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Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Chronic Pruritus of Unknown Origin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03841331
Recruitment Status : Completed
First Posted : February 15, 2019
Results First Posted : September 23, 2020
Last Update Posted : September 23, 2020
Sponsor:
Information provided by (Responsible Party):
Menlo Therapeutics Inc.

Brief Summary:
A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Chronic Pruritus of Unknown Origin

Condition or disease Intervention/treatment Phase
Pruritus Drug: 5 mg Serlopitant Tablets Drug: Matching Placebo Tablets Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 233 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 Chronic Pruritus of Unknown Origin
Actual Study Start Date : January 22, 2019
Actual Primary Completion Date : December 10, 2019
Actual Study Completion Date : January 21, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Itching

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

Placebo Comparator: 5 mg Placebo Tablets
Placebo Tablets
Drug: Matching Placebo Tablets
Placebo Tablets




Primary Outcome Measures :
  1. Worst Itch Numeric Rating Scale 4-point Responder Rate at Week 10 [ Time Frame: At Week 10 ]

    During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments was reported by the subject via eDiary. The daily NRS results were summarized. The daily results were averaged to create weekly measures.

    The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects 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 subject was a 4-point responder if their change from baseline is ≤ -4 (i.e. a decrease of at least 4).


  2. WI-NRS 4-point Responder Rate at Weeks 2 4, 6, and 8 [ Time Frame: At Weeks 2, 4, 6, and 8 ]

    During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments was reported by the subject via eDiary. The daily NRS results were summarized. The daily results were averaged to create weekly measures.

    The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects 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 subject was a 4-point responder if their change from baseline is ≤ -4 (i.e. a decrease of at least 4).


  3. WI-NRS 3-point Responder Rate at Weeks 2, 4, 6, 8, and 10 [ Time Frame: At Weeks 2, 4, 6, 8, and 10 ]

    During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments was reported by the subject via eDiary. The daily NRS results were summarized. The daily results were averaged to create weekly measures.

    The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects 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 subject was a 3-point responder if their change from baseline is ≤ -3 (i.e. a decrease of at least 3). Results presented below is of subjects who were a 3-point responder but not a 4-point responder.


  4. Change From Baseline in WI-NRS at Weeks 2, 4, 6, 8, and 10 [ Time Frame: At Weeks 2, 4, 6, 8, and 10 ]

    During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments was reported by the subject via eDiary. The daily NRS results were summarized. The daily results were averaged to create weekly measures.

    The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects 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.


  5. Change From Baseline in Daily WI-NRS Scores Through Week 2 [ Time Frame: Through 2 weeks ]

    During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments was reported by the subject via eDiary. The daily NRS results were summarized. The daily results were averaged to create weekly measures.

    The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects 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.


  6. Change From Baseline in Worst-Itch Visual Analog Scale at Weeks 2, 4, 6, and 10 [ Time Frame: At Weeks 2, 4, 6, and 10 ]
    The Itch Visual Analog Scale (VAS) is a validated, self-reported instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects to rate the worst intensity of their itch on a 100-mm horizontal line ranging from 0 mm (no itch) to 100 mm (worst itch imaginable). Higher scores indicated greater itch intensity. The VAS measurement were summarized in centimeters. WI-VAS assessments were reported by the subject via a paper form administered at study visits.


Secondary Outcome Measures :
  1. Number of Subjects With Treatment Emergent Adverse Events (TEAEs) 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 subjects who discontinued study drug early. ]
    Adverse events (AEs) were recorded to assess the safety and tolerability of repeated oral doses of serlopitant in adult subjects with chronic pruritus of unknown origin. Adverse events (AEs) and SAEs were recorded from the first study drug administration through the follow-up visit. After informed consent was signed, but prior to initiation of study drug, only SAEs considered by the investigator to be caused by a protocol-mandated intervention were collected.

  2. Plasma Concentrations of Serlopitant and Metabolites [ Time Frame: At Week 10 ]
    The plasma concentrations of serlopitant and metabolites were combined with the data from other serlopitant clinical studies for population pharmacokinetic analysis.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion:

  • Male or female, age 18 years or older at consent.
  • The subject must have ongoing chronic pruritus
  • The subject's pruritus is assessed by the investigator to be of unknown origin at baseline.
  • 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.
  • The pruritus must have been unresponsive to prior treatment with emollients.
  • The subject's pruritus must be present on multiple segments of the body
  • Willing and able to complete daily eDiary entries within a consistent timeframe for the duration of the study
  • All females who are of childbearing potential must be willing to practice highly effective contraception and not be pregnant or nursing
  • Willing to comply with study visits and study related requirements including providing written informed consent.
  • Adequate cognitive and physical ability, in the investigator's opinion, to comply with study visits and study related requirements including providing written informed consent

Exclusion

  • Prior treatment with any NK1-receptor antagonists
  • Known dermatologic or systemic condition(s), other than dry skin, that is considered by the investigator to be the primary cause of current pruritus.
  • Untreated or inadequately treated thyroid, adrenal, or pituitary disease or nodules, or history of thyroid malignancy.
  • Use of an excluded therapy within 3 weeks prior to randomization
  • Treatment with any investigational therapy within 3 weeks prior to randomization.
  • Serum creatinine, total bilirubin, alanine aminotransferase or aspartate aminotransferase > 2.5 times the upper limit of normal during screening.
  • History of malignancy within 3 years prior to randomization, with the (actinic keratosis, non-metastatic cutaneous squamous cell carcinoma, basal cell carcinoma of skin).
  • Any known major psychiatric diagnosis that would impact the subject's ability to complete the study
  • Suicidal ideation within 3 years prior to randomization, or any history of suicide attempt.
  • Known use of recreational drugs.
  • Documented history of parasitic infection, including skin parasites such as scabies, within 12 weeks prior to randomization.
  • Presence of clinically significant dementia, intellectual impairment, or any medical condition or disability that, in the investigator's opinion, could interfere with the assessment of safety or efficacy in this trial or compromise the safety of the subject.
  • History of hypersensitivity to serlopitant or any of its components.
  • Planned or anticipated major surgical procedure or other activity that would interfere with the subject's ability to comply with protocol-mandated assessments (e.g. extended international travel) during the subject's 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): NCT03841331


Locations
Show Show 41 study locations
Sponsors and Collaborators
Menlo Therapeutics Inc.
  Study Documents (Full-Text)

Documents provided by Menlo Therapeutics Inc.:
Study Protocol  [PDF] February 11, 2019
Statistical Analysis Plan  [PDF] January 30, 2020

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Responsible Party: Menlo Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT03841331    
Other Study ID Numbers: MTI-117
First Posted: February 15, 2019    Key Record Dates
Results First Posted: September 23, 2020
Last Update Posted: September 23, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Menlo Therapeutics Inc.:
Pruritus
Additional relevant MeSH terms:
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Pruritus
Skin Diseases
Skin Manifestations
Serlopitant
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs