Trial Outcomes & Findings for Tradipitant in Treatment-resistant Pruritus Associated With Atopic Dermatitis (NCT NCT02651714)

Last Updated: 2024-06-13

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

168 participants

Primary outcome timeframe

56 days

Results posted on

2024-06-13

Participant Flow

Participant milestones

Participant milestones
Measure	Tradipitant Oral Tradipitant	Placebo Oral Placebo
Overall Study STARTED	84	84
Overall Study COMPLETED	59	56
Overall Study NOT COMPLETED	25	28

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Tradipitant in Treatment-resistant Pruritus Associated With Atopic Dermatitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tradipitant n=84 Participants Oral Tradipitant	Placebo n=84 Participants Oral Placebo	Total n=168 Participants Total of all reporting groups
Age, Continuous	41.05 years STANDARD_DEVIATION 13.139 • n=99 Participants	39.13 years STANDARD_DEVIATION 13.568 • n=107 Participants	40.09 years STANDARD_DEVIATION 13.350 • n=206 Participants
Sex: Female, Male Female	52 Participants n=99 Participants	53 Participants n=107 Participants	105 Participants n=206 Participants
Sex: Female, Male Male	32 Participants n=99 Participants	31 Participants n=107 Participants	63 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	23 Participants n=99 Participants	21 Participants n=107 Participants	44 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	61 Participants n=99 Participants	63 Participants n=107 Participants	124 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race/Ethnicity, Customized White	49 Participants n=99 Participants	57 Participants n=107 Participants	106 Participants n=206 Participants
Race/Ethnicity, Customized Black or African American	24 Participants n=99 Participants	18 Participants n=107 Participants	42 Participants n=206 Participants
Race/Ethnicity, Customized Asian	6 Participants n=99 Participants	5 Participants n=107 Participants	11 Participants n=206 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	2 Participants n=99 Participants	0 Participants n=107 Participants	2 Participants n=206 Participants
Race/Ethnicity, Customized Other	3 Participants n=99 Participants	3 Participants n=107 Participants	6 Participants n=206 Participants
Region of Enrollment United States	84 Participants n=99 Participants	84 Participants n=107 Participants	168 Participants n=206 Participants
Average Pruritus VAS at Baseline	81.3 mm STANDARD_DEVIATION 10.78 • n=99 Participants	80.3 mm STANDARD_DEVIATION 8.68 • n=107 Participants	80.8 mm STANDARD_DEVIATION 9.77 • n=206 Participants

PRIMARY outcome

Timeframe: 56 days

Population: All participants randomized (1:1) to placebo or tradipitant.

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).

Outcome measures

Outcome measures
Measure	Tradipitant n=59 Participants Oral Tradipitant	Placebo n=55 Participants Oral Placebo
Mean Change From Baseline in Pruritus Symptoms, as Measured by the 24-hour Average Pruritus Visual Analogue Scale (VAS) Score	-41.5 score on a scale Standard Error 3.89	-35.8 score on a scale Standard Error 4.03

Adverse Events

Tradipitant

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Tradipitant n=83 participants at risk Oral Tradipitant	Placebo n=82 participants at risk Oral Placebo
Skin and subcutaneous tissue disorders Dermatitis atopic	4.8% 4/83 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 100 days) regardless of seriousness or relationship to investigational product.	11.0% 9/82 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 100 days) regardless of seriousness or relationship to investigational product.

Additional Information

Vanda Pharmaceuticals Inc.

Phone: 202-734-3400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER