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
(m)]2);

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
visit;

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
duress;

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.