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Study of the Long Term Safety of Serlopitant for the Treatment of Pruritus (Itch)

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ClinicalTrials.gov Identifier: NCT03540160
Recruitment Status : Recruiting
First Posted : May 30, 2018
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
Menlo Therapeutics Inc.

Brief Summary:
Study of the long term safety of serlopitant for the treatment of pruritus in adults.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Long-Term Safety Study of Serlopitant for the Treatment of Pruritus
Actual Study Start Date : March 15, 2018
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Itching

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




Primary Outcome Measures :
  1. Incidence of treatment-emergent adverse events (TEAEs) and SAEs [ Time Frame: 57 weeks ]
  2. Mean change from baseline in clinical laboratory parameters following study drug exposure [ Time Frame: 57 weeks ]
  3. Mean change from baseline in heart rate (beats per minute) follow study drug exposure [ Time Frame: 57 weeks ]
  4. Mean change from baseline in blood pressure (mmHg) following study drug exposure [ Time Frame: 56 weeks ]
  5. Mean change from baseline in respiration rate (breaths per minute) following study drug exposure [ Time Frame: 57 weeks ]
  6. Mean change from baseline in temperature (°F / °C) following study drug exposure [ Time Frame: 57 weeks ]
  7. Mean change from baseline in PR interval (ms) following study drug exposure [ Time Frame: 57 weeks ]
  8. Mean change from baseline in the QRS interval (ms) following study drug exposure [ Time Frame: 57 weeks ]
  9. Mean change from baseline in the QT (ms) interval following study drug exposure [ Time Frame: 57 weeks ]
  10. Mean change from baseline in the QTcB (ms) interval following study drug exposure [ Time Frame: 57 weeks ]
  11. Mean change from baseline in the QTcF (ms) interval following study drug exposure [ Time Frame: 57 weeks ]
  12. Change from baseline in the Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 57 weeks ]
  13. Change from baseline in the Epworth Sleepiness Scale (ESS) [ Time Frame: 57 weeks ]

Secondary Outcome Measures :
  1. Change in severity of pruritus in subjects with PN, AD, or psoriasis using the worst-itch numeric rating scale (WI-NRS), a subject-reported number from 0-10 with higher numbers indicating worse itch [ Time Frame: 52 weeks ]
  2. Change in severity and extent of PN using the Investigator's Global Assessment of PN Stage (IGA PN-S), for those subjects with PN [ Time Frame: 52 weeks ]
  3. Incidence of prespecified treatment-emergent adverse events that are associated with physical dependency, in the 5-week post-drug discontinuation period. [ Time Frame: 57 weeks ]


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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:

  • Male or female, age 18 years or older at consent.
  • Pruritus associated with prurigo nodularis, atopic dermatitis, or psoriasis.
  • Female subjects of childbearing potential must be willing to practice highly effective contraception until 5 weeks after last dose of study drug.
  • Willing and able to comply with study visits and study related requirements including providing written informed consent.

Exclusion Criteria:

  • Malignancy within 5 years prior to enrollment (exception for non-melanoma cutaneous malignancies).
  • Any known major psychiatric diagnosis, such as major depressive disorder, bipolar disorder, schizophrenia, psychotic disorder, intellectual disability, severe alcohol use disorder, which may confound the assessment of serlopitant safety or efficacy, or interfere with the subject's ability to comply with protocol-mandated activities, within 3 years prior to enrollment.
  • Untreated or inadequately treated thyroid, adrenal, or pituitary nodules or disease, or history of thyroid malignancy; or the prescense of any medical condition or disability, that could interfere with the assessment of safety in this study or compromise the safety of the subject.
  • Investigational therapy within 4 weeks or 5-half-lives prior to enrollment (whichever is longer) or expected participation in another clinical study involving an investigational product or device during the subject's participation in this study.
  • Treatment with other neurokinin-1 receptor (NK1-R) antagonists (e.g., aprepitant, fosaprepitant, rolapitant) within 4 weeks.
  • Treatment with strong cytochrome P450 3A4 inhibitors within 4 weeks.
  • Currently pregnant or breastfeeding or planning to become pregnant during 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): NCT03540160


Contacts
Contact: Menlo Study Director 650-486-1416 nularis3@menlotx.com

  Show 51 Study Locations
Sponsors and Collaborators
Menlo Therapeutics Inc.

Responsible Party: Menlo Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT03540160     History of Changes
Other Study ID Numbers: MTI-107
2017-004211-40 ( EudraCT Number )
First Posted: May 30, 2018    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Psoriasis
Dermatitis
Dermatitis, Atopic
Eczema
Pruritus
Prurigo
Skin Diseases, Papulosquamous
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Skin Manifestations
Signs and Symptoms
Serlopitant
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs