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

NCT ID: 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

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

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=5 Participants	39.13 years STANDARD_DEVIATION 13.568 • n=7 Participants	40.09 years STANDARD_DEVIATION 13.350 • n=5 Participants
Sex: Female, Male Female	52 Participants n=5 Participants	53 Participants n=7 Participants	105 Participants n=5 Participants
Sex: Female, Male Male	32 Participants n=5 Participants	31 Participants n=7 Participants	63 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	23 Participants n=5 Participants	21 Participants n=7 Participants	44 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	61 Participants n=5 Participants	63 Participants n=7 Participants	124 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized White	49 Participants n=5 Participants	57 Participants n=7 Participants	106 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	24 Participants n=5 Participants	18 Participants n=7 Participants	42 Participants n=5 Participants
Race/Ethnicity, Customized Asian	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Other	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment United States	84 Participants n=5 Participants	84 Participants n=7 Participants	168 Participants n=5 Participants
Average Pruritus VAS at Baseline	81.3 mm STANDARD_DEVIATION 10.78 • n=5 Participants	80.3 mm STANDARD_DEVIATION 8.68 • n=7 Participants	80.8 mm STANDARD_DEVIATION 9.77 • n=5 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

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

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.

Vanda Pharmaceuticals Inc.

Phone: 202-734-3400

Email: clinicaltrials@vandapharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER