Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03568331 | Evaluating the Effects of Tradipitant vs. Placebo in Atopic Dermatitis (EPIONE) | PHASE3 | COMPLETED | 375 | — | — | Jul 9, 2018 | Dec 27, 2019 | May 13, 2024 | 70 | United States |
| NCT02651714 | Tradipitant in Treatment-resistant Pruritus Associated With Atopic Dermatitis | PHASE2 | COMPLETED | 168 | — | — | Jan 19, 2016 | Aug 4, 2017 | Jun 13, 2024 | 28 | United States |
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 \[0=No Itch, 10=Worst Itch Imaginable\].
Responses were measured on a 100-mm Visual Analogue Scale (VAS), where the left endpoint was marked "no itch" (0 mm) and in the right endpoint was marked "worst imaginable itch" (100 mm).
| Arm | Type | Description |
|---|---|---|
| Tradipitant | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Tradipitant | DRUG | Oral Capsule |
| Placebo | DRUG | Oral Capsule |
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 ...