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VLY-686

Phase 2

Treatment-resistant Pruritus Associated With Atopic Dermatitis | Small molecule | Immunology |Vanda Pharmaceuticals Inc.|Last Updated: Jun 11, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment69
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02004041Proof of Concept of VLY-686 in Subjects With Treatment-Resistant Pruritus Associated With Atopic DermatitisPHASE2 COMPLETED 69Dec 10, 2013Feb 19, 2015Jun 11, 20245 Germany
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Study Endpoints
Primary Endpoints
Change From Baseline to Endpoint (Day 28 or Early Termination) in Visual Analogue Scale (VAS) Pruritus 24 Hour Average Intensity.
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).

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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
VLY-686EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
VLY-686DRUG -
PlaceboDRUG -
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Men and women ages 18 - 65 years, inclusive; suffering from atopic dermatitis with a SCORAD index at inclusion ≤80; with atopic lesions on arms, legs, trunk and neck; * Chronic pruritus with pruritus being actively present for at least 6 weeks prior to screening; * Males, non-...

Countries:Germany
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