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Navarixin

Phase 2

Psoriasis | Small molecule | Immunology |Merck & Company, Inc.|Last Updated: Feb 5, 2019

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 Enrollment31
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00684593A Study to Assess the Clinical Effects of Navarixin in Participants With Psoriasis (MK-7123-009)PHASE2 COMPLETED 31Jun 1, 2007Oct 1, 2007Feb 5, 2019 -
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Study Endpoints
Primary Endpoints
Mean Percent Change From Baseline in the Psoriasis and Activity Severity Index (PASI) Score at Day 29
Baseline and Day 29

PASI score is a means to qualify the extent and severity of psoriatic lesions. The total score is calculated as the sum of the extent and severity of lesions on the head, arms, trunk, and legs and the score can range from 0 (no symptoms) to 72 (maximum symptoms).

Secondary Endpoints
Number of Participants by Physician's Assessment of Global Improvement (PGA) Score At Day 29
Day 29
Mean Maximum Plasma Concentration (Cmax) of Navarixin at Day 28
Day 28
Mean Area Under the Plasma Concentration-Time Curve From Time 0-24 Hours (AUC [0-24]) of Navarixin at Day 28
Day 28
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
NavarixinEXPERIMENTALNavarixin 30 mg administered orally once daily for 28 days.
PlaceboPLACEBO_COMPARATORMatching placebo to Navarixin administered orally once daily for 28 days.
Interventions
NameTypeDescription
Navarixin 10 mgDRUGNavarixin capsules orally, once daily for 28 days.
PlaceboOTHERMatching placebo capsules to Navarixin orally, once daily for 28 days.
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Body Mass Index (BMI) 19 to 34, BMI = weight (kg)/height (m\^2). * Must have a diagnosis of psoriasis vulgaris (PASI \>8) present for at least 1 year. Participants with an on-therapy PASI \<=8 at Screening may be considered for inclusion. Participants must be discussed with th...

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