Tradipitant in Treatment-Resistant Pruritus Associated With Atopic Dermatitis

Status:Not yet recruiting
Conditions:Psoriasis, Dermatology, Dermatology, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Age Range:18 - 65
Start Date:February 2016
Contact:Krista Bohnert
Phone:212 772 7242

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A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety And
Efficacy of Tradipitant in Treatment-Resistant Pruritus Associated With Atopic Dermatitis

Inclusion Criteria:

1. Male and non-pregnant, non-lactating female subjects aged 18-65 (inclusive);

2. Diagnosed with atopic dermatitis

1. with a SCORAD index at inclusion ≤80 at the screening and baseline visits;

2. With atopic lesion(s) present at the screening and baseline visits;

3. Suffering from chronic pruritus with pruritus being actively present for at least 6
weeks prior to screening despite the use of antihistamines or corticosteroids;

4. Average pruritus intensity (VAS) ≥70 mm (during one of the three days preceding the
screening and baseline visits);

5. Patient assessment of pruritus (VRS (1-5) item "pruritus") ≥3 at screening and
baseline visits;

6. Subjects with Body Mass Index (BMI) of ≥18 and ≤35 kg/m2 (BMI = weight (kg)/ [height

7. Subjects must agree to the following study restrictions:

1. Males of procreative capacity (not surgically sterile via vasectomy) will use an
acceptable method of contraception from randomization through 1 month following
the last dose of study medication. Examples of acceptable contraception for
males include abstinence, use of a barrier method, or surgically-sterilized or
post-menopausal partner;

2. Females of child-bearing potential (not surgically sterile or post-menopausal,
defined as 12 months without menses) will use an acceptable method of
contraception from the earlier of screening or 1 month prior to randomization
through 1 month after the last dose of study medication. Examples of acceptable
methods of contraception for females include abstinence, the use of 2
independent barrier methods, or hormonal contraception plus 1 barrier method, or
surgically sterilized partner;

8. Ability to provide written informed consent;

9. Willing and able to comply with all study requirements and restrictions;

10. Willing to not participate in any other interventional trial for the duration of
their participation;

11. Subjects must be in good health as determined by past medical history, physical
examination, electrocardiogram, clinical laboratory tests and vital signs.

Exclusion Criteria:

1. Chronic pruritus due to condition other than atopic dermatitis (AD)

2. Superinfection of AD;

3. Unwilling or unable to follow medication restrictions described in Section 7.2, or
unwilling or unable to sufficiently washout from use of restricted medication.

4. Under medical treatment for a skin disease with a therapy listed in the prohibited
medications section that may influence the results of the study;

5. Recent history (within six months of screening) of Alcohol Use Disorder or Substance
Use Disorder as defined in DSM-5 or a positive drug or alcohol screen at the
Screening visit;

6. Subject has ever made a suicide attempt and/or had suicidal ideation of type 4 or 5
on the Columbia Suicide Severity Rating Scale (C-SSRS) or subject is at risk of
suicide at Screening or Baseline, in the opinion of the investigator;

7. Any medical procedure requiring general anesthetic within three months of the
Baseline Visit or any procedure requiring sedation within one month of the baseline

8. Current clinically significant cardiovascular, respiratory, neurologic, hepatic,
hematopoietic, renal, gastrointestinal or metabolic dysfunction unless currently
controlled and stable, including (but not limited to) the following:

1. Uncontrolled diabetes mellitus defined as HbA1c >7%;

2. Positive hepatitis C antibody test (anti-HCF);

3. Positive hepatitis B surface antigen (HBsAg);

9. History (including family history) or current evidence of congenital long QT syndrome
or known acquired QT interval prolongation;

10. Exposure to any investigational medication, including placebo, within 60 days of the
Baseline Visit;

11. History of intolerance and/or hypersensitivity to medications similar to tradipitant
and its accompanying excipients;

12. Participation in a previous tradipitant (LY686017 or VLY-686) trial;

13. Indication of impaired liver function (values for AST, ALT, or bilirubin > 1.5 times
the Upper Limit of Normal);

14. Has a creatinine level > 1.25x ULN;

15. Anyone affiliated with the site or sponsor and/or anyone who may consent under

16. Any other sound medical reason as determined by the clinical Investigator including
any condition which may lead to an unfavorable risk-benefit of study participation,
may interfere with study compliance or may confound study results.
We found this trial at
911 Park Avenue
New York, New York 10075
New York, NY
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