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PruritusPhase 3NCT03677401

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 40 sites in 3 countries.

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

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
295 participants
Where
40 sitesin 3 countries
Study dates
29 Aug 2018to 6 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:

  1. Male or female, age 18 years or older at consent.
  2. Prurigo nodularis (PN), with at least ten nodules on at least two different body surface areas.
  3. 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.
  4. 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.
  5. Female subjects of childbearing potential must be willing to practice highly effective contraception until 5 weeks after last dose of study drug.
  6. Willing and able to complete daily eDiary entries within a consistent timeframe for the duration of the study.
  7. 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):

  1. Prior treatment with serlopitant.
  2. 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).
  3. Treatment with any of the following therapies within 4 weeks.
  4. Other neurokinin-1 receptor antagonists (e.g., aprepitant, fosaprepitant, rolapitant).
  5. Systemic or topical immunosuppressive/immunomodulatory therapies.
  6. Systemic therapies with recognized anti-pruritic properties.
  7. Strong cytochrome-P 3A4 inhibitors.
  8. Use of an indoor tanning facility, or natural sun exposure resulting in significant tanning or sunburn.
  9. Treatment with topical anti-pruritic therapies within 2 weeks.
  10. Treatment with biologic therapies within 8 weeks or 5 half-lives, whichever is longer.
  11. Treatment with any investigational therapy within 4 weeks (8 weeks for investigational biologic therapies) or 5 half-lives, whichever is longer.
  12. Serum creatinine, total bilirubin, alanine aminotransferase or aspartate aminotransferase > 2.5 times the upper limit of normal during screening.
  13. Untreated or inadequately treated thyroid adrenal, or pituitary nodules or disease, or history of thyroid malignancy.
  14. Malignancy within 5 years prior to enrollment (exception for non-melanoma cutaneous malignancies).
  15. 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.
  16. Documented history of parasitic infection, including skin parasites such as scabies, within 8 weeks.
  17. 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.
  18. History of hypersensitivity to serlopitant or any of its components.
  19. Currently pregnant or breastfeeding or planning to become pregnant during the study.
  20. 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

40 sites in 3 countries.

40 sites in 3 countries

Germany20 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 640

    Potsdam, 14467

  • 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: 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

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 groups in NCT03677401
Study groupRoleWhat they receive
5 mg Serlopitant TabletsExperimentalNot described
Receives: Drug: 5mg Serlopitant Tablets
Matching Placebo TabletsPlacebo comparatorNot described
Receives: Drug: Placebo Tablets

What is being measured

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

  1. Percent of Participants With Worst Itch Numeric Rating Scale (WI-NRS) 4-point Responder Rate at Week 10

    During the study, WI-NRS assessments were reported by the participant 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 participants 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. A participant was a 4-point responder if their change from baseline is ≤ -4 (i.e. a decrease of at least 4).

    Measured: At Week 10

Secondary outcomes (9)

  1. Percent of Participants With WI-NRS 4-point Responder Rate at Week 4

    During the study, WI-NRS assessments were reported by the participant 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 participants 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. A participant was a 4-point responder if their change from baseline is ≤ -4 (i.e. a decrease of at least 4).

    Measured: At Week 4

  2. Percent of Participants With WI-NRS 4-point Responder Rate at Week 2

    During the study, WI-NRS assessments were reported by the participant 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 participants 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. A participant was a 4-point responder if their change from baseline is ≤ -4 (i.e. a decrease of at least 4).

    Measured: At Week 2

  3. Change From Baseline in WI-NRS at Weeks 2, 4, 6, and 10

    During the study, WI-NRS assessments were reported by the participant 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 participants 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

  4. Percent of Participants With WI-NRS 3-point Responder at Weeks 2, 4, and 10

    During the study, WI-NRS assessments were reported by the participant 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 participants 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. A participant was a 3-point responder if their change from baseline is ≤ -3 (i.e. a decrease of at least 3).

    Measured: At Weeks 2, 4, and 10

  5. 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 participant'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 participant 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

  6. Change From Baseline in DLQI Question 1 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 participant'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 participant 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

  7. Change From Baseline in Investigator's Global Assessment of Prurigo Nodularis 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

  8. 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

  9. Number of Participants 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: 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 participants 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.

  1. First posted19 Sep 2018
  2. Study start29 Aug 2018
  3. Primary completion9 Jan 2020
  4. Study completion6 Feb 2020

Resources

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
295 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03677401
Sponsor's protocol ID
MTI-106
Other IDs
2017-004210-25, 2017
Status last verified
May 2021
First submitted
17 Sep 2018
Last updated
20 May 2021
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

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 40 sites in 3 countries.

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 40 sites in 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. 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 28 Oct 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 Participants With Worst Itch Numeric Rating Scale (WI-NRS) 4-point Responder Rate 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?

On the ClinicalTrials.gov record for NCT03677401.

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.

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