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INCB009471

Phase 2

HIV Infections | Small molecule | Infectious Disease |Incyte Corporation|Last Updated: Mar 26, 2018

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 Enrollment45
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00393120Safety/Effectiveness of Oral Chemokine Coreceptor 5 (CCR5) Antagonist INCB009471 in R5-tropic HIV Infected PatientsPHASE2 COMPLETED 45 — — Oct 1, 2006Sep 1, 2007Mar 26, 20186 United States
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Study Endpoints
Primary Endpoints
Safety and tolerability will be assessed by monitoring adverse experiences.
Baseline, every 1-7 days following the initiation of treatment through Day 28 and then at Day 42 or the early study termination visit.
Secondary Endpoints
The virological response to INCB009471 as monotherapy will be assessed by measuring HIV-1 RNA levels by the Roche Amplicor HIV-1 Monitor® Test, v1.5 - Quantitative.
Baseline, Days 4, 7, 10, 14, 16, 20 and 28 or the early termination study visit.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Treatment A - INCB009471 100mg IREXPERIMENTALINCB009471, 100 mg IR orally once daily
Treatment B - INCB009471 300mg SREXPERIMENTALINCB009471, 300 mg SR orally once daily
Treatment C - PlaceboPLACEBO_COMPARATORPlacebo matching INCB009471
Interventions
NameTypeDescription
INCB009471DRUG100mg SR (sustained release) orally once daily
Placebo comparatorDRUGOrally once daily
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: Asymptomatic HIV-1 infected individuals that are treatmen naïve (ie less than 2 weeks prior ARV exposure) or treatment experienced subjects who are not currently on HAART and have not received any ARVs for 3 months prior to Screening. * Males between 18 years and 65 years of ag...

Countries:United States
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