Atopic Dermatitis
Conditions
Keywords
Chronic Pruritus, Eczema
Brief summary
This is a multicenter, randomized, double-blind, placebo-controlled study to be conducted in the United States in subjects with atopic dermatitis.
Interventions
DRUGTradipitant
BID
DRUGPlacebo
BID
Sponsors
Vanda Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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 60 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Worst Itch Numeric Rating Scale (WI-NRS) Responder Rate at Week 2 | 2 weeks | The WI-NRS responder is defined as a patient achieving at least 4 points reduction from baseline in weekly average of diary WI-NRS. Responses were measured on a scale of 0 - 10, with 0 being no itch and 10 being the worst itch imaginable. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tradipitant Oral Capsule
Tradipitant: BID | 43 |
| Placebo Oral Capsule
Placebo: BID | 44 |
| Total | 87 |
Baseline characteristics
| Characteristic | Placebo | Total | Tradipitant |
|---|---|---|---|
| Age, Continuous | 39.2 years STANDARD_DEVIATION 15.1 | 40.4 years STANDARD_DEVIATION 14.84 | 41.7 years STANDARD_DEVIATION 14.63 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 15 Participants | 27 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 28 Participants | 58 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 3 Participants | 5 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants | 8 Participants | 5 Participants |
| Race/Ethnicity, Customized Black or African American | 10 Participants | 22 Participants | 12 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 28 Participants | 50 Participants | 22 Participants |
| Region of Enrollment United States | 44 Participants | 87 Participants | 43 Participants |
| Sex: Female, Male Female | 26 Participants | 51 Participants | 25 Participants |
| Sex: Female, Male Male | 18 Participants | 36 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 43 | 0 / 44 |
| other Total, other adverse events | 13 / 43 | 10 / 44 |
| serious Total, serious adverse events | 1 / 43 | 1 / 44 |
Outcome results
Primary
Worst Itch Numeric Rating Scale (WI-NRS) Responder Rate at Week 2
The WI-NRS responder is defined as a patient achieving at least 4 points reduction from baseline in weekly average of diary WI-NRS. Responses were measured on a scale of 0 - 10, with 0 being no itch and 10 being the worst itch imaginable.
Time frame: 2 weeks
Population: All participants randomized (1:1) to placebo or tradipitant.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tradipitant | Worst Itch Numeric Rating Scale (WI-NRS) Responder Rate at Week 2 | 2 Participants |
| Placebo | Worst Itch Numeric Rating Scale (WI-NRS) Responder Rate at Week 2 | 4 Participants |