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
Oral Capsule
DRUGPlacebo
Oral Capsule
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 8 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tradipitant Tradipitant: Oral Capsule | 188 |
| Placebo Placebo: Oral Capsule | 187 |
| Total | 375 |
Baseline characteristics
| Characteristic | Placebo | Total | Tradipitant |
|---|---|---|---|
| Age, Continuous | 41.9 years STANDARD_DEVIATION 15.1 | 41.8 years STANDARD_DEVIATION 15 | 41.7 years STANDARD_DEVIATION 14.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 46 Participants | 88 Participants | 42 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 140 Participants | 284 Participants | 144 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 2 Participants |
| Race/Ethnicity, Customized Race American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Asian | 12 Participants | 22 Participants | 10 Participants |
| Race/Ethnicity, Customized Race Black or African American | 45 Participants | 96 Participants | 51 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or Other Pacific Islander | 3 Participants | 4 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Other | 4 Participants | 7 Participants | 3 Participants |
| Race/Ethnicity, Customized Race White | 123 Participants | 246 Participants | 123 Participants |
| Region of Enrollment United States | 187 Participants | 375 Participants | 188 Participants |
| SCORing Atopic Dermatitis (SCORAD) Index | 50.76 units on a scale STANDARD_DEVIATION 14 | 50.16 units on a scale STANDARD_DEVIATION 14.3 | 49.56 units on a scale STANDARD_DEVIATION 14.5 |
| Sex: Female, Male Female | 119 Participants | 243 Participants | 124 Participants |
| Sex: Female, Male Male | 68 Participants | 132 Participants | 64 Participants |
| Validated Investigator's Global Assessment scale for atopic dermatitis (vIGA-AD) Score Almost Clear (1) | 0 Participants | 2 Participants | 2 Participants |
| Validated Investigator's Global Assessment scale for atopic dermatitis (vIGA-AD) Score Mild (2) | 39 Participants | 77 Participants | 38 Participants |
| Validated Investigator's Global Assessment scale for atopic dermatitis (vIGA-AD) Score Moderate (3) | 105 Participants | 218 Participants | 113 Participants |
| Validated Investigator's Global Assessment scale for atopic dermatitis (vIGA-AD) Score Severe (4) | 26 Participants | 44 Participants | 18 Participants |
| Worst Itch Numeric Rating Scale (NRS) Score | 8.1 units on a scale STANDARD_DEVIATION 1.3 | 8.2 units on a scale STANDARD_DEVIATION 1.3 | 8.2 units on a scale STANDARD_DEVIATION 1.2 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 188 | 0 / 187 |
| other Total, other adverse events | 23 / 188 | 11 / 187 |
| serious Total, serious adverse events | 2 / 188 | 1 / 187 |
Outcome results
Primary
Reduction of Worst Itch in Atopic Dermatitis
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 \[0=No Itch, 10=Worst Itch Imaginable\].
Time frame: 8 weeks
Population: All participants randomized (1:1) to placebo or tradipitant.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tradipitant | Reduction of Worst Itch in Atopic Dermatitis | -3.6 units on a scale | Standard Deviation 2.8 |
| Placebo | Reduction of Worst Itch in Atopic Dermatitis | -3.5 units on a scale | Standard Deviation 2.75 |
Secondary
Improvement of Disease Severity in Atopic Dermatitis
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).
Time frame: 8 weeks
Population: All participants randomized (1:1) to placebo or tradipitant.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tradipitant | Improvement of Disease Severity in Atopic Dermatitis | 51 Participants |
| Placebo | Improvement of Disease Severity in Atopic Dermatitis | 54 Participants |
Secondary
Proportion of Patients With Improvement on Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of at Least 2-point Reduction
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.
Time frame: 8 weeks
Population: All participants randomized (1:1) to placebo or tradipitant.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tradipitant | Proportion of Patients With Improvement on Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of at Least 2-point Reduction | 37 Participants |
| Placebo | Proportion of Patients With Improvement on Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of at Least 2-point Reduction | 36 Participants |
Post Hoc
Reduction in Sleep Disturbances as Measured by SCORing Atopic Dermatitis Index, Adjusted for Investigator Global Assessment
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).
Time frame: 2 weeks
Population: Participants rated 1 or 2 by the IGA scale, randomized (1:1) to placebo or tradipitant.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Tradipitant | Reduction in Sleep Disturbances as Measured by SCORing Atopic Dermatitis Index, Adjusted for Investigator Global Assessment | -2.07 units on a scale |
| Placebo | Reduction in Sleep Disturbances as Measured by SCORing Atopic Dermatitis Index, Adjusted for Investigator Global Assessment | -0.7 units on a scale |
Post Hoc
Reduction of Worst Itch in Atopic Dermatitis as Measured by Numerical Rating Scale (NRS), Adjusted for Investigator Global Assessment (IGA)
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 \[0=No Itch, 10=Worst Itch Imaginable\].
Time frame: 2 weeks
Population: Participants rated 1 or 2 by the IGA, randomized (1:1) to placebo or tradipitant.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Tradipitant | Reduction of Worst Itch in Atopic Dermatitis as Measured by Numerical Rating Scale (NRS), Adjusted for Investigator Global Assessment (IGA) | -2.6 units on a scale |
| Placebo | Reduction of Worst Itch in Atopic Dermatitis as Measured by Numerical Rating Scale (NRS), Adjusted for Investigator Global Assessment (IGA) | -1.0 units on a scale |