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

Use our guide to learn which trials are right for you!

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
Fremont, California 94538
?
mi
from
Fremont, CA
Click here to add this to my saved trials
Ann Arbor, Michigan 48103
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Austin, Texas
?
mi
from
Austin, TX
Click here to add this to my saved trials
Aventura, Florida 33180
?
mi
from
Aventura, FL
Click here to add this to my saved trials
Bellaire, Texas 77401
?
mi
from
Bellaire, TX
Click here to add this to my saved trials
Bexley, Ohio 43209
?
mi
from
Bexley, OH
Click here to add this to my saved trials
Birmingham, Alabama 35211
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Boston, Massachusetts
?
mi
from
Boston, MA
Click here to add this to my saved trials
Brooklyn, New York 11215
?
mi
from
Brooklyn, NY
Click here to add this to my saved trials
Bryant, Arkansas 72022
?
mi
from
Bryant, AR
Click here to add this to my saved trials
Buffalo, New York 14215
?
mi
from
Buffalo, NY
Click here to add this to my saved trials
Cleveland, Ohio 44142
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Coral Gables, Florida 33134
?
mi
from
Coral Gables, FL
Click here to add this to my saved trials
Dallas, Texas 75216
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Detroit, Michigan 48202
?
mi
from
Detroit, MI
Click here to add this to my saved trials
Dublin, Ohio 43016
?
mi
from
Dublin, OH
Click here to add this to my saved trials
761 New Jersey 33
East Windsor, New Jersey 08520
?
mi
from
East Windsor, NJ
Click here to add this to my saved trials
Fridley, Minnesota 55432
?
mi
from
Fridley, MN
Click here to add this to my saved trials
Glenn Dale, Maryland 20769
?
mi
from
Glenn Dale, MD
Click here to add this to my saved trials
Henderson, Nevada 89052
?
mi
from
Henderson, NV
Click here to add this to my saved trials
High Point, North Carolina 27262
?
mi
from
High Point, NC
Click here to add this to my saved trials
Houston, Texas 77004
?
mi
from
Houston, TX
Click here to add this to my saved trials
Johnston, Rhode Island
?
mi
from
Johnston, RI
Click here to add this to my saved trials
Knoxville, Tennessee 37317
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
Louisville, Kentucky 40202
?
mi
from
Louisville, KY
Click here to add this to my saved trials
New Orleans, Louisiana 70112
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
New York, New York 10029
?
mi
from
New York, NY
Click here to add this to my saved trials
Newnan, Georgia 30263
?
mi
from
Newnan, GA
Click here to add this to my saved trials
North Hollywood, California
?
mi
from
North Hollywood, CA
Click here to add this to my saved trials
North Miami Beach, Florida 33162
?
mi
from
North Miami Beach, FL
Click here to add this to my saved trials
Omaha, Nebraska 68144
?
mi
from
Omaha, NE
Click here to add this to my saved trials
Orange Park, Florida 32073
?
mi
from
Orange Park, FL
Click here to add this to my saved trials
Pflugerville, Texas
?
mi
from
Pflugerville, TX
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19104
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15212
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Saint Joseph, Missouri
?
mi
from
Saint Joseph, MO
Click here to add this to my saved trials
San Antonio, Texas
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Diego, California 92103
?
mi
from
San Diego, CA
Click here to add this to my saved trials
Santa Ana, California 92701
?
mi
from
Santa Ana, CA
Click here to add this to my saved trials
Tulsa, Oklahoma 74136
?
mi
from
Tulsa, OK
Click here to add this to my saved trials
Webster, Texas 77598
?
mi
from
Webster, TX
Click here to add this to my saved trials