders if they had at least a 4-point reduction from baseline in weekly average WI-NRS at Week 10.
Measured: At Week 10
Secondary outcomes (9)
Percent of Subjects With WI-NRS 4-point Responder at Week 4
During the study, WI-NRS assessments were reported by the subject via eDiary once daily from screening/mid-screening visit through the follow-up visit. The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity and subjects were asked 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 Week 4
Percent of Subjects With WI-NRS 4-point Responder at Week 2
During the study, WI-NRS assessments were reported by the subject via eDiary once daily from screening/mid-screening visit through the follow-up visit. The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity and subjects were asked 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 Week 2
Change From Baseline in WI-NRS at Weeks 2, 4, 6, and 10
During the study, WI-NRS assessments were reported by the subject via eDiary once daily from screening/mid-screening visit through the follow-up visit. The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity and subjects were asked 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, and 10
Percent of Subjects With WI-NRS 3-point Responder at Weeks 2, 4, and 10
During the study, WI-NRS assessments were reported by the subject via eDiary once daily from screening/mid-screening visit through the follow-up visit. The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity and subjects were asked 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. For the 3-point responder rate, subjects were considered responders if they had at least a 3-point reduction between baseline and the corresponding week.
Measured: At Weeks 2, 4, and 10
Change From Baseline in Investigator's Global Assessment of Prurigo Nodularis Activity (IGA PN-A) to Weeks 2, 4, and 10
The IGA PN-A is an instrument used to assess the overall activity of PN lesions at a given time point, as determined by the investigator. It consists of a 5-point scale ranging from 0 (clear) to 4 (severe). Higher scores indicate severe prurigo nodularis.
Measured: At Weeks 2, 4, and 10
Change From Baseline in Investigator's Global Assessment of PN Stage (IGA PN-S) to Weeks 2, 4, and 10
The IGA PN-S is an instrument used to assess the overall number and thickness of PN lesions at a given time point, as determined by the investigator. It consists of a 5-point scale ranging from 0 (clear) to 4 (severe). Higher scores indicate severe prurigo nodularis.
Measured: At Weeks 2, 4, and 10
Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 10
Dermatology Life Quality Index (DLQI) is a dermatology specific quality of life (QoL) instrument designed to assess the impact of the skin disease on a subject's QoL over the prior week. It is a ten item questionnaire that assesses overall QoL and six aspects that may affect QoL (symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment). The DLQI questions are rated by the subject as 0 (not at all) to 3 (very much). Scores range from 0 to 30 with higher scores indicating poor QoL.
Measured: At Week 10
Change From Baseline in DLQI Question 1 to Week 10
DLQI is a dermatology specific QoL instrument designed to assess the impact of the skin disease on a subject's QoL over the prior week. It is a ten item questionnaire that assesses overall QoL and six aspects that may affect QoL (symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment) The DLQI question 1 is to measure how itchy, sore, painful or stinging the subject's skin had been. It is rated by the subject as 0 (not at all) to 3 (very much). Scores range from 0 to 30 with higher scores indicating poor QoL.
Measured: At Week 10
Number of Subjects With Treatment-emergent Adverse Events and Serious Adverse Events (SAEs)
Adverse events (AEs) 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: 35 days (+3 days) after Week 10 or Early Treatment Discontinuation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study start2 May 2018
- Primary completion14 Jan 2020
- Study completion14 Feb 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 285 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vyne Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03546816
- Sponsor's protocol ID
- MTI-105
- Status last verified
- May 2021
- First submitted
- 23 May 2018
- Last updated
- 20 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
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 Prurigo Nodularis
- ClinicalTrials.gov ID
- NCT03546816
- Acronym / sponsor ID
- MTI-105
- Conditions
- Pruritus, Prurigo Nodularis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 285 participants (actual)
- Lead sponsor
- Vyne Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 2 May 2018 (actual)
- Primary completion
- 14 Jan 2020 (actual)
- Study completion
- 14 Feb 2020 (actual)
- First posted
- 6 Jun 2018 (actual)
- Results
- Posted 7 Sep 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 efficacy, safety, and tolerability of serlopitant for the treatment of pruritus in adults with prurigo nodularis
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: 5mg Serlopitant Tablets |
| Matching Placebo Tablets | Placebo comparator | Drug: Placebo Tablets |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| 5mg Serlopitant TabletsAlso: VPD-737Serlopitant Tablets | Drug | 5 mg Serlopitant Tablets |
| Placebo TabletsPlacebo Tablets | Drug | Matching Placebo Tablets |
Primary outcome
Percent of Subjects With Worst-Itch Numeric Rating Scale 4-point Responder at Week 10
Time frame: At Week 10
During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments were reported by the subject via eDiary once daily from screening/mid-screening visit through the follow-up visit. The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity and subjects were asked 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. Subjects were considered responders if they had at least a 4-point reduction from baseline in weekly average WI-NRS at Week 10.
9 secondary outcomes
Percent of Subjects With WI-NRS 4-point Responder at Week 4
Time frame: At Week 4
Percent of Subjects With WI-NRS 4-point Responder at Week 2
Time frame: At Week 2
Change From Baseline in WI-NRS at Weeks 2, 4, 6, and 10
Time frame: At Weeks 2, 4, 6, and 10
Percent of Subjects With WI-NRS 3-point Responder at Weeks 2, 4, and 10
Time frame: At Weeks 2, 4, and 10
Change From Baseline in Investigator's Global Assessment of Prurigo Nodularis Activity (IGA PN-A) to Weeks 2, 4, and 10
Time frame: At Weeks 2, 4, and 10
Change From Baseline in Investigator's Global Assessment of PN Stage (IGA PN-S) to Weeks 2, 4, and 10
Time frame: At Weeks 2, 4, and 10
Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 10
Time frame: At Week 10
Change From Baseline in DLQI Question 1 to Week 10
Time frame: At Week 10
Number of Subjects With Treatment-emergent Adverse Events and Serious Adverse Events (SAEs)
Time frame: 35 days (+3 days) after Week 10 or Early Treatment Discontinuation
Results and safety
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.
49 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 5mg Serlopitant Tablets in people with Pruritus and Prurigo Nodularis, run by Vyne Therapeutics Inc. at 49 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?
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 49 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 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 7 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?
Percent of Subjects With Worst-Itch Numeric Rating Scale 4-point Responder at Week 10 (time frame: At Week 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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; AzTrials last refreshed its copy on 8 Nov 2026.