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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03677401
Other study ID # MTI-106
Secondary ID 2017-004210-25
Status Completed
Phase Phase 3
First received
Last updated
Start date August 29, 2018
Est. completion date February 6, 2020

Study information

Verified date May 2021
Source Vyne Therapeutics Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 295
Est. completion date February 6, 2020
Est. primary completion date January 9, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
5mg Serlopitant Tablets
Serlopitant Tablets
Placebo Tablets
Placebo Tablets

Locations

Country Name City State
Austria Study Site 649 Graz
Austria Study Site 648 Linz
Austria Study Site 650 Vienna
Germany Study Site 623 Bad Bentheim
Germany Study Site 607 Berlin
Germany Study Site 641 Berlin
Germany Study Site 600 Bielefeld
Germany Study Site 617 Bochum
Germany Study Site 608 Bonn
Germany Study Site 642 Buxtehude
Germany Study Site 606 Dresden
Germany Study Site 621 Erlangen
Germany Study Site 602 Frankfurt am main
Germany Study Site 639 Hamburg
Germany Study Site 605 Heidelberg
Germany Study Site 611 Leipzig
Germany Study Site 620 Mahlow
Germany Study Site 614 Mainz
Germany Study Site 601 Münster
Germany Study Site 618 Osnabrück
Germany Study Site 640 Potsdam
Germany Study Site 615 Selters
Germany Study Site 643 Stuttgart
Poland Study Site 636 Bydgoszcz
Poland Study Site 628 Iwonicz-Zdrój
Poland Study Site 624 Kraków
Poland Study Site 633 Kraków
Poland Study Site 635 Kraków
Poland Study Site 629 Lódz
Poland Study Site 631 Olsztyn
Poland Study Site 625 Osielsko
Poland Study Site 644 Poznan
Poland Study Site 645 Poznan
Poland Study Site 634 Rzeszów
Poland Study Site 638 Szczecin
Poland Study Site 632 Torun
Poland Study Site 627 Warszawa
Poland Study Site 630 Wroclaw
Poland Study Site 637 Wroclaw
Poland Study Site 647 Wroclaw

Sponsors (1)

Lead Sponsor Collaborator
Vyne Therapeutics Inc.

Countries where clinical trial is conducted

Austria,  Germany,  Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). At Week 10
Secondary 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). At Week 4
Secondary 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). At Week 2
Secondary 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. At Weeks 2, 4, 6, and 10
Secondary 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). At Weeks 2, 4, and 10
Secondary 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.). At Week 10
Secondary 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.). At Week 10
Secondary 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. At Weeks 2, 4 and 10
Secondary 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. At Weeks 2, 4, and 10
Secondary 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. 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
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