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

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ClinicalTrials.gov Identifier: NCT03677401
Recruitment Status : Completed
First Posted : September 19, 2018
Results First Posted : October 28, 2020
Last Update Posted : May 20, 2021
Sponsor:
Information provided by (Responsible Party):
Vyne Therapeutics Inc.

Brief Summary:
Study of the efficacy, safety, and tolerability of serlopitant for the treatment of pruritus in adults with prurigo nodularis

Condition or disease Intervention/treatment Phase
Pruritus Prurigo Nodularis Drug: 5mg Serlopitant Tablets Drug: Placebo Tablets Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 295 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : August 29, 2018
Actual Primary Completion Date : January 9, 2020
Actual Study Completion Date : February 6, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Itching

Arm Intervention/treatment
Experimental: 5 mg Serlopitant Tablets Drug: 5mg Serlopitant Tablets
Serlopitant Tablets
Other Name: VPD-737

Placebo Comparator: Matching Placebo Tablets Drug: Placebo Tablets
Placebo Tablets




Primary Outcome Measures :
  1. Percent of Participants With Worst Itch Numeric Rating Scale (WI-NRS) 4-point Responder Rate at Week 10 [ Time Frame: 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).


Secondary Outcome Measures :
  1. Percent of Participants With WI-NRS 4-point Responder Rate at Week 4 [ Time Frame: 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).

  2. Percent of Participants With WI-NRS 4-point Responder Rate at Week 2 [ Time Frame: 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).

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

  4. Percent of Participants With WI-NRS 3-point Responder at Weeks 2, 4, and 10 [ Time Frame: 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).

  5. Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 10 [ Time Frame: At 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.).

  6. Change From Baseline in DLQI Question 1 to Week 10 [ Time Frame: At 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.).

  7. Change From Baseline in Investigator's Global Assessment of Prurigo Nodularis Stage (IGA PN-S) to Weeks 2, 4, and 10 [ Time Frame: At 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.

  8. 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 ]
    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.

  9. Number of Participants With Treatment-emergent Adverse Events 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 participants who discontinued study drug early ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03677401


Locations
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Sponsors and Collaborators
Vyne Therapeutics Inc.
Investigators
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Principal Investigator: Sonja Stander, MD Universitätsklinikum Münster Klinik für Hautkrankheiten Zentrale Studienkoordination für innovative Dermaologie (ZID)
Principal Investigator: Jacek Szepietowski, MD, Ph.D Lukasz Matusiak 4HEALTH
Principal Investigator: Franz Josef Legat, MD Medizinische Universität Graz
  Study Documents (Full-Text)

Documents provided by Vyne Therapeutics Inc.:
Study Protocol  [PDF] December 16, 2019
Statistical Analysis Plan  [PDF] December 16, 2019

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Responsible Party: Vyne Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT03677401    
Other Study ID Numbers: MTI-106
2017-004210-25 ( EudraCT Number )
First Posted: September 19, 2018    Key Record Dates
Results First Posted: October 28, 2020
Last Update Posted: May 20, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pruritus
Prurigo
Neurodermatitis
Skin Diseases
Skin Manifestations
Dermatitis
Skin Diseases, Eczematous
Serlopitant
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs