Evaluating the Effects of Tradipitant vs. Placebo in Atopic Dermatitis (EPIONE)

• Tradipitant (Drug): Oral Capsule
• Placebo (Drug): Oral Capsule

Primary outcomes

• Reduction of Worst Itch in Atopic Dermatitis [8 weeks]: Reduction of worst itch in atopic dermatitis as measured by Numerical Rating Scale (NRS). Worst Itch NRS is an assessment tool that is used to report the maximum intensity of participant's itch during a 24-hour recall period. Participants were asked the following question: Please rate the itching severity that describes your worst level of itching in the past 24 hours \[0=No Itch, 10=Worst Itch Imaginable\].

Secondary outcomes

• Improvement of Disease Severity in Atopic Dermatitis [8 weeks]: Proportion of participants achieving 50% reduction on the SCORing Atopic Dermatitis (SCORAD) index. SCORAD is an assessment scale used to determine the severity of AD. SCORAD combines the investigator's rating of extent and intensity and the patient reported itch and sleep disturbance. Total score ranges from 0 (absent disease) to 103 (severe disease).
• Proportion of Patients With Improvement on Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of at Least 2-point Reduction [8 weeks]: As measured by the validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD). IGA is an assessment scale used to determine severity of AD. It is assessed by the investigator on a 5-point scale (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe) based on erythema, induration/papulation, lichenification, and oozing/crusting.

Sex: All, ages: 18 Years to 70 Years

Inclusion Criteria:

* Male and non-pregnant, non-lactating female patients aged 18 - 70 years (inclusive);
* Diagnosed with atopic dermatitis;
* Suffering from chronic pruritus;
* Body Mass Index (BMI) of ≥18 and ≤40 kg/m2

Exclusion Criteria:

* Chronic pruritus due to condition other than atopic dermatitis (AD);
* A positive test for drugs of abuse at the screening or evaluation visits;
* Exposure to any investigational medication in the past 8 weeks

Participant flow

Outcome results

• Reduction of Worst Itch in Atopic Dermatitis (Primary), Mean, units on a scale: Tradipitant -3.6 +/- 2.8; Placebo -3.5 +/- 2.75
• Improvement of Disease Severity in Atopic Dermatitis (Secondary), Count of participants, Participants: Tradipitant 51; Placebo 54
• Proportion of Patients With Improvement on Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of at Least 2-point Reduction (Secondary), Count of participants, Participants: Tradipitant 37; Placebo 36
• Reduction of Worst Itch in Atopic Dermatitis as Measured by Numerical Rating Scale (NRS), Adjusted for Investigator Global Assessment (IGA) (Post hoc), Mean, units on a scale: Tradipitant -2.6 (-3.2 to -2.0); Placebo -1.0 (-1.6 to -0.4)
• Reduction in Sleep Disturbances as Measured by SCORing Atopic Dermatitis Index, Adjusted for Investigator Global Assessment (Post hoc), Mean, units on a scale: Tradipitant -2.07 (-2.61 to -1.53); Placebo -0.7 (-1.24 to -0.15)

Adverse events

Time frame: All Adverse Events (AEs) were collected from signature of the informed consent up to the final visit (Week 8) regardless of seriousness or relationship to investigational product. Patients with non-serious AEs that are ongoing at the patient's last study visit must be followed until resolution or for 30 days after the patient's last study visit, whichever comes first.

Serious adverse events by term

Other adverse events by term

• Study Protocol (PDF, 2019-08-12)
• Statistical Analysis Plan (PDF, 2019-08-12)