Trial Outcomes & Findings for Proof of Concept of VLY-686 in Subjects With Treatment-Resistant Pruritus Associated With Atopic Dermatitis (NCT NCT02004041)

NCT ID: NCT02004041

Last Updated: 2024-06-11

Results Overview

Responses were measured on a 100-mm Visual Analogue Scale (VAS), where the left end point was marked "no itch" (0 mm) and in the right end point was marked "worst imaginable itch" (100 mm).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 69 participants
• Primary outcome timeframe: 28 days
• Results posted on: 2024-06-11

Participant Flow

Participant milestones

Measure	VLY-686 VLY-686	Placebo Placebo
Overall Study STARTED	34	35
Overall Study COMPLETED	30	31
Overall Study NOT COMPLETED	4	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Proof of Concept of VLY-686 in Subjects With Treatment-Resistant Pruritus Associated With Atopic Dermatitis

Baseline characteristics by cohort

Measure	VLY-686 n=34 Participants VLY-686	Placebo n=35 Participants Placebo	Total n=69 Participants Total of all reporting groups
Age, Continuous	36.6 years STANDARD_DEVIATION 15.6 • n=5 Participants	40.2 years STANDARD_DEVIATION 14.5 • n=7 Participants	38.4 years STANDARD_DEVIATION 15.1 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	21 Participants n=7 Participants	40 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	14 Participants n=7 Participants	29 Participants n=5 Participants
Region of Enrollment Germany	34 participants n=5 Participants	35 participants n=7 Participants	69 participants n=5 Participants
Pruritus 24 hours average intensity Visual Analogue Scale (VAS) at baseline	76.1 units on a scale STANDARD_DEVIATION 9.74 • n=5 Participants	77.2 units on a scale STANDARD_DEVIATION 10.87 • n=7 Participants	76.6 units on a scale STANDARD_DEVIATION 10.27 • n=5 Participants

PRIMARY outcome

Timeframe: 28 days

Responses were measured on a 100-mm Visual Analogue Scale (VAS), where the left end point was marked "no itch" (0 mm) and in the right end point was marked "worst imaginable itch" (100 mm).

Outcome measures

Measure	VLY-686 n=34 Participants VLY-686	Placebo n=33 Participants Placebo
Change From Baseline to Endpoint (Day 28 or Early Termination) in Visual Analogue Scale (VAS) Pruritus 24 Hour Average Intensity.	-40.5 mm Standard Error 5.30	-36.5 mm Standard Error 4.96

Adverse Events

VLY-686

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	VLY-686 n=34 participants at risk VLY-686	Placebo n=34 participants at risk Placebo
Gastrointestinal disorders Diarrhoea	0.00% 0/34 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 63 days) regardless of seriousness or relationship to investigational product.	5.9% 2/34 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 63 days) regardless of seriousness or relationship to investigational product.
General disorders Fatigue	14.7% 5/34 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 63 days) regardless of seriousness or relationship to investigational product.	5.9% 2/34 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 63 days) regardless of seriousness or relationship to investigational product.
Nervous system disorders Headache	11.8% 4/34 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 63 days) regardless of seriousness or relationship to investigational product.	5.9% 2/34 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 63 days) regardless of seriousness or relationship to investigational product.
Nervous system disorders Dizziness	5.9% 2/34 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 63 days) regardless of seriousness or relationship to investigational product.	0.00% 0/34 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 63 days) regardless of seriousness or relationship to investigational product.
Respiratory, thoracic and mediastinal disorders Nasopharyngitis	0.00% 0/34 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 63 days) regardless of seriousness or relationship to investigational product.	8.8% 3/34 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 63 days) regardless of seriousness or relationship to investigational product.
Skin and subcutaneous tissue disorders Dermatitis atopic	11.8% 4/34 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 63 days) regardless of seriousness or relationship to investigational product.	2.9% 1/34 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 63 days) regardless of seriousness or relationship to investigational product.
Skin and subcutaneous tissue disorders Skin burning sensation	0.00% 0/34 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 63 days) regardless of seriousness or relationship to investigational product.	5.9% 2/34 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 63 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