Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03546816
Other study ID # MTI-105
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date May 2, 2018
Est. completion date February 14, 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 285
Est. completion date February 14, 2020
Est. primary completion date January 14, 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
United States Study Site 506 Ann Arbor Michigan
United States Study Site 365 Austin Texas
United States Study Site 501 Aventura Florida
United States Study Site 520 Bellaire Texas
United States Study Site 516 Bexley Ohio
United States Study Site 504 Birmingham Alabama
United States Study Site 379 Boston Massachusetts
United States Study Site 507 Brooklyn New York
United States Study Site 508 Buffalo New York
United States Study Site 509 Cleveland Ohio
United States Study Site 210 Coral Gables Florida
United States Study Site 502 Dallas Texas
United States Study Site 515 Detroit Michigan
United States Study Site 524 Dublin Ohio
United States Study Site 201 East Windsor New Jersey
United States Study Site 534 Fort Lauderdale Florida
United States Study Site 204 Fremont California
United States Study Site 525 Glenn Dale Maryland
United States Study Site 526 Henderson Nevada
United States Study Site 341 High Point North Carolina
United States Study Site 224 Houston Texas
United States Study Site 345 Johnston Rhode Island
United States Study Site 511 Knoxville Tennessee
United States Study Site 228 Louisville Kentucky
United States Study Site 530 Miami Florida
United States Study Site 531 Miami Florida
United States Study Site 532 Morgantown West Virginia
United States Study Site 805 Nashville Tennessee
United States Study Site 527 New Orleans Louisiana
United States Study Site 500 New York New York
United States Study Site 517 New York New York
United States Study Site 510 Newnan Georgia
United States Study Site 383 North Hollywood California
United States Study Site 222 North Miami Beach Florida
United States Study Site 227 Omaha Nebraska
United States Study Site 359 Pflugerville Texas
United States Study Site 523 Philadelphia Pennsylvania
United States Study Site 522 Pittsburgh Pennsylvania
United States Study Site 533 Rogers Arkansas
United States Study Site 371 Saint Joseph Missouri
United States Study Site 528 Saint Louis Missouri
United States Study Site 361 San Antonio Texas
United States Study Site 356 San Diego California
United States Study Site 514 Santa Ana California
United States Study Site 388 Skokie Illinois
United States Study Site 806 Spokane Washington
United States Study Site 112 Tulsa Oklahoma
United States Study Site 529 Verona New Jersey
United States Study Site 226 Webster Texas

Sponsors (1)

Lead Sponsor Collaborator
Vyne Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. At Week 10
Secondary 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. At Week 4
Secondary 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. 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 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. At Weeks 2, 4, 6, and 10
Secondary 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. 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 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. 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 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. At Week 10
Secondary 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. At Week 10
Secondary 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. 35 days (+3 days) after Week 10 or Early Treatment Discontinuation
See also
  Status Clinical Trial Phase
Completed NCT05038982 - Efficacy of Abrocitinib for Reducing Pruritus in Adults With Prurigo Nodularis and Chronic Pruritus of Unknown Origin Phase 2
Completed NCT04510090 - Evaluate the Safety, Tolerability, and PK of EP547 in Healthy Subjects and Subjects With Cholestatic or Uremic Pruritus Phase 1
Completed NCT02143973 - Open Label Extension Study of Nalbuphine HCl ER in Hemodialysis Patients With Uremic Pruritus Phase 2/Phase 3
Terminated NCT01825655 - Study of Using Long Acting Antihistamine to Treat Opioid Induced Itching Phase 4
Completed NCT01236859 - Gabapentin for Prophylaxis Intrathecal Morphine-Induced Pruritus N/A
Completed NCT00782054 - Evaluation of Post Burn Rehabilitation Population for Itch Control Phase 4
Completed NCT04999787 - A Clinical Trial Evaluating the Efficacy, Safety, and Pharmacokinetics of HSK21542 Injection in Liver Disease Subjects With Pruritus Phase 2
Recruiting NCT04256759 - Dupilumab for the Treatment of Moderate to Severe Chronic Hepatic Pruritus Phase 2
Completed NCT04337073 - The Effect of Propofol on Dexamethasone-induced Perineal Pruritus Early Phase 1
Completed NCT04415034 - Scalp Pruritus Measurement Using Visual Analog Scale and 5-d Itch Scale in Children With Pediculosis Capitis
Active, not recruiting NCT05525520 - Study to Evaluate EP547 in Subjects With Cholestatic Pruritus Due to Primary Biliary Cholangitis or Primary Sclerosing Cholangitis Phase 2
Recruiting NCT03340155 - Mechanisms of Action of Photo(Chemo)Therapy in Skin Diseases N/A
Completed NCT04399525 - Influence of H1-antihistamines on the Dermal Blood Flow Response to Histamine, Cinnamaldehyde and Capsaicin. N/A
Recruiting NCT02432508 - Efficacy of Laser Acupuncture on Pruritus in Patients With Chronic Kidney Disease Undergoing Hemodialysis N/A
Completed NCT02653703 - L-menthol as a Topical Counter-irritant to TRPA1-induced Neurogenic Inflammation and Pain N/A
Completed NCT01963793 - Topical Aprepitant in Prurigo Patients Phase 2
Completed NCT01232985 - Efficacy and Tolerability Study of Device, RD047-26 for the Treatment of Mild to Moderate Atopic Dermatitis in Adults Phase 2
Not yet recruiting NCT00577967 - Gabapentin - A Solution to Uremic Pruritus? N/A
Recruiting NCT06120907 - Swiss Itch Registry
Recruiting NCT04589429 - Adding Nalbuphine for Control of Intrathecal Morphine Pruritus Phase 2