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



Status:Recruiting
Conditions:Allergy, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery, Otolaryngology
Healthy:No
Age Range:18 - Any
Updated:3/27/2019
Start Date:May 2, 2018
End Date:December 2019
Contact:Menlo Study Director
Email:nularis1@menlotx.com
Phone:650-486-1416

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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

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


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.
We found this trial at
41
sites
Cleveland, Ohio 44142
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Ann Arbor, Michigan 48103
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Austin, Texas
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Aventura, Florida 33180
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Bellaire, Texas 77401
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Bexley, Ohio 43209
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Birmingham, Alabama 35211
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Boston, Massachusetts
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Brooklyn, New York 11215
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Bryant, Arkansas 72022
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Buffalo, New York 14215
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Coral Gables, Florida 33134
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Dallas, Texas 75216
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Detroit, Michigan 48202
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Dublin, Ohio 43016
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761 New Jersey 33
East Windsor, New Jersey 08520
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Fremont, California 94538
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Fridley, Minnesota 55432
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Glenn Dale, Maryland 20769
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Henderson, Nevada 89052
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High Point, North Carolina 27262
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Houston, Texas 77004
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Johnston, Rhode Island
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Knoxville, Tennessee 37317
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Louisville, Kentucky 40202
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New Orleans, Louisiana 70112
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New York, New York 10029
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Newnan, Georgia 30263
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North Hollywood, California
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North Miami Beach, Florida 33162
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Omaha, Nebraska 68144
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Orange Park, Florida 32073
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Pflugerville, Texas
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Philadelphia, Pennsylvania 19104
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Pittsburgh, Pennsylvania 15212
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Saint Joseph, Missouri
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San Antonio, Texas
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San Diego, California 92103
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Santa Ana, California 92701
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Tulsa, Oklahoma 74136
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Webster, Texas 77598
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