Trial Outcomes & Findings for Evaluating the Effects of Tradipitant vs. Placebo in Atopic Dermatitis (EPIONE) (NCT NCT03568331)
NCT ID: NCT03568331
Last Updated: 2024-05-13
Results Overview
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 \[0=No Itch, 10=Worst Itch Imaginable\].
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
375 participants
Primary outcome timeframe
8 weeks
Results posted on
2024-05-13
Participant Flow
Participant milestones
| Measure |
Tradipitant
Tradipitant: Oral Capsule
|
Placebo
Placebo: Oral Capsule
|
|---|---|---|
|
Overall Study
STARTED
|
188
|
187
|
|
Overall Study
COMPLETED
|
142
|
144
|
|
Overall Study
NOT COMPLETED
|
46
|
43
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Number analyzed in row differs from overall due to availability of data.
Baseline characteristics by cohort
| Measure |
Tradipitant
n=188 Participants
Tradipitant: Oral Capsule
|
Placebo
n=187 Participants
Placebo: Oral Capsule
|
Total
n=375 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.7 years
STANDARD_DEVIATION 14.9 • n=188 Participants
|
41.9 years
STANDARD_DEVIATION 15.1 • n=187 Participants
|
41.8 years
STANDARD_DEVIATION 15.0 • n=375 Participants
|
|
Sex: Female, Male
Female
|
124 Participants
n=188 Participants
|
119 Participants
n=187 Participants
|
243 Participants
n=375 Participants
|
|
Sex: Female, Male
Male
|
64 Participants
n=188 Participants
|
68 Participants
n=187 Participants
|
132 Participants
n=375 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
42 Participants
n=188 Participants
|
46 Participants
n=187 Participants
|
88 Participants
n=375 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
144 Participants
n=188 Participants
|
140 Participants
n=187 Participants
|
284 Participants
n=375 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=188 Participants
|
1 Participants
n=187 Participants
|
3 Participants
n=375 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
0 Participants
n=188 Participants
|
0 Participants
n=187 Participants
|
0 Participants
n=375 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
10 Participants
n=188 Participants
|
12 Participants
n=187 Participants
|
22 Participants
n=375 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
51 Participants
n=188 Participants
|
45 Participants
n=187 Participants
|
96 Participants
n=375 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Other Pacific Islander
|
1 Participants
n=188 Participants
|
3 Participants
n=187 Participants
|
4 Participants
n=375 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
123 Participants
n=188 Participants
|
123 Participants
n=187 Participants
|
246 Participants
n=375 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
3 Participants
n=188 Participants
|
4 Participants
n=187 Participants
|
7 Participants
n=375 Participants
|
|
Region of Enrollment
United States
|
188 Participants
n=188 Participants
|
187 Participants
n=187 Participants
|
375 Participants
n=375 Participants
|
|
Worst Itch Numeric Rating Scale (NRS) Score
|
8.2 units on a scale
STANDARD_DEVIATION 1.2 • n=188 Participants
|
8.1 units on a scale
STANDARD_DEVIATION 1.3 • n=187 Participants
|
8.2 units on a scale
STANDARD_DEVIATION 1.3 • n=375 Participants
|
|
SCORing Atopic Dermatitis (SCORAD) Index
|
49.56 units on a scale
STANDARD_DEVIATION 14.5 • n=188 Participants
|
50.76 units on a scale
STANDARD_DEVIATION 14.0 • n=187 Participants
|
50.16 units on a scale
STANDARD_DEVIATION 14.3 • n=375 Participants
|
|
Validated Investigator's Global Assessment scale for atopic dermatitis (vIGA-AD) Score
Almost Clear (1)
|
2 Participants
n=171 Participants • Number analyzed in row differs from overall due to availability of data.
|
0 Participants
n=170 Participants • Number analyzed in row differs from overall due to availability of data.
|
2 Participants
n=341 Participants • Number analyzed in row differs from overall due to availability of data.
|
|
Validated Investigator's Global Assessment scale for atopic dermatitis (vIGA-AD) Score
Mild (2)
|
38 Participants
n=171 Participants • Number analyzed in row differs from overall due to availability of data.
|
39 Participants
n=170 Participants • Number analyzed in row differs from overall due to availability of data.
|
77 Participants
n=341 Participants • Number analyzed in row differs from overall due to availability of data.
|
|
Validated Investigator's Global Assessment scale for atopic dermatitis (vIGA-AD) Score
Moderate (3)
|
113 Participants
n=171 Participants • Number analyzed in row differs from overall due to availability of data.
|
105 Participants
n=170 Participants • Number analyzed in row differs from overall due to availability of data.
|
218 Participants
n=341 Participants • Number analyzed in row differs from overall due to availability of data.
|
|
Validated Investigator's Global Assessment scale for atopic dermatitis (vIGA-AD) Score
Severe (4)
|
18 Participants
n=171 Participants • Number analyzed in row differs from overall due to availability of data.
|
26 Participants
n=170 Participants • Number analyzed in row differs from overall due to availability of data.
|
44 Participants
n=341 Participants • Number analyzed in row differs from overall due to availability of data.
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: All participants randomized (1:1) to placebo or tradipitant.
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 \[0=No Itch, 10=Worst Itch Imaginable\].
Outcome measures
| Measure |
Tradipitant
n=171 Participants
Tradipitant: Oral Capsule
|
Placebo
n=170 Participants
Placebo: Oral Capsule
|
|---|---|---|
|
Reduction of Worst Itch in Atopic Dermatitis
|
-3.6 units on a scale
Standard Deviation 2.8
|
-3.5 units on a scale
Standard Deviation 2.75
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: All participants randomized (1:1) to placebo or tradipitant.
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).
Outcome measures
| Measure |
Tradipitant
n=171 Participants
Tradipitant: Oral Capsule
|
Placebo
n=170 Participants
Placebo: Oral Capsule
|
|---|---|---|
|
Improvement of Disease Severity in Atopic Dermatitis
|
51 Participants
|
54 Participants
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: All participants randomized (1:1) to placebo or tradipitant.
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.
Outcome measures
| Measure |
Tradipitant
n=171 Participants
Tradipitant: Oral Capsule
|
Placebo
n=170 Participants
Placebo: Oral Capsule
|
|---|---|---|
|
Proportion of Patients With Improvement on Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of at Least 2-point Reduction
|
37 Participants
|
36 Participants
|
POST_HOC outcome
Timeframe: 2 weeksPopulation: Participants rated 1 or 2 by the IGA, randomized (1:1) to placebo or tradipitant.
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 \[0=No Itch, 10=Worst Itch Imaginable\].
Outcome measures
| Measure |
Tradipitant
n=40 Participants
Tradipitant: Oral Capsule
|
Placebo
n=39 Participants
Placebo: Oral Capsule
|
|---|---|---|
|
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
Interval -3.2 to -2.0
|
-1.0 units on a scale
Interval -1.6 to -0.4
|
POST_HOC outcome
Timeframe: 2 weeksPopulation: Participants rated 1 or 2 by the IGA scale, randomized (1:1) to placebo or tradipitant.
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).
Outcome measures
| Measure |
Tradipitant
n=40 Participants
Tradipitant: Oral Capsule
|
Placebo
n=39 Participants
Placebo: Oral Capsule
|
|---|---|---|
|
Reduction in Sleep Disturbances as Measured by SCORing Atopic Dermatitis Index, Adjusted for Investigator Global Assessment
|
-2.07 units on a scale
Interval -2.61 to -1.53
|
-0.7 units on a scale
Interval -1.24 to -0.15
|
Adverse Events
Tradipitant
Serious events: 2 serious events
Other events: 23 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tradipitant
n=188 participants at risk
Tradipitant: Oral Capsule
|
Placebo
n=187 participants at risk
Placebo: Oral Capsule
|
|---|---|---|
|
Infections and infestations
Extradural abscess
|
0.00%
0/188 • 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.
|
0.53%
1/187 • Number of events 1 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
0.53%
1/188 • Number of events 1 • 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.
|
0.00%
0/187 • 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.
|
|
Skin and subcutaneous tissue disorders
Dyshidrotic eczema
|
0.53%
1/188 • Number of events 1 • 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.
|
0.00%
0/187 • 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.
|
Other adverse events
| Measure |
Tradipitant
n=188 participants at risk
Tradipitant: Oral Capsule
|
Placebo
n=187 participants at risk
Placebo: Oral Capsule
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
3.7%
7/188 • Number of events 7 • 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.
|
2.1%
4/187 • Number of events 4 • 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.
|
|
Nervous system disorders
Headache
|
3.7%
7/188 • Number of events 7 • 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.
|
2.7%
5/187 • Number of events 5 • 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.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
2.1%
4/188 • Number of events 4 • 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.
|
0.53%
1/187 • Number of events 1 • 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.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.7%
5/188 • Number of events 5 • 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.
|
0.53%
1/187 • Number of events 1 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI is restricted from presenting or publishing independently until the expiration of eighteen (18) months from the completion of the Clinical Trial or as otherwise noted in the Investigator's clinical trial agreement.
- Publication restrictions are in place
Restriction type: OTHER